Pilot of the HAI / MeTA Tool MEDICINES PROMOTION...

Pilot of the HAI / MeTA Tool

MEDICINES PROMOTION: ASSESSING THE NATURE, EXTENT AND IMPACT OF

REGULATION IN THE PHILIPPINES

CONSULTANT’S REPORT

Prepared By Katherine Ann V. Reyes, MD, MPP

ii

Table of Contents

ACRONYMS ...................................................................................................................................................... III

1.0 BACKGROUND ....................................................................................................................................... 1

2.0 OBJECTIVE .............................................................................................................................................. 2

3.0 METHODOLOGY ................................................................................................................................... 2

4.0 RESULTS .................................................................................................................................................. 4 4.1. NATURE AND SCOPE OF REGULATION .................................................................................................................... 4 4.2. REGULATORY BODY: THE FOOD AND DRUG ADMINISTRATION ................................................................... 21 4.3 MONITORING ...................................................................................................................................................... 25 4.4 ENFORCEMENT ................................................................................................................................................... 27 4.5. RELATIONSHIP BETWEEN THE DIFFERENT BODIES / DEPARTMENTS INVOLVED IN MEDICINES

PROMOTION REGULATION ............................................................................................................................................. 30 4.6. DISCLOSURE OF BUDGET FOR PROMOTION AND ADVERTISING ..................................................................... 30 4.7 REGULATION OF GENERIC SUBSTITUTION (SUBSTITUTION BY PHARMACISTS) ........................................... 30 4.8 REGULATION OF PRESCRIBING PRACTICES ....................................................................................................... 31 4.9 PROVISION OF INDEPENDENT, NON-PROMOTIONAL INFORMATION ON MEDICINES ................................... 32

5.0 DISCUSSION .......................................................................................................................................... 33 5.1 NATURE OF REGULATION .................................................................................................................................. 35 5.2 IMPORTANCE OF STRONG AND EFFECTIVE GOVERNMENT REGULATION ...................................................... 40 5.3 IMPACT AND EFFECTIVENESS OF REGULATION ............................................................................................. 41 5.4 THE USE OF THE HAI/META TOOL AS A WAY TO INVESTIGATE THE REGULATORY FRAMEWORK ........... 42

6.0 CONCLUSION ........................................................................................................................................ 42

7.0 REFERENCES ........................................................................................................................................ 43

ANNEX A1. INTERVIEW SCHEDULE: KEY INFORMANT FROM DRUG REGULATORY AUTHORITIES ................................................................................................................................................. 46

ANNEX A2. INTERVIEW SCHEDULE: HEALTHCARE PROFESSIONAL INFORMANT ................. 51

ANNEX A3. INTERVIEW SCHEDULE: PHARMACEUTICAL INDUSTRY, THE INSURERS, AND THE MEDIA ...................................................................................................................................................... 55

ANNEX A4. INTERVIEW SCHEDULE: CIVIL SOCIETY ORGANIZATION OR PATIENT GROUP OR WHO COUNTRY OFFICE ........................................................................................................................ 59

ANNEX B. INVENTORY OF DOCUMENTS REVIEWED WITH PROVISIONS ON REGULATING MEDICINE PROMOTION .............................................................................................................................. 63

ANNEX C. DOCUMENT CHECKLIST .......................................................................................................... 66

ANNEX D. DATA COMPILATION TOOL ................................................................................................... 74

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Acronyms

AdBoard Advertising Board

AO Administrative Order

APEC Asia Pacific Economic Cooperation

ASC Ads Standards Council

BFAD Bureau of Food and Drugs

CDRR Center for Drug Regulation & Research

CME Continuing Medical Education

CPE Continuing Pharmacy Education

DOH Department of Health

EO Executive Order

FDA Food and Drugs Administration

GMP Good manufacturing practice

HAI Health Alliance International

IFPMA International Federation of Pharmaceutical Manufacturers and Associations

KII Key Informant Interview

MeTA Medicines Transparency Alliance

MNC Multi national company

OTC Over-the-counter

PCPI Philippine Chamber of Pharmaceutical Industries

PHAP Pharmaceutical & Healthcare Association of the Philippines

PMA Philippine Medical Association

RA Republic Act

RFO Regional Field Office

WHO World Health Organization

1

1.0 BACKGROUND Medicines are important in the management of diseases. Its beneficial use is optimized when patients consume drugs with appropriate composition, dose, timing, and with the least possible cost. Since rational use of drugs could be a function of physicians’ prescribing behavior and patient compliance, it is important that physicians, pharmacists and patients receive information about medicines that is accurate, unbiased, and with clear description of risks and benefits.

However, without a consistent, reliable and accessible source of independent and non-promotional information on medicines, health care providers and consumers tend to utilize the much readily available information from the pharmaceutical industry. The industry though is inherently conflicted between the health goal of producing medicines and the business goal of achieving profits. This creates a case for government to regulate information about medicinal drugs that get passed on to prescribers, dispensers and consumers. The neo-classical view sees regulation in health care as necessary when the public needs to be protected from failures of the market1, such as in the case of information asymmetry between companies that promote their medicines and the prospective consumers. A broader perspective would posit that the need to regulate is justified so that equity and protection of health rights is achieved by changing patterns of medicine consumption towards rational use.2 There is a public health responsibility to protect health consumers that could lead to irrational drug use especially that Philippine households direct 40% of their expenditure on medicine. 3 Both perspectives suggest that regulation aims to serve both economic (e.g., curb wasteful purchases) and social (e.g., appropriate behavior supportive of rational drug use) purposes. Regulatory architecture governing promotion of medicinal drugs may differ between countries. The World Health Organization (WHO) Ethical Criteria for Medical Drug Promotion (1998) provides a general guide on the scope of regulation for governments to consider. According to local institutional capacity, political and cultural environment, countries could then decide on the scope of regulation, how to implement it, and how to enforce the terms of regulation. Apart from government, relevant stakeholders such as the pharmaceutical companies, professional organization, general media and consumer groups are encouraged to adopt voluntary system of ensuring compliant medicinal drug promotional and advertising activities. An effective regulation of medicinal drug promotion is expected to impact on rational use of medicines. In the recent years, leaders of the Asia Pacific Economic Cooperation (APEC) agreed to support The Mexico City Principles for Voluntary Codes of Business Ethics in the Pharmaceutical Sector that aims to

1 Marc Roberts, et al. (2004). Introduction to Health Care Regulations IN: International Comparative Review of

Health Care Regulatory Systems. New York: Oxford University Press, Inc. 2 Kabir Sheikh, Prasanna Saligram, and Lakshmi E. Prassad. 2013. Mapping the regulatory architecture of for

health care delivery in mixed health systems in low-and middle-income countries. Melbourne, Australia: Nossal Institute for Global Health 3 National Statistics Office (2009). Family Income Expenditure Survey 2009

2

strengthen ethical practice by pharmaceutical companies with respect to their interaction with health care professionals. In 2013 the Philippine Food and Drugs Administration (FDA) adopted this Principle. Medicines Transparency Alliance (MeTA), a multi-sectoral collaboration working to improve access to medicines conducted two relevant local initiatives in 2010 that focused on medicines promotion. A multi-stakeholders workshop on ethical drug promotion and marketing was held. This was complemented by a commissioned study, “Survey of Promotional Practices in the Philippine Pharmaceutical Industry”. Both provided input to the succeeding efforts on defining the boundaries of drug promotion in the Philippines. An acceptable scenario would have any form of promotional activity that will not impact negatively on rational drug use. Having the industry stakeholders adopt a code of practice consistent with the Mexico City Principles would be good; achieving a strong, relevant, effective, and efficient government regulatory framework would be better. As such, the question that needs to be answered in the area of medicines promotion in the Philippines is this: What is the appropriate mode and mechanism of regulating the promotion of medicinal products such that rational drug use is protected?

2.0 OBJECTIVE The general objective of this study is to develop country-specific policy recommendations on medicines promotion to ensure adequate and effective regulation that will promote rational drug use. To achieve this objective, this study aims to specifically: 1. Provide a detailed overview of the current regulatory structure for medicines

promotion in the Philippines; 2. Assess the effectiveness of pharmaceutical promotions regulations and

recommend measures to improve implementation and enforcement;

3. Identify gaps in the medicines regulatory framework which need to be addressed; and

4. Assess the effectiveness of the HAI/MeTA methodology as a tool to

determine the scope of medicines regulation and enforcement mechanisms in the country setting.

3.0 METHODOLOGY The scope of Philippine’s regulatory framework on medicinal drug promotion was assessed through a thorough literature search. Literature search yield was

3

systematically catalogued using the “Document Checklist”, a tool developed by Health Alliance International (HAI) / Medicine Transparency Alliance (MeTA). 4 A complementary “Data Compilation” tool provided a more detailed structure of mapping out four aspects of the regulatory framework: scope of regulation, the body/ies responsible for issuing the regulation, the body/ies in-charge of monitoring regulation and finally, the body/ies tasked to enforce regulation. This tool complements the structure and principles highlighted in the WHO Ethical Criteria for Medicinal Drugs Promotion that serves as the international guide for pharmaceutical promotion. In the review of literature, examples of existing forms of unethical promotion occurring in the country were likewise identified. According to evidence gathered, the manner by which these practices breach legislation or codes of practice will be described. A series of semi-structured key informant interviews were conducted over a 4-week period to confirm findings and fill information gaps that were not collected from existing documents / literature. Using a tool designed by HAI/MeTA, the interview schedule was also intended validated the information gathered from literature (Annexes A1 to A4). Perceptions of key stakeholders on the state of medicinal drug regulation in the country were elicited. The personalities interviewed were to cover three broad categories of stakeholders: drug regulatory authorities, healthcare professionals, and civil society/patient group/WHO country office. The interview was conducted over a period of four weeks in which a total of 22 respondents were able to fully participate. The rest either decided that they are not an appropriate key informant, a few could not set a schedule during the study period, while the rest could not participate in the interview.

Government Four respondents representing different roles and functions in the regulatory body

All target respondents were interviewed face-to-face

Industry Self-Regulatory Body

Three respondents from a research-based industry association with recognized self-regulatory mechanism and two from a local industry association with beginning steps towards self-regulation

Two target respondents were interviewed face-to-face, two responded via email

One respondent represented a target respondent who was not available during the time of interview

Professional Association

Two out of three professional associations invited were able to participate; One respondent was the actual person invited while the other one was a representative

One professional association that was invited did not have any free schedule during the duration of the interviews

Research-Based

One of the two target key informant was able to participate in the face to face interview while the other did not have time or

4 MeTA and HAI. Medicines Promotion: Assessing the Nature, Extent and Impact of Regulation. Report and

Preliminary Methodology for Pilot-testing.

4

Industry schedule during the interview phase

Local Industry One representative form a local industry was able to participate in a face-to-face interview

International distributor

The target respondent was interviewed face-to-face

Local retailer / Distributor

Three out of five key respondents were interviewed face-to-face

One of those who were not able to answer assessed that they are not the best informant while the other one did not want to participate

Insurance The target respondent was not available during the day of the interview; representative was able to discuss briefly to say that their agency does not have much participation when it comes to regulation of medicine promotion

The plan to send an email response within the study period did not materialize

Civil Society Organization

Of the five CSOs invited, four were able to do the face-to-face interview. The fourth one was initially able to schedule but this did not materialize

Patient Group The sole target respondent was able to participate in a face-to-face interview

Alliance The target respondent was able to accommodate a face-to-face interview

Advertising Group

The initial target group was reached by phone and email in which they decided that they are not the best respondent and the investigator was referred to colleagues

Succeeding exchanges did not yield substantial and specific content relevant to medicines promotion

Majority of the interviews were conducted in a face-to-face meeting in a venue most convenient to the respondent. Each interview lasted between one hour to one hour and a half. Informants who were interested to participate but for some reason could not do the face-to-face interview answered the questionnaires and submitted the completed form via email.

4.0 RESULTS

4.1. Nature and Scope of Regulation Having clearly written regulatory instruments is important in defining the scope of regulation. How the scope describes the legal structures serves as the foundation of drug regulation framework in a given country. Globally, there are benchmarks designed by assembly of experts, but these are not legally binding.

5

WHO Ethical Criteria for Medicinal Drug Promotion (1988)5 The World Health Assembly brought forth a recommended framework towards ethical medical drug promotion, with the overall aim to uphold rational medical drug use. The general principles presented by the document can serve as a guide, with no assumption of legal obligations from member countries, with the understanding that nations may require different mechanisms for regulation to work. Further, the ethical criteria are to be applied for prescription and non-prescription drugs, traditional medicines and all products that are marketed as medicine. Philippines subscribes to this guideline.

Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector (2011)6

Six principles were set to guide relationships of pharmaceutical companies with healthcare professionals and other stakeholders. It is urged that these interactions remain ethical so that patients benefit from best decisions made. Very recently, the country adapted this Code as a national guide for the pharmaceutical industry to follow.7

International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice (2012)8

The Code of Practice has eight guiding principles that are expounded in the document. This Code applies to all IFPMA members and is used to ensure the ethical promotion, selling and distribution of medicinal drug products. There is particular focus on managing the interactions between the pharmaceutical companies and different stakeholders.

Facets of regulating the promotion of medicines are found in several instrumentalities - legislative acts on health, in the national medicines policy, and in the country’s consumer act. Annex B has the full list. Complementary are two published voluntary codes that of the Pharmaceutical and Healthcare Association of the Philippines (PHAP) directed to its 46 member companies plus the local subsidiaries of IFPMA member companies and the Philippine Medical Association (PMA), which is designed for member doctors.

5 WHO (1988). Ethical criteria for medicinal drug promotion

6 APEC (2011). The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical

Sector 7 FDA (2013). Circular No 2013-024 Adoption and Implementation of “The Mexico City Principles for Voluntary

Codes of Business Ethics in the Biopharmaceutical Sector. 8 IFPMA (2012). IFPMA Code of Practice

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Table 1.a. Mapping of regulatory provisions referring to regulation of medicines promotion in the Philippines

- mentioned; ☐ - not mentioned

Scope of Regulation (HAI/MeTA Tool)

WHO Ethical Criteria for Medicinal Drug

Promotion (1988)

The Mexico City Principles

Philippine Legal Provision

Pharmaceutical and Healthcare Association

of the Philippines

Philippine Medical Association

“Advertisement” is defined

☐ ☐ BFAD Regulation 5

1987 s1.a

DOH AO 65 1989 s1.1

Consumer Act of the Philippines 1991 Art 4.b

Definition, Appendix

☐

“Promotion” is defined ☐ BFAD Regulation 5

1987 s1.b

DOH AO 65 1989 s1.2

Consumer Act of the Philippines 1991 Art

1.bm

Definition, Appendix

☐

Provisions on promotion/advertisement is specified

Section 2.A, Section

2.B

BFAD Regulation 5

1987 s2

Generics Act of 1988. Section 2 & 4

DOH AO 65 1989 s2.2


Title III, Art 48, Art 50, Title III, Chapter IV, Art 74, Art 86, Art 108, Art

112

Guiding Principle, 2.4,

2.5, 2.7.1, 2.8

☐

7

DOH DC 2011-0101, Article V Section 2

FDA Circular 2013-024,

Objectives

Traditional and complementary medicines are covered in a specific way

☐ EO 174 1987 s3

EO 175 1987 s5

DOH AO 65 1989 s1


4.ad

Food, Drug and Cosmetic Act Amended

1992, Section 10

FDA Act 2009 Section 10.f

DOH DC 2011-0101

1.1

☐

Compliance with an approved product information / label

☐ DOH AO 65 1989 s3.1

2.1

☐

Specific provisions for medicines that are banned from advertising

☐ EO 175 1987 s7

DOH AO 65 1989 s2.1

Food, Drug and

Cosmetic Act Amended 1992, Section 11,

Chapter VI, Section 21

2.3.1

☐

8

FDA Act 2009 Section

11

Scope of advertising to the general public defined according to the category of medicine and media channel

☐ BFAD Regulation 5

1987 s4 and s5

Generics Act of 1988, Section 6.c

DOH AO 51 s1988 14.1

and 14.3

DOH AO 65 1989 s2.3

4.8, 16.1 to 16.10

☐

Scope of advertising to health professionals defined according to the category of medicine and the media channel

☐ DOH AO 51 s1988 15

DOH AO 65 1989 s2.3

4.1, 4.2, 4.4

☐

Information included in an advertisement specified including the media channel

Preamble 5

Generics Act of 1988, Section 2, 4, and 6.b

DOH AO 65 1989 s3.1,

3.2, 3.3, 3.4

MO 133

2.3, 3.1, 3.2

☐

Similar requirements for advertising between exported and imported medicines and locally produced medicines

☐ ☐ ☐ ☐

Set minimal qualifications for pharmaceutical representatives

Section 12.A.1

DOH A0 65 1989 s2.4

8.1 to 8.5

☐

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Using the HAI/MeTA Tool, mapping the legislative provisions from the documents reviewed (Table 1.a) shows that except for a specific guidance on parameters for promoting domestic and exported medicine products, most of the WHO recommended general scope of regulation are covered in various legal issuances. The same can be said by the voluntary code of the PHAP. Although this review was able to identify corresponding elements between the WHO Guideline and local legislative instrument, a closer examination would should that the actual content were not exactly equivalent. Protecting the Filipinos’ right to health is enshrined in the Philippine 1987 constitution, and the necessity to instill health consciousness among the people is a recognized step to achieve this goal.9 Thus, it warrants that interventions that could help patients decide appropriately for their health must be well supported.

Defining advertisement and promotion Promotion and advertisement were clearly defined in legal documents. The “Consumer Act of the Philippines”10, a piece of legislature providing coverage for general consumers, spelled out a detailed operational definition of both activities. In comparison, “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988”11 by Department of Health (DOH) and Bureau of Food and Drugs (BFAD)’s Guidelines on Advertisement and Promotions of Prescription Pharmaceutical Products12 tailored their definition to cover pharmaceutical products (Note: BFAD is the former name of the FDA). PHAP Code of Practice also contextualized the definition with reference to pharmaceutical products.13

Specific provisions concerning medicines promotion / advertisement According to the WHO guideline, promotion and advertising activities must be within the country’s legal regulation framework. The information it contains should be accurate, not misleading and fair. The “Generics Act of 1988”14 is a landmark decree such that it sets the parameter to require the use of generic terminology to advertising and promotion. This policy emphasizes the use of scientifically sound utilization of medicines and highlighting the role of using generic names in the value chain leading to the dispensing of drugs. Further, the legislation gives weight to promoting generics that are in the country’s Essential Drug List. A follow-up issuance by the DOH “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988”15 stipulated the necessity of approval from the then BFAD for claims made in advertising and promotion. Therapeutic claims must be backed up with very strong evidence and should be limited only for indications approved by BFAD.

9 Philippine 1987 Constitution, Article II Section 15

10 Republic Act 7394, Article 4.b and Article 1.bm

11 DOH Administrative Order No 65 s 1989, Section 1.1 and 1.2

12 BFAD Regulation No. 5 s 1987, Section 1.a

13 PHAP, Appendix

14 Republic Act 6675, Sections 2 and 4

15 DOH AO 65 s 1989, Sections 2.1 and 2.2

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Very recently, DOH through FDA announced that Philippines will be officially and adapting the “Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector”. This Code communicates the importance of upholding professionalism and high ethical standards in the conduct of business between the pharmaceutical industry and health professionals as well as the regulatory body.16 According to the Code, a country’s regulatory agency must approve a medical product for marketing before the medicine can be marketed. This approval must also be consistent with a locally approved product information label. Consistent with the WHO guidelines, the Code prescribes that any information used in promotion must be clear, legible, accurate, balanced, fair, objective and sufficiently complete so that health professionals can make informed decision.17 Complementing the above health laws are provisions in “The Consumer Act of the Philippines” 18 that offers a general protection against “deceptive, unfair, and unconscionable sales acts or practices”, misleading advertisement and fraudulent sales and promotion practices. Covered in this act is compelling business to comply with proper product labeling, which includes food, drugs, cosmetics and devices. Provisions of the “Generics Act” will apply in the labeling of drugs. There are likewise specific requirements for advertising drug products, emphasizing on the role of approving department as the standard by which violations will be measured against. The guideline of PHAP Code of Practice is silent about the use of generics but did include provision on ethical, accurate and balanced promotion. Their members are urged to conform to acceptable standards in the country.19 While there are laws already in place generally describing the guidance for advertising medicines, FDA confirms during the interview that current advertisements appeal to viewers with claims that may seem believable but are actually incomplete and exaggerated. Respondents from the professional societies, industry, civil society organizations (CSOs), and patient group affirm this observation that advertisements are biased and generally not helpful at all in making rational choice in medicine use.

Range of regulation: products that are included, products that are banned, dealing with off-label use, and dealing with domestic- and export-sourced drugs

Medicinal drug defined - Earlier presidential issuances that contributed to the National Drug Policy and the Food and Drugs Cosmetics Act anchored its definition of what are considered as drugs from the US Formulary: “(1) articles recognized in the current official United States Pharmacopoeia or the United States Official National Formulary (ISP-NF), official Homeopathic Pharmacopoeia of the United States, official National Drug Formulary, or any supplement to any of them; and (2) articles intended for use in the prevention of disease in man or animals; (3) articles

16

FDA Circular No 2013-024 Objectives and Rationale 17

APEC (2013). The Mexico City Principles, Section 2.A and Section 2.B 18

RA 7394, Title III, Article 48, Article 50, Title III Chapter IV, Article 74, Article 86, Article 108, 112 19

PHAP Guiding Principle, Section 2.4, Section 2.5, Section 2.7.1, Section 2.8

11

(other than food) intended to affect the structure or function of the body of man or animals; and articles intended for use as a component of any articles specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories)”.20,21 The definition was later on localized to recognize the adoption and recognition of Philippine Food and Drug Administration. 22 Further, the terminology is elaborated in “Guidelines on Advertisement and Promotions to Implement the Generics Act” 23 as being applicable to pharmaceutical products, prescription or ethical drugs, and non-prescription drugs/over the counter drugs. This definition is expanded in “The Consumers Act of the Philippines” to cover herbal and or traditional drugs.24 The Consumer Act of the Philippines provided a wider scope of what can be considered as ‘medicine product’ and therefore whose promotion must be covered under the law. Yet, as concurred by all KII respondents, the boundaries appear to be blurred with regards to traditional products that carry the disclaimer “No Approved Therapeutic Claims”. Prohibitions in advertising and promotion - It is a fundamental requirement for products to first be registered by BFAD before it could be advertised or promoted.25,26,27 DOH also prohibits the mass media advertisement or promotion of products classified by BFAD as prescription or ethical drugs. 28 Misbranded and adulterated drugs must not also be advertised.29,30 PHAP supports the prohibition of promotion for products that are not registered by the FDA.31 Off-label use – There is no specific legal item that regulates off-label use. PHAP on the other hand does not recommend the promotion of products on indications that are not included in their registered indications.32 The common practice is to generally support the non-marketing/non-promotion of off-label indication even if there is no specific law prohibiting it. KII result concurs this. Off-label use however is sometimes practiced at the discretion of the prescriber. Requirements for exported and imported goods relative to locally produced medicines – No definite guidance on the boundaries of promotion for exported goods is found among the existing legislative instruments. None among the KII respondents were also able to identify otherwise.

20

Executive Order Numbers 174 and 175 Section 3 21

RA 3720 Section 10 22

RA 9711 Section 10.f 23

DOH AO 65 s1989 Section 1 24

RA 7394 Article 4.ad 25

DOH AO 65 s1989 Section 2.1 26

Executive Order 175 Section 7 27

RA 3720 Chapter VI, j 28

DOH AO 65 s 1989 Section 3.3 29

RA 3720, Section 11 30


PHAP Section 2.3.1 32

PHAP 2.3.1

12

Advertising compliance with approved product information level

WHO’s Guideline suggests consistency of advertising and promotional content with approved data sheet that is scientific and accurate. A prominent directive for advertising and promotional materials in all media type to prominently feature the generic name of drug products is spelled out the DOH’s “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988”.33 PHAP’s Code of Practice strongly emphasizes the responsibility and accountability of companies in ensuring that claims must be supported by Product Information, literature and Data on File.34

Information included in advertising and media type specification Dissemination of accurate information on drugs and medicines to physicians and public is encouraged under the National Drug Policy.35 The Mexico City Principles urge companies to be responsible for information that are provided to medical professionals. Information must be objective, accurate, and balanced.36 The legal coverage of inclusion of information on generics is provided by the “Generics Act of 1988”.37 The use of generics is required in marketing, advertising and promotion activities. There is also specific emphasis to promote generics that are included in the Essential Drug List. The requirement to make generic labels prominent covers print, visual, or auditory media.38 PHAP Code of Practice provided a wider scope on this clause.39 It upholds that information, claims and graphical representations be current, accurate, balanced and not misleading, with full or abridged product disclosure be made available.

Advertising to the general public The “Generics Act of 1988” strongly urge traditional and non-traditional drug outlets to inform their buyers about drugs having the same generic name, through verbal communication and by means of visible posters in their establishments.40 From the DOH Central Office, the Public Information and Health Education Service was tasked to produce and disseminate informational materials so that the public is made aware about the use of generic drugs.41 All stakeholders, especially the distributor of pharmaceutical products agree that acceptance of generics has improved since the formal passage of the law. In a closer look however, much still needs to be done to change the perception of generics being labeled as ‘cheap’ when what the government really intends to convey is accessibility / affordability and quality.

33

DOH AO 65 s 1989 Section 3.1 34

PHAP Section 2.1 35

Memorandum Order No 133 36

APEC (2013) The Mexico City Principles Preamble 5 37

RA 6675 Section 2, Section 4, Section 6.b) 38

DOH AO 65 1989 s 3.1 39

PHAP 2.3, 3.1, and 3.2 40

RA 6675 Section 6.c) 41

DOH AO 52 s 1988 “Implementing Guidelines for Department of Health Compliance with RA 6675” Section 14.1 and 14.3

13

Over-the-counter (OTC) drugs can be advertised to the public but there is no clear legal guideline. Self-regulating PHAP does not also overstep into regulating OTC advertisement of their member companies. FDA, CSOs and patient group are particularly concerned how the lack of defined boundaries for OTC advertising could result to possible misuse by the public. For instance, there are medicines that are classified OTC in lower doses but will already require a prescription when used in higher doses. Other vulnerabilities suggested by stakeholders in the KIIs are the conduct of disease awareness campaigns as well as the creative ways that marketing strategists are launching products in the market. Among the drug classifications, prescription and ethical drugs could not be advertised in any form to the general public.42 PHAP likewise disallows lay media advertising for prescription products. 43 Any promotion efforts must encourage health-seeking behavior to appropriate healthcare professional.

Advertising to health professionals

In implementing the Generics Law, a DOH implementing guideline directed the Head Agencies particularly their respective Therapeutics Committees to conduct promotional activities on the use of generics, directed to DOH personnel, especially physicians and nurses.44 Ethical and prescription drugs may be advertised and promoted to medical and allied professions through marketing collaterals that are directed to this population segment.45 Advertising to healthcare professionals through medical journals must contain the prescribed disclosure of information about the drug, as recommended by PHAP.46 The same should apply for advertisement in MIMS, company commissioned articles, and even for short advertisements.

Additional note on advertisements generated from foreign sources Due to technological advancement that enables information to flow from different sources, advertising and promotional activities that involved medicines can find channels in non-traditional conduits. KII respondents from the FDA, professional societies, CSOs, and patient group agreed that this type of information is passed on through internet, cable television, foreign-sourced magazines and similar platforms. Typically, it will be the mid- to higher-income group as well as educated individuals who will have access to such information sources. Unless otherwise proven by technical investigation, there is a general comment that foreign-sourced information on medicine, especially those coming from the United States tend to be objective and compliant with requirements compared to locally produced advertisements.

42

DOH AO 65 Section 3.3 43

PHAP 4.8 and 16.1-16.10 44

DOH AO 51 series of 1988 “Implementing Guidelines for Department of Health Compliance with Republic Act 6675, Section 15 45

DOH AO 65 series 1989, Section 3.3 46

PHAP 4.1

14

Requirement for Pharmaceutical Sales Representatives

By adopting the Mexico City Principles, FDA is keen to see that all pharmaceutical representatives who interact with healthcare professionals be trained about related regulatory laws. It is the responsibility of the Companies to ensure adequate training for their representatives.47 Characteristics of good pharmaceutical sales representative were described in the PHAP Code of Practice. 48 They must have adequate training to represent the products in accurately through current and balanced information. Representatives are expected to observe ethical practice by conforming to industry codes and institutional regulations. In practice however, the weak guidance on the qualification, skills and conduct of medical representatives may be the cause of what stakeholders would regard as unprofessionalism. Pharmaceutical sales representatives are expected to be able to convey objectively information about the medicines that they sell but this is not often the case. Going further in this review, legal articles that pertain to specific promotional activities were plotted according to the HAI/MeTA Tool, depicted on Table 1.b. In this table, it is seen that there are very few items covered in legal instruments, perhaps not enough to provide a thorough guidance for the industry and this was confirmed during the Key Informant Interview (KII). This could be potentially strengthened through the effective adoption / localization of the Mexico City Principles. In comparison, the PHAP Code has guidance for most of the interactions between the industry and healthcare professional as recommended by WHO.

Promotion and health professionals

o Promotion through gifts/payments to doctors or other health professionals

Regulation according to the Mexico City Principles prohibits the provision of payments in cash or cash equivalents or gifts that will be for the personal benefit of the healthcare professional.49 On the other hand, giveaway items directed to individuals for the purpose of promotion is allowed by PHAP as long as it is of low economic value (e.g., below P 1,000). More expensive items can never be given to individuals but is acceptable for donation to institutions.50 The PMA is a little vague in this regard; it allows gifts of ‘reasonable value’ that could help patients and are related to the practice of the profession.51

47

APEC (2013) The Mexico City Principles Section 12.A.1 48

PHAP 8.1 – 8.5 49

APEC (2013) The Mexico City Principles Section 7 50

PHAP 4.5.4, 6.1, 6.2-6.5, 13.2 51

PMA Article VI, Section 3

15

Table 1.b. Mapping of regulatory provisions referring to regulation of medicines promotion in the Philippines – specific stipulations on different forms of

promotion

- mentioned; ☐ - not mentioned

Scope of Regulation (HAI/MeTA Tool)

WHO Ethical Criteria for Medicinal Drug

Promotion (1988)

The Mexico City Principles

Philippine Legal Provision

Pharmaceutical and Healthcare Association

of the Philippines

Philippine Medical Association

Gifts and payments to doctors or other health professionals

Section 7

☐ 4.5.5, 6.1, 6.2 to 6.5,

13.2

Article VI, Section 3

Pharmaceutical sales representatives’ interaction with healthcare professionals

Preamble 2, Preamble 3, Section 1.c, Section

5A

FDA Circular 2013-024,

Rationale

Guiding Principle, 3.0,

4.5, 11.7, 13.3

☐

Discounts and rebates on medicines

☐ ☐ ☐ 17.0

☐

Distribution of free medicines samples

Section 9.B

BFAD Regulation 5

1987 s6

9.1 to 9.5

Article VI Section 1

Sponsorship of Continuing Medical or Pharmacy Education

Section 8.A.1, Section

8.B

☐ 11.1 to 11.2, 11.9 to

12.0

Article VI, Section 10, Article IV, Section 12, Article IV, Section 14, Article IV, Section 15, Article IV, Section 16

Sponsorship of scientific meetings

Section 4, Section 4.c

☐

Article IV, Section 7

Information on patients (package insert contents)

☐ ☐ ☐ ☐

Packaging and labeling ☐ EO 175 1987 s7 and

s11

Generics Act of 1988, Section 7

☐ ☐

16

Consumer Act of the Philippines 1991 Art 86

Internet and related social networking media

☐ ☐ 4.6.1, 5.5, 7.0

☐

Post-marketing studies Section 2.B.4

☐ 14.7


Clinical trials and promotion

Section 14.B

☐ Guiding Principles, 14.0


Promotion of off-label indications

☐ ☐ ☐ 2.3.1

☐

Others ☐ Section 6, Section 10.1, Section 13, Section 15,

Section 16

☐ 4.6.1, 5.0, 10.2, 14.8,

15.0 to 15.5

Article VI, Section 11 Article VI, Section 4

17

Representatives from professional societies, CSOs and patient group did not find the level of gift giving to healthcare professionals as a cause of concern as it used to be. There is a perception that some level of ‘giving’ is permissible according to Filipino culture of promoting goodwill as long as it abides by standards set forth by existing rules. o Promotion through interactions of pharmaceutical sales representatives with

healthcare professionals The Mexico City Principles promote the observance of ethical relationships between representatives and healthcare professionals, guided by existing laws and guidelines. Interactions that will result to undue influence to the prescribing practice of healthcare professionals are prohibited.52 Consistent with the expected competency of pharmaceutical sales representatives, their interaction with healthcare professionals is expected to be ethical at all times, as described in the PHAP Code of Practice.53 Their hospitality activities directed to healthcare professionals must be within bounds of the Code. Stakeholders from the professional associations, CSOs and patient groups agreed that there is a close relationship between health care professionals and the pharmaceutical industry, mostly due to interactions initiated by the latter. There remains a general perception that this relationship is driven by the goal to increase profit for the industry by influence the prescribing behavior of doctors.

o Promotion through sponsorship of Continuing Medical or Pharmacy Education (CME or CPE) and Scientific Meetings

According to The Mexico City Principles, any financial support to a CME or CPE must not constitute an inducement to prefer prescribing a particular brand of medicine or treatment. The same is true with any form of grant, scholarship, subsidies, consulting contracts, educational or practice-related items.54 In the same principle, sponsorship to individual providers for attendance to scientific meetings should not be conditional to obligation to prescribe, recommend, or promote any medicine.55 PHAP spelled out restrictions in sponsoring trips to scientific meetings, especially those which would require travel outside of healthcare provider’s home country.56 The sponsorship must never be conditional to the obligation to promote or prescribe any medicinal product. PMA asserts that continuing medical education must be organized by the society to benefit patients by ensuring updates to the medical audience.57 Honoraria and subsidies from the industry are allowed according to the contribution and

52

APEC (2013) The Mexico City Principles. Preamble 2, Preamble 3, Section 1.C 53

PHAP Guiding Principle, 3.0, 4.5, 11.7, and 13.3 54

APEC (2013) The Mexico City Principles Section 8.A.1 and 8.B 55

APEC (2013) The Mexico City Principles Section 4 and Section 4.c 56

PHAP Section 11 and 12 57

PMA Article IV Section 10, Section 12, Section 14, Section 15, Section 16

18

participation in the activity. The use of generics is a priority in the lectures but companies are allowed to indicate their brands at the end of the presentation. Similarly, PMA urges full disclosure of sponsorship in the publication or presentation of articles during scientific conferenced.58

The issue on CME or CPE sponsorships was discussed to all stakeholders interviewed. There is a general agreement that the industry, except for the distributor of generic products, does sponsor these conferences for the purpose of further learning of healthcare professionals. The sponsorship could be a partnership between professional societies and the industry or it could be a stand-alone conference with a smaller more targeted audience. The perception that sponsorship is a vehicle to influence product acceptability still exists. Professional societies and the industry claim though that sponsorship in society-organized CME/CPE abides by society policies and will have very minimal influence from the industry in terms of agenda. Vulnerability for industry-driven information campaign during educational conferences appear to be higher if the activity is stand alone and not organized with a bigger society/association that has well-defined rules on sponsorships.

o Post-marketing studies Disguising promotion within post-marketing studies activities is prohibited. Post-marketing studies must be strictly for scientific or educational purpose.59 Member companies of PHAP are prohibited from compensating healthcare providers that participate in post-marketing studies.60 PMA allows its member physicians to participate in post-marketing studies, with the understanding that healthcare providers observe informed consent from participants.61 Physicians must also report the findings to proper authorities.

o Clinical trials and promotion The Mexico City Principles prohibits the use of clinical trials for inducement of sales.62 A detailed guidance on the conduct of clinical studies and related activities is also provided by PHAP.63 Transparency and disclosure must be observed in the conduct of these activities. The purpose of studies and trials must remain for the furtherance of knowledge and advance of medicine and science. PMA further clarifies that clinical trials be “ethically defensible, socially responsible, and scientifically valid” and must always abide with local provisions on the protection of human subjects. If there are renumeration, this must not constitute an enticement.64

58

PMA Section 7 59

APEC (2013) The Mexico City Principles Section 2.B.4 60

PHAP 14.7 61

PMA Article VI, Section 2 62

APEC (2013) The Mexico City Priciples, Section 14.B 63

PHAP 14.0 64

PMA Article VI Section 5 and 6

19

Promotion to health professionals, patients and general public

o Promotions through discounts and rebates on medicines PHAP prohibits the direct access of patients to discounts or coupons.65 These promotional items could only be given with the guidance of a physician, with support of a prescription. Any activity that will cause self-medication is discouraged. According to the stakeholders who participated in the KII, there are undocumented reports that discounts / rebates are extended to doctors allegedly done by local companies. All of them agree that this should be prohibited. There is an observation that in some areas in the country, the practice of doctors to directly dispense medicines may also be fueling this behavior. There was also an observation that this practice may have already shifted from involving doctors to pharmacists who are directly responsible for dispensing medicines. Provision of discounts or coupons directly to customers, particularly for OTC is still being practiced. o Promotion through distribution of free medicine samples

Direct giving of samples to the public is prohibited.66 This can be provided with no charge to healthcare professionals and should be done for the purpose of improving patient care.67 These samples must not be resold. Upon the consent of healthcare professionals, pharmaceutical representatives could give free medicine samples to their person.68 These are not to be sold but to be used such that initiation of therapy can be done and for the healthcare professional to gain experience. PHAP further allows the distribution of free medicine samples for humanitarian reason, but must still be dispensed with physician’s prescription. PMA affirms that physicians must not derive material gain from product samples.69

Majority of the stakeholders do not see anything wrong with providing doctors with samples but this must be done properly. There is still no agreement what constitutes a proper sample but there are common behavior identified to be desirable: samples must be given to patients for free with proper information and consent, it must be enough to properly gauge impact, and it must not lead to wrong / corrupt practices.

65

PHAP 17.0 66

BFAD Regulation No 5 s 1987 67

APEC (2013). The Mexico City Principles. Section 9.B 68

PHAP 9.1 – 9.5 69

PMA Article VI Section 1

20

o Promotion using the internet and related social networking media

PHAP promotes full disclosure and transparency on the intended audience and the sponsor company in any pharmaceutical product related websites.70 Content must comply with the Code and local regulation. There should not be any unsolicited electronic transmission or replicas that will be sent to audiences for promotional purposes.

Packaging, labeling and product inserts

Packaging and labeling should not compromise the safety of consumers. Misrepresentation, misbranding, and misleading labels are prohibited. 71 This includes non-inclusion of information required by government to place on labels. The “Generics Act of 1988” calls for drug companies to be accountable in the quality of drugs being sold by ensuring that generically labeled medicines contain the name of country manufacture, dates of manufacture, and expiration.72 The “Consumer Act of the Philippines” affirmed that provisions of the Generics Act apply in the labeling of drugs.73 Others There was a few more guidance provided by The Mexico City Principles. Sponsorship for sole purpose of entertainment is prohibited.74 Whenever healthcare professionals are engaged as consultants or speakers to events sponsored by the Companies, these interactions must not result to inducement for preferential prescribing. Compensation or reimbursement must be guided by the fair market value of service rendered.75 Companies may support charitable causes through donations but this must not constitute any form of promotion. In the process of supporting activities for charities, donations must not lead healthcare professionals to prescribe improperly.76 In cases when Companies have to deal with the public sector, they must observe legal boundaries that protect transactions against corruption and undue inducements.77 A possible vulnerability explored is the case of selecting medicines for reimbursement in hospitals. Not all stakeholders were familiar of the process. The few who have some knowledge concur that there is some level of influence from the industry in the manner by which they detail the physicians, submit product information to the hospital’s therapeutic committee, or participate in the vetting process. There may be an unintentional bias over the methodology of shortlisting the participating industry companies, as requirements tend to be favorable towards the larger research-based firms. More investigation may be required to assess how

70

PHAP 4.6.1, 5.5, 7.0 71

Executive Order 175 Section 11 Amending Section 11 of RA 3720 72


RA 7394, Article 86 74

APEC (2013). The Mexico City Principles. Section 6 75

APEC (2013). Section 10.1 76

APEC (2013). The Mexico City Principles. Section 15. 77

APEC (2013). Section 13.

21

this transaction impacts on overall use of medicine, particularly in hospital-based therapeutics. The industry must respect the autonomy of patients and patient groups such that any form of support must not be linked with direct promotion of a specific medicine.78 In the Philippines, patient group participation or influence in the area of medicine selection is not pronounced. KII respondents identify two possible groups that do lobby and these are those that are involved in supporting patients with cancer and patients suffering from renal failure. There is no perception that these groups are driven by industry influence, rather they seemed to be motivated by the felt need of the patients.

4.2. Regulatory Body: The Food and Drug Administration In as much as the State provides for the protection of every Filipino’s right to health, the 1987 Constitution likewise covers for the establishment and maintenance of a regulatory system that will govern food and drugs. 79 Two main national legal instruments embody the nature and extent of this regulatory body: Republic Act 3720 “Food, Drugs and Devices and Cosmetics Act” and the most recent Republic Act 9711 Food and Drug Administration Act of 2009”. Voluntary / self-regulation by PHAP member industries and the PMA for its member physicians are governed by their own Code of Practices.

Philippine Food and Drug Administration (FDA) The regulatory agency has its beginnings as a subcommittee of Food and Drugs under the Department of Health in 1961 to 1962.80 At the onset, this subcommittee was mandated to spearhead the process of drafting a law that will support the promotion of safe, pure and quality foods, drugs, and cosmetics. Republic Act 3720, “Food, Drug, and Cosmetic Act” was enacted in 1963 to provide coverage for such purpose. It was in 1966 that the Federal Drug and Administration became fully operational. The FDA was abolished in 1982 to become the Bureau of Food and Drugs by virtue of the Executive Order 851. BFAD become functional in 1984. Due to the assessed limitation of BFAD’s function and scope, Republic Act 9711 reinstated the Food and Drug Authority to replace BFAD. This legal issuance imputes upon FDA a wider authority and more support to implement improvement in regulating foods, drugs, cosmetics and hazardous products.

78

APEC (2013). Section 16 79

Philippine 1987 Constitution, Article XIII, Section 12 80

Food and Drug Administration website http://www.fda.gov.ph/about-food-and-drug-administration/1-history-of-fda

22

Mission and coverage of FDA The Vision and Mission of the FDA are found on their website and are stated as81:

Vision

Food and Drug Administration to be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos.

Mission To ensure safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with

international best practices.

As part of its overall function, FDA is expected to prescribe standards, guidelines and regulations relevant to activities involved in marketing health products. 82 Particularly, the Center for Drug Regulation and Research (CDRR) formulates guidelines covering applications and approval of promotional, advertisement, and/or sponsorship materials.83 In particular, the Market Communication Unit under CDRR is tasked to police drug promotion activities. FDA is lodged under the Office of the Secretary of DOH.84

Human resource staffing The Administration is led by a Director General and Deputy Director General. Specific for drug regulation, there is a Director for the Center for Drug Regulation and Research. A full time staff manages the Market Communication Unit charged of the mandate to look after promotion activities involving medicinal drugs. In general, the informants agree that positions in the FDA are identified by specific qualification requirements. Individual roles are clear and their performance are evaluated regularly every six months. Central Office staffs are expected to provide expertise in defining the regulatory framework. Regional Field Offices are tasked to monitor activities covered by the FDA mandate but it is admitted that advertising / promotion activities are not prioritized. A Regulatory Enforcement Unit as well as a Legal Office oversees enforcement activities. The main concern is mismatch between the staffing that FDA needs and the actual allotment that is funded by the government as defined by policies set by the Department of Budget and Management. This renders some critical positions to be handled by contractual employees that pose a weakness to an agency whose role is to regulate practices that impact on health. As it is, one inspector supervises around 500 outlets while only 18 evaluators process more than 2,000 requests annually.

81

Food and Drugs Agency Website, www.fda.gov.ph/about-food-and-drug-administration 82

RA 9711 Section 4.c 83

FDA Circular 2013-024 Guideline 2 84

RA 3720, Chapter III, Section 4 and RA 9711 Section 4

http://www.fda.gov.ph/about-food-and-drug-administration

23

Activities related to advertising and promotion is not exactly prioritized when gauged against other tasks that need to be done in the agency. Apart from the number of staff, possessing the right kind of skill for the job is another concern raised during the interview. In the perspective of regulating medicines promotion, health workers who are the usual human resource complement of FDA are not particularly trained on how to deal with the industry that it is regulating. It is not fully determined whether what is required is to hire additional staffs with training on marketing or is it to spur innovation within the current system so that the Administration is able to accomplish its objectives within the constraints of its operation.

Managing possible conflict of interest There is a specific clause on preventing conflict of interest for the personalities appointed to the positions of Director General and Deputy Director-General. 85 Previous regular and full-time employment in a regulated establishment will disqualify a potential candidate in taking up these positions within three (3) years from termination of employment. Full disclosure of possible conflict of interest is expected from prospective Director-General and Deputy-Director General. Respondents to the KII mentioned a standing rule that separated employees must wait for a period of at least one (1) year before they are allowed legally to take a position in the industry. However, this is seldom adhered to especially by contractual staffs who take employment in the industry within this restricted period.

Funding the regulatory activities The “Food and Drug Administration Act” mentioned two possible funding sources of funding. From the budget of the DOH under the General Appropriations Act, there is an allocation for FDA.86 In addition, FDA is allowed to retain the amount of fees collected and other similar income. The agency is likewise allowed to accept grants, donations and other endowments87 but this has yet to be implemented. The Market Communications Unit has a set annual budget to support its regular program activities, which so far has been sufficient.

Other activities Apart from regulating medicinal drugs, FDA is also tasked to look after food, cosmetics, and hazardous substances. Likewise, on top of regulating advertisement and promotion activities, FDA has many functions to fulfill. It conducts research, performs analysis on samples, it sets standards for the industry.88 FDA is also one of the agencies tasked to implement the National Drug Policy.89

Public dissemination of information about regulation

85

RA 9711 Section 7.g 86



RA 9711 Section 4, RA 3720, Section 4 89

DOH AO 48 s 1988

24

On the website of FDA, can be found decisions, pronouncement, and statements on regulatory matters. FDA likewise issues paper-based advisories. Occasionally, broadsheets are used for wider dissemination.

Accountability of FDA FDA directly reports to the Office of the Secretary.90 Alongside this mechanism is the involvement of the National Drug Committee that conducts technical reviews on the decisions and regulations of the then BFAD, now the FDA.91 Another layer of oversight is provided through the Congressional Oversight Committee who will review the performance of FDA for five years (or until 2013) after the enactment of RA 9711.92

Role of the pharmaceutical industry in regulation FDA recognizes the role of pharmaceutical industry in regulating its own ranks – and that they should be able to do this effectively. PHAP is already widely known to practice self-regulation especially with their circulated Code, systematic training for compliance, and established mechanism to processed complaints. PCPI is perceived as hesitant as it has yet to publish its own Code. During the interview, PCPI mentioned that there are still provisions in their draft Code that are under discussion. With a mechanism of self-regulation in place for a portion of industry members, FDA however does not require them to report their activities and it also does not exercise an active oversight function. PHAP expressed that although there is no formal mandate for them to report to FDA, their system is fully transparent for further scrutiny, including the performance and outcome of decision making exercised by their Ethics Committee, the body that processes complaints and potential vulnerabilities among their member companies. Alongside the self-regulatory measures implemented (and to be implemented) by the industry groups, there are inherent rules within each company that binds them to a certain range of allowable advertising and promotion activities. Multi-national companies (MNCs) specifically the research-based companies must abide by the standards set by their home companies that often operate in a more stringent market system. They regard themselves as having to operate in a stricter environment because of this set-up. Local companies on the other hand cite the Good Manufacturing Practice (GMP) audits conducted by FDA as a mechanism to ensure compliance to prescribed government policies. GMP audit is done for local companies but not for local subsidiaries of MNCs.

90


DOH AO 48 s1988 92

RA 9711 Section 23

25

Role of CSO in regulating medicine promotion and advertisement CSO representatives who participated in the KII admitted that although medicine promotion and advertisement is a concern, the issue has not been on top of their advocacy agenda. There is currently no active participation from the CSOs in terms of regulating this activity. At present, the main issue that CSOs actively participate in is providing better access to medicines. There is interest to widen the scope of their participation as probably reflected in the plans to organize a Medicines Watch in support of government. However, the scant funding resource to conduct activities for medicines promotion regulation is an identified restriction by some CSOs.

4.3 Monitoring Government’s monitoring system FDA is tasked to monitor advertisement and promotion of drug products.93 The agency also receives and processes complaints that could arise from such activities. The CDRR specifically is tasked to implement compliance measures, monitor advertisements, promotion and marketing activities.94 The Regional Field Operation (RFO) Unit will assist CDRR.

Monitoring body, organizational mission and governance In the former BFAD, the Legal Division was in-charged of all legal and compliance aspects that included monitoring of advertisements and promotions.95 Now, under the revitalized FDA, this function was transferred to the Center for Drug Regulation and Research.96 Field inspectors are in the best position to monitor advertisements but due to the volume of work that they need to accomplish, this is rarely done.

Other activities FDA’s Center for Drug Regulation and Research not only monitors advertising but also regulates the manufacture, importation, exportation, distribution, sale and transfer of health products.97

Pre-approval criteria: determination, responsible agency, and application fees FDA’s predecessor, BFAD does not require clearance to the initial printing and broadcast or dissemination of advertisement and other promotional materials for medicinal drugs.98 Currently, it was confirmed during the KII that there is no pre-approval or screening process on the content of advertisement or promotions collateral. FDA’s focus is mainly on the labels and not on the actual promotional materials. Concurrently, there is an expectation that Medical Directors of

93

DOH AO No 65 s1989 Section 4.4 94

FDA Circular No 2013-024 Guideline 3 95

RA 3720 Section 5f 96

RA 9711 Section 5.a.1 97

RA 9711 Section 5.a.1 98

DOH AO No 65 s.1989 Section 4.3

26

pharmaceutical industries should be reviewing and ensuring proper content of promotional materials but it’s not being done at the level that it should be. Once the advertisement goes on air, the Ads Standards Council (ASC) performs general screening but this is regarded as superficial as technical expertise to conduct an in-depth assessment may not be present in the ASC. In instances when a complaint is raised on a particular advertisement material for medicinal drugs, FDA takes over and processes the issue. FDA likewise must conduct a post-audit on advertisement materials. For sales promotion on the other hand, FDA requires the interested party to secure a permit from the agency to conduct such activity. However, there is no assurance that this process will examine the entire content and possible effect of promotion to consumer use of medicines.

Complaint mechanism, publication and timeline FDA is mandated to receive, process, and decide on complaints about advertisement and promotion of drug products.99 On the website of FDA, there is a electronic reporting system (eReport), formally called the FDA Public Assistance, Information and Complaints Desk. Complaints can be emailed through this portal and will be directed to the address [email protected]. 100 However, this portal mainly entertains complaints about customer experience on the products and not on the advertisement and promotion. The latter has been largely dealt with through email correspondents. Very recently, FDA issued an internal guidance on how to handle all complaints including promotions and advertisements but it still has to be implemented.

Publication of monitoring outcomes Monitoring of advertisement and promotions ideally is done actively and passively but in the case of FDA, it is mostly the latter due to resource constraints. There is no published database on violations. Monitoring among PHAP members DOH “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988” espoused that compliance with guidelines on drug advertisement and promotion is a responsibility of drug establishment that owns the registration.101 It is highly suggested that internal review mechanism be present in these companies so that they are able to comply. In a similar vein, medical companies are encouraged to actively participate in the industry-wide self-regulation. This is reinforced by The Mexico City Principles. Companies are to be responsible to set-up internal mechanism that will support compliance among its staff. It urges

99

DOH AO No 65 s1989 Section 4.4 100

www.fda.gov.ph/report 101

DOH AO No 65 s1989 Section 4.1 and 4.2

mailto:[email protected]

27

the leadership to document the internal compliance procedure and have employees become familiar with it.102 Companies who are members of the Pharmaceutical and Healthcare Association of the Philippines and local subsidiaries of IFPMA members are covered by the provision written on the PHAP’s Code of Practice.103 Consistent with the DOH guidance stipulated in the previous paragraph, the Code imputes the responsibility of implementing the statutes of self-regulation to the General Managers, Presidents or Managing Directors of their respective companies.

Monitoring body, organizational mission and governance PHAP’s Code has jurisdiction over its member companies and also over those whose mother companies adhere to the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) Code of Practice. PHAP organizes an Ethics Committee that reviews cases filed against a certain company.

Complaint mechanism, publication and timeline Members of the public and the industry can file complaints for any violation done by a PHAP member company. Complaints arising from the member companies are encouraged to be settled among themselves rather than elevating it right away to the PHAP Ethics Committee.104 A maximum of 95 days is allotted for the cycle to validate, process, decide, appeal and give the final decision on a complaint received by PHAP.105

Publication of monitoring outcomes The PHAP Code of Practice stipulates that a summary of the cases that are being processed or had been processed shall be published on the PHAP website.106

4.4 Enforcement Apart from setting the terms and framework of medicines promotion regulation, and monitoring how it is being implemented, FDA likewise enforces the terms of regulation. With proven violations, CDRR implements the penalties and violation, in consultation with the FDA Director General.107

Sanctions and Appeal Mechanism Violative advertising and promotional materials relative to provisions written about the role of generics in advertising will result to a cease and desist order from FDA,

102

APEC (2013). The Mexico City Principles. Section 11. 103

PHAP Guiding Principles, Section 1.3, and Section 18.1 104

PHAP Section 19.2 105

PHAP Section 19 106


FDA Circular No 2013-024 Guideline 5

28

upon formal notification of the responsible company.108 With the cease and desist order, the material could no longer be released, printed, broadcasted, or disseminated. The drug establishment involved could contest FDA’s decision and matters will be settled through a formal hearing.109 However, repeated violations of the same serious nature will lead to heavier sanctions that could lead to eventual revocation of license to operate of the drug establishment.110 When in it is found that advertising and promotional materials involve misbranding of the drug products, more serious sanction is meted out, including imprisonment and a hefty fine.111 Even the self-regulating body of advertisers, the Adboard, violative contents will be a breach of their ethical standards and this will cause print and broadcast materials not to be advertised.

Range of Sanctions

Violation Sanction

Violation related to the FDA Act (selling, promoting, advertising products that are misbranded)

Corrective actions against repeated/serious violations

Seizure and confiscation of products that are subject of violative case of repeated and serious violations

Withdrawal of the FDA of accreditation of the drug establishment’s medical director

Suspension of the license to operate of the drug establishment

Cancellation of the CPR

Revocation of the license to operate of the drug establishment

Penalties for advertisement of misbranded products

Imprisonment ranging from one (1) year to not more than ten (10) years OR

Fine of not less than fifty thousand pesos (P50,000) but not more than five hundred thousand pesos (P500,000) OR

Both

Administrative sanctions (RA 9711 Section 11)

Violation of guidelines about the role of Cease and desist order on the

108

DOH AO No 65 s 1989 Section 4.5 109



RA 9711 Section 11

29

generics in advertising advertising activity (DOH AO No 65 s1989 Section 4.5)

Repeated serious violation on the guidelines about inclusion of generics in advertising

Withdrawal of accreditation, suspension of license to operate, cancellation of the certification of the product registration, and revocation of license to operate of the drug establishment (DOH AO No 65 s1989 Section 4.7)

Violations in general advertising ethics as governed by Adboard

All media will refuse to print or broadcast violative advertising materials

Violations on advertising practices according to the Consumer Act

Fine of not less than Five hundred (P500.00) pesos but not more than Five thousand (P5,000.00) Pesos; or

Imprisonment of not less than one (1) month but not more than six (6) months or both upon the discretion of the court

Issuance of cease and desist order (RA 7394 Art 110-115; Art 123)

Violation on promotion practices according to the Consumer Act

Fine of less than Two Hundred (P200.00) Pesos but not more than Six Hundred (P600.00) Pesos; or

Imprisonment of not less than one (1) month but not more than six (6) months or both upon the discretion of the court

(RA 7394 Art 116-121)

On top of these legal sanctions, PHAP also imposes penalties to members that violate any provision of the Code. First offense would cost the offender two hundred thousand pesos (P200,000) and any repeat of the same violation will impute additional seven hundred fifty thousand pesos (P750,000) per offense.112 However, in the occasion that a violator does not commit any more offense of the same nature within a 12-month period, a “clean slate” status can be declared to the former offender. For doctors who are under the jurisdiction of PMA, there is an ethics committee that provides a mechanism to process and enforce possible violations in the Code. A substantial evidence proving that a violation was committed could result to reprimand or suspension. Results of such decision is not published.

Reporting DOH, through the Office of the Secretary could report and illustrate the results of investigations relevant to the products it regulates113 but this is not yet routinely done.

112


Executive Order 175 Section 21, amending RA 3720 Section 29

30

4.5. Relationship between the different bodies / departments involved in medicines promotion regulation The FDA is an agency under the Office of the Secretary of DOH. DOH on the other hand is a member of the National Consumers Affairs Council, whose task is to improve the management, coordination and effective of programs that affect consumers.114 However, this is a rarely used mechanism by the FDA in terms of augmenting its capacity to regulate medicines promotion. What is occasionally tapped into is their partnership with the ASC and their standing agreement for the latter to do screening of advertisements.

4.6. Disclosure of budget for promotion and advertising All businesses registered in the Philippines are required by the Bureau of Internal Revenue to disclose their annual Financial Statements, which when done correctly should include spending related to advertising and promotion.115 All respondents of the KII from the pharmaceutical industry who were asked about this information said that budget for promotion and advertising is private and confidential. Three respondents discussed this matter further and posited that the cost of advertising and promotion may no longer be a significant driver of medicine cost. There has to be an acceptable level of cost devoted to promotion and advertising as long as it is able to achieve patient-centered objectives of sharing the proper information on drugs. It was suggested that it may be time for government to conduct an objective assessment whether promotion and advertisement cost remains a significant contributor to medicine price or other schemes (e.g., transfer pricing) are causing this phenomenon.

4.7 Regulation of generic substitution (substitution by pharmacists) A DOH issuance supporting the Generics Act defined generic dispensing as “dispensing the patient’s/buyer’s choice from among generic equivalent.116 With the informed choice of the patient/buyer, all drug outlets are required to practice generic dispensing, with some exemptions, modifications or qualifications.117 Generic dispensing is practiced at the pharmacy level and FDA said that it is allowed and acceptable as long as the substitution is within the formulary and the medicines are therapeutically equivalent. Patients must likewise be properly informed and their consent secured when a substitution is done. Pharmacists and their assistants must be ready to do the substitution properly where patients are guided using a substitution card.

114

RA 7394, Title V, Article 148 and 149 115

Republic Act 8424 116

DOH AO 62 s1989 1.4 117

DOH AO 63 s1989 3.1, 3.1.1

31

KII respondents who represent the medicine distributors said that this practice is acceptable to consumers especially those who are seeking out more affordable alternatives.

4.8 Regulation of prescribing practices First off, only licensed and registered medical, dental, and veterinary practitioners are allowed to prescribe drugs.118 Prescription by the medical, dental and veterinary professionals shall include the generic name, even as the brand name may be included.119 Further prescriptions must contain the minimum required information such as the name of prescriber, office address, professional registration number, professional tax receipt number, date of prescription and patient/client’s name, age and sex. 120 DOH requires all its facilities to exclusively use generic names/terminology in doctors prescriptions and orders.121 In general, stakeholders agree that with respect to prescribing in generics, doctors remain to prescribe their preferred brands at one time or the other. This is observed in both public and private practice. Compared to doctors in practice however, there is recognition that those who are serving in public health facilities tend to prescribe in generic and has been increasingly compliant with the Generics Law. Stakeholder respondents representing drug distributors cited examples of violations that some healthcare providers employ despite of the Law. There are doctors who would write “Do Not Replace” on the prescription pad. There are those who do write both generic and brand name but the generic label is not readable. No active monitoring to keep the prescribing practice of physicians in check. Patients are deemed to affect the prescribing practice of physicians. This is usually observed among those who are the capacity and willingness to pay for the brand of their choice. This behavior is probably influenced also by the high out of pocket expense for medicines that shifts the purchasing power to individuals. The same group of consumers has access to information that makes them more likely to request for alternatives form what doctors prescribe. On the same note, knowledge and access to generic alternatives has also led to increasing trend in requests for the more alternative.

Note on the availability of prescription medicine over the counter Irregularities in prescribing practices are worsened by the availability of prescription medicines over the counter. The extent of this wrong activity is not known but there is general agreement that this is widespread. Due to lack of monitoring and enforcement of appropriate penalties, patients can readily purchase ethical drugs without proper prescription. Local distributors mentioned that they are putting in measures to moderate this practice. One intervention is allowing the purchase

118

DOH AO 62 s1989 2.1 119

RA 6675 Section 6.a 120

DOH AO 62 s1989 2.2 121

DOH AO 169 s. 2004

32

without prescription only for those who are already in their database and are buying for the same indication for a chronic condition. Aside from the non-compliance from the pharmacies who dispense without prescription, patient income situation can be a factor why they choose to purchase even without doctor’s advise. Given a limited money, patients would rather seek advise from pharmacy staffs and spend what they have directly for medicines rather than divert some of that fund towards professional fee payment.

Note on black market peddling of medicines Almost all stakeholder respondents assent that there is some form of ‘black market’ of medicines especially for antibiotics. This is happening even with the fact that ethical drugs can be purchased from legitimate point of sale without proper prescription. This can be an indication of unmet need for medicine access and the concurrent weak monitoring and regulation by government. “Black markets” are identified in sari-sari stores (small convenience stores), itinerant vehicles, supermarkets, and even online market place.

4.9 Provision of independent, non-promotional information on medicines There are some avenues for DOH to independently provide the public information about medicines, in particular about encouraging the use of generics. The Generics Act for instance mandates DOH to publish in a national broadsheet a list of drugs and medicines in the Philippines, with their generic and brand name. This should be done at least once a year.122 Complementary to this activity that targets the general public, is a recommended joint activity between DOH, Department of Education, Philippine Information Agency and the Department of Interior and Local Government that will facilitate the continuing education of the public and the health professionals on the benefits of using generics.123,124

In instances when the DOH deemed it necessary to inform the public about a potential danger to health or an abject deception to consumer, the Office of the Secretary could disseminate to the public these important information.125 However, the lack of access to independent information on medicines from the government still renders the pharmaceutical industry as the main source of information. Publicly available literature such as MIMS or PPD is not user friendly for lay users.

Source of information for health care practitioners Most practitioners are trained to seek out information from academic sources (e.g., internet, books, journals, meetings, and scientific convention). These sources are

122



DOH AO 51 s1988 5.3 125

Executive Order 175 Section 21 Amending RA 3720 Section 29

33

considered as independent from pharmaceutical industry. Treatment guidelines are also useful resource but not all health care practitioners are using these properly.

Source of independent information to patients As of now, doctors would be the best resource who could provide patients objective information about medicine but the limited encounter time also shortens the content of info passed on to patients. Patients who are more educated and are better economically can also source information from relatively independent sources. FDA can consider these sources of information mentioned above when designing how to provide info that will support rational drug use.

5.0 DISCUSSION There were three standing assumptions from previous studies on the impact of medicines promotion that deemed important enough to justify attention to regulatory practices126,127:

Medicine information from pharmaceutical companies tend to be biased towards over promotion of benefits and undermining risks;

Healthcare professionals and the public rely more and more to industry-generated information to update their knowledge about medicines; and

This information exerts a significant influence in the prescribing, dispensing and consumption of medicine; there is a general tendency towards irrational drug use as a result.

Inherent to the business model of pharmaceutical companies are activities that advertise and promote medicinal drug products to increase sales and recoup the investment made in drug development. However, medicine intake is not without risks. Unnecessary antibiotic use for example can lead to resistance that will result to an even larger public health problem. In this interplay among the pharmaceutical industry, health workers and general public, it is important that correct information is filtered through the right media to prevent needless purchase and encourage rational use. The impact of irrational drug use stemming from improper and unethical promotion of medicines justifies government resource to regulate this practice. Pharmaceutical industry promotion tactics can directly and indirectly influence health worker prescribing behavior. Ideally, educational and professional institutions had properly guided physicians on how to properly deal with these inducements. However, this is not always the case; prescribing pattern could be another source of irrational drug use. Similarly, medicine users could also be exposed to advertisements that may sway their purchasing.

126

WHO/HAI, 2005 127

Wazana, 2000

34

It is in this environment that government must shape a regulatory system that could effectively contain behaviors towards collective good (Figure 1). By identifying proper aspects of these interactions that could be acceptably controlled by regulation, then have the capacity to implement these measures, and have the political and institutional capability to enforce the rules, government is then able to ensure rational drug use. Regulation in the health sector has to be designed such that government could effectively use its legal mandate through policy instrumentalities with the goal to improve health system performance.128 In the case of regulating the promotions of drug products, the objective is to eventually support rational drug prescription and use.

There are five key steps to regulating behaviors of stakeholders that are being

128

World Bank. “Health Systems Regulation”, http://web.worldbank.org/WBSITE/EXTERNAL/TOPICS/EXTHEALTHNUTRITIONANDPOPULATION/EXTHSD/0,,contentMDK:22523877~menuPK:6485077~pagePK:148956~piPK:216618~theSitePK:376793~isCURL:Y,00.html

Pharmaceutical Manufacturer and

Distributor of prescription, non-

prescription medicines, traditional

medicines, and products promoted

as medicines

Physicians (Prescribers) Pharmacist, Dispensers

Health Workers involved in the supply and distribution of

medicines

Patients, Buyers, General Public

Promotion Industry Professional and

General Media

Universities Teaching

Institutions Professional Associations

Regulatory System that is Politically, Culturally, and Institutionally Feasible

Curb Wasteful Use of Medicine

Support Rational Drug Use

Figure 1. Environment of medicinal drug promotion and rationale for regulation

http://web.worldbank.org/WBSITE/EXTERNAL/TOPICS/EXTHEALTHNUTRITIONANDPOPULATION/EXTHSD/0,,contentMDK:22523877~menuPK:6485077~pagePK:148956~piPK:216618~theSitePK:376793~isCURL:Y,00.html



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regulated. 129 Often, a national regulatory framework is determined and expressed as a law or policy issuance. From the legislative level, the law can be further operationalized and interpreted through simplified codes and industry standards. Once the parameters are described and disseminated to the concerned stakeholders, government and relevant bodies who are given the proper authority will proceed with monitoring activities to ensure that the regulated industry comply with the standards. In the process of monitoring, identified violations will be subject to enforcement with sanctions that will deter violation of rule. Finally, the effectiveness of the regulatory framework and implementation is evaluated so that weakness can be identified and subsequently strengthened. Implementing a national regulation is also resource intensive and every investment on it must translate into better behaviors from the regulated parties.

5.1 Nature of Regulation For any type of regulation, framing or writing the rules is very critical. Specific and clear rules facilitate effective implementation. National laws with provisions on regulating industry behavior on promotion and advertisement provide general terms of acceptable and non-acceptable parameters. In the issue of medicines promotion, what surfaced from this review is the need for the regulatory framework to describe the rules on how information is channeled such that:

- the bias of industry-generated information is reduced; - access to objective and non-promotional information on medicines is made

available to healthcare professionals and the public; and - the transfer of information form industry to health care provider will not induce

irrational behavior. Using the HAI/MeTA Tool and WHO Guidelines as benchmarks, there exists laws that clarified legal provisions on the definition, scope, and nature of drugs that can be promoted to specific audience – the public or the health care professionals. There are provisions that provide parameters on compliance with approved product information, ensuring the accuracy of information, and instructions on labeling and packaging of product inserts. Defining the scope of what are medicinal products – that it should also include traditional and herbal products is clear but there is no defined guidance on how to regard them with respect to promotion restrictions as they seem to enjoy a wider berth than registered over-the-counter (OTC) drugs with the disclaimer being “There is no approved therapeutic claims”. The legislative documents were likewise silent about boundaries for export products or even guidance for information coming from international jurisdiction. The backbone of Philippine legal mandate rests on the strong emphasis in the preference for use of generics drugs. This study did not include a review on the performance of the generics law per se thus issues on implementation will not be

129

WHO/HAI Regulation of pharmaceutical promotion: why does regulation matter? IN: Understanding and Responding the Pharmaceutical Promotion

36

discussed here. That notwithstanding, in relation to medicines promotion, the generics law appears to be focused more on labels rather than the actual information content. For self-regulation, PHAP is silent about generics but it does have very good guidance on the overall emphasis on abiding by what is acceptable in the law pertaining to medicines promotion. On the other hand, the code of the Philippine Medical Association (PMA) did not mention much about general parameters of regulation but instead focused on guidance for direct interaction of doctors with the industry. While general stipulations on medical advertisement and promotions are mentioned in national laws, there are items that were not covered especially those that refer to the direct interaction of the industry with health professionals. This can be responded to by the decision of the government to adopt the Mexico City Principles that complements the existing laws well. There are also no national-level legal instrument to guide the proper qualification of pharmaceutical company sales representatives and how they should conduct themselves with health care professionals. There are likewise no explicit terms governing gifts/payments to doctors, sponsorship during continuing medical/pharmacy education, conduct of post-marketing studies, clinical trials, use of discounts/coupons, and free medicine samples. No mention on off-label use, advertising terms for imported or exported goods and the use of internet and social networking can be found in national legislations. With the adoption of the Mexico City Principles, government must then need to move this further and consider how to translate this into operational format to properly address the gaps stated. As such, current legal issuances may not need a major overhaul as most of the required general parameters are in place. What is needed are clearly stated guidance and processes to strengthen the impact of existing laws by effectively communicating what government wants done. Priorities identified in this review are clarifications in the following areas:

Patient’s good outcome as the goal, the pathway for this to be achieved by regulation, and the manner by which progress / success is measured Regulating the information passed along during promotional and advertising activities must be properly and objectively contextualized within the overall goal of improving patient outcome.

Generics as a logical option for access and quality, not just because it’s ‘cheaper’

Better description of boundaries for advertising and promotion: o Scope of what is considered as ‘medicine’ vs products marketed loosely

as food supplements o Government’s reach over exported medicines

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Proactive stance from the government in reducing information bias from promotional and advertising materials and activities o Screening content

Active mechanism from the government to provide appropriate and non-promotional information on medicines and rational drug use, not being limited by simply promoting generic drug use o Identification of appropriate channels and using it for efficient information

control (internet)

Effective structure to manage a professional transfer and exchange of information from and between the industry and health care professionals o Maximizing the strength of self-regulation as a way to improve compliance

with the Mexico City Principles but without taking out the reach and influence of government regulation / oversight

o Upholding the accountability of companies over the conduct of its medical representative

o Capitalize on the structures and process of professional societies in influencing the ethical attitudes and behaviors of health care professionals especially in dealing with gifts, incentives, and medicine samples, and protecting the integrity of scientific information dissemination during CME/CPE Professional societies could consciously and deliberately influence

health care even at the onset of their training. Providers must be made aware of potential vulnerabilities and be provided with skills on how to avoid these.

o Harnessing the role of hospital therapeutic committees in minimizing the influence of the industry in selecting medicines in the hospital formulary

o Empowering civil societies and patient groups as partners The above guidance has to be equally applied to all participants who are selling products marketed as having medicinal effects. FDA will need to discuss and negotiate with stakeholders how the parameters that it will set will result to an ‘even playing field” for the industry. In crafting the guideline, FDA will likewise need to improve on describing clearer procedures for regulation as well as articulating the substance of regulation. Regulated bodies need to be clear on the procedures but they also need to understand and buy into the rationale for each. In a survey commissioned by MeTA in 2010, 130 Performance of the Regulatory Body in Implementation and Enforcement

FDA is the sole government regulator with jurisdiction over medicines promotion. It is legally established through a Republic Act, consistent with the constitutional mandate to establish an agency that will ensure the health and safety of the general

130

MeTA (2010). Survey of Promotional Practices in the Philippine Pharmaceutical Industry. Compendium Edition.

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public. It’s vision and mission spells out that it is responsible for a wider scope of regulation involving food, drugs, and hazardous products. In the 2010 assessment of Philippine health regulatory system, it was assessed that FDA failed to regulate unethical marketing practices of pharmaceutical companies.131 The inability to curb excessive marketing and promotion led to brand loyalty that not only gave pharmaceutical companies power to set prices above competitive ceilings, it eventually resulted to irrational drug use. Organized drug industry association (i.e. Philippine Healthcare Association of the Philippines) responded by installing self-regulatory activities but this remains limited relative to the larger ecosystem of unaffiliated and local drug companies. Three years after, the general assessment remain unchanged. As the body that defines the regulatory framework and at the same time conducts the actual implementation, monitoring and enforcement, FDA has a tall mandate to fulfill. In this brief review and discussion with stakeholders, the following priorities were suggested for consideration:

Organizational alignment such that bureaucratic form conforms to the function expected for FDA

There are skill sets needed so that FDA staffs assigned to the spectrum of tasks in regulating the information flow of medicines promotion and advertising. Technical guideline development for instance will need actual field experience and proper legal background such that procedures are crafted well. Active monitoring or pre-approval process will also require skills in uncovering nuances in the content of promotional/advertising materials. FDA has for instance recently required pre-approval of sales promotion activities132, which is an improvement from an earlier DOH issuances. This could facilitate better tracking of promotion activities when these activities are registered with FDA. If FDA decides to require pre-approval procedures for advertising, skills in screening materials will come in handy. Confidence in managing industry influence is also a desirable trait that is needed. Even the ability to understand the entire workflow of FDA and being able to partner with their colleagues is a skill that can work wonders in a regulatory environment. There may be existing mechanisms that need not be reinvented, only enhanced such that activities within the agency can be done in tandem and not in silos. In designing the framework of skill sets needed to complete the organizational tasks, the issue of having enough human resource will definitely arise. It will not only be a question of numbers. FDA will need to have a human resource management structure that will enforce competence, loyalty and integrity among its officers.

131

Kenneth Hartigan-Go (2010). Regulatory Reforms. Acta Medica Philippina. Volume 44 No 4. Oct – Dec 2010. 132

FDA Memorandum Circular No 2013 - 028

39

On top of these, there are two overarching matters that will need to factor in the proposal to improve the organizational structure of FDA. One is the environment that will encourage innovative solutions among its mangers in particular. The pharmaceutical industry hires very creative professionals and government could not fall behind in their strategy to effectively manage the flow of information on medicines directed to the public and healthcare professionals. Another consideration is the ability of the organization to demonstrate and communicate that their activities are not conducted independently. Regulation of medicine promotion and advertisement is not a stand-alone policy – it has to be aligned (and therefore well supported with resources) to FDA’s mission and vision. FDA exists to govern the marketplace towards making medicine safe and accessible. Stakeholders must consistently get this message in whatever FDA is doing.

Improvement of financing support

In order to implement and enforce the law, government needs to have adequate funding for the resources that it will need. According to the law, FDA has several sources of funding: from the General Appropriations Act, from the fees it collects, and grants from funding agencies. With appropriate funding, FDA will be in the position to enforce the requirements for therapeutic equivalency, for instance. However, FDA is still in the process of working this out. There are two aspects that FDA can consider regarding the issue of finances. First is with regards to the extraction of fees and second is in shifting the purchasing power towards its favor. In extracting fees, stakeholders need to support this move so that compliance is ensured. The industry expressed its support to FDA but they would also need the assurance of transparency and rationality in the manner by which fees are collected and used. This review further shows that one of the eventualities affecting procurement of medicine is the purchasing power of consumers. When it is the consumers that pay, they could decide to follow what they prefer even if its contrary to what their doctors advise. At the systems level, PhilHealth, the largest purchaser of services in the country could be a partner in shifting the purchasing power in favor of rational drug use. Admittedly, even with PhilHealth, out of pocket expense remain high, so the impact of harnessing PhilHealth’s resources may not be as big initially but it can be a start. In the attempt to discuss this issue with PhilHealth, the target key informant said that PhilHealth does not make decisions in the selection of medicine for reimbursement but rather they just follow what DOH prescribes. This can be an area of discussion between FDA and PhilHealth so they can both use their internal mechanism complementarily. Example, PhilHealth has health

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technology assessment that can also be use in the rational selection of drugs that will be reimbursable through its system.

Installation of reliable information technology and management structure

Information is key in regulating the promotion and advertisements of medicine. However, information is everywhere and regulation can become very expensive if there is no strategy and infrastructure that could properly identify where government needs to intervene. FDA’s information structure and management will have to be strategically placed and linked with that of DOH. Investment should be able to yield information that will be helpful in managing the control knobs identified in its regulatory framework and accompanying guidelines. The information pathway that this infrastructure will create must for instance be able to provide access to the rules and regulation that is understandable to all its stakeholders. Information on enforcement and monitoring mechanism must also be clear such that those who file reports would experience that these are properly processed. Importantly, the information structure must also be able to track results not just on the output of the regulation per se but also on the actual impact on patients. One example is in encouraging the use of generics. While the law is already in place, and uptake to this practice is increasing, government still has to properly track outcomes. Evidence that is properly generated can be a powerful tool that can tighten up the regulatory wheel and help government decide on the best way to use its resources.

Improving on the mechanism to harness partnerships

Regulation is probably one of the most difficult and challenging government function. With resource constraints and the enormity of expectation from FDA, it could seriously study how to maximize existing linkages and partnerships. Civil society organizations, patient groups, and local government units are potential partners.

5.2 Importance of strong and effective government regulation Strengths of the Regulatory Framework Stakeholders concur that the presence of a regulatory framework that describes FDA’s mandate and legal reach is the main strength. In this framework, there is a clear and strong message about prioritization of generics in advertisement and promotion. Some level of self-regulation augments the existing mechanism. The current leadership is also cited as a positive factor that gives strength to the regulatory structure.

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Weakness / Gaps of the Regulatory Framework Mapping the existing documents that support national regulation of medicine promotion showed that the framework is silent on specific guidance on interactions between the industry and healthcare practitioners. The recent decision of FDA to adopt the Mexico City Principles is a step forward to closing this gap as this provides a more detailed guidance in the said issue. Stakeholders are unanimous in citing the level of FDA capacity to detect, decide and act on violations as a cause of concern. This factors into the perceived inefficient regulation of medicine promotion. FDA is also unable to effectively influence the interaction of doctors and the pharmaceutical industry. Majority of the stakeholders identify the internal organization and bureaucratic structure of FDA as a significant factor affecting performance. Making the regulatory framework function will require FDA to be appropriately organized and supported but this is not the case. For example, they could not yet retain their income that could be used to augment their financial resources. Another evidence is the scant number of lawyers to process decisions, which is critical in a regulatory agency. FDA is also perceived to be doing many things and covering a scope of work that could be larger than what it is able to do. Role and Extent of Self-regulation PHAP’s Code governing the self-regulation among its members is extensive but covers only prescription medicine. It has specific provision from general advertising down to the personal interaction of the industry with health care providers. PHAP even implements an accreditation program of medical representatives through the Medical Representatives Accreditation Program (MRAP) that is a step forward to ensure ethical and professional behavior during product presentation and promotion. From 2007 to 2011, PHAP Ethics Committee processed less than 10 cases a year, with less than 5 on 2011. 133 Top violation and penalties refer to clauses on interaction with healthcare providers: clinical trial / post-marketing studies, continuing medical education, and discount cards. In 2011, PHAP received 20 or so inquiries with majority deals with relationship with healthcare providers such as sponsorship to CMEs, donation of appliances to clinics, adjustment of investigator’s fee for the conduct of post-marketing surveillance and gift giving during holiday season. PCPI, another group of industry players is still in the process of completing their own Code.

5.3 Impact and Effectiveness of Regulation The general sense is that the level of regulation is not able to effectively control the nature of pharmaceutical promotion to abide by recommended standards. Without a well-defined measure of effectiveness and impact it will be difficult to provide an

133

PHAP Ethics Cases and Rulings. http://www.phap.org.ph/sub.php?id=8&sid=30

http://www.phap.org.ph/sub.php?id=8&sid=30

42

exact description of such. It would be ideal in the future to set actual metrics that will measure how regulation impacts patient well-being.

5.4 The use of the HAI/MeTA Tool as a way to investigate the regulatory framework The data collection tool is self-explanatory but very detailed and tends to be repetitive. The tool is a useful form to compare the extent of coverage of one law/guideline/ policy from each other. It covers more regulatory domains than what is included in the WHO Ethical Guide for Medicinal Drug Promotion. It provides a useful start in assembling information that could be processed later on for more analytic depth. As a tool that meticulously curates information from available literature, the categories of information may not be easily linked to specific policy areas for action. One possible configuration that could be considered is designing a suggested area of health system component that the information gathered is linked to – is it supposed to feed into assessment and recommendation on governance, financing, etc. This could assist in coming up with a succinct analysis with a health systems perspective of the overall picture that the tool facilitated to assemble. Finally, just by using the tool, the impact of regulation may not be discerned. Regulating the promotion of medicines is supposed to eventually impact prescribing and buying behaviors but the tool does not have features to measure this aspect. This may require a separate data-gathering instrument and methodology (e.g, survey) that could gauge how medicines are actually prescribed, dispensed and utilized at points of care. In the discussion section above, it is suggested that FDA installs a mechanism to tract these activities as results could also provide a picture of FDA’s performance in many aspects, not just in regulating information flow on medicines.

6.0 CONCLUSION Investing in regulating the promotion and advertisements in medicine is justified by the desire to protect rational prescribing, dispensing and use of medicines in the Philippines. In a generation when information can be accessed almost everywhere, regulation can become more challenging. It will require strategies that are appropriate to the current environment but also be able to adapt as information and technology are evolving quickly. FDA’s regulatory framework on the promotion and advertisement of medicine will have to be strengthened to further reduce information bias from the pharmaceutical industry, to reduce the reliance of the public and healthcare professional to information generated by the industry, and to foster a professional environment between the industry and healthcare professional that will positively influence rational prescribing, dispensing and utilization. There are two main suggestions for FDA generated from this review. First is crafting a Guideline that will clarify ambiguities in the rules. The Guideline has to be

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applicable and enforceable to all industry players. Self-regulation must be aligned to the guidance provided by government. The second recommendation focused on prioritizing the strengthening of FDA as a regulatory, implementing, monitoring and enforcing agency. The work is immense and FDA must be organized, funded, and equipped to do its job, track results, and communicate its progress to stakeholders. Even in an environment where some companies practice self-regulation, the large portion of pharmaceutical marketplace remains unchecked. It is not sufficient that rules are defined in a regulatory framework. The machinery to implement it must be so designed and equipped to be able to put the framework into action.

7.0 REFERENCES ADBOARD. 2006. Standards of Trade Practices and Conduct in the Advertising Industry. 4th Revision. Available at http://adboard.amplified360.com/sites/default/files/STANDARDS%20OF%20TRADE%20PRACTICES%20%26%20CONDUCT%20MANUAL.pdf Asia Pacific Economic Cooperation. 2011. The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector. http://www.phap.org.ph/files/ethics/Mexico-City-Declaration.pdf BFAD Regulation No. 5 s. 1987 “Guidelines on Advertisement and Promotions of Prescription Pharmaceutical Products DOH Administrative Order No 51 series 1988 “Implementing Guidelines for Department of Health Compliance with Republic Act 6675 (Generics Act 1988) DOH Administrative Order No 62 series 1989 “Rules and Regulations to Implement Prescribing Requirements under the Generics Act of 1988 (RA 6675); Amended in DOH AO 76 s 1989; Amendment in DOH AO 40 s 1990 Amendment to AO 62 s1989 re: Rules and Regulations to Implement Prescribing Requirements DOH Administrative Order No 63 s 1989 “Rules and Regulations to Implement Dispensing Requirements under the Generics Act of 1986 (RA 6675); Amended in DOH AO no 77 s 1989 DOH. Administrative Order No 65 s. 1989. Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988. DOH AO No. 69 s 1989 “Amendment to AO No 65 re: Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988” DOH Administrative Order No 2013 – 0021 “Adoption of the Association of Southeast Asian Nations (ASEAN) Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for the Registration of Pharmaceutical Products for Human Use” DOH AO No 169 s 2004 “Implementing Guidelines for the Exclusive Use of Generic Names or Generic Terminology in all Prescriptions and Orders in all DOH Facilities

http://adboard.amplified360.com/sites/default/files/STANDARDS%20OF%20TRADE%20PRACTICES%20%26%20CONDUCT%20MANUAL.pdf


http://www.phap.org.ph/files/ethics/Mexico-City-Declaration.pdf

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DOH. Department Circular No. 2011-0101. The Rules and Regulations Implementing Republic Act No. 9711 – The Food and Drug Administration Act of 2009. Executive Order 174 “Further Amending Republic Act 5921, Entitled ‘An Act Regulating the Practice of Pharmacy and Setting Standards of Pharmaceutical Education in the Philippines and for other Purposes’ as Amended”. (1987) Executive Order 175 “Further Amending Republic Act No. 3720 ‘An Act to Ensure the Safety and Purity of Foods, Drugs, and Cosmetics Being Made Available to the Public by Creating the Food and Drug Administration Which Shall Administer and Enforce the Laws Pertaining Thereto’, as Amended and for other Purposes.” (1987) Food and Drugs Authority website. www.fda.gov.ph FDA Circular No 2013-024 Adoption and Implementation of “The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector” FDA Memorandum Circular No 2013-028 General Guidelines on the Promo Permit Applications and for other Purposes International Federation of Pharmaceutical Manufacturers & Association. 2012. Code of Practice. http://www.phap.org.ph/files/ethics/IFPMA_Code_of_Practice_2012.pdf Memorandum Order No. 133 Directing the Secretary of Health to Properly Implement the National Drug Policy Set Forth in Executive Orders Nos. 174 and 175. National Statistics Office (2009). Family Income Expenditure Survey 2009 Pharmaceutical & Healthcare Association of the Philippines. 2013. Code of Practice. http://www.phap.org.ph/files/ethics/PHAP-Code-Of-Practice.pdf Pharmaceutical & Healthcare Association of the Philippines. 2012. Factbook 8th ed, August 2012. Accessed at http://www.phap.org.ph/files/ethics/PHAP-Factbook.pdf Philippine Medical Association. 2008. Code of Ethics of the Philippine Medical Association. https://www.philippinemedicalassociation.org/downloads/pma-codes/FINAL-PMA-CODEOFETHICS2008.pdf Republic Act 3720 “Food, Drugs and Devices and Cosmetics Act (1963) Republic Act 3720. Food, Drug and Cosmetics Act as Amended by Executive Order No 175 (1987) Republic Act 6675. “Generics Act of 1988” Republic Act 7394 “The Consumer Act of the Philippines” (1991) Republic Act 8424 “Tax Reform Act of 1997” Republic Act 9711. An act strengthening and rationalizing the regulatory capacity of the bureau of food and drugs (BFAD) by establishing adequate testing laboratories and field offices, upgrading its equipment, augmenting its human resource complement, giving authority to retain its income, renaming it to the food and drug administration (FDA), amending certain section of republic act no. 3720, as amended and appropriating funds thereof.”

http://www.fda.gov.ph/

http://www.phap.org.ph/files/ethics/IFPMA_Code_of_Practice_2012.pdf

http://www.phap.org.ph/files/ethics/PHAP-Code-Of-Practice.pdf

http://www.phap.org.ph/files/ethics/PHAP-Factbook.pdf

https://www.philippinemedicalassociation.org/downloads/pma-codes/FINAL-PMA-CODEOFETHICS2008.pdf


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Roberts, Marc et al. (2004). Introduction to Health Care Regulations IN: International Comparative Review of Health Care Regulatory Systems. New York: Oxford University Press, Inc Sheikh, Kabir, Prasanna Saligram, and Lakshmi E. Prassad. 2013. Mapping the regulatory architecture of for health care delivery in mixed health systems in low-and middle-income countries. Melbourne, Australia: Nossal Institute for Global Health Wazana, A. 2000. Physicians and the pharmaceutical industry: is a gift ever just a gift? JAMA 283 (3): 373-80. World Health Organization. 1998. Ethical criteria for medicinal drug promotion. Geneva. http://apps.who.int/medicinedocs/documents/whozip08e/whozip08e.pdf

http://apps.who.int/medicinedocs/documents/whozip08e/whozip08e.pdf

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Annex A1. Interview Schedule: Key Informant from Drug Regulatory Authorities

Country

Date and Location

Recording ☐ Yes ☐ No

INTERVIEWEE

FULL NAME:

TITLE AND AFFILIATION:

E-MAIL:

ADDRESS:

PHONE NUMBER:

INTERVIEWER

FULL NAME:

E-MAIL:

REMARKS:

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General introduction: The purpose of this interview is to gather information on the regulatory system in your country concerning medicines promotion. In many countries this is a grey area, there is little awareness about the legislation, what is authorized and what is not. We want to learn more about the regulatory framework, but we also want to know what are the promotional practices used in Philippines to advertise medicines. The goal is to identify problems and best practices by gathering information in multiple countries. We review the legislation and interview key stakeholders, such as Drug Regulatory Authorities, healthcare professionals, civil society, the pharmaceutical industry, etc. With this, we hope to provide recommendations to strengthen regulatory systems to improve medicines use and public health in general. After the assessment in your country will be carried out, we will get back to you with the findings. Did you see the fact sheet on the project? Do you have questions about it? First of all, I would like you to introduce yourself and to talk to me briefly about the main areas you focus on in your work. Do you think you are the right person I should talk to in order to learn more about promotional practices? If not, could you let me know of other people you think might be able to provide valuable contribution?

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1. Does the government provide or support independent information on medicines to health care professionals and/or consumers?

2. What do you think of the content of advertisements for medicines in general? Do you think that information in advertisements is consistent with the actual product characteristics?

3. Are prescription-only medicines advertised to the public? In which ways? Are

there disease awareness campaigns in your country? Do they display brand names?

4. Are consumers exposed to advertisements from other countries? Which

countries? Through which media? Are they different from advertisements from your country? How?

5. What is the implication of the ASEAN Common Technical Document to the

promotion of medical products? 6. What is the way forward to ensure compliance with The Mexico City Principles? 7. Do doctors or pharmacists receive discounts, rebates or bonuses as an incentive

to prescribe and dispense more? 8. Are medicines prescribed by brand or generic name? Does it vary between

sectors (public and private)? How? 9. Are medicines promoted and/or prescribed apart from the registered indications

for that particular product? 10. Is generic substitution allowed? Who is allowed to substitute? Is it done in actual

practice? What do patients think about it? 11. Who is involved in the process by which medicines are selected to be supplied

and/or reimbursed? What is the influence of pharmaceutical companies? 12. Do patient organizations advocate for specific medicines to be registered or

reimbursed in your country? Who funds these organizations? 13. Are medicines sold informally on the (black) market, in kiosks? Are those

activities monitored? By whom?

Does the pharmaceutical industry have an official role in the regulation of drug promotion? Which sort of role? If the industry self regulates its promotional activities, does the government have an oversight on the mechanism? How? If not, do you think it has an informal role? How?

14. What proportion of the promotional material is approved when going through the

pre-approval process (if applicable)?

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15. Are there concerns about promotional activities? Who is taking action? Consumers? Industry competitors? Do you know of formal complaints being filed? What was the outcome? What do you think of the complaint mechanism?

16. Are there penalties against offenders? How many penalties were applied in the

last five years? Can you give examples? Are they published? Do the sanctions deter future violations? If not, why? (Clarify the sanctions and penalties stipulated by law) (Ask for a recent case)

17. How is data on violations collected? (Active vs Passive)

18. Can you describe the complaints system? How effective is it? 19. How are staffs recruited? How is a potential conflict of interest managed?

20. Are staffing roles clear? Is there an assessment on how effective staffs are in

fulfilling their roles? 21. What is your personal experience in performing your task in regulating medicines

promotion? 22. Are there different staffing complements responsible for (a) defining the

regulatory framework, (b) monitoring, and (c) enforcement? 23. What do you think of the budget and staffing allocated to the regulation of drug

promotion is sufficient? (How much and from which source?)

24. What can you say about the capacity of your organization in performing your task

as regulators?

(For PHAP): What can you say about the reach of your regulation relative to the size of the pharmaceutical industry in the country?

25. Who are the other stakeholders involved in regulation? What and how is your

agency’s relationship with them? 26. In your opinion what are the main strengths in the control of drug promotion in

your country? 27. In your opinion what are its main weaknesses? 28. Have important development affecting drug promotion regulation taken place

during the past few years? Are there important upcoming events which will likely influence medicine promotion regulation in your country or region? Please describe them.

50

29. What is the first thing you would do if you were in a position to change the regulatory situation on medicine promotion?

30. Is there a national law describing specific provisions guiding how interactions

between the pharmaceutical industry and medical practitioners?

51

Annex A2. Interview Schedule: Healthcare Professional Informant

Country

Date and Location


INTERVIEWEE

FULL NAME:


E-MAIL:

ADDRESS:

PHONE NUMBER:

INTERVIEWER

FULL NAME:

E-MAIL:

REMARKS:

52


53

31. Where do healthcare professionals usually go for information on medicines? Are there sources of independent information? Which sources do you use? How do you know about them?


33. Do healthcare professionals use treatment guidelines? Who is involved in their

development? On which basis? 34. Are medicines promoted for uses outside of approved indications? Which ones?

Do you have examples? 35. Do companies sponsor professional development such as scientific events or

Continuing Medical Education? Do sponsors have a role in choosing the speakers or setting the agenda?

36. What is the usual process to have a medicine added to a hospital formulary? Do

you think medicines promotion influences this process? In what way? 37. What information is given to patients when medicines are dispensed? (Package

inserts and labeling available) 38. Are prescription-only medicines advertised to the public? In which ways? Are


39. Do patient organizations advocate for specific medicines to be registered or

reimbursed in your country? Who funds these organizations? 40. Do patients request for specific brands of medicines? How much influence does it

have on prescribing practices? 41. Are prescription medicines available over the counter? Is this a widespread

phenomenon? (What proportion of sales?) 42. Are medicines sold informally on the (black) market, in kiosks? Are those

activities monitored? By whom? 43. Are you exposed to advertisements from other countries? Which countries?

Through which media? Are they different from advertisements from your country? How?

44. Are medicines prescribed by brand or generic name? Does it vary between

sectors (public and private)? How? 45. Is generic substitution allowed? Who is allowed to substitute? Is it done in actual

practice? What do patient think about it?

54

46. What is the relationship between health care professionals (doctors, pharmacists, others) and pharmaceutical companies?

47. Do doctors or other health professionals receive gifts from medicine providers or

producers? What kinds of gifts are most common? What do you think of this practice?

48. Do doctors receive free samples of medicines? How many free samples of

medicines do doctors receive on average in a month? What do you think about this practice?

49. Do doctors or pharmacists receive discounts, rebates or bonuses as an incentive

to prescribe and dispense more? 50. Are there concerns about promotional activities? Who is taking action?

Healthcare professionals? Consumers? Industry competitors? Do you know of formal complaints being filed? What was the outcome? What do you think of the complaint mechanism?

51. Are there penalties against offenders? Are they published? Do the sanctions

deter future violations? If not, why? Is corrective information given to healthcare professionals? Give examples.

52. In your opinion what are the main strengths in the way medicines promotion is

regulated in your country? 53. In your opinion what are its main weaknesses? 54. Have important developments affecting drug promotion regulation taken place

during the past few years? Are there important upcoming events which will likely influence medicine promotion regulation in your country or region? Please describe them.

55. What is the first thing you would do if you were in a position to change the

regulatory situation on medicine promotion?

55

Annex A3. Interview Schedule: Pharmaceutical Industry, the Insurers, and the Media

Country

Date and Location


INTERVIEWEE

FULL NAME:


E-MAIL:

ADDRESS:

PHONE NUMBER:

INTERVIEWER

FULL NAME:

E-MAIL:

REMARKS:

56


57


2. Do patients request for specific brands of medicines? How much influence

does it have on prescribing practices?

3. Do doctors or pharmacists receive discounts, rebates or bonuses as an incentive to prescribe and dispense more?

4. Are prescription-only medicines advertised to the public? In which ways? Are


5. Are prescription medicines available over the counter? Is this a widespread

phenomenon? (What proportion of sales?)

6. Are medicines sold informally on the (black) market, in kiosks? Are those activities monitored? By whom?

7. Does the pharmaceutical industry have an official role in the regulation of drug

promotion? Which sort of role? If the industry self regulates its promotional activities, does the government have an oversight on the mechanism? How? If not, do you think it has an informal role? How?


reimbursed in your country? Who funds these organizations?

9. Who is involved in the processes by which medicines are selected to be supplied and/or reimbursed? What is the influence of pharmaceutical companies?

10. Are medicines prescribed by brand or generic name? Does it vary between

sectors (public and private)? How?

11. Is generic substitution allowed? Who is allowed to substitute? Is it done in actual practice? What do patient think about it?

12. Do companies sponsor professional development such as scientific events or

Continuing Medical Education? Do sponsors have a role in choosing the speakers or setting the agenda?

13. Are medicines promoted for uses outside of approved indications? Which

ones? Do you have examples?

14. Does the pharmaceutical industry have a standard of how much spending is allowed for advertising / promoting of medical products? Is this information reported to the public domain?

58

15. Are there concerns about promotional activities? Who is taking action? Healthcare professionals? Consumers? Industry competitors? Do you know of formal complaints being filed? What was the outcome? What do you think of the complaint mechanism?


regulated in your country?

17. In your opinion what are its main weaknesses?

18. Have important developments affecting drug promotion regulation taken place during the past few years? Are there important upcoming events which will likely influence medicine promotion regulation in your country or region? Please describe them



59

Annex A4. Interview Schedule: Civil Society Organization or Patient Group or WHO Country Office

Country

Date and Location


INTERVIEWEE

FULL NAME:


E-MAIL:

ADDRESS:

PHONE NUMBER:

INTERVIEWER

FULL NAME:

E-MAIL:

REMARKS:

60


61

1. Where do consumers usually go for information on medicines? Are there sources of independent information? Which sources do you use? How do you know about them?

2. What do you think of the content of advertisements for medicines in general?

Do you think that information in advertisements is consistent with the actual product characteristics?

3. Are consumers exposed to advertisements from other countries? Which

countries? Through which media? Are they different from advertisements from your country? How?

4. What is the relationship between health care professionals (doctors,

pharmacists, others) and pharmaceutical companies?

5. Do doctors or other health professionals receive gifts from medicine providers or producers? What kinds of gifts are most common? What do you think of this practice?

6. Do doctors receive free samples of medicines? What do you think about this

practice?

7. Do doctors or pharmacists receive discounts, rebates or bonuses as an incentive to prescribe and dispense more?

8. Who is involved in the processes by which medicines are selected to be

supplied and/or reimbursed? What is the influence of pharmaceutical companies?


reimbursed in your country? Who funds these organizations?

10. Do companies sponsor professional development such as scientific events or Continuing Medical Education? Do sponsors have a role in choosing the speakers or setting the agenda?

11. Are medicines sold informally on the (black) market, in kiosks? Are those

activities monitored? By whom?

12. Are prescription medicines available over the counter? Is this a widespread phenomenon? (What proportion of sales?)

13. Are medicines promoted for uses outside of approved indications? Which

ones? Do you have examples?

14. Are prescription-only medicines advertised to the public? In which ways? Are there disease awareness campaigns in your country? Do they display brand names?

62

15. Are medicines prescribed by brand or generic name? Does it vary between sectors (public and private)? How?

16. Is generic substitution allowed? Who is allowed to substitute? Is it done in

actual practice? What do patient think about it?

17. Are there concerns about promotional activities? Who is taking action? Healthcare professionals? Consumers? Industry competitors? Do you know of formal complaints being filed? What was the outcome? What do you think of the complaint mechanism?

18. Are there penalties against offenders? Are they published? Do the sanctions

deter future violations? If not, why?

19. Are consumers/civil society organizations involved in regulating promotion? Does the pharmaceutical industry have an official role in the regulation of drug promotion? Which sort of role>

20. If the industry self regulates its promotional activities, does the government

have an oversight on the mechanism? How? If not, do you think it has an informal role? How?


regulated in your country?

22. In your opinion what are its main weaknesses?

23. Have important developments affecting drug promotion regulation taken place during the past few years? Are there important upcoming events which will likely influence medicine promotion regulation in your country or region? Please describe them



63

Annex B. Inventory of documents reviewed with provisions on regulating medicine promotion Legislative Documents

1. Medicines regulation law/act Republic Act 6675 “Generics Act of 1988.”

o Supported by: DOH Administrative Order No 51 series 1988 “Implementing Guidelines for Department of Health Compliance with Republic Act 6675 (Generics Act 1988)

o Supported by: DOH Administrative Order No 62 series 1989 “Rules and Regulations to Implement Prescribing Requirements under the Generics Act of 1988 (RA 6675); Amended in DOH AO 76 s 1989; Amendment in DOH AO 40 s 1990 Amendment to AO 62 s1989 re: Rules and Regulations to Implement Prescribing Requirements

o Supported by: DOH Administrative Order No 63 s 1989 “Rules and Regulations to Implement Dispensing Requirements under the Generics Act of 1986 (RA 6675); Amended in DOH AO no 77 s 1989

o Supported by: DOH AO No 169 s 2004 “Implementing Guidelines for the Exclusive Use of Generic Names or Generic Terminology in all Prescriptions and Orders in all DOH Facilities

DOH Administrative Order No. 65 s1989 “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988” o Supported by: DOH AO No. 69 s 1989 “Amendment to AO No 65 re:

Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988”

Republic Act 3720 “Food, Drugs and Devices and Cosmetics Act (1963) Republic Act 3720 “Food, Drugs and Devices and Cosmetics Act” as amended

by Executive Order No 175 (1987) Republic Act 9711 “Food and Drug Administration Act of 2009”

o Supported by: DOH Department Circular No 2011-0101 The Rules and Regulations Implementing Republic Act No 9711-The Food and Drug Administration Act of 2009

BFAD Regulation No. 5 s. 1987 “Guidelines on Advertisement and Promotions of Prescription Pharmaceutical Products”

FDA Circular No 2013 – 024 “Adoption and Implementation of ‘The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector” o Supported by: The Mexico Principles for Voluntary Codes of Business Ethics

in the Biopharmaceutical Sector

National Medicines Policy Executive Order 174 “Further Amending Republic Act 5921, Entitled ‘An Act

Regulating the Practice of Pharmacy and Setting Standards of Pharmaceutical Education in the Philippines and for other Purposes’ as Amended”. (1987)

Executive Order 175 “Further Amending Republic Act No. 3720 ‘An Act to Ensure the Safety and Purity of Foods, Drugs, and Cosmetics Being Made Available to the Public by Creating the Food and Drug Administration Which Shall Administer and Enforce the Laws Pertaining Thereto’, as Amended and for other Purposes.” (1987)

64

Memorandum Order No. 133 Directing the Secretary of Health to Properly Implement the National Drug Policy Set Forth in Executive Orders Nos. 174 and 175.

2. Supranational / regional agreements

ASEAN Common Technical Document / APEC Declaration for Ethical Marketing

of Bio-Pharmaceuticals o Concurred nationally through DOH Administrative Order No 2013 – 0021

“Adoption of the Association of Southeast Asian Nations (ASEAN) Common Technical Dossier (ACTD) and Common Technical Requirements (ACTR) for the Registration of Pharmaceutical Products for Human Use”

3. Sub-national policies/laws 4. Advertisement law 5. Commerce law 6. Consumer protection law

Republic Act 7394 “The Consumer Act of the Philippines” (1991)

7. Other WHO Ethical Criteria for Medicinal Drug Promotion (1988) Republic Act 8424 Tax Reform Act of 1997

Self- Regulation

1. Pharmaceutical industry code(s)

Pharmaceutical and Healthcare Association of the Philippines (PHAP) Code of

Practice (2013)

2. Related procedures for enforcement 3. Advertising industry code

ADBOARD Standards of Trade Practices and Conduct in the Advertising Industry

Others

1. Procedures for - obtaining pre-approval of advertisements for medicines

DOH Administrative Order No. 65 s1989 “Guidelines on Advertisement and

Promotions to Implement the Generics Act of 1988” FDA Memorandum Circular No 2013-028 General Guidelines on the Promo

Permit Applications and for other Purposes - complaining about medicines promotion

DOH Administrative Order No. 65 s1989 “Guidelines on Advertisement and

Promotions to Implement the Generics Act of 1988”

- sanctions and enforcement

65

DOH Administrative Order No. 65 s1989 “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988

Republic Act 6675 “Generics Act of 1988.”

2. Annual reports / descriptive material on the work of regulatory authorities on promotion

3. List of institutions or departments involved in promotion regulation and the areas the cover (organigram) Organization Structure of Food and Drug Administration

4. Number of staff involved in promotion regulation and their positions (organigram) 5. Description of activities the bodies involved in promotion regulation

Republic Act 3720 “Food, Drugs and Devices and Cosmetics Act (1963) Republic Act 3720 “Food, Drugs and Devices and Cosmetics Act” as amended

by Executive Order No 175 (1987) Republic Act 9711 “Food and Drug Administration Act of 2009 Pharmaceutical and Healthcare Association of the Philippines Code of Practice

(2013)

6. Conflicts of interests policies of the bodies involved in promotion regulation

Republic Act 9711 Food and Drugs Administration Act of 2009

7. Published research on promotion in the country 8. Other relevant policies / regulation from

- Professional associations Code of Ethics of the Philippine Medical Association

- Medical schools - Hospitals - Scientific offices

66

Annex C. Document Checklist This checklist is indicative and aims at helping the researcher in his work by giving indicators as to which documents might be relevant to medicines promotion and control. Many countries might have only few of these documents available. The material found shall be used as support to answer the questions in the data compilation part.

Document Exist / does not exist

Name of the document and date

Source (if available on the internet, please include URL) Reason, if not provided

Legislative documents

Medicines regulation law / act

Exist Republic Act 6675 “Generics Act of 1988”

Website of the Food and Drug Administration http://www.fda.gov.ph/issuances/29035-repubic-act-no-6675-generic-act-of-1988

DOH Administrative Order No. 51 series 1988 “Implementing Guidelines for Department of Health Compliance with Republic Act 6675 (Generics Act of 1988)

Website of the Food and Drug Administration http://old.fda.gov.ph/AO/ao%2051%20s%201988.pdf

DOH Administrative Order No 62 s 1989 “Rules and Regulations to Implement Prescribing Requirements under the Generics Act of 1988 (RA 6675)

Website of the Food and Drugs Administration http://old.fda.gov.ph/AO/ao%2062%20s%201989.pdf

DOH Administrative Website of the Food and Drug Administration

http://www.fda.gov.ph/issuances/29035-repubic-act-no-6675-generic-act-of-1988

http://old.fda.gov.ph/AO/ao%2051%20s%201988.pdf


67

Order No 63 s 1989 Rules and Regulations to Implement Dispensing Requirements under the Generics Act of 1986 (RA 6675)


DOH Administrative Order No. 65 s. 1989 “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988


DOH AO 69 s 1989 Amendment to AO No 65 re: Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988

Website of the Department of Health http://home.doh.gov.ph/ais_public/aopdf/ao_backup/ao/htm_bkup/ao_all.htm

Republic Act 3720 “Foods, Drugs and Cosmetics Act” (1963)

Website of The LAWPhilProject, Arellano Law Foundation, Philippine Laws and Jurisprudence Databank http://www.lawphil.net/statutes/repacts/ra1963/ra_3720_1963.html

Republic Act 3720 “Foods, Drugs and Devices, and Cosmetics Act” as amended by Executive Order 175 (1987)

Website of the Food and Drug Administration http://www.fda.gov.ph/attachments/article/29032/RA%203720.pdf

Republic Act 9711 “Food and Drug Administration Act of 2009”

Website of the Food and Drug Administration http://old.fda.gov.ph/republic%20acts/RA%209711-BFAD%20Strengthening%20Law.pdf

DOH Department Website of the Food and Drug Administration



http://home.doh.gov.ph/ais_public/aopdf/ao_backup/ao/htm_bkup/ao_all.htm

http://www.lawphil.net/statutes/repacts/ra1963/ra_3720_1963.html

http://www.fda.gov.ph/attachments/article/29032/RA%203720.pdf

http://old.fda.gov.ph/republic%20acts/RA%209711-BFAD%20Strengthening%20Law.pdf


68

Circular No 2011-0101 The Rules and Regulations Implementing Republic Act No 9711-The Food and Drug Administration Act of 2009

http://old.fda.gov.ph/Department%20Circular/IRR%20of%20RA%209711.pdf

BFAD Regulation No. 5 s. 1987 “Guidelines on Advertisement and Promotions of Prescription Pharmaceutical Products

Website of the Food and Drug Administration

FDA Circular No 2013 – 024 “Adoption and Implementation of ‘The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector”

Website of the Food and Drug Administration http://www.fda.gov.ph/attachments/article/103511/Fda%20Circular%20No.2013-024%20Adoption.......new.pdf

The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector

Website of PHAP: http://www.phap.org.ph/files/ethics/Mexico-City-Declaration.pdf

National Medicines Policy

Exist Executive Order Number 174

Website of the Food and Drug Administration http://www.fda.gov.ph/attachments/article/29033/eo%20174.pdf

Executive Order Number 175

http://old.fda.gov.ph/republic%20acts/eo%20175.pdf

Memorandum Order No 133

Website of the Food and Drug Administration http://www.gov.ph/downloads/1987/11nov/19871118-MO-0133-CCA.pdf

http://old.fda.gov.ph/Department%20Circular/IRR%20of%20RA%209711.pdf

http://www.fda.gov.ph/attachments/article/103511/Fda%20Circular%20No.2013-024%20Adoption.......new.pdf

http://www.fda.gov.ph/attachments/article/103511/Fda%20Circular%20No.2013-024%20Adoption.......new.pdf

http://www.phap.org.ph/files/ethics/Mexico-City-Declaration.pdf

http://www.fda.gov.ph/attachments/article/29033/eo%20174.pdf

http://old.fda.gov.ph/republic%20acts/eo%20175.pdf

http://www.gov.ph/downloads/1987/11nov/19871118-MO-0133-CCA.pdf

69

If relevant, provisions pertaining to medicines promotion in:

Supranational / regional agreements

Exist ASEAN Common Technical Document / APEC Declaration for Ethical Marketing of Bio-Pharmaceuticals

Sub national policies / laws

Advertisement law

Commerce law

Consumer protection law

Exist Republic Act 7394 The Consumer Act of the Philippines (1991)

Website of the Food and Drug Administration http://dtincr.ph/files/LawsAndPolicies-ConsumerAct.pdf

Other (guidelines, codes)

Exist WHO Ethical Criteria for Medicinal Drug Promotion (1988)

Website of the World Health Organization http://apps.who.int/medicinedocs/en/m/abstract/Jwhozip08e/

Republic Act 8424 Tax Reform Act of 1997

Website of the Bureau of Internal Revenue http://www.bir.gov.ph/taxcode/taxcode.htm

Self - Regulation

Pharmaceutical industry code (s)

Exist Pharmaceutical and Healthcare Association of the Philippines Code of Practice (2013)

Website of Philippine Healthcare Association of the Philippines http://www.phap.org.ph/sub.php?id=4&sid=18

Code of Ethics of the Philippine Medical Association

Website of the Philippine Medical Association https://www.philippinemedicalassociation.org/downloads/pma-codes/FINAL-PMA-CODEOFETHICS2008.pdf

Advertising agency

Exist ADBOARD Standards of Trade Practices and

Website of ADBOARD http://adboard.amplified360.com/sites/default/files/STANDARDS%20OF%20TRAD

http://dtincr.ph/files/LawsAndPolicies-ConsumerAct.pdf

http://apps.who.int/medicinedocs/en/m/abstract/Jwhozip08e/

http://www.bir.gov.ph/taxcode/taxcode.htm

http://www.phap.org.ph/sub.php?id=4&sid=18




70

industry code

Conduct in the Advertising Industry (2006)

E%20PRACTICES%20%26%20CONDUCT%20MANUAL.pdf

Related procedures for enforcement

Other Relevant Documents

Procedures for:

-obtaining pre-approval of advertisements for medicines

Exist DOH Administrative Order No. 65 s. 1989 “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988


FDA Memorandum Circular No 2013-028 General Guidelines on the Promo Permit Applications and for other Purposes

Website of the Food and Drug Administration

-complaining about medicines promotion

Exist DOH Administrative Order No. 65 s. 1989 “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988


-sanctions and enforcement

Exist DOH Administrative Order No. 65 s. 1989 “Guidelines on Advertisement and Promotions to






71

Implement the Generics Act of 1988

Annual reports/descriptive material on the work or regulatory authorities on promotion

List of institutions or departments involved in promotion regulation and the areas they cover (organigram)

Number of staff involved in promotion regulation and their positions (organigram)

Description of activities the bodies involved in promotion regulation

Exist Republic Act 3720 “Foods, Drugs and Cosmetics Act” (1963)

Website of The LAWPhilProject, Arellano Law Foundation, Philippine Laws and Jurisprudence Databank http://www.lawphil.net/statutes/repacts/ra1963/ra_3720_1963.html

Republic Act 3720 “Foods, Drugs and

Website of the Food and Drug Administration http://www.fda.gov.ph/attachments/article/29032/RA%203720.pdf

http://www.lawphil.net/statutes/repacts/ra1963/ra_3720_1963.html

http://www.fda.gov.ph/attachments/article/29032/RA%203720.pdf

72

Devices, and Cosmetics Act” as amended by Executive Order 175 (1987)

Republic Act 9711 “Food and Drug Administration Act of 2009”


Pharmaceutical and Healthcare Association of the Philippines Code of Practice (2013)

Conflicts of interests policies of the bodies involved in promotion regulation

Exist Republic Act 9711 “Food and Drug Administration Act of 2009”


Published research on promotion in the country (GGM/MeTA/other)

Other relevant policies / regulation from:

Professional associations

Exist Code of Ethics of the Philippine Medical Association

Website of the Philippine Medical Association https://www.philippinemedicalassociation.org/downloads/pma-codes/FINAL-PMA-CODEOFETHICS2008.pdf

Medical schools







73

Hospitals

Scientific offices

74

Annex D. Data Compilation Tool

Scope of the regulation Republic Act 6675 “Generics Act of 1988

1. What is defined as “advertisement”? -

2. What is defined as “promotion”? -

3. What are the provisions concerning medicines promotion / advertisement?

It is hereby declared the policy of the State: to promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs. [Section 2] It is hereby declared the policy of the State: to emphasize the scientific basis for the use of drugs, in order that health professionals may become more aware and cognizant of the therapeutic effectiveness [Section 2] In the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drug List…[Section 4]

4. Does it cover traditional medicines, complementary medicines? How?

-

5. Do advertisements have to comply with approved product information/label?

-

6. Are certain categories of medicines banned from advertising? Which ones (unregistered medicines, narcotics…)?

-

7. Is advertising to the general public authorized? For which substances? Through which media?

Drug outlets, including drugstores, hospital and non-hospital pharmacies and non-traditional outlets such as supermarkets and stores shall inform any buyer about all other drug products having the same generic name, together with their corresponding prices so that the buyer may adequately exercise his option…shall post in conspicuous places in their establishment a list of drug products with the same generic name and their corresponding prices (RA 6675 Sec 6.c)

75

8. For which medicines is advertising to health professionals authorized? Through which media? (e.g. medical journals only?)

-

9. What information has to be included in an advertisement? Specify by media type.

To promote, encourage and require the use of generic terminology in the importation, manufacture, distribution, marketing, advertising and promotion, prescription and dispensing of drugs (RA 6675, Sec 2) In the promotion of the generic names for pharmaceutical products, special consideration shall be given to drugs and medicines which are included in the Essential Drug List…(RA 6675, Sec4) Any organization or company involved in the manufacture, importation, repacking, marketing and/or distribution of drugs and medicine shall indicate prominently the generic name of the product labels as well as in advertising and other promotional materials (RA 6675 Sec 6.b)

10. Are requirements for advertising identical for exported and/or imported medicines and/or locally produced medicines?

-

11. Are there minimal qualifications listed as necessary to be a pharmaceutical sales representative? What are they?

-

Forms of promotion covered: what is written about…

12. Gifts/payments to doctors or other health professionals -

13. Pharmaceutical sales representatives’ interaction with healthcare professionals

-

14. Discounts and rebates on medicines -

15. Distribution of free medicine samples -

16. Sponsorship of Continuing Medical or Pharmacy Education -

17. Sponsorship of scientific meetings -

18. Information to patients (package insert contents) -

19. Packaging and labeling In order to assure responsibility of drug quality in all instances, the label of drugs and medicine shall have the following: name and country of manufacture, dates of manufacture and expiration. The quality of such generically labeled drugs and medicines shall be duly certified by the Department of Health (RA 6675 s7)

20. Internet and related social networking media -

76

21. Post-marketing studies -

22. Clinical trials and promotion -

23. Promotion of off-label indications -

24. Other -

Scope of the regulation DOH Administrative Order No 51 series of 1988 Implementing Guidelines for Department of Health Compliance with Republic Act 6675

(Generics Act of 1988)




-


-


-


-


All heads of agencies shall take the necessary and sufficient steps to inform the public about measures to implement RA 6675 and the rationale for these measures. The Public Information and Health Education Service at the central office shall produce and disseminate informational materials necessary to inform the public on these matters. [DOH AO 51 s1988 14.1 and 14.3]


Heads of agencies, assisted by their respective Therapeutic Committees, shall plan and undertake promotional activities among DOH personnel, particularly physicians and nurses. These activities should (a) clarify the provisions of the law and the implementing regulations (b) explain the reasons for generic names in drug use; (c) answer the most common misinformation, apprehensions and complaints. The central staff for NDP implementation shall organize and deploy well qualified resource persons for lectures and seminars on NDP implementation. [DOH AO 51 s1988 15]

77


-


-


-




-






19. Packaging and labeling -





24. Other -

Scope of the regulation DOH Administrative Order No. 65 s1989 “Guidelines on Advertisement and Promotions to Implement the Generics Act of 1988”

1. What is defined as “advertisement”? Advertisement – any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any pharmaceutical product [Section 1.1]

2. What is defined as “promotion”?

Promotion – practice of giving temporary additional value to a brand, product, or service to achieve specific marketing objectives. This includes the distribution of free / sample pharmaceutical products. [Section 1.2]


All therapeutic claims for drugs, medicines or any pharmaceutical product made in advertising or promotional materials must be based

78

on adequate scientific, pharmacological, and clinical evidence, responsible medical opinion or long experience demonstrating their safety, efficacy and therapeutic value, and must be within their therapeutic indications approved by the BFAD [Section 2.2]


Pharmaceutical products, prescription or ethical drugs, non-prescription drugs / over the counter drugs [Section 1]


Consistent with section 6 ( c ) of RA 6675, all advertising and promotional materials, whether print, visual or auditory, shall feature prominently the generic name of the drug product designated by BFAD. In the case of branded products, the prominence of the generic name shall be insured in all print, visual or auditory materials that feature the brand name. No pharmaceutical product classified by BFAD as a Prescription or Ethical Drug shall be advertised or promoted in any form of mass media except through medical journals, publications and/or literature solely intended for medical and allied professions. [Section 3.1]


No person shall advertise or promote a pharmaceutical product unless such product is duly-registered by Bureau of Food and Drugs <BFAD> [Section 2.1]


No pharmaceutical product classified by BFAD as a Prescription or Ethical Drug shall be advertised or promoted in any form of mass media except through medical journals, publications and/or literature solely intended for medical and allied professions. [DOH AO No 65 s1989, Section 2.3]


No pharmaceutical product classified by BFAD as a Prescription or Ethical Drug shall be advertised or promoted in any form of mass media except through medical journals, publications and/or literature solely intended for medical and allied professions. [DOH AO No 65 s1989, Section 2.3]


Consistent with section 6 ( c ) of RA 6675, all advertising and promotional materials, whether print, visual or auditory, shall feature prominently the generic name of the drug product designated by BFAD. In the case of branded products, the prominence of the generic name shall be insured in all print, visual or auditory materials that feature the brand name. No pharmaceutical product classified by

79

BFAD as a Prescription or Ethical Drug shall be advertised or promoted in any form of mass media except through medical journals, publications and/or literature solely intended for medical and allied professions. [Section 3.1] Print and Static Visual Materials (e.g., posters, billboards) – the pertinent provisions of AO 55 s 1988…in all cases, the generic name shall be prominently printed element on the advertising and other promotional material defined as the one with the highest point size among the various printed elements on the advertising and other promotional material. It shall be enclosed exclusively by an outlined box rendered in the same color as the generic name. The background color inside the box, against which the generic name is rendered, should be the same color as the background color outside the box, against which the brand name is rendered. [Section 3.2] For other forms of visual materials, such as television, cinema or movies, etc, the general principle in 3.1 will be applied, and consistent with AO 55 s. 1988 as amended, the generic name designated by BFAD shall appear prominently within the outlined box, immediately above an in larger point-size than the brand name, if any. No pharmaceutical product classified by BFAD as a Prescription or Ethical Drug shall be advertised or promoted in any form of mass media except through medical journals, publications and/or literature solely intended for medical and allied professions. [DOH AO No 65 s1989, Section 3.3] For auditory materials used in radio or other media, the general principle in 3.1 will be adopted according to the convention of the medium. [Section 3.4]


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24. Other The pharmaceutical company which owns the pharmaceutical product, and its Medical Director shall be responsible and accountable for the content and form of its advertisement and promotional material (Section 2.4)

Scope of the regulation Executive Order No. 174 (1987)




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Drug means (1) articles recognized in the current official United States Pharmacopoeia or the United States Official National Formulary (ISP-NF), official Homeopathic Pharmacopoeia of the United States, official National Drug Formulary, or any supplement to any of them; and (2) articles intended for use in the prevention of disease in man or animals; (3) articles (other than food) intended to affect the structure or function of the body of man or animals; and articles intended for use as a component of any articles specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories.

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[Section 3]


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24. Other -

Scope of the regulation Executive Order 175 (1987)


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-


Drug means (1) articles recognized in the current official United States Pharmacopoeia or the United States Official National Formulary (ISP-NF), official Homeopathic Pharmacopoeia of the United States, official National Drug Formulary, or any supplement to any of them; and (2) articles intended for use in the prevention of disease in man or animals; (3) articles (other than food) intended to affect the structure or function of the body of man or animals; and articles intended for use as a component of any articles specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories. [Section 5]


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Section 11 of RA 3720 is amended to read: The following acts and causing thereof are hereby prohibited: (k) The manufacture, importation, exportation, sale, offering for sale, distribution, or transfer of any drug or device by any person without the license from the Bureau required under this Act [Section 7]


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13. Pharmaceutical sales representatives’ interaction with -

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healthcare professionals






19. Packaging and labeling Section 11 of RA 3720 is amended to read: The following acts and causing thereof are hereby prohibited: (h) The use, on the labeling of any drugs or in any advertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one and twenty-one B hereof, or that such drug complex with the provisions of such actions. [Section 7] Section 19 of RA 3720 is amended to read as “A drug or device shall be deemed misbranded: if the labeling is false or misleading in any particular; if any word, statement or other information required by or under authority of This Act to appear on the label or labeling is not prominently placed thereon…; unless the labeling bears adequate directions for use and such adequate warning against use in those pathological conditions or by children…; [Section 11]





24. Other -

Scope of the regulation Memorandum Order No 133




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Wider dissemination of adequate and accurate information on drugs and medicines to both physicians and the public at large


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24. Other -

Scope of the regulation

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BFAD Regulation No 5 s 1987 Guidelines on Advertisement and Promotions of Prescription Pharmaceutical Products (1987)

1. What is defined as “advertisement”? Any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any pharmaceutical product. [Section 1.a]

2. What is defined as “promotion”? The practice of giving temporary additional value to a brand, product, or service to achieve specific marketing objectives. It includes the distribution of free/sample pharmaceutical products. [Section 1.b]


No person shall advertise or promote prescription drugs unless such product is duly registered by the BFAD [Section 2]


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No pharmaceutical product classified by the BFAD as a prescription drug shall be advertised or promoted in any form or mass media except through medical journals, publications and/or literature solely intended for medical and allied profession. [Section 4] Any change in product presentation, such as change in packaging, of a prescription drug may be advertised for public information, provided no medical claims, comparative statements, or promotional messages are included in the announcement, provided further that the following statement is always clearly indicated: “This pharmaceutical drug product is approved for sale by BFAD as a prescription drug and should be bought only with a prescription. [Section 5]


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11. Are there minimal qualifications listed as necessary to be a -

86

pharmaceutical sales representative? What are they?




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15. Distribution of free medicine samples The giving of sample of a prescription drug direct to the lay public is strictly prohibited. The distribution of free/sample pharmaceutical products during medical missions and within outpatient dispensaries is not considered a violation of this provision provided that the distribution is under the supervision of a physician. [Section 6]









24. Other -

Scope of the regulation FDA Circular No 2013-024 Adoption and Implementation of “The Mexico City Principles for Voluntary Codes of Business Ethics in the

Biopharmaceutical Sector”

1. What is defined as “advertisement”?



To officially adopt and implement “The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector” [Objectives]



6. Are certain categories of medicines banned from advertising?

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Which ones (unregistered medicines, narcotics…)?







12. Gifts/payments to doctors or other health professionals


…It is essential that professionalism and high ethical standard are maintained between the biopharmaceutical companies, the health professionals, and the regulatory body. [Rationale]

14. Discounts and rebates on medicines

15. Distribution of free medicine samples

16. Sponsorship of Continuing Medical or Pharmacy Education

17. Sponsorship of scientific meetings

18. Information to patients (package insert contents)

19. Packaging and labeling

20. Internet and related social networking media

21. Post-marketing studies

22. Clinical trials and promotion

23. Promotion of off-label indications

24. Other

Scope of the regulation The Mexico City Principles for Voluntary Codes of Business Ethics in the Biopharmaceutical Sector



3. What are the provisions concerning medicines promotion / No medicines shall be promoted for use in a specific economy until

88

advertisement?

the requisite approval for marketing for such use has been given in that economy. Promotion should be consistent with locally approved product information [Section 2.A] Promotional information should be clear, legible, accurate, balanced, fair, objective and sufficiently complete to enable healthcare professionals to form his or her own opinion of the therapeutic value of the medicines concerned [Section 2.B]







For Medical Professionals: Companies have an obligation and responsibility to provide objective, accurate, balanced information about their medicines to healthcare professionals…[Preamble 5]



Companies should ensure that all representatives who are employed by or acting on behalf of the companies, and who visit healthcare professionals, receive training about the applicable laws, regulations and industry codes of this..ensure that they have sufficient knowledge of general science and product-specific information… [Section 12.A.1]


12. Gifts/payments to doctors or other healt professionals Payments in cash or cash equivalents (such as gift certificates) or gifts for the personal benefit of healthcare professionals should not be provided or offered to healthcare professionals. [Section 7]


Ethical relationships with healthcare professionals, government officials, patients and other stakeholders are critical to the mission of Companies to help patients by developing and making medicines

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available [Preamble 2] In interacting with all stakeholders, Companies are committed to following the highest ethical standards as well as all applicable laws and regulations. [Preamble 3] All interaction with healthcare professionals are to be conducted in a professional and ethical manner. [Section 1.C]

1. Healthcare professionals must not be improperly influenced by Companies.

2. Nothing should be offered or provided by a Company in a manner that inappropriately influences a healthcare professional’s prescribing practices.

3. Education and promotional activities should encourage the appropriate use of medicines by presenting them objectively and without exaggerating their properties, and should be in compliance with the provisions prescribed by these Principles and applicable local, national, and regional industry codes of ethics.

4. Relationships between Company personnel and healthcare professionals should encourage the development of a medical practice committed to patients’ well-being and be based on truthful, accurate, and updated evidence.

In order to provide important scientific information and to respect health professionals’ abilities to manage their schedules and provide patient care, Company representatives may take the opportunity to present information during healthcare professionals’ working day, including mealtimes, in accordance with applicable laws and regulations. [Section 5.A]


15. Distribution of free medicine samples In accordance with local laws and regulation, samples of medicines supplied at no charge may be provided to healthcare professionals in order to enhance patient care. Samples must not be resold or otherwise misused. [Section 9.B]

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16. Sponsorship of Continuing Medical or Pharmacy Education Financial support is not an inducement to prescribe or recommend a particular medicine or course of treatment. [Section 8.A.1] Grants, scholarships, subsidies, consulting contracts, educational or practice related items should not be provided or offered to a healthcare professional in exchange for recommending and prescribing medicines, or otherwise in a manner that would interfere with the ethics and the independence of a healthcare professional’s prescribing practices. [Section 8.B]

17. Sponsorship of scientific meetings The purpose and focus of all symposia, congresses and other promotional or non-promotional, scientific or professional meetings (an “Event”) for healthcare professionals organized or sponsored by a Company should be to inform healthcare professionals about products and/or to provide scientific or educational information. [Section 4] Any sponsorship provided to individual healthcare professionals must not be conditional upon an obligation to prescribe, recommend, or promote any medicine. [Section 4.c]




21. Post-marketing studies Clinical assessments, postmarketing surveillance and experience programmes and postauthorization studies must be disguised promotion. Such assessments, programmes and studies must be conducted with a primarily scientific or educational purpose. [Section 2.B.4]

22. Clinical trials and promotion Clinical trials should not be used as inappropriate inducements for past or future sales. [Section 14.B]


24. Other Company interactions are professional in nature and are intended to facilitate the exchange of medical or scientific information that will benefit patient care. (Referring to entertainment sponsorship) [Section 6]

Companies should continue to ensure that consultant and speaking arrangements are neither inducements nor rewards for prescribing or

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recommending a particular medicine or course of treatment. [Section 10.1] Any compensation or reimbursement made in conjunction with a consulting or speaking arrangement should be reasonable and based on fair market value.

Compliance with Public Section Relationship and Procurement laws [Section 13]

On donations for charitable purposes: companies should ensure that such support is not undertaken solely for product promotional reasons, and is not directed solely for product promotion purposes…no incentives to prescribe, recommend, purchase, supply or administer a product based on financial support [Section 15]

Respect to patient organization autonomy and support must not be conditional on the promotion of a specific medicine [Section 16]

Scope of the regulation









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24. Other

Scope of the regulation Republic Act 7394 “The Consumer Act of the Philippines”

1. What is defined as “advertisement”? Advertising – the business of conceptualizing, presenting or making available to the public, through any form of mass media, fact, data or information about the attributes, features, quality or availability of consumer products, services or credit [Art 4.b]

2. What is defined as “promotion”? Sales promotion – techniques intended for brand consumer participation which contain promises of gain such as product, security service or winning in contest, game, tournament and other similar competitions which involved determination of winner/s and which utilizes mass media or other widespread media of information. It also

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means techniques purely intended to increase the sales, patronage and/or goodwill of a product [Art 1.bm]


Protection against deceptive, unfair and unconscionable sales acts or practices [Title III] In general – The state shall promote and encourage fair, honest and equitable relations among parties in consumer transactions and protect the consumer against deceptive, unfair and unconscionable sales acts or practices. [Art 48] In general – A deceptive act or practice by a seller or supplier in connection with a consumer transaction violates this Act whether it occurs before, during or after the transaction. An act or practice shall be deemed deceptive whenever the producer, manufacturer, supplier or seller through concealment, false representation of fraudulent manipulation, induces a consumer to enter into a sales or lease transaction of any consumer product or service [Art 50] Proper labeling of food, drugs, cosmetics and devices [Title III, Chapter IV] The State shall enforce compulsory labeling and fair packaging to enable the consumer to obtain accurate information as to the nature, quality and quantity of the contents of consumer products and to facilitate his comparison of the value of such products. [Art 74] The Generics Act shall apply in the labeling of drugs [Art 86] The state shall protect the consumer from misleading advertisement and fraudulent sales and promotion practices [Art 108] Special Advertising Requirements for Food, Drug, Cosmetic, Device or Hazardous substance [Art 112] a. No claim in the advertisement may be made which is not contained

in the label or approved by the concerned department b. No person shall advertise any food, drug, cosmetic, devise or

hazardous substance in a manner that is false, impression regarding its character, value, quantity, composition, merit, safety.

c. Where a standard has been prescribed for a food, drug, cosmetic, or device, no person shall advertise any article or substance in

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such a manner that is likely to be mistaken for such product, unless the article complies with the prescribed standard or regulation.

d. No person shall, in the advertisement of any food, drug, cosmetic, devise or hazardous substance, make use of any reference to any laboratory report of analysis required to be furnished to the concerned department, unless such laboratory report is duly approved by such department

e. Any businessman who is doubtful as to whether his advertisement relative to food, drug, cosmetics, device or hazardous substance will violate or does not conform with this Act or the concerned department’s pertinent rules and regulations may apply to the same advertisement is disseminated to the public. In this case, the concerned department gives its opinion and notify the applicant of its action within thirty (30) days from the date of application, otherwise, the application shall be deemed approved.

f. No person shall advertise any food, drug, cosmetic, device, or hazardous substance unless such product is duly registered and approved by the concerned department for such use in any advertisement.


Drugs – included herbal and / or traditional drug [Article 4.ad]


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-

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-



16. Sponsorship of Continuing Medical or Pharmacy Education --



19. Packaging and labeling Proper labeling of food, drugs, cosmetics and devices [Title III, Chapter IV] The State shall enforce compulsory labeling and fair packaging to enable the consumer to obtain accurate information as to the nature, quality and quantity of the contents of consumer products and to facilitate his comparison of the value of such products. [Art 74] The Generics Act shall apply in the labeling of drugs [Art 86]





24. Other -

Scope of the regulation Republic Act 3720, Food, Drug and Cosmetic Act (1963)

Republic Act 3720, Food, Drug and Cosmetic Act, as Amended




-


“Drug” – articles recognized in the official United States Pharmacopoeia, official Homoepathic Pharmacopoeia of the United States or official National Formulary, or any supplement to any of them; and (2) articles intended for use in the diagnosis, cure,

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mitigation, treatment, or prevention of disease in man or other animals; and (3) articles (other than food) intended to affect the structure or any function of the body of man or animals; and (4) articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but not included devices or their components, parts, or accessories [RA 3720 Section 10]


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The following acts and the causing thereof are hereby prohibited: (a) the manufacture, sale, offering for sale or transfer of any food, drug, device or cosmetic that is adulterated or misbranded; The use, on the labeling of any drug or in any advertising relating to such drug, of any representation or suggestion that an application with respect to such drug is effective under Section twenty-one hereof (NEW DRUGS), or that such drug complies with the provisions of such section; the use in labeling, advertising or other sales promotion of any reference to any report or analysis furnished in compliance with Section twenty-six hereof (RA 3720, Section 11) The manufacture, importation, exportation, sale, offering for sale, distribution, or transfer of any drug or device which is not registered with the bureau pursuant to this act [RA 3720, Chapter VI, j] No person shall manufacture, sell, offer for the sale or transfer any new drug, unless an application filed pursuant to subsection (b) is effective with respect to such drug [RA 3720 Section 21]


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11. Are there minimal qualifications listed as necessary to be a -

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pharmaceutical sales representative? What are they?




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24. Other -

Scope of the regulation Republic Act 9711 Food and Drug Administration Act of 2009




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“Drug” means (1) articles recognized in official pharmacopeias and formularies, including official homeopathic pharmacopeias, or any documentary supplement to any of them, which are recognized and adopted by the FDA; (2) articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals; (3) articles (other than food) intended to affect the structure of any function of the body of humans or animals; or (4) articles intended for use as a component of any articles specified in clauses (1), (2) or (3) but do not include devices or their components, parts or accessories. [RA 9711 Section 10, f]

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-


The following acts and the causing thereof are hereby prohibited: (a) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertising or sponsorship of any health product that is adulterated, unregistered or misbranded; (j) The manufacture, importation, exportation, sale, offering for sale, distribution, transfer, non-consumer use, promotion, advertisement, or sponsorship of any health product which, although requiring registration is not registered with the FDA pursuant to this Act. [RA 9711 Section 11]


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24. Other -

Scope of the regulation DOH Department Circular 2011-0101

The Rules and Regulations Implementing Republic Act No 9711-The Food and Drug Administration Act of 2009




No health product that has not been registered or authorized shall be advertised, promoted or subjected to any marketing activities; No claim in the advertisement, promotion and sponsorship, and other marketing activities shall be made other than those contained in the approved label or packaging or the health product, or as duly approved by the FDA; No claims, therapeutic or scientific otherwise, shall be made that has not been duly approved by the FDA; All health products that are permitted to be promoted must specifically state the authority or reference number that approved the same promotional, sponsorship, or marketing activities. [Article V Section 2]


Drug means (1) Articles recognized in official pharmacopoeias and formularies,

including official homeopathic pharmacopoeias or any documentary supplement to any of them, which are recognized and adopted by the FDA;

(2) Articles intended for use in the diagnosis, cure, mitigation, treatment, or prevention of disease in man or other animals;

(3) Articles (other than food) intended to affect the structure of any function of the body of human beings or animals; or

(4) Articles intended for use as a component of any articles specified in clauses (1), (2), or (3) but do not include devices or their component, parts or accessories.

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24. Other

Scope of the regulation Pharmaceutical and Healthcare Association of the Philippines (PHAP) Code of Practice (2013)

1. What is defined as “advertisement”? Advertisement: promotion of a product, service, advocacy or institution

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by way of paid placement through media (print, broadcast, billboards, collaterals) at a guaranteed target date and time. This includes any representation by any means whatever for the purpose of promoting directly or indirectly the sale or disposal of any pharmaceutical product. [Appendix]

2. What is defined as “promotion”? Promotion – the practice of giving temporary additional value to a brand, product or service to achieve scientific marketing objectives. This includes distribution of free/sample pharmaceutical products.


Promotion must be ethical, accurate, balanced and must not be misleading. Information in promotional materials must support proper assessment of the risks and benefits of the product and its appropriate use [Guiding Principle]. All promotional and educational material (including graphics and other visual representations) must conform to generally accepted standards of good taste and recognize the professional standing of the recipients. These materials must not contain anything that would likely cause serious or widespread offense against prevailing community standards. [2.4] Unqualified superlatives must not be used. All claims must not imply that a product or an active ingredient is ‘unique’ or has some special merit, quality or property, unless the claim (s) can be substantiated. The word ‘safe’ for example must not be used without qualification. [2.5] Comparison of products must not be disparaging but must be factual, fair and capable of substantiation and referenced to its source. Care must be taken to ensure that it does not mislead by distortion, by undue emphasis or by any other way. Clinical terminology, rather than mere claims that a product is better, stronger or more widely prescribed, should be used to describe improved benefits. [2.7.1] Promotional information should not imitate the devices, copy, slogans, or general layout adapted by other manufacturers in a way that is

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likely to mislead or confuse [2.8]


Pharmaceutical Product – any pharmaceutical or biological product (irrespective of patent status and/or whether the product is branded or not) which is intended to be used on the prescription of, or under the supervision of a healthcare professional, and which is intended for use in the prevention, diagnosis and treatment of disease in humans, or to affect the structure of any function of the human body [1.1] The Code does not seek to regulate the following activities: promotion / advertising / detailing of over-the-counter products to the trade and public.


It is the responsibility of companies, their employees and their medical / technical advisers to ensure that the contents of all promotional and medical claims are balanced, accurate, correct and fully supported by the Product Information, literature or “Data on File” or appropriate industry source, where these do not conflict with the Product Information. [2.1]


Products that have not been approved for registration by the FDA cannot be promoted. This restriction also applies to unapproved indications for registered products. [2.3.1]


Lay media advertising shall not be allowed for prescription products. [4.8] More specifications are given. It should encourage health seeking behavior to appropriate healthcare professional. [16.1-16.10]


Advertisement in healthcare professional journals must contain the following (a) brand name, (b) generic name of the active substances, (c) name and address of the supplier, (d) full disclosure product information in advertisements appearing within 12 months after product launch, (e) the clause “Please review product information before prescribing” and (f) date of production of the advertisement. The minimum information needed when there is no promotional claims : (g) brand name, (h) generic name, (i) name and address of the supplier, (j) the statement “Additional information is available upon request” [4.1]

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MIMS advertising shall also abide by the requirement for journal advertising [4.2] Company commissioned articles must be identified and the PHAP member responsible should be clearly identified at either the top of the bottom of the article. It must conform to all relevant provisions. [4.3] Short advertisements in reference manuals shall correspond to the requirements of full product information. [4.4]


All information, claims and graphical representations provided to healthcare professionals and members of the general public must be current, accurate, balanced and must not be misleading either directly by implications or by omission. [2.3] A full disclosure Product Information must accompany all promotional materials for at least 12 months from the date of product launch. Product Information should include (a) the brand name and the generic name of each active substance, (b) pharmacological data, (c) clinical information, (d) pharmaceutical information. [3.1] Abridged disclosure product information (a) brand name, (b) approved indications for use, (c) contraindications, (d) precautions, (e) adverse effects and drug interactions, (f) available dosage forms and dosage regimens, (g) routes of administration and (h) reference to special groups of patients [3.2]


-


They should posses sufficient medical and technical knowledge to present information on the company’s products in an accurate, current, and balanced manner, and should be cognizant of all provisions of this Code. Members have a responsibility to maintain high standards of continuing competency training for representatives and shall be required to conduct the mandatory courses under the Integrity and Proficiency Program in the Pharmaceutical Sector. They

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should at all times, maintain a high standard of ethical conduct in discharging their duties. They must conform to institutional regulations governing their calls. They must provide the approved Product Information whenever they make promotional claim. [8.1-8.5]


12. Gifts/payments to doctors or other health professionals Promotional giveaway items, such as pens, notepads, t-shirts and mugs, where no promotional claims are made do not require Product Information. However these items should be of nature of economic value (i.e., valued less than P1,000) which would bring discredit upon the industry or the recipient. Items of higher cost may be donated to institutions (such as medical societies, professional organizations, and hospital departments) but never to individuals. [4.5.4] Raffles and competitions are permitted only during official conventions organized by the PMA or its affiliates. They should not conflict with any of the official convention activities. [6.1] Competitions must be based on medical knowledge or on the acquisition of it. The process must be relevant and specific to the practice of medicine. Prizes may include stethoscope and other medical equipment. Individual prices offered are to be of low monetary value or be items of educational material. Entry into a competition must not depend on prescribing, ordering or recommending a product and no such condition shall be made or implied. [6.2-6.5] Guidelines on gifts specified [13.2]


Pharmaceutical companies’ interactions with stakeholders must at all times be ethical, appropriate and professional. Nothing should be offered or provided by a company in a manner or on conditions that would have an inappropriate influence to ensure the independence of the healthcare professional [Guiding Principle]. Pharmaceutical companies are responsible for providing accurate, balanced, and scientifically valid data on products [Guiding Principle].

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..provision of relevant information to healthcare providers. Such information should include knowledge gained from the research and development of medicines as well as from their clinical use. Healthcare providers in the Philippines should have access to similar data as those being communicated in developed countries [3.0] Materials used by Medical Representatives: (a) claims must be accompanied by product information; (b) printed and audiovisual materials must contain full or abridged product information [4.5] Limits of hospitality are described [11.7] Hospitality and meal limitations specified [13.3]

14. Discounts and rebates on medicines No financial benefit or benefit-in-kind may be provided or offered to a healthcare professional in exchange for prescribing or recommending the product [17.0] Discounts or coupons must not be given to patients directly but must be through a qualified oversight of a physician and backed by prescription. It should not be advertised and should not be tied to sales promotion, raffles or promise of reward that may encourage self medication.

15. Distribution of free medicine samples In accordance with BFAD regulation, free samples of a pharmaceutical product may be supplied to healthcare professionals and only with their consent. Samples shold not be sold or otherwise misused. The quantity should be enough to initiate therapy, gain clinical experience. It may be given for humanitarian reasons with healthcare provider supervision during dispensing. Product inserts must accompany samples. Samples must comply with the labeling requirements of BFAD. [9.1-9.5]

16. Sponsorship of Continuing Medical or Pharmacy Education No company may organize or sponsor an event for healthcare professionals that takes place outside of their home country unless it is appropriate and justified to do so from the logistical or security point of view. If travel is justified, travel should be by economy class. The scientific agenda must be the primary basis for the company’s sponsorship of or participation in the event and any support to

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individual doctors should not be conditional upon any obligation to prescribe or promote any medicinal product [11.1-11.2] Specific guidelines in company- or medical society-sponsored events [11.9 and 12.0]




20. Internet and related social networking media For pharmaceutical product related websites, the following guidelines should be observed: (a) the identity of the pharmaceutical company and of the intended audience should be readily apparent; (b) The presentation [content, links, etc] should be appropriate and clear to the intended audience; (c) country-specific information should comply with local laws and regulations. [4.6.1] Unsolicited electronic transmissions or replicas thereof must not be used for promotional purposes [5.5] Local websites have to follow all rules of the Code on promotion and advertising. [7.0]

21. Post-marketing studies Whereas Post Marketing Surveillance ceases to be an FDA requirement for drug registration, a member company is not banned from conducting such activity in conformity with its risk management strategies. However, healthcare providers are not to be compensated for participation to such activities [14.7]

22. Clinical trials and promotion All clinical trials and scientific research sponsored or supported by companies will be conducted with the intent to develop knowledge that will benefit patients and advance science and medicine. Pharmaceutical companies are committed to the transparency of industry sponsored clinical trials in patients [Guiding Principles]. Detailed guidance on conduct of clinical studies and related activities is described [14.0]

23. Promotion of off-label indications Products that have not been approved for registration by the FDA cannot be promoted. This restriction also applies to unapproved

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indications for registered products. [2.3.1]

24. Other All previously discussed rules apply to electronic promo materials, including audiovisuals such as powerpoint presentations, CDs and DVDs. [4.6.1] Mail, faxes, email and text messages must comply with all relevant provisions of the Code and should be sent only to those categories of healthcare professionals whose need for, or interest in, the particular information can be reasonably assumed. Exposed mail, including postcards, envelopes, and wrappers, must not carry matter that might be regarded as advertising to the general public or that could be considered unsuitable for public view. [5.0] Exhibit booths must be directed only to healthcare professionals. [10.2] Details on arrangements for honoraria is described [14.8] Companies may work with patient organizations but not for purposes of promotion [15.0-15.5]

Scope of the regulation Code of Ethics of the Philippine Medical Association




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-


-


-

108


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-


-


-


12. Gifts/payments to doctors or other health professionals Only gifts of reasonable value that primarily entail benefit to patient care or related to physicians’ work may be accepted by a physician from a health product company [Article VI Section 3]


-


15. Distribution of free medicine samples The physician shall not derive any form of material gain from product samples [Article VI Section 1]

16. Sponsorship of Continuing Medical or Pharmacy Education Continuing medical education conferences and professional meetings must contribute to improve and optimize patients care or address the educational needs of the targeted medical audience. They must be organized by a medical society on its own or in cooperation with sponsoring entities. [Article IV, Section 10] Physicians may accept reasonable subsidies from health and other industries to support their participation in CME events. [Article IV, Section 12] The faculty/speaker/consultant of conferences or meetings is allowed to accept from health industries honoraria and reimbursement for reasonable transportation, lodging and meals expenses [Section 13] Scholarships for physicians and medical students are permissible as long as the selection of scholars are made by the organizers or academic institutions concerned. [Article IV, Section 14]

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Generic names shall be used during the course of CME activities. However, after the lectures, the sponsoring entity may promote or indicate their branded products [Article IV, Section 15] When commercial exhibits are part of the overall program, arrangements for these should not influence the planning nor interfere with the CME activities. Only relevant information of the product should be included in the exhibit area. [Article IV, Section 16]

17. Sponsorship of scientific meetings Written articles and scientific presentations in scientific conferences should include full disclosure of any pharmaceutical support and should be independent of any commercial influence [Article IV, Section 7]




21. Post-marketing studies Physicians may participate in post-marketing or similar activities where they are asked to try new products on patients provided that the patients are properly informed and have given their informed consent. Physicians are encouraged to report or share the result of such activities to the duly constituted authorities [Article VI Section 2]

22. Clinical trials and promotion Research activities shall be ethically defensible, socially responsible and scientifically valid. Any renumeration should be reasonable and should not constitute an enticement. [Article VI Section 5] Research trials conducted by physician for an industry should be done in accordance with the national or institutional guidelines for the protection of human subjects [Article VI Section 6]


24. Other Funds from commercial sources may be accepted for the benefit of the association or society [Article IV, Section 11] Physicians may request donations for a charitable purpose for as long as it does not redound to his or her personal benefit. [Article VI Seciton 4]

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Scope of the regulation ADBOARD Standards of Trade Practices and Conduct in the Advertising Industry, 4th Revision (2006)

1. What is defined as “advertisement”? Advertising – any paid form of non-personal presentation and selling of ideas, goods, or services by an Advertiser. Advertising may be interchangeably used with advertisement, in any form of media or any other communication devise designed for public exposure. [Section IV.5]

2. What is defined as “promotion”? Promotions refer to the practice of giving temporary additional value to a product or service toward the realization of specific marketing objectives [Section IV. 43]


In general advertising: must be self-regulating according to industry standard of ethics


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13. Pharmaceutical sales representatives’ interaction with -

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healthcare professionals











24. Other -

Issuing regulation/codes/guidelines

1. Which body (ies) issue (s) regulations on medicines promotion? To carry out the provisions of this Act, there is hereby created an office to be call the Bureau of Food and Drug in the Department of Health. (RA 3720,Section 4) The Bureau of Food and Drugs is hereby renamed the Food and Drug Administration. (RA9711 Sec 1) BFAD Legal Division in charge of all legal and certain aspects of compliance and information activities of the bureau, including monitoring of advertisements and promotions of products under BFAD jurisdiction [RA 3720 Section 5f] FDA Center for Drug Regulation and Research – shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of and/or where appropriate the use and testing of health products [RA 9711 Section 5.a. 1]

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The guidelines for applications and approval of promotional, advertisement, and/or sponsorship materials for pharmaceutical and biological products, among other health products shall be formulated and issued by the Center for Drug Regulation and Research (CDRR) [FDA Circular 2013-024 Guideline 2]

2. What is its stated mission? Vision of FDA: Food and Drug Administration to be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos. Mission of FDA: To ensure safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with international best practices. [www.fda.gov.ph/about-food-and-drug-administration]

3. How is the body covered? Said Bureau shall be under the Office of the Secretary and shall have the following functions, powers and duties (RA 3720, Chapter III, Section 4) To carry out the provisions of this Act, there is hereby created an office to be called the Food and Drug Administration (FDA) in the Department of Health (DOH). Said Administration shall be under the Office of the Secretary. [RA 9711 Section 4]

4. Number of full-time equipment staff for medicines promotion regulation?

Center Director (Center for Drug Regulation and Research); Division Chief (Product Research and Standards Development Division) RA9711 Sec5b2);

5. Budget for medicines promotion regulation in USD and as percentage of total budget for pharmaceuticals

The appropriations for the BFAD and the BHDT included in the budget of the DOH under the current General Appropriations Acts shall be used to carry out the implementation of this Act (RA 9711 Sec 21)

6. What are its other activities? FDA’s functions, powers and duties: Collection of samples, subsequent analysis, standard setting, issues certificate of compliance, levy / assess / collect fees; covering, apart from drugs – food, cosmetics, and hazardous household products [RA 3720 Section 4] Drug, Food, Cosmetics, and Devise (RA9711 Sec 5.1-4) Activities: Regulation and Research; BFAD is also the one of the responsible agency to implement the

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national drug policy (AO 48 s1988)

7. Funding mechanisms (fees, fines and / or public funds?) To levy, assess and collect fees for inspection, analysis and testing of products and materials submitted in compliance with the provisions of this Act (RA 3720, Chapter III, Section 4, f) Fees and other income; can accept grants, donations and all other endowments (RA9711 Sec 11) The amount of one million pesos is hereby appropriated from any funds in the national Treasury not otherwise appropriated to augment the funds transferred to this Office under Section eight for the implementation of this Act. All income derived from fees authorized in Section four of this Act shall accrue to the General Fund. [RA 3720, Section 32, amended]

8. How is information about regulation disseminated/made public? Through official publications, newsletters, websites?

9. Can staff of the regulatory body also work in/be funded by the pharmaceutical industry? Sit on boards?

For Director General and Deputy Director-General: A person who was previously employed in a regular full-time capacity regardless of its consultative designation at higher management supervisory levels in regulated establishments, including related foundations, shall be disqualified from appointment as director-general and deputy director-general within three (3) years from termination of employment…director-general and deputy director-general must disclose all their incomes for the past three (3) years from all establishments regulated by this Act…declare any conflict of interest (RA9711 Sec 7.g)

10. To whom is the body responsible for issuing regulations accountable?

National drug committee will review from a technical standpoint all decision and regulations of the BFAD, particularly those related to the approval, disapproval, withdrawal, or restriction of drug products, prior to final action by the Secretary of Health (AO 48 s1988) Advisory Committee Board advises advise the Director of BFAD on the following matters: recommend proposals to improve the technical basis of regulatory implementation, streamline systems and

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procedures, strengthen actual field effectivity of regulatory standards and policies and enhance transparency and objectivity of regulatory implementation (AO 48 s1988) FDA should be under the Office of the Secretary (RA9711 Sec5) A Congressional Oversight Committee is created…to oversee the implementation of this Act for a period of five years and to review the accomplishments and the utilization of income of the FDA (RA 9711 Sec 23)

Monitoring medicines promotion 1. Is there a governmental system is place for monitoring of medicines promotion? Any other monitoring system, such as an industry self-regulatory system or other body?

Government BFAD shall monitor advertisement and promotion of drug products as well as receive complaints regarding these. On the basis of its monitored finding or complaints, BFAD shall determine if any advertising or promotional material violates these guidelines. [DOH AO No 65 s1989, Section 4.4] Industry Self-Regulation The drug establishment under whose name the drug product is registered shall be responsible for ensuring that its advertisement and other promotional materials comply with these guidelines. It shall establish suitable mechanism for internally reviewing such materials, specifically with the participation of its medical directors. [DOH AO No 65 s1989, Section 4.1] In addition, the drug establishment may participate in other industry-wide mechanism for self-or voluntary regulation. Such participation, however, shall not in anyway diminish the fundamental responsibility and accountability of the drug establishment with respect to compliance with these regulations. [DOH AO No 65 s1989, Section 4.2]

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The PHAP Code of Practice covers not only member companies but also local subsidiaries of IFPMA member companies [PHAP Guiding Principles] The General Manager / President / Managing Director is responsible for the proper implementation of the Code and its implementing Guidelines [PHAP 1.3] The administration of PHAP Code shall be supervised by the Ethics Committee of the Association. The committee in reaching a decision as to whether or not a breach has occurred may seek expert advise externally. [PHAP 18.1] It is the responsibility of Companies to ensure that internal compliance procedures exist that facilitate compliance with these Principles and the spirit they embody. These procedures should be documented and provided to employees to further enhance compliance. [Mexico City Declaration Section 11]

2. If so, is it active monitoring (collection of samples, watching television advertisements, pre-approval) or passive monitoring (complaint mechanisms by competing companies and/or consumers)? Describe

BFAD shall monitor advertisement and promotion of drug products as well as receive complaints regarding these. On the basis of its monitored finding or complaints, BFAD shall determine if any advertising or promotional material violates these guidelines. [DOH AO No 65 s1989, Section 4.4] The Commissioner of Customs shall cause to be delivered to the Bureau samples taken at random from every incoming shipment of food, drugs, devices, and cosmetics which are being imported or offered for import into the Philippines giving notice thereof to the owner or consignee…if with violation…the Director shall so inform the Commissioner and such article shall be refused admission. If…at a post of entry other than Manila, the collection of such samples shall be the responsibility of the Regional Food and Drug Supervisor having jurisdiction over the port of entity and such samples shall be forwarded to the Buresu. [Executive Order No 175 Section 23 Amending RA

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3720 Section 30]

3. Which body is responsible for monitoring? To carry out the provisions of this Act, there is hereby created an office to be call the Bureau of Food and Drug in the Department of Health. (RA 3720,Section 4) The Bureau of Food and Drugs is hereby renamed the Food and Drug Administration. (RA9711 Sec 1) BFAD Legal Division in charge of all legal and certain aspects of compliance and information activities of the bureau, including monitoring of advertisements and promotions of products under BFAD jurisdiction [RA 3720 Section 5f] FDA Center for Drug Regulation and Research – shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of and/or where appropriate the use and testing of health products [RA 9711 Section 5.a. 1] The CDRR shall implement compliance with the Mexico City Principles and among others, monitor advertisements and other marketing instruments and promotion, sponsorship, and other marketing activities in the country. [FDA Circular No 2013-024 Guideline 3] All monitoring, surveillance, and investigations on complaints and violations pertinent to the provisions of Section 4.0 of the FDA Act of 2009 and other pertinent rules and regulations shall be conducted with the assistance of the Regional Field Operation (RFO) Unit [FDA Circular No 2013-024 Guideline 4]

4. What is its stated mission? Vision of FDA: Food and Drug Administration to be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos. Mission of FDA: To ensure safety, efficacy, purity, and quality of products we regulate through effective implementation of the national

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regulatory framework consistent with international best practices. [www.fda.gov.ph/about-food-and-drug-administration]

5. How is the body governed?

6. Number of full-time equivalent staff for monitoring medicines promotion?

7. Budget for monitoring medicines promotion in USD and as percentage of total budget for pharmaceuticals


8. What are the body’s other activities? FDA’s functions, powers and duties: Collection of samples, subsequent analysis, standard setting, issues certificate of compliance, levy / assess / collect fees; covering, apart from drugs – food, cosmetics, and hazardous household products [RA 3720 Section 4] Drug, Food, Cosmetics, and Devise (RA9711 Sec 5.1-4) Activities: Regulation and Research; BFAD is also the one of the responsible agency to implement the national drug policy (AO 48 s1988)

9. Funding mechanisms (fees, fines and or/government?) Fees and other income; can accept grants, donations and all other endowments (RA9711 Sec 11)

10. If pre-approval: Which material, on which media, for which audience, for which substances?

No prior clearance from BFAD is required for initial printing and broadcast or dissemination of advertisement and other promotional materials for drug products. [DOH AO No 65 s1989, Section 4.3] At least thirty (30) days before the actual commencement of the sales promotion, applicant will file an application for sales promotion permit. This will be processed within ten (10) working days upon receipt. Seven (7) days before the actual activity, company can submit the Notice or Invitation for Promo Supervision/Attestation of an Authorized DOH-FDA representative. The request will be processed by Center for Drug Regulation and Research [FDA MC 2013-028)

11. What are the criteria/requirements for pre-approval? Are they

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publicly available? If so where?

12. Who develops those criteria?

13. Is there a fee for submitting promotional material for pre-approval? How much is it in USD?

14. Is there is complaint mechanism, who can complain? BFAD shall monitor advertisement and promotion of drug products as well as receive complaints regarding these. On the basis of its monitored finding or complaints, BFAD shall determine if any advertising or promotional material violates these guidelines. [DOH AO No 65 s1989, Section 4.4] RA7394 Chapter III on Consumer Complaints [Articles 159-165] FDA Public Assistance, Information, and Complaints Desk (eReport) Contact [email protected] With online portal [www.fda.gov.ph/ereport] Industry/Voluntary: Member companies are encouraged to settle matters among themselves before elevating the issue to the PHAP Ethics Committee. Complainant could be from the industry or a private person. [19.2]

15. Are complaints published? Are the outcomes published? Industry/Self-regulation: A summary of the cases will be published on the PHAP website. [PHAP 19.10]

16. What is the timeline for the complaint mechanism to be completed from the time to complaint is filed?

RA7394 In hearing the complaint, the mediation officer shall use every and all reasonable means to ascertain the facts in each complaints speedily and objectively in suits before courts. The complaint shall be decided within fifteen (15) days from the time the investigation was terminated. [Art 163] Industry/ Voluntary: Complaints will be validated within five working days. If information about the complaint is inadequate, the complainant must provide additional information within the five working days. Within five working

mailto:[email protected]

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days from receipt of a valid complaint, notice will be sent to the respondent company. Response must be given within 15 working days. Cases should be decided within 30 days from receipt of respondent’s reply. An appeal can be made within 15 days to the receipt of decision. The decision of the Appeals Board, given within 30 days is final and executory. [Section 19]

17. How is information about monitoring activities disseminated/made public?

18. Can staff of the monitoring body also work in/be funded by the pharmaceutical industry? Sit on industry boards?

19. To whom is the body responsible for monitoring accountable? A Congressional Oversight Committee is created…to oversee the implementation of this Act for a period of five years and to review the accomplishments and the utilization of income of the FDA (RA 9711 Sec 23)

Enforcing medicines promotion regulation 1. Which body enforces the law? To carry out the provisions of this Act, there is hereby created an

office to be call the Bureau of Food and Drug in the Department of Health. (RA 3720,Section 4) The Bureau of Food and Drugs is hereby renamed the Food and Drug Administration. (RA9711 Sec 1) BFAD Legal Division in charge of all legal and certain aspects of compliance and information activities of the bureau, including monitoring of advertisements and promotions of products under BFAD jurisdiction [RA 3720 Section 5f] FDA Center for Drug Regulation and Research – shall regulate the manufacture, importation, exportation, distribution, sale, offer for sale, transfer, promotion, advertisement, sponsorship of and/or where appropriate the use and testing of health products [RA 9711 Section 5.a. 1]

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All sanctions and penalties in violation of this Circular shall be imposed by the CDRR in consultation with the Office of the FDA Director General [FDA Circular No 2013-024 Guideline 5]

2. What is its stated mission? Vision of FDA: Food and Drug Administration to be an internationally recognized center of regulatory excellence safeguarding the health of the Filipinos. Mission of FDA: To ensure safety, efficacy, purity, and quality of products we regulate through effective implementation of the national regulatory framework consistent with international best practices. [www.fda.gov.ph/about-food-and-drug-administration]

3. How is the body governed?

4. Number of full-time equivalent staff for enforcement of medicine promotion regulation?

5. Budget for enforcing medicines promotion regulation in USD and as percentage of total budget for pharmaceuticals


6. What are its other activities? FDA’s functions, powers and duties: Collection of samples, subsequent analysis, standard setting, issues certificate of compliance, levy / assess / collect fees; covering, apart from drugs – food, cosmetics, and hazardous household products [RA 3720 Section 4] Drug, Food, Cosmetics, and Devise (RA9711 Sec 5.1-4) Activities: Regulation and Research; BFAD is also the one of the responsible agency to implement the national drug policy (AO 48 s1988)

7. Funding mechanisms (fees, fines and/or public funds?) Fees and other income; can accept grants, donations and all other endowments (RA9711 Sec 11)

8. What are the sanctions: warning letters, issue of corrective advertisement, prohibition of the advertisement, fines, revocation of registration, jail, expulsion from association (for industry self-regulation?

Any advertising or promotional material found to be violative of these guidelines will be identified and the drug establishment responsible shall be notified. BFAD shall issue a cease and desist order stopping the further release, printing, broadcast or dissemination of the violative advertising or promotional material. [DOH AO No 65 s1989, Section

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4.5] On violations related to Generics Act: RA 6675 Section 12 A. Any person who shall violate Section 6(a) or 6(b) of this Act shall

suffer the penalty graduated hereunder, viz: 1. For the first conviction, he shall suffer the penalty of

reprimand, which shall be officially recorded in the appropriate books of the Professional Regulation Commission;

2. The second conviction, the penalty of fine in the amount of not less than two thousand pesos (P2,000).

3. For the third conviction, the penalty of fine in the amount of not less than five thousand pesos (P5,000) but not exceeding ten thousand pesos (P10,000) and suspension of his license to practice his profession for thirty days at the discretion of the court.

4. For the fourth subsequent convictions, the penalty of fine in the amount of not less than ten thousand pesos (P10,000) and suspension of his license to practice his profession one year or longer at the discretion of the court.

B. Any judicial person violates Section ©, 6(d), 7 or 8 shall suffer the penalty of fine of not less than five thousand pesos (P5,000) nor more than ten thousand pesos (P10,000) and suspension or revocation of license to operate such drug establishment or drug outlet at the discretion of the Court: Provide, that its officers directly responsible for the violation shall suffer the penalty of fine and suspension or revocation of license to practice profession, if applicable, and by imprisonment of not less than six (6) months nor more than one (1) year of both fine and imprisonment at the discretion of the Court: and provided further that if the guilty party is an alien, he shall be ipso facto deported after service of sentence without need of further proceedings.

C. The Secretary of Health shall have the authority to impose administrative sanctions such as suspension or cancellation of

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license to practice profession to the Professional Regulation Commission as the case may be for the violation of the Act.

Sales promotion that involves misbranding [RA 3720 Section 12] (a) Any person who violates any of the provisions of Section eleven

hereof shall, upon conviction, be subject to imprisonment of not less than six months and one day, but not more than five years, or a find of not less than one thousand pesos, or both such imprisonment and fine, in the discretion of the Court.

Amended in [RA 9711 Section 11] Any person who violates any of the provisions of Section eleven hereof shall, upon conviction, suffer the penalty of imprisonment ranging from one (1) year but not more than ten (10) years or a fine of not less than fifty thousand pesos (P50,000) but not more than five hundred thousand pesos (P500,000) or both at the discretion of the court; There are also Administrative Sanctions Industry / Self-Regulation First offense is P 200,000 Succeeding offense of the same nature P 750,000 per offense Clean slate if no violence of the same offense are committed within a 12-month period. [PHAP 19.9]

9. What is the range of sanctions (for fines: in USD). List offences and sanctions range.

If the drug establishment wishes to context BFAD’s findings, a formal hearing shall be conducted. From finding after the hearing, BFAD shall decide along the following possibilities: (a) the initial finding was found untenable and the cease and desist order is then lifted, (b) the initial finding was found valid so the cease and desist order remains [DOH AO No 65 s1989, Section 4.6] Repeated or serious violations of these guidelines may be regarded by BFAD as indicative of the subject drug establishment’s inability to perform adequately in a manner that assures the proper use of its drug product. Under such condition and after due hearing, BFAD may impose the following sanctions: withdrawal by BFAD of the

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accreditation of the establishment’s medical director; suspension of the license to operate of the drug establishment; cancellation of the certification of product registration; and revocation of the license to operate of the drug establishment. [DOH AO No 65 s1989, Section 4.7] On violations related to Generics Act: RA 6675 Section 12 D. Any person who shall violate Section 6(a) or 6(b) of this Act shall

suffer the penalty graduated hereunder, viz: 5. For the first conviction, he shall suffer the penalty of

reprimand, which shall be officially recorded in the appropriate books of the Professional Regulation Commission;

6. The second conviction, the penalty of fine in the amount of not less than two thousand pesos (P2,000).

7. For the third conviction, the penalty of fine in the amount of not less than five thousand pesos (P5,000) but not exceeding ten thousand pesos (P10,000) and suspension of his license to practice his profession for thirty days at the discretion of the court.

8. For the fourth subsequent convictions, the penalty of fine in the amount of not less than ten thousand pesos (P10,000) and suspension of his license to practice his profession one year or longer at the discretion of the court.

E. Any judicial person violates Section ©, 6(d), 7 or 8 shall suffer the penalty of fine of not less than five thousand pesos (P5,000) nor more than ten thousand pesos (P10,000) and suspension or revocation of license to operate such drug establishment or drug outlet at the discretion of the Court: Provide, that its officers directly responsible for the violation shall suffer the penalty of fine and suspension or revocation of license to practice profession, if applicable, and by imprisonment of not less than six (6) months nor more than one (1) year of both fine and imprisonment at the discretion of the Court: and provided further that if the guilty party

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is an alien, he shall be ipso facto deported after service of sentence without need of further proceedings.

F. The Secretary of Health shall have the authority to impose administrative sanctions such as suspension or cancellation of license to practice profession to the Professional Regulation Commission as the case may be for the violation of the Act.

10. Are the sanctions made public? How? Nothing in this Section shall be construed to prohibit the Secretary from collecting, reporting, and illustrating the results of the investigations of the Department. [Executive Order 175 Section 21, Amending RA 3720 Section 29]

11. Is there an appeal mechanism? If the drug establishment wishes to context BFAD’s findings, a formal hearing shall be conducted. From finding after the hearing, BFAD shall decide along the following possibilities: (a) the initial finding was found untenable and the cease and desist order is then lifted, (b) the initial finding was found valid so the cease and desist order remains [DOH AO No 65 s1989, Section 4.6]

12. Who can appeal? To whom? All pleadings…shall be filed with the docketing unit in the FDA Central Office..[DOH DC 2011-0101 Article V Section 1]

13. What is the timeline for the appeal process from when the appeal is launched until its completion?

Within five (5) days from the commencement of action, summons shall be served on the respondent/s, attaching thereto the complaint/petition…answer within a non-extensible period of ten (10) days from receipt of the summons…preliminary conference not later than fifteen (15) days from the receipt of the answer…in cases where a preliminary conference / clarificatory hearing is conducted, within fifteen (15) days from the termination thereof, the parties shall simultaneously submit their respective position paper…within fifteen (15) days from the time the case is submitted for decision, the regional field director shall make his/her findings and recommendations in wirting…15 days with the deputy director general…15 days with the director general..final and executor within 15 days, may file a motion for reconsideration within this 15 days

14. Can staff of the enforcement body also work in/be funded by the pharmaceutical industry? Sit on industry boards?

15. To whom is the body responsible for enforcement accountable? A Congressional Oversight Committee is created…to oversee the implementation of this Act for a period of five years and to review the

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accomplishments and the utilization of income of the FDA (RA 9711 Sec 23)

16. Are civil society and/or other stakeholders asked for comments on pending decisions?

17. Are the reasons for the decisions published?

Others 1. What are the relationships between the different bodies/departments involved in medicines promotion regulation (issuing regulations, monitoring and enforcement)

RA 7394 Title V – The National Consumers Affairs Council To improve the management, coordination and effectiveness of consumer program…shall be composed of representatives from the following government agencies and non-government agencies…DOH [Art 148, 149]

2. Do companies producing and/or selling medicines have to disclose their budget for promotion and advertising? How and where is this disclosure made? How much is that budget at a national level for a given year?

3. How is generic substitution regulated? (e.g., substitution by pharmacists)

Generic Dispensing means dispensing the patient’s/buyer’s choice from among generic equivalent i.e., finished pharmaceutical products having the same active ingredients, same dosage form and same strength as the prescribed drug [DOH AO 62 s1989 1.4] All drug outlets are required to practice generic dispensing with some exemptions, modifications or qualifications…[DOH AO 63 s1989 3.1] * Informed choice of patient/buyer [3.1.1]

4. How is prescribing regulated? All medical, dental and veterinary practitioners, including private practitioners, shall write prescriptions using generic name. The brand name maybe included if so desired. [RA 6675 Section 6.a.] DOH AO 62 s1989 1.1 Only validly-registered medical, dental and veterinary

practitioners…are authorized to prescribe drugs. 1.2 …all prescriptions must contain the following information: name

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of prescriber, office address, professional registration number, professional tax receipt number, patient’s/client’s name, age, sex, and date of prescription

1.3 (Specific restriction for dangerous drugs) Section 3 – use of generics in prescription

5. Is there a legal provision requiring the government to provide independent information on medicines to health professionals and/or consumers?

The Department of Health shall publish annually in at least two newspapers of general circulation in the Philippines the generic names, and the corresponding brand name under which they are marketed, of all drugs and medicines available in the Philippines. [RA 6675 Section 5] The Department of Health jointly with the Department of Education, Culture and Sports, Philippine Information Agency and the Department of Local Government shall conduct a continuous information campaign for the public and a continuing education and training for the medical and allied medical profession on drugs with generic names as an alternative of equal efficacy to the more expensive brand name drug. [RA 6675 Section 11] The Secretary may cause to be disseminated information regarding foods, drugs, devices or cosmetics in situations involving in the opinion of the Secretary, imminent danger to health, or gross deception to the consumer. [Executive Order 175 Section 21, Amending RA 3720 Section 29] DOH is also one of the key government agencies mandated to promote use of generic terminology through public information and continuing education of health professionals; [DOH AO 51 s1988, 5.3]

Pilot of the HAI / MeTA Tool MEDICINES PROMOTION...

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