CHAMBERS Global Practice Guides BELGIUM IRELAND ... · Pharmaceutical Advertising. 2018. ......

IRELAND

LAW AND PRACTICE: p.3Contributed by Arthur Cox

The ‘Law & Practice’ sections provide easily accessible information on navigating the legal system when conducting business in the jurisdic-tion. Leading lawyers explain local law and practice at key transactional stages and for crucial aspects of doing business.

DOING BUSINESS IN IRELAND: p.116

Chambers & Partners employ a large team of full-time researchers (over 140) in their London office who interview thousands of clients eachyear. This section is based on these interviews. The advice in this section is based on the views of clients with in-depth international experience.

BELGIUM

LAW AND PRACTICE: p.3Contributed by Van Bael & Bellis


DOING BUSINESS IN BELGIUM: p.<?>

Chambers & Partners employ a large team of full-time researchers (over 140) in their London office who interview thousands of clients eachyear. This section is based on these interviews. The advice in this section is based on the views of clients with in-depth international experience.

CHAMBERSGlobal Practice Guides

Law and Practice – Ireland

Contributed byArthur Cox

PharmaceuticalAdvertising

2018

IRELAND

LAW AND PRACTICE: p.3Contributed by Arthur Cox


Law and Practice ireLandContributed by Arthur Cox Authors: Colin Kavanagh, Ciara Farrell

3

Law and PracticeContributed by Arthur Cox

CONTENTS1. regulatory Framework p.4

1.1 Laws and Self-Regulatory Codes p.41.2 Application and Legal Value of Regulatory Codes p.4

2. Scope of advertising and General Principles p.52.1 Definition of Advertising p.52.2 Difference Between Information and Advertising p.52.3 Restrictions on Press Releases p.52.4 Comparative Advertising p.5

3. advertising for Unauthorised Medicines orUnauthorised indications p.53.1 Restrictions on Provision of Information on

Unauthorised Medicines or Indications p.53.2 Provision of Information During a Scientific

Conference p.63.3 Provision of Information to Healthcare

Professionals p.63.4 Provision of Information to Healthcare Institutions

p.6

4. advertising to the General Public p.64.1 Main Restrictions on Advertising to the General

Public p.64.2 Information Contained in Advertising to the

General Public p.74.3 Restrictions on Interactions Between Patients

or Patient Organisations and Industry p.74.4 Restrictions on Endorsements by Healthcare

Professionals p.7

5. advertising to Healthcare Professionals p.75.1 Restrictions on Information Contained in

Advertising Directed at Healthcare Professionals p.75.2 Reference to Data Not Included in the Summary

of Product Characteristics p.85.3 Restrictions on Reprints of Journal Articles p.8

6. Vetting requirements and internal Verificationcompliance p.86.1 Requirements for Prior Notification/Authorisation p.86.2 Compliance with Rules on Medicinal

Advertising p.8

7. internet p.87.1 Regulation of Advertising on the Internet for

Medicinal Products p.87.2 Advertising for Medicines on Social Media p.97.3 Access Restrictions on Websites p.9

8. inducement/anti-Bribery General p.98.1 General Anti-Bribery Rules p.98.2 Legislative or Self-Regulatory Provisions p.10

9. Gifts, Hospitality, congresses and related Payments p.109.1 Gifts to Healthcare Professionals p.109.2 Limitations on Providing Samples to Healthcare

Professionals p.109.3 Sponsorship of Scientific Meetings p.109.4 Sponsorship of Cultural, Sports or Other

Non-scientific Events p.119.5 Grants or Donations to Healthcare Professionals

or Healthcare Institutions p.119.6 Restrictions on Rebates or Discounts to Healthcare

Professionals or Healthcare Institutions p.119.7 Payment for Services Provided by Healthcare

Professionals p.119.8 Prior Authorisations or Notifications p.11

10. transparency p.1110.1 Requirement to Disclose Details of Transfers

of Value p.1110.2 Foreign Companies and Companies That Do Not

Yet Have Products on the Market p.12

11. enforcement p.1211.1 Enforcement Bodies p.1211.2 Initiating Proceedings for Advertising

Infringements p.1211.3 Penalties for Violating Advertising Rules and

Rules on Inducements to Prescribe p.1211.4 Relationship Between Regulatory Authorities

and Courts p.1311.5 Recent Enforcement Trends p.13

ireLand Law and PracticeContributed by Arthur Cox Authors: Colin Kavanagh, Ciara Farrell

4

arthur cox is one of Ireland’s largest law firms, with of-fices in Dublin, Belfast, London, New York and Silicon Val-ley. It is a market leader in the provision of legal services to the life sciences industry, with a multidisciplinary practice group serving the pharmaceutical, biotechnology, medical devices, food and cosmetics industries. The life sciences team advise overseas and domestic clients on establishing operations in Ireland and on all stages of a product’s life cy-cle. The firm is the sole Irish member of Conference Bleu,

the highly regarded regulatory life sciences network; it has been at the forefront of developments in corporate transac-tions in the sector; and has leading practices in regulatory and compliance. Its team regularly advises on clinical trials, product classification, marketing authorisation, CE Mark-ing, licensing, importation, manufacture and distribution, promotion and marketing, packaging and labelling, mar-ket access queries, pharmacovigilance, data protection and pricing and reimbursement.

authorscolin Kavanagh is a partner in the corporate group and head of the firm’s life sciences and media groups, who practises in life sciences, corporate/M&A, regula-tory and compliance, commercial con-tracts and agreements, and IP. Colin is an

affiliate member of the Irish Pharmaceutical Healthcare Association and the Irish MedTech Association.

ciara Farrell, a senior associate in the life sciences group, practises in life sciences, regulatory and compliance, healthcare, product liability and product safety, and privacy, data protection and information management. Ciara is an affiliate member

of the Irish Pharmaceutical Healthcare Association and is an active member of the Irish MedTech Association Code of Ethics Steering Committee.

1. regulatory Framework

1.1 Laws and Self-regulatory codes The advertising of medicinal products is governed by a com-bination of legislation and self-regulatory codes of practice. The principal regulations are the Medicinal Products (Con-trol of Advertising) Regulations 2007 (S.I. No. 541 of 2007) (the Regulations), which implement Titles VIII and VIIIa of Directive 2001/83/EC (as amended) (the Directive). In addition, general laws concerning advertising and commer-cial practices are set out in the Consumer Protection Act 2007 (the CPA) and the European Communities (Misleading and Comparative Marketing Communications) Regulations 2007 (the Misleading Advertising Regulations). The Ethics in Public Office Acts, 1995 and 2001 (as amended) (the Ethics Acts), apply to promotional practices involving healthcare professionals who also hold certain designated public posi-tions or directorships. The Prevention of Corruption Acts 1889 to 2010 and the Criminal Justice (Theft and Fraud Of-fences) Act 2001, as amended, also apply in circumstances where promotional practices are found to be corrupt.

The law is supplemented by a number of codes of practice. The Irish Pharmaceutical Healthcare Association (IPHA), the industry body representing the international research-based pharmaceutical industry in Ireland, has published two relevant codes of practice: the IPHA Code of Practice for the Pharmaceutical Industry (Edition 8.2, 2017) (the Pharma-ceutical Code); and the IPHA Code of Standards of Adver-tising Practice for the Consumer Healthcare Industry (Re-

vision 5.2, 2017) (the Consumer Code) (together the IPHA Codes). These IPHA Codes apply only to those pharmaceuti-cal companies that have voluntarily agreed to be members of IPHA. The Irish Generics Medicines Association (IGMA), the industry body representing manufacturers of generic medicinal products, has published the Code of Practice on Advertising of Medicinal Products, a similar code based on the Regulations and the Directive. The Advertising Stand-ards Authority for Ireland (ASAI), the independent self-reg-ulatory body for the advertising industry, has issued a Code of Standards for Advertising and Marketing Communica-tions in Ireland (7th Edition) (ASAI Code), which applies to advertising generally, while the Broadcasting Authority of Ireland has produced a General Commercial Communica-tions Code, which applies to advertising broadcasts on radio or television channels licensed in Ireland.

1.2 application and Legal Value of regulatory codesThe self-regulatory IPHA Codes listed above apply only to those pharmaceutical companies that have voluntarily agreed to be members of IPHA. They do not apply to health-care professionals. The IPHA Codes fit into the framework established by Regulation 26 of the Regulations, which rec-ognises the role of voluntary control of advertising of me-dicinal products. In general, the pharmaceutical industry usually looks to the IPHA Codes as best practice for adver-tising of medicinal products in Ireland.


5

The ASAI Code and General Commercial Communications Code apply to the advertising and broadcasting industries respectively. Industries that are involved in releasing market-ing communications and sales promotions that promote the sale of medicinal products are bound by these codes. Again, neither of these codes apply to healthcare professionals.

2. Scope of advertising and General Principles2.1 definition of advertisingAdvertising is defined in the Regulations as any form of door-to-door information, canvassing activity or induce-ment designed to promote the prescription, supply, sale or consumption of medicinal products. This specifically in-cludes: advertising to the general public and those who are qualified to prescribe or supply medicinal products; supply of samples; inducements to prescribe or supply by the gift, offer or promise of any benefit or bonus, in money or in kind; sponsorship of promotional meetings and scientific conferences attended by persons qualified to prescribe or supply; and, in particular, the payment of travelling and ac-commodation expenses associated with such conferences.

2.2 difference Between information and advertisingThere is no definition of information as opposed to promo-tion in the applicable Irish legislation and codes of practice. The legitimate exchange of medical and scientific informa-tion to healthcare professionals is not prohibited, provided such information or activity does not constitute any form of promotion that would be prohibited under the Regulations.

Disease awareness campaigns are permitted to the extent that they do not in any way promote a brand of medicinal product, either directly by naming a product, or indirectly, for example:

•If there are non-prescription, as well as prescription-only, medicinal products available to treat a particular condition, advising patients to visit their doctor for treatment could be regarded as promoting the use of a prescription-only me-dicinal product. To avoid any such inference, the Pharma-ceutical Code advises that consideration should be given to advising patients to talk to their doctor or pharmacist.

•In the case of a disease awareness campaign sponsored by a company which promotes the only available medicinal product for that disease/condition, particular care is re-quired to ensure that the campaign could not be regarded as promoting that product. The Pharmaceutical Code notes that statements such as: “Your doctor can prescribe a me-dicinal product to help you,” should be avoided.

2.3 restrictions on Press releasesWhile not explicitly classified as advertising in the Regu-lations, press releases are expressly included in the defini-tion of promotion in the Pharmaceutical Code. The Phar-maceutical Code prohibits the advertising or promotion of prescription-only medicinal products to the general public. However, information about a scientific discovery of a me-dicinal product may be supplied where it is desirable or nec-essary to do so in the public interest, or where the object is to keep the public informed of scientific or medical progress.

Press releases with this information must be presented in a balanced way to avoid the risk of raising unfounded hopes in the public mind from the results of treatment. Statements must not be made to or designed for the purpose of encour-aging members of the public to ask their doctor to prescribe a medicinal product. Therefore, press releases must include only factual and non-promotional information.

2.4 comparative advertisingComparative advertising is governed by the Misleading Ad-vertising Regulations and the CPA. Comparative advertising is permitted but there are restrictions on such advertising and instances where comparative advertising is not per-mitted. For instance, misleading comparative advertising is prohibited. In addition, comparative advertising must not discredit or denigrate the goods or services provided by a competitor. For instance, under the Pharmaceutical Code, the use of competitor brand names cannot be used in comparator advertisements without the prior consent of the relevant brand owner. In addition, the products, services and promotions of other companies cannot be disparaged in advertising either directly or implicitly.

3. advertising for Unauthorised Medicines or Unauthorised indications 3.1 restrictions on Provision of information on Unauthorised Medicines or indicationsThe Regulations prohibit the promotion of medicinal prod-ucts that are not the subject of a marketing authorisation or a certificate of traditional use registration (the latter registra-tion relates to herbal medicinal products). The IPHA Codes also prohibit promotion of products prior to authorisation, subject to certain exceptions such as materials at interna-tional congresses and symposia held within Ireland. Sepa-rately, the CPA deems as a “prohibited commercial practice” a representation that a product has an authorisation which it does not have. Advertisements as part of a vaccination campaign, however, are approved (provided the Minister has permitted it). However, the legitimate exchange of medical and scientific information to healthcare professionals is not prohibited, provided such information or activity does not


6

constitute any form of promotion that would be prohibited under the Regulations.

Scientific, complete, objective, factual and non-promotional information concerning the off-label use of the products may be provided to healthcare professionals by representatives of the medical departments in response to an unsolicited re-quest by the healthcare professional for such information.

In addition, correspondence to healthcare professionals in response to an unsolicited specific question about a par-ticular medicinal product – which may include material of a non-promotional nature, and non-promotional, generic information about companies, including financial data, de-scriptions of research and development programmes – and discussions of regulatory developments affecting the com-pany and its products, are not prohibited.

3.2 Provision of information during a Scientific conferenceIndications for unauthorised medicinal products and unau-thorised indications in Ireland may be referenced in promo-tional material appearing on exhibition stands or distributed at international congresses or symposia held in Ireland, pro-vided such medicinal products and indications are in fact ap-proved in at least one other country in the EEA. This excep-tion applies only to meetings that are truly international and scientific. A clearly visible and legible statement must also be included, indicating that the material relates to a prod-uct or indication that is unapproved in Ireland. In addition, where prescribing information is provided, an explanatory statement must also be included indicating that licensing conditions differ internationally.

If products are not approved in the EEA or where the in-dication is not approved, no promotional material may be displayed or distributed, but legitimate, balanced and non-promotional scientific papers that include off-label infor-mation or information concerning unauthorised medicinal products may be provided at the medical booths at symposia or conferences in response to an unsolicited request from a healthcare professional for that specific information. Such information must not be distributed along with promotional materials or contain references to promotional materials. In addition, such information should not be distributed to pa-tients or members of the general public.

3.3 Provision of information to Healthcare ProfessionalsMarketing Authorisation Holders (MAHs) are not permit-ted to proactively distribute such information to healthcare professionals. As above, MAHs are only permitted to pro-vide such information in response to an unsolicited request from the healthcare professional specifically requesting such information.

3.4 Provision of information to Healthcare institutionsThe Pharmaceutical Code does not specifically exclude in-formation on unauthorised medicines or unauthorised in-dications from the definition of promotion. Moreover, there is nothing to prohibit companies from providing non-pro-motional, generic information about companies, including financial data, descriptions of research and development programmes, and discussions of regulatory developments affecting the company and its products to healthcare institu-tions. The proactive provision of information on unauthor-ised medicines or unauthorised indications in the absence of a specific request by the institution could be deemed pro-motional, and therefore subject to the prohibition on the promotion of unapproved products.

4. advertising to the General Public

4.1 Main restrictions on advertising to the General PublicThe Regulations prohibit the advertisement of prescription-only medicinal products or controlled drugs which are “di-rected wholly or mainly at members of the general public.” This does not apply to the promotion of a vaccination cam-paign in respect of a vaccine or serum, provided the cam-paign is approved by the Minister.

Advertising of non-prescription medicinal products to the general public is permitted subject to the requirements of the Regulations, the Consumer Code and the ASAI Code. Before a medicinal product can be advertised, it must be the subject of a marketing authorisation or a certification of tra-ditional use (in respect of herbal medicinal products). Such an advertisement must be accurate and present the product objectively and be consistent with the terms of the marketing authorisation and the Summary of Product Characteristics (SmPC), and encourage rational use of the product. It must not contain material which:

•gives the impression that a medical consultation or surgical operation is unnecessary by offering treatment or diagnosis remotely;

•suggests that the effects of the medicinal product are guar-anteed, are unaccompanied by adverse reactions or are better than, or equivalent to, those of another treatment or product;

•suggests that the product enhances health or is necessary for the health of the subject or that the health of the subject could be affected by not taking the product;

•leads the public to assume that the product has some spe-cial property or quality which is unknown or unrecognised;

•claims that the product will promote sexual virility or be effective in treating sexual weakness, etc (unless authorised for such indication);


7

•is directed exclusively or principally at children or might result in harm to children or exploit their credulity;

•is endorsed by scientists, healthcare professionals or ce-lebrities;

•suggests that the product is a foodstuff, cosmetic or other consumer product;

•suggests that the safety or efficacy of the product is due to the fact that it is natural;

•might, by the use of a case history, lead to erroneous self-diagnosis;

•refers in improper, alarming or misleading terms to claims of recovery; and

•inappropriately uses pictorial representations of changes in the human body as a result of disease or injury or as a result of using the product.

The Regulations contain requirements as to the form and content of advertisements in that the product must be clearly identified as a medicinal product and include certain min-imum information, such as the name of the product and instructions for use. The Consumer Code outlines further requirements, including that advertisements: must be ac-curate, truthful and easily intelligible; should not bring the industry into disrepute; should not offer treatment for a se-rious disease requiring intervention by a healthcare profes-sional; should not offer to treat by correspondence, denigrate or unfairly attack other products; and should not exaggerate or influence consumers, or refer to a doctor or hospital tests or colleges or institutes (unless it can be substantiated) or use testimonials (unless the opinions are genuine and made within the last three years).

Certain non-prescription medicinal products should not be promoted to the public, such as analgesics containing codeine, and special requirements apply when advertising antihistamines and/or sympathomimetics. The general pro-visions of the CPA regarding misleading commercial prac-tices and prohibited commercial practices apply, prohibiting, for example, a representation that a product is able to cure an illness, dysfunction or malformation, if it cannot.

The Pharmaceutical Code also prohibits the making of ex-aggerated claims in advertising, as well as making dispar-aging references to other producers’ products, services or promotions. The use of a rival producer’s logos or brands is prohibited unless their consent has been received. It is pro-hibited to advertise a product as being “new” if it has been generally available in Ireland for more than 12 months. It is also prohibited to use the word “safe” in an advertisement without qualification. Comparisons with rival products must be factual, fair and capable of substantiation and meet the requirements of the Misleading Advertising Regulations.

The ASAI Code also includes specific provisions in relation to the advertisement of medical products, including medici-

nal products. Those provisions largely reflect the require-ments provided in the Regulations, the Pharmaceutical Code and the Consumer Code.

4.2 information contained in advertising to the General PublicSee 4.1 Main restrictions on advertising to the General Public for information requirements. There is no prohibi-tion on the inclusion of pricing information.

4.3 restrictions on interactions Between Patients or Patient Organisations and industry Annex III of the Pharmaceutical Code contains guidelines for pharmaceutical companies on working with patient or-ganisations. Pharmaceutical companies must ensure that the independence of patient organisations is respected and guar-anteed. Medicinal products must not be directly or indirectly promoted through these groups.

It is permissible for a pharmaceutical company to donate to a patient organisation for general purposes, for a particular project or piece of research, sponsoring speakers for events or undertaking projects of joint interest. Each IPHA mem-ber company must make publicly available a list of patient organisations to which it provides financial support and/or significant indirect/non-financial support. This information may be provided on a national or European level and should be updated at least annually.

A pharmaceutical company may contract services from pa-tient organisations, but only where such services are pro-vided for the purpose of supporting healthcare or research. The compensation must be reasonable and not exceed the fair market value of services provided.

Any hospitality provided by a pharmaceutical company to patient organisations and their members, should be reason-able, and secondary, to the main purpose of the event for which it is provided, and must not involve sponsoring or organising entertainment.

4.4 restrictions on endorsements by Healthcare Professionals Advertising of medicinal products to the public must not include endorsements by scientists, healthcare professionals or celebrities.

5. advertising to Healthcare Professionals 5.1 restrictions on information contained in advertising directed at Healthcare ProfessionalsThe Regulations require certain minimum information to be provided to healthcare professionals, including the product’s


8

name, a list of active ingredients using the common name placed immediately adjacent to the most prominent display of the product name, the classification for the sale or sup-ply of the product, one or more of the product’s indications and the method of administration where it is not obvious. A clear and legible statement of the information in the SmPC regarding adverse reactions, precautions and contraindica-tions, dosage and method of use relevant to the indications must be positioned within the advertisement so as to en-able the reader to readily appreciate the relationship between this information and the claims and indications of the prod-uct. The name and address of the holder of the marketing authorisation, certification of registration or certificate of traditional use registration or the business name and ad-dress of the part of the business responsible for placing the medicinal product on the market should also be provided along with the authorisation number. If applicable, the words “traditional herbal medicinal product for use in,” followed by one or more therapeutic-approved indications, and fol-lowed by the words “exclusively based upon long-standing use,” should be included.

Separate requirements exist for abbreviated reminder ad-vertisements. The Pharmaceutical Code adds that this in-formation should be clear, legible and an integral part of the promotional material. There is no requirement to include the price of the product nor is there any restriction on including this information.

5.2 reference to data not included in the Summary of Product characteristics The Regulations are silent on the specific point of referring to studies which are not in the SmPC, except to say that infor-mation may not be included if it is not accurate, up-to-date, verifiable and sufficiently complete to enable the recipient to form his or her own opinion of the therapeutic value of the product. The Pharmaceutical Code requires all promo-tional information to be consistent with the information in the SmPC. MAHs must therefore ensure that all information concerning studies not included in the SmPC is consistent with and does not contradict the information in the SmPC. It is also prohibited to include in written advertising any quotation, tables or other illustrative matter taken from a medical journal or other scientific work unless it is accu-rately reproduced and the precise sources of the information are indicated.

5.3 restrictions on reprints of Journal articlesThe Pharmaceutical Code does not inhibit the exchange of medical and scientific information. The distribution of re-prints of journal articles is permissible provided, however, certain requirements are met. For instance, journal articles that contain information on unlicensed products or unli-censed indications must not be proactively distributed to healthcare professionals. However, legitimate, balanced and

non-promotional scientific papers that include off-label information or information concerning unauthorised me-dicinal products may be provided in response to an unsolic-ited request from a healthcare professional for that specific paper/journal. Such information must not be distributed along with promotional materials or contain references to promotional materials.

6. Vetting requirements and internal Verification compliance 6.1 requirements for Prior notification/authorisationThere is no necessity to have advertising pre-approved by a regulatory or industry authority. However, the Health Prod-ucts Regulatory Authority (HPRA) reserves the right to pre-review advertisements.

6.2 compliance with rules on Medicinal advertisingThe Regulations require that a scientific service be estab-lished within the company to compile and collate all infor-mation relating to products. Medical sales representatives must be adequately trained and have sufficient scientific knowledge to enable them to provide information which is as precise and as complete as possible about the product they are promoting.

The Pharmaceutical Code requires that the scientific service must include a doctor or, where appropriate, a pharmacist or other suitably qualified person who must approve all promo-tional material prior to release. Such person must certify that the advertisement complies with the Pharmaceutical Code and all applicable laws, is consistent with the relevant SmPC, and is a fair and truthful presentation of the facts concerning the medicinal product being promoted. The Pharmaceutical Code requires that each company appoint at least one senior employee who is responsible for supervising the compliance with the Pharmaceutical Code.

There are no legal or code requirements for standard op-erating procedures (SOPs) governing advertising activities, although this would be considered best practice.

7. internet

7.1 regulation of advertising on the internet for Medicinal Products The general rules relating to the advertising of medicinal products apply to the use of the internet and/or social me-dia. Annex IV (Guidance on Digital Communication in the Pharmaceutical Sector) of the Pharmaceutical Code includes


9

a specific section on the use of social media in the context of pharmaceutical advertising.

7.2 advertising for Medicines on Social MediaOnly non-prescription medicinal products can be advertised to the public, and this includes marketing that is conducted online or by post, telephone, e-mail or any other electronic communications. The rules discussed in 4 advertising to the General Public apply to the use of social media in this regard.

Prescription medicinal products can be advertised through the internet, but only to individuals qualified to prescribe or supply them, and only with the individuals’ prior consent. Restricted information should only be placed in a secure part of a website for registered users or subscribers only.

Annex IV advises that pharmaceutical companies should have a clear policy in place regarding social media use by company employees. It states that providing responses to enquiries received from healthcare professionals through digital channels is acceptable if performed in accordance with the Pharmaceutical Code. The use of electronic data communications for promotion is prohibited except with the prior permission, or upon the request, of the recipient. The responsibility rests with the company to ensure that receipt of the response is restricted to the healthcare professional making the enquiry or their nominee. It may be acceptable to contact patients through social media channels in certain circumstances (eg, reminding them to regularly take their prescribed medication) if documented approval from both the healthcare professional and the patient is received and, in the example given, the message carries no purpose other than supporting patient compliance with the medication schedule instructed by the patient’s healthcare professional.

7.3 access restrictions on websites The use of electronic data communications for promotion is prohibited except with the prior permission, or upon the request, of the recipient. The responsibility rests with the company to ensure that receipt of the response is restricted to the healthcare professional making the enquiry or their nominee.

Restricted information should only be placed in a secure part of a website for registered users or subscribers only. Annex IV of the Pharmaceutical Code suggests that effec-tive processes preventing access to others should be used at the entry point of website sections aimed at healthcare professionals. In certain circumstances, the use of a promi-nent disclaimer on the site to inform visitors that the site is suitable for healthcare professionals only and providing a hyperlink to a site appropriate to the general public may be possible. Caution should be exercised in relation to link-ing and reverse linking to sites, which may raise copyright

issues or breach the Acceptable Use Policy of the relevant website. Companies should be careful not to target online advertisement to countries where the product in question may not have a MA.

Annex IV also advises that companies should have a clear policy in place regarding social media use by company em-ployees. Annex IV advises that it is a question of policy for a pharmaceutical company as to whether it is appropriate to correct erroneous entries on non-company mediated sites but cautions that care needs to be exercised since, if a com-pany corrects certain information but omits to correct other information that may be perceived as related, such behaviour may be interpreted as a breach of the Pharmaceutical Code.

8. inducement/anti-Bribery General

8.1 General anti-Bribery rules Irish legislation makes the active or passive bribery of a member, officer or servant of a public body a criminal of-fence. The principal statutory offence is contained within the Public Bodies Corrupt Practices Act 1889. Section 1 (2) of the Act states that it is an offence for any person alone, or in conjunction with others, to corruptly give, promise or offer any gift, or advantage whatsoever as an inducement to, or reward for, or otherwise on account of an officer holder or his special adviser or a director of, or occupier of a posi-tion of employment in a public body. A gift can take the form of money or property. Public bodies in Ireland include the Health Service Executive, which covers all publicly run hospitals within the state. Public bodies can also include any other body, organisation or group which is financed wholly or partly out of monies provided by the Irish government. As such, semi-private or private hospitals may also fall within the scope of the Act if those hospitals receive funding from the state.

The Prevention of Corruption Acts 1906 to 2010 and the Ethics Acts and the Civil Service Code of Standards and Be-haviour are also relevant.

Holders of certain public positions (including senior per-sonnel within the Health Service Executive (HSE), HPRA, the Department of Health and in voluntary hospitals) must disclose certain interests to the Standards in Public Office Commission. These include gifts and/or the provision of travel facilities, living accommodation, meals or entertain-ment valued at more than EUR650 in aggregate in any given year. While responsibility for compliance rests with the re-cipient of the gift, the provider of the gift can be requested to assist the Standards in Public Office Commission in its investigations, and failure to do so can be a criminal offence.


10

Moreover, the Regulations and the relevant self-regulatory codes of conduct contain provisions on interactions with and provision of benefits to healthcare professionals and or-ganisations. Both the Regulations and the IPHA Codes pro-hibit the supply, offer or promise gifts, pecuniary advantages or benefits in kind to healthcare professionals, in the course of promoting medicinal products. Healthcare professionals are also prohibited from accepting such items. These pro-hibitions are not specific to healthcare organisations. How-ever the anti-bribery legislation above would apply to such organisations.

8.2 Legislative or Self-regulatory Provisions Please see 8.1 General anti-Bribery rules. The prohibition on benefits in the Regulations and the IPHA Codes does not apply to the transmission of information or educational ma-terials or to items of medical utility which will be permitted in certain circumstances. The transmission of information or educational materials will be permitted, provided they are: (i) inexpensive; (ii) directly relevant to the practice of medi-cine or pharmacy; and (iii) directly beneficial to the care of patients. Companies may provide items such as pens and paper pads exclusively during company organised meetings, as long as they are non-product branded and inexpensive. Items of medical utility aimed directly at the education of healthcare professionals and patient care may be provided if they are inexpensive and do not offset the cost of routine business practice of the recipient. These are not considered gifts.

9. Gifts, Hospitality, congresses and related Payments9.1 Gifts to Healthcare ProfessionalsIt is prohibited to supply, offer or promise gifts, pecuniary advantages or benefits in kind to healthcare professionals, in the course of promoting medicinal products. Healthcare professionals are also prohibited from accepting such items. The transmission of information or educational materials will be permitted, provided they are: (i) inexpensive; (ii) directly relevant to the practice of medicine or pharmacy; and (iii) directly beneficial to the care of patients. There is no monetary limit on these.

9.2 Limitations on Providing Samples to Healthcare ProfessionalsThe Regulations prescribe requirements in relation to the distribution of samples. Free samples of medicinal prod-ucts may only be supplied to persons who are qualified to prescribe such products, on an exceptional basis only and for the purpose of acquiring experience in dealing with the product. When distributed by medical representatives, they must be handed directly to the individual qualified to pre-scribe, or his agent. Samples may only be provided in re-

sponse to a written request (signed and dated). A maximum of six samples, per year, per recipient, may be provided and only in the smallest presentation of the product on the mar-ket, marked “Free Medical Sample – Not for Sale”.

Under the Pharmaceutical Code, sampling shall not extend beyond two years after the samples were first requested for each particular new medicinal product. Additional strengths or different dosages cannot be considered as new medicinal products. Each sample must be accompanied by the most up-to-date SmPC and, if sent by post, adequately packaged to be reasonably secure from the access of children. Free samples of anti-depressants, hypnotics, sedatives or tran-quillisers are prohibited, along with any controlled drug as defined in Section 2 of the Misuse of Drugs Act 1977, as amended. The Regulations also require the supplier of samples to maintain an adequate system of control and ac-countability.

9.3 Sponsorship of Scientific MeetingsCompanies may legitimately provide assistance that is di-rectly related to the bona fide continuing education of healthcare professionals and which genuinely facilitates at-tendance of the healthcare professional for the duration of the educational aspect of the event. Where appropriate and depending on the time, location and length of the meet-ing, support to healthcare professionals may cover actual travel expenses, meals, refreshments, accommodation and registration fees. Certain restrictions will apply. For instance:

•hospitality is permitted subject to restrictions, eg, where pharmaceutical companies provide or offer meals to healthcare professionals, the value of each meal (including food and beverages) may not exceed the monetary thresh-old set by the Pharmaceutical Code, currently EUR80 per recipient. This threshold includes VAT but excludes any gratuity, and only applies to events held in Ireland;

•it should be the programme that attracts delegates and not the associated venue or hospitality;

•companies must not organise or sponsor meetings to co-incide with sporting, entertainment or other leisure events or activities; and

•the event must be held at an appropriate venue that is con-ducive to the main purpose of the event.

Sponsorship of continuing medical education is permitted provided it is related to bona fide continuing education. Any support or financial assistance given must be “unrestricted,” which means that the content must be developed indepen-dently of the pharmaceutical company’s influence and not adversely affect the judgement of a medical practitioner.


11

9.4 Sponsorship of cultural, Sports or Other non-scientific events Pharmaceutical companies are not permitted to sponsor, secure and/or organise, directly or indirectly, any entertain-ment, sporting or leisure events.

9.5 Grants or donations to Healthcare Professionals or Healthcare institutionsA pharmaceutical company may provide support in the form of educational, research or employment grants and the dona-tion or sponsorship of medical equipment for the betterment of patients. Such support must be in response to a written request from the healthcare organisation or healthcare pro-fessional for a specific type of support that must be genuinely needed. While healthcare professionals may request the sup-port provided, grants must be paid directly to the relevant healthcare organisation only and the support provided must be relevant to the practice of medicine or pharmacy and be intended for use solely in the organisation. The provision of any such support must not be conditional on the prescrip-tion, supply or use of the company’s products or be linked in any way to promotion. The support must be modest, reason-able and in proportion to the scale and scope of the recipient institution. The Pharmaceutical Code also obliges compa-nies to make publicly available information in relation to these donations, grants and sponsorship, and from 1 January 2016 companies were required to make public details of all “Transfers of Value” that occurred in 2015.

9.6 restrictions on rebates or discounts to Healthcare Professionals or Healthcare institutionsThe negotiation of price margins and discounts is allowed in the ordinary course of business. Any discounts must be clearly set out in the sales invoice.

9.7 Payment for Services Provided by Healthcare ProfessionalsHealthcare professionals can be used as consultants and ad-visers, whether in groups or individually, for:

•services (eg, chairing or speaking at meetings, being in-volved in medical/scientific studies or in clinical trials);

•training;•participating in advisory board meetings; and•participating in market research where such participation

involves remuneration and/or travel.

The Pharmaceutical Code states that they are entitled to be remunerated for their time as long as there is a legitimate need for the services, a written contract is signed in advance, records of services are maintained, the engagement is not an inducement to prescribe and the compensation is reasonable and reflects the fair market value of the services provided.

Consultants are encouraged to disclose their relationships with companies when they write or speak in public. More-over, companies are required to make public details of all transfers of value that occurred from 1 January 2015. A fur-ther point to note in relation to consultants is that transfers of value relating to expenses agreed in the written agree-ment covering their activity will be disclosed as two separate amounts.

9.8 Prior authorisations or notifications There are no prior authorisations or requirements in relation to any of the activities above.

10. transparency

10.1 requirement to disclose details of transfers of ValueThere is no requirement in the applicable Irish legislation for companies to make publicly available information about transfers of value provided by them to healthcare profession-als, healthcare organisations or patient organisations.

The requirements for companies to make publicly available information about transfers of value is set out in the self-regulatory Pharmaceutical Code and are applicable only to members of IPHA or the European Federation of Pharma-ceutical Industries and Associations (EFPIA). Pharmaceu-tical companies are required to disclose transfers of value made by them, whether directly or indirectly. This obliga-tion does not extend to transfers of value that: (i) are solely related to over-the-counter medicinal products; (ii) are not listed in Article 4 of Annex V of the Pharmaceutical Code, including items of medical utility, meals and drinks, sam-ples; or (iii) are part of the ordinary course of purchases and sales of medical products by and between a pharmaceutical company and a healthcare professional or healthcare organi-sation.

Disclosures must be made from 1 January 2016 on an annual basis and each reporting period covers a full calendar year. The Pharmaceutical Code allows for disclosure by way of either (i) the company’s website; or (ii) a central platform. The first reporting period was from 1 January 2015 and the information was made public from 1 July 2016. Disclosures must be made by pharmaceutical companies within six months after the end of the relevant reporting period, and the information disclosed must remain in the public domain for a minimum of three years after the time such informa-tion is first disclosed, unless the recipient’s consent relating to a specific disclosure has been revoked. Pharmaceutical companies must document all transfers of value required to be disclosed and maintain the relevant records of the disclo-sures for a minimum of five years after the end of the relevant reporting period.


12

Except as expressly provided by the Pharmaceutical Code, transfers of value shall be disclosed on an individual basis. Pharmaceutical companies must disclose, on an individual basis for each clearly identifiable recipient, the amounts at-tributable to transfers of value to such recipient in each re-porting period which can be reasonably allocated to one of the following categories.

In relation to transfers of value to a healthcare organisation, disclosure requirements are in respect of amounts related to: (i) donations and grants; (ii) contribution to costs related to events; or (iii) fees for service and consultancy.

In relation to transfers of value to a healthcare professional, disclosure requirements are in respect of amounts related to: (i) contribution to costs related to events; or (ii) fees for service and consultancy.

Where a transfer of value, which would otherwise reason-ably be allocated to one of the above categories, cannot be disclosed on an individual basis for valid legal reasons, a pharmaceutical company must disclose the amounts at-tributable to such transfers in each reporting period on an aggregate basis. A template form in respect of disclosure of transfers of value has been included at Article 5 of Annex V of the Pharmaceutical Code. This form should be used for disclosures so as to ensure consistency and that the require-ments of the Code are met.

The Pharmaceutical Code implements the EFPIA Disclosure Code without variation.

10.2 Foreign companies and companies That do not Yet Have Products on the MarketIn relation to foreign companies, it will depend on the par-ticular factual circumstances. For instance, the following scenarios may apply:

•foreign company makes a payment to an HCP, no presence in Ireland: no disclosure obligation;

•foreign company makes a payment to an HCP, presence through a local subsidiary that is a member of IPHA: dis-closure obligation; and

•foreign company makes a payment to an HCP, presence through a local subsidiary that is NOT a member of IPHA: no disclosure obligation.

The disclosure requirements do not specifically exclude companies that do not yet have products on the market. The rules concern transfers of value provided to Irish healthcare professionals and organisations regardless of the marketing status of the product in Ireland.

11. enforcement

11.1 enforcement BodiesThe HPRA is the body responsible for monitoring the adver-tising of medicinal products and enforcing the Regulations. The Competition and Consumer Protection Commission is the regulatory body with oversight of general consumer law.

Prosecutions may be brought by the HPRA, the Minister for Health (the Minister), the Pharmaceutical Society of Ireland and the Health Service Executive. A competitor may inform any of the above bodies of non-compliant advertising.

On the self-regulatory side, IPHA regulates compliance with the IPHA Codes.

11.2 initiating Proceedings for advertising infringementsProsecutions may be brought by the HPRA, the Minister, the Pharmaceutical Society of Ireland and the HSE. A competi-tor may inform any of the above bodies of non-compliant advertising.

The HPRA can order the withdrawal of a misleading adver-tisement and the issuing of a corrective statement in respect of a published advertisement. Decisions of the HPRA may be appealed to the Irish courts. The Irish courts can order the withdrawal of an advertisement and that a corrective statement be issued where a party is convicted of a speci-fied offence under the Irish Medicines Board Act 1995, as amended (the IMB Act), and the court is satisfied that the advertisement was misleading.

IPHA may require the withdrawal of an advertisement if it is of the opinion that it is not in the interests of consumer safety. A competitor may inform IPHA of non-compliant advertising provided they first make a reasonable effort to resolve differences with the competitor directly. Decisions of the IPHA Code Council may be appealed to the IPHA Appeals Board, and the decision of the IPHA Appeals Board is final and binding.

General consumer law complaints may also be brought be-fore the Competition and Consumer Protection Commis-sion.

11.3 Penalties for Violating advertising rules and rules on inducements to Prescribe Penalties for a breach of the Regulations range from a fine of up to EUR2,000 and/or imprisonment of up to 12 months on summary conviction; and to a fine of up to EUR120,000 and/or a term of imprisonment of up to ten years on indictment. On subsequent convictions, the maximum fine increases to EUR300,000. If an offence is committed by a body corporate, personal liability may apply to the officers.


13

Penalties for breach of the IPHA Codes are dealt with by the Code Council of IPHA and range from: an order to cease the breach; a reprimand; an order for the recovery of offending material; publication of a corrective statement; publication of the decision; referral of the matter to the Minister; and suspension or expulsion from IPHA. A competitor may in-form IPHA of non-compliant advertising.

Penalties for breach of the Misleading Advertising Regula-tions and the CPA consist of a fine of up to EUR3,000 and/or imprisonment not exceeding six months on summary conviction; a fine of up to EUR5,000 and/or imprisonment not exceeding 12 months for subsequent summary convic-tions; a fine of up to EUR60,000 and/or up to 18 months’ imprisonment on a first conviction on indictment; a fine of up to EUR100,000 and/or up to 24 months’ imprisonment for subsequent convictions on indictment; and a daily fine of up to EUR500 for each day that the contravention continues following summary conviction, with this daily fine rising to a maximum of EUR10,000 for each day that the contravention continues following conviction on indictment. The Mislead-ing Advertising Regulations and the CPA allow a competitor to apply to court for an order preventing a company from engaging in misleading marketing or prohibited compara-tive advertising.

11.4 relationship Between regulatory authorities and courtsThe IPHA Codes fit into the framework established by Regulation 26 of the Regulations, which recognises the role

of voluntary control of advertising of medicinal products. Breaches of the Pharmaceutical Code are generally dealt with by the Code Council; however, IPHA may refer difficult or persistent breaches of the IPHA Codes to the Minister. IPHA may also advise the ASAI of its findings against an advertiser and recommend action.

In addition, advertising is monitored and regulated by the HPRA. It supervises compliance with the Regulations by performing random reviews of advertisements in various media, including journal publications, newspapers, radio and television advertising. It may also carry out inspections at the offices of any MAHs which advertise human medicinal products, and investigate complaints received in relation to advertisements. If such investigations show non-compliance with the Regulations and/or the IPHA Codes, the HPRA will either require that the advertisement be corrected or, less frequently, take legal proceedings.

11.5 recent enforcement trendsAs a result of the increased use of social media, we expect that future codes of practice will increasingly refer to promo-tion using this method. Social media is unlikely to be treated differently from any other advertising platform.

The HPRA is increasingly active and is pursuing more cases arising out of breaches of the Regulations each year. The HPRA has been increasingly monitoring advertising prac-tices through social media.

arthur coxTen Earlsfort TerraceDublin 2D02 T380Ireland

Tel: +353 1 920 1000Fax: +353 1 920 1020Email: [email protected]: www.arthurcox.com

CHAMBERS Global Practice Guides BELGIUM IRELAND ... · Pharmaceutical Advertising. 2018. ......

Documents

Transcript of CHAMBERS Global Practice Guides BELGIUM IRELAND ... · Pharmaceutical Advertising. 2018. ......