BEIJING BRUSSELS CHICAGO DALLAS FRANKFURT GENEVA HONG KONG HOUSTON LONDON LOS ANGELES NEW YORK PALO ALTO SAN FRANCISCO SHANGHAI SINGAPORE SYDNEY TOKYO WASHINGTON, D.C.

Compliance Issues Arising from Marketing & Promotional Activities

2nd Asia Pacific Pharmaceutical Compliance Congress and Best Practices Forum, Shanghai (September 11 -

13, 2012)

Yuet

Ming Tham, Partner

What will be covered?• Off-Label Use v. Off-Label Promotion

• DTC advertising; OTC advertising

• Comparing legislation in the US, HK, Singapore, Taiwan, Korea, Japan

• Off-label promotion is a serious risk in the US, due to high penalties. Not as risky in Asia, but a regulatory risk nevertheless which can lead to fines and reputational damage.

• Chances of being caught are high due to public nature of the above activities – competitors often lodge complaints to the regulators.

2

Compliance Issues

• Compliance Issues – mainly in the area of Grants/Donations– Disease Awareness Campaigns – use of company name/logo or

product name

– Paying HCP to appear on a radio program for disease awareness, or sponsoring a radio program

– Grants/sponsorship of charitable events

– Sponsorship of journalists to attend pharmaceutical conferences overseas or journalism awards

3

Off-Label

• “Off-label use” = use that has not been approved or cleared

– Sometimes (improperly) understood to include unlabeled dosing regimens, use in combination, etc.

• Generally lawful, common, and sometimes the standard of care

• Off-label promotion:

– Generally not allowed

– Governed by local laws and regulations; also local IFPMA Codes

4

Off-Label Communications • If off-label use is lawful and common, arguably the

communication of more, rather than less, truthful, non- misleading information about off-label uses would benefit both physicians and patients

• FDA has to some extent recognized the benefit of off-label communications by manufacturers, establishing (at least) four “safe harbors”:

– “Scientific exchange” (regulation)

– Responses to unsolicited questions (draft guidance)

– Dissemination of reprints (guidance)

– Financial support for CME (guidance)

• But “rules” are murky

5

Enforcement Environment

• Despite lack of clarity, DOJ has continued to investigate and obtain settlements in numerous off- label matters:

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Company Allegations Settlement Amount Date

Abbott Laboratories Improper marketing of Depakote $1.5 billion (civil and criminal)

May 7, 2012

Johnson & Johnson Improper marketing of Risperdal $158 million (civil) January 19, 2012

GlaxoSmithKline Improper marketing and drug pricing $3 billion (civil and criminal)

July 2, 2012

Genentech, Inc. Off-label promotion of Rituxan $20 million (civil) November 21, 2011

Pfizer Off-label promotion of Bextra and Celebrex

$2.3 B March 20, 2009

Current Efforts to Seek Clarity

• Citizen petition of July 5, 2011– Submitted by Sidley Austin LLP and Ropes & Gray on

behalf of seven medical product manufacturers

– Requests clarity as to:• Scope of scientific exchange

• Manufacturer responses to unsolicited requests

• Dissemination of third-party clinical practice guidelines

• Communications with payors about investigational products/new uses

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DTC Advertising

• 3 types of DTC advertising:

– Claims are made naming a specific product and its therapeutic claims

– Reminder ads where the product is named but no therapeutic claims made

– Disease Awareness campaigns to inform consumers of new treatment options for conditions and telling consumers to consult their doctor regarding treatment options. May include company name and telephone number/website.

• All three allowed in the US and New Zealand

• In Asia, the first two categories mostly not allowed; but leeway for disease-awareness campaigns. Grey area.

8

UNITED STATES

• DTC advertising – allowed; regulated by the FDA

• OTC advertising – allowed; regulated by the Federal Trade Commission (FTC)– section 5 of the Federal Trade Commission Act states

that ‘unfair or deceptive acts or practices’ is unlawful. The principle is that all advertising should be truthful and not misleading and all claims substantiated

• New Zealand is the only other country that allows DTC advertising.

9

TAIWAN• In Taiwan, promotion of “medicaments” (i.e. drugs and medical

devices) is regulated under the Pharmaceutical Affairs Law and its subordinate legislation, Pharmaceutical Affairs Regulations.

• Article 24: "advertisement of medicaments“ is the act of advertising the medical efficacy of medicaments aiming to solicit and promote the sale thereof.

• Article 66: For publishing or broadcasting medicament advertisement, pharmaceutical dealers shall, before publishing or broadcasting, submit all the written or spoken words and/or drawings or pictures constituting the advertisement to the central or municipal competent health authority for approval, and shall forward the approval document to the mass communication medium concerned for verification.

10

TAIWAN

• Article 67: Where medicaments are required to have the prescriptions of physicians…the advertisements thereof shall be published only in academic medical journals. NB: no DTC advertising.

• Article 68: Medicament advertisements shall not be made in any of the following manners:

– To publicize the medicament by making use of the name of other person(s);

– To warrant the efficacy or functions of the medicament by making use of the materials or information contained in a book or publications;

– To publicize the medicament by means of releasing an interview or news report; or

– To publicize the medicament by any other improper means

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TAIWAN

• Article 70: Interviews, news reports or propaganda containing information implying or suggesting medical efficacy shall be regarded as advertisements of medicaments.

NB: makes sure companies do not try and get round prohibition by getting a journalist to write an article aimed at promoting the device or medicine.

12

HONG KONG

• In Hong Kong, pharmaceutical advertising for some prescription drugs allowed though restricted. Based on disease type.

• Undesirable Medical Advertisements Ordinance (Cap. 231):

– pharmaceutical advertising for the treatment of major diseases (gynecological, sexual virility, tumors, venereal diseases, cardiovascular disease) not allowed.

– pharmaceutical advertising for the treatment of minor diseases (coughs, colds, influenzas, rhinitis, indigestion, headache, dry skin) allowed.

• Pharmaceutical advertising on TV and radio further regulated by the Generic Code of Practice on Television Advertising Standards.

• OTC advertising is allowed.

13

HONG KONG

• Advertisement of some medical preparations and treatments such as for smoking cessation, clinics for the treatment of hair and scalp, pregnancy testing services are prohibited.

• In addition to the kind of diseases to be advertised, the design and the contents are strictly controlled:– No doctors or other medical professionals in the ads.

– No showing of patient undergoing treatment, dramatization of ailments, and offensive descriptions of the illness.

• No exaggerated claims such as ‘safest’, ‘the most successful’ or ‘quickest.’

• No reference to a prize competition or sales promotions such as gifts, premium offers and samples.

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HONG KONG• A defense to prove that the advertisement was made only in a publication

of a technical character intended for circulation mainly amongst persons of the following classes, or of one or some of them- (Amended 16 of 2005 s. 6)– medical practitioners registered under the Medical Registration Ordinance (Cap

161), or persons deemed to be medical practitioners under section 29 thereof;

– pharmacists registered under the Pharmacy and Poisons Ordinance (Cap 138);

– the medical and para-medical staff of-

• any hospital or maternity home to which the Hospitals, Nursing Homes and Maternity Homes Registration Ordinance (Cap 165) applies;

• any clinic to which the Medical Clinics Ordinance (Cap 343) applies;

• any hospital, maternity home or clinic maintained by the Government, the Chinese University of Hong Kong or the University of Hong Kong;

• any hospital, maternity home or clinic managed or controlled by the Hospital Authority established under the Hospital Authority Ordinance (Cap 113);

– Chinese medicine practitioners registered or listed under the Chinese Medicine Ordinance

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SINGAPORE• Promotion of medicine is regulated under the Medicines Act (Chapter

176).

• Promotion of medical devices is regulated under the Health Product (Medical Devices) Regulations 2010.

• Under section 49(1) of the Medicines Act, “advertisement” includes every form of advertising, whether in a publication, or by the display of any notice or signboard, or by means of any catalogue, price list, letter (whether circular or addressed to a particular person) or other documents, or by words inscribed on any article, or by the exhibition of a photograph or a cinematograph film, or by way of sound recording, sound broadcasting or television, or in any other way, and any reference to the issue of an advertisement shall be construes accordingly.

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SINGAPORE• No Off-label promotion

– It is stipulated under section 50(2) that where a product license is in force, the purpose of which the product may be recommended to be used are limited to those specified in the license. Any person will be guilty of an offence if he or she issues or causes another person to issue an advertisement relating to the product which consists of or includes unauthorized recommendation.

• Section 50(3) prohibits making a false or misleading presentation (including a presentation that consists of or includes unauthorized recommendation) relating to a medicinal product in connection with the sale of the product. A person will be guilty of an offence if the false or misleading presentation is made to: – a practitioner for the purpose of inducing him to prescribe or supply medicinal

products of that description;

– a patient or client of a practitioner for the purpose of inducing him to request the practitioner to prescribe medicinal products of that description; or

– a person for the purpose of inducing him to purchase medicinal products of that description from a person selling them by retail.

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SINGAPORE• Under section 50(6), an advertisement will be regarded as “false or

misleading” if: – it falsely describes the description of medicinal products to which it relates;

– it is likely to mislead as to the nature or quality of medicinal products of that description or as to their uses or effects.

• Under section 50(8), “unauthorized recommendation” means recommendations whereby medicinal products of a description to which the license in question is applicable are recommended to be used for purposes other that those specified in the license.

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SINGAPORE• Promotion of medical devices is regulated under the Health Product

(Medical Devices) Regulations 2010. Section 14(1)(b) limits how a presentation of medical devices can be made. It is provided that: – “no change or modification made, or caused to be made, to the presentation of

the medical device, for the purpose of promoting or demonstrating the use of the medical device, shall cause the medical device to depart from its product owner’s specifications in relation to its intended purpose, design, components and method of installation or operation.”

• Where a manufacturer/importer/supplier/registrant contravenes s14(1)(b), the Health Sciences Authority may order that manufacturer/importer/supplier/registrant do the following at their own cost:– to stop the description with immediate effect;

– to take such measures as may be reasonable and necessary in the circumstances to discontinue or remove any trade description that may already have been disseminated, used or published;

– to disseminate, apply or publish a corrective trade description in such manner and containing such information as the Authority may require.

20

KOREA

• Korean Pharmaceutical Affairs Law strictly regulates advertising of OTC drugs, and prohibits provision of information to the public about prescription drugs.

• Law changed in 2008 to allow advertising of prescription drugs against communicable epidemic diseases.

• Grey area in the context of disease awareness campaigns and sponsorship to medical associations to launch diseases awareness advertising: – anti-smoking campaign sponsored by Pfizer that markets Champix

(aid to tobacco cessation)

– cervical cancer prevention campaign by MSD that markets Gardasil (cervical cancer vaccine).

* Pharmaceutical Advertising in Korea, Japan, Hong Kong, Australia, and the US: Current Conditions and Future Directions, P Monica Chien (Health Communication Research 2011, Vol. 3 No. 1, 1-63)

21

JAPAN

• The “Pharmaceutical Affairs Law” (PAL) and the “Standards for Appropriate Advertisements of Pharmaceuticals” (SAAP), a directive issued by Japan’s Ministry of Health, Labor and Welfare (MHLW) regulate the pharmaceutical industry.

• SAAP prohibits advertisements for prescription-only medicines to the general public.

• Disease awareness campaigns permitted provided no mention of specific drug brand names.

• All classes of OTC medicines can be advertised in Japan. However, OTC advertising is subject to strict compliance with regulatory and voluntary controls. Comparative advertising not allowed, but comparison with a company's own products is.

22

AUSTRALIA

• In Australia, advertising of medicines governed by the Therapeutic Goods Act and 2 industry codes: – the Therapeutic Goods Advertising Code by the

Therapeutic Goods Administration – covers OTC & complementary medicines; and

– Medicines Australia Code of Conduct contains section on Communications with the Public covering media releases about named prescription products, general media articles and patient education.

23

Compliance Issues

• Pharmaceuticals – is inviting HCPs from therapeutic area for which off label use is common = off label promotion?

• Medical devices – sales representatives often asked to assist HCPs during surgical procedures to calibrate instruments or demonstrate how to use the devices. What happens if off-label use?

• Do you have an SOP for situation when the company employee accompanies the HCP during a surgical procedure?

24

Compliance Issues

– Disease Awareness Campaigns – use of company name/logo or product name

– Paying HCP to appear on a radio program for disease awareness, or sponsoring a radio program

– Grants/sponsorship of charitable events

– Sponsorship of journalists to attend pharmaceutical conferences overseas or journalism awards

25

Questions

Yuet Ming THAM

Partner, Hong Kong

yuetming.tham@sidley.com

(852) 2509 7645 (direct)(852) 2509 3110 (fax)

26

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