The Hong Kong Association of the Pharmaceutical Industry (HKAPI):

Promoting Code of practice

Sabrina Chan Executive Director

The Hong Kong Association of the Pharmaceutical Industry April 1, 2014

HKAPI: Background & Mission

• Formed in 1968;

Membership

• Full members: 40 R&D based multinational companies – supply 70% of prescription medicine in Hong Kong

• Affiliate members: 1 R&D based multinational companies with no pharmaceutical product launched in HK

• Associate members: 32 companies providing services to our full members, including Clinical Trial Centre of University of Hong Kong, law firms and PR firms; also medical devices companies

• Mission – to ensure patients have expedient access of innovative and effective drug to enhance better health and quality of life in Hong Kong

Some Business Questions – risk management considerations

1. How to run a company in compliance with local law?

2. How to run a company in compliance of company practice and rules?

3. How to run a company in accordance to the standard of the local industry?

4. How to run a company to meet the expectation of customers/society?

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Prevention of Bribery Ordinance (POBO)

• Enacted in 1971

• Enforced by Independent Commissioner of Corruption

• Under the POBO, it is not a statutory defence to show that an advantage is of de minimis value or that it is customary to any profession, trade, vocation or calling to accept the advantage. However, it is a general defence for any person to prove that he had offered, accepted or solicited the advantage with lawful authority or reasonable excuse.

No misleading information/off-label promotion

• False labelling and advertisement of food or drugs Cap 132 Public Health and Municipal Services, enforce by Food and

Health Bureau

• Misleading information, misleading omissions, bait

advertising: • Cap 362 Trade Description Ordinance, enforced by Custom and Excise

• Off-label promotion - Code of Practice: IFPMA, PhrMA, JPMA, HKAPI

The HKAPI Code incorporates

• The Hong Kong Code incorporates the principles set out in: – The International Federation of Pharmaceutical Manufacturers and

Associations (IFPMA) Code of Pharmaceutical Marketing Practice

– The World Health Organization’s Ethical Criteria for Medicinal Drug Promotion

– The Mexico-City Principles

• Leveraging professional knowledge – Learning from members

– Learning from Associate members

– Learning from law enforcement party ( e.g. Independent Commission Against Corruption)

– Learning from stakeholders ( Public Hospitals, Physicians, Pharmacists, Patients, Consumer Council)

A Code with “life” - Revisit the Code every two years by taking international reference and case law in Hong Kong

Historical Milestones

Date Event

March 2010 The 14th edition of the Code of Marketing Practice is adopted.

March 2009 The constitution was amended to provide greater simplicity and clarity.

June 2008 40th Anniversary of HKAPI.

April 2008 The 13th edition of the Code of Marketing Practice was adopted.

July 2007 IFPMA Code Compliance Network - Train the Trainer session held in Singapore.

April 2007 The 12th edition of the Code of Marketing Practice was adopted.

February 2007 IFPMA Code Compliance Network - Asia Roll Out Meeting held in HK.

April 2006 The 11th edition of the Code of Marketing Practice was adopted.

April 2005 The 10th edition of the Code of Marketing Practice was adopted.

April 2000 The 9th edition of the Code of Pharmaceutical Marketing Practice was adopted.

April 1999 The 8th edition of the Code of Pharmaceutical Marketing Practice was adopted.

November 1997 1st IFPMA Asian Regulatory Conference was jointly organized by IFPMA and the HKAPI. The Regulatory and Clinical Aspects of Bio- equivalence meeting, organized by the HKAPI.

March 1997 The 7th edition of the Code of Pharmaceutical Marketing Practice was adopted.

March 1996 The 6th edition of the Code of Pharmaceutical Marketing Practice was adopted.

March 1993 The 5th edition of the Code of Pharmaceutical Marketing Practice was adopted.

October 1992 HKAPI Executive Director elected to the Council of IFPMA, 1992-94. HKAPI delegation to China.

March 1990 The 4th edition of the code of Pharmaceutical Marketing Practices was adopted.

March 1988 The first awards of "Cert.Med.Rep. (HKAPI)" were made to the 64 successful candidates in the examination at the end of the 1987/88 Training Programme.

January 1986 A revised and expanded 3rd edition of the Code of Pharmaceutical Marketing Practices was adopted.

15 November 1973 IFPMA Council Meeting held in Hong Kong.

September 1971 HKAPI as a member of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA).

18 March 1970 Code of Marketing Practice for Medical Specialties unanimously adopted at Second Annual General Meeting.

20 June 1968 HKAPI registered under Societies Ordinance.

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Past & Present: variant focus on implementation

• Past (before 2007): more internal monitoring – Fair, balance, scientific-evidence information with good taste

– How product information is communicated to doctors

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Present (after 2007): concern about the interaction with healthcare professionals Stricter provisions regarding international events, company sponsorship of

health care professionals, the provision of hospitality and entertainment, as well as its more precise definitions of acceptable gifts – Based on the requirements of IFPMA

Set a scene of what/how can be done

Content of Latest Edition

• Introduction • Definition of certain terms for the purpose of the Code • General Principles • General Provisions Applicable to the Code • Method of Promotion to Healthcare Professionals • Symposia, Congresses and Other Means of Verbal Communication to

Healthcare Professionals • Medical Representatives • Samples • Hospitality, Promotional Items and Items of Medical Utility • Marketing Research • Relations with the General Public and Lay Communication Media • Interaction with Patients’ Organization • Operating procedures • Appendix

Promotion of Code – After New Code was enacted April 1 2013

Target Receiver Channel Objective update

External Public Inform public about the

spirits and principles of

our Code and enhance industry’s image

The code is on the website Website

Organizations/

Associations (local &

overseas)e.g. Consumer Council, HKMHDIA,

MEHK seminars/Briefing

meetings; association meeting

Promote our Code to

overseas Event organizers

Via HK tourism Board

Further discuss the co-

promotional activities

e.g. Medical Devices Association

Meeting done and the association will put forward to plan to make it mandatory

Doctors/Healthcare

Professionals e.g. HKMA, FMSHK, Doctors Union, PPA, PSHK, SHPHK, PCCC

By mailing/meetings with

HKMA and doctors

union/MEHK Associations

meeting (gather all the

medical associations for

a briefing) Letter to council heads Journal adv to highlight key messages and link of COP

To understand our

marketing practices and

responsibilities in

providing accurate

information on members’ products

Have sent letters to associations all regarded stakeholders An advertisement on the July, 2013 version of medical Journal

Government

Stakeholders e.g. Food & Health Bureau, LegCo members, HA, DH, PPB

By mailing/face-to-face meetings

To ensure our business

practices should

conform to all relevant

laws and regulations of Hong Kong and Macau

Mail sent Met legco members – Joe Lee, Helena Wong

Patient Groups By mailing/patient groups’ activities

Promote our

commitment to the

improvement of patients’ quality of life

Mail sent with their acknowledgement

Universities e.g. HKU & CUHK

By mailing, meetings and educational talks

Through the universities

to educate the

pharmacy students

about our industry’s code of practice

Put it in the industry seminars

Other Stakeholders Newsletter To reach some

stakeholder may not know about our Code

Will reinforce the message in the June version

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Anti-corruption Legislation in China

• Criminal Law (which punishes the most serious cases of bribery)

• Unfair Competition Law (which covers cases of bribery undertaken by business operators for a business purpose which can be criminal or non-criminal in nature)

• The Interim Regulations on Prohibition of Commercial Bribery issued by the State

• Administration for Industry and Commerce

• other relevant interpretations issued by the Supreme People’s Court, the Supreme People’s Procuratorate or the State Administration for Industry and Commerce

• Regulations issued by the Communist Party of China, targeted at officials who do not necessarily participate in bribery but act passively, ie, do not take action against bribery and corruption in the jurisdiction under their authority.

Oct. 2013, 8 Associations jointly announced that they are adopting a Code of ethics aligned with

the Mexico City Principles

A drafted Code, using APEC principles as a key reference, was assembled and consulting with 8 associations including

– China Pharmaceutical Industry Association (CPIA),

– China Pharmaceutical Industry Research & Development Association (SINO-PhiRDA),

– China Chamber of Commerce for Import & Export of Medicines & Health Products (CCMPHE),

– R&D Based Pharmaceutical Association Committee (RDPAC),

– China Pharmaceutical Enterprise Promotion Association (CPEP)

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Thank you www.hkapi.hk