WE, THE MEMBERS OF THE HONG KONG ASSOCIATION OF THE PHARMACEUTICAL INDUSTRY, being committed to the improvement of the health of mankind through the research, development, production and marketing of pharmaceutical products of reliable quality, in accordance with internationally defined standards of good practice, and being aware of our responsibilities in providing the healthcare professionals with accurate information on our products.

ACCEPT the principles: -

AND ACCORDINGLY, to ensure that these responsibilities and principles are fulfilled, WE ADOPT this Code of Pharmaceutical Marketing Practices “(hereinafter referred to as ‘the Code’)” for our activities in the Hong Kong and Macau Special Administrative Regions (each referred to as a “city” herein), which indicates acceptance of, and embodies the principles set out in the IFPMA Code of Pharmaceutical Marketing Practices 2006 edition (“IFPMA Code”), including the provision that we shall require our licensees and agents if any, to observe the Code and the IFPMA Code.

The term ‘promotion’ means those informational and marketing activities including audio-visual material, undertaken by a pharmaceutical company or with its authority, the purpose of which is to ensure proper and rational use, supply or administration of its pharmaceutical products.
It includes the activities of representatives and all other aspects of sales promotion in whatever form, such as journal and direct mail advertising; participation in exhibitions; the use of audio-cassettes, films, records, tapes and video recordings, the use of Internet, viewdata systems and data storage devices such as memory discs accessed and reproduced on television apparatus, visual display units and the like; the provision of samples, gifts and hospitality.

The term ‘pharmaceutical product’ in this concept means any pharmaceutical or biological product intended for use in the diagnosis, cure, mitigation, treatment of prevention of disease in humans, or to affect the structure or any function of the human body, which is promoted and advertised to the healthcare professionals rather than directly to the lay public. It is anticipated that members will adhere to the spirit of this Code when promoting any of their pharmaceutical products, including those that may legally be sold overthe- counter.

The terms ‘healthcare professional’ should be interpreted to extend to medical, dental, pharmacy, nursing and/or other para-medical professions, who in the course of his or her professional activities may prescribe, recommend, purchase, supply or administer a pharmaceutical product.

The term ‘medical representative’ means a representative whose duties comprise or include calling upon healthcare professionals.

Prescribing information means comprehensive product information as submitted to and filed with the relevant division of the Department of Health in connection with the registration of a pharmaceutical product or substance, and any subsequent amendments.

In all matters of application, interpretation and enforcement of any section of the Code, it is to be understood that compliance with local laws, regulations and regulatory decisions and requirements with take precedence.

Substantiated information on serious and unexpected adverse reactions associate with pharmaceutical products should be reported to the appropriate health authority as a priority.

Member companies’ relationships with healthcare professionals are intended to benefit patients and to enhance the practice of medicine. Interactions should be focused on informing healthcare professionals about products, providing scientific and educational information and supporting medical research and education.

No financial benefit or benefit-in-kind (including grants, scholarships, subsidies, support, consulting contracts or educational or practice related items) may be provided or offered to a healthcare professional in exchange for prescribing, recommending, purchasing, supplying or administering products or for a commitment to continue to do so. Nothing may be offered or provided in a manner or on conditions that would have an inappropriate influence on a healthcare professional’s prescribing practices.

Promotion should encourage the appropriate use of pharmaceutical products by presenting them objectively and without exaggerating their properties.

In all cases, all relevant laws, local regulations and industry codes must be observed and companies have a responsibility to check local requirements, in advance of preparing promotional material or events in any specific city.

Promotion should not be disguised. Clinical assessments, post-marketing surveillance and experience programmes and post-authorization studies must not be disguised promotion. Such clinical assessments, post-marketing surveillance, experience programmes and post-authorization studies must be conducted with a primarily scientific or educational purpose. Material relating to pharmaceutical products and their uses, whether promotional in nature or not, which is sponsored by a company should clearly indicate by whom it has been sponsored.

Marketing practices should never be such as to bring discredit upon the pharmaceutical industry.

Information in promotional material should be based on an up-to-date evaluation of evidence that is scientifically valid, and should not give an incorrect or misleading impression.

Any claim used in promotional material should be documented either by the prescribing information authorised by the city authorities or by other accessible sources. In the latter case the original source should be indicated as reference. Superlatives should not be used in product claims unless these can be scientifically substantiated.

All such information should be accurate, objective, fair, balanced and should not be misleading either directly or by implication.

Disparaging reference to other products or manufacturers should be avoided.

Comparative claims should be well founded on data from adequate and wellcontrolled clinical studies and should be consistent with the evidence of other clinical data. Non-clinical comparative studies on antibiotics are acceptable provided the tests are well-established scientific and evident based standards activity used in the medical community. Statements based on animal models or in-vitro data must be identified clearly. Such data may be used only if human data are not available. The claimed differences between drugs should only be statistically significant. Comparative statements should mention the comparison drug.

The use of a competitor product brand name requires written consent from that company. Absolute or all-embracing claims should be used with caution and only with adequate qualification and substantiation. The word ‘safe’ or “no side effects” must not be used without qualification.

Particular care should be taken that essential information as to pharmaceutical products’ safety, contraindications and side effects or toxic hazards is appropriately and consistently communicated subject to the legal, regulatory and medical practices of the city.

Companies should establish and maintain appropriate procedures to ensure full compliance with relevant codes and applicable law and to review and monitor all of their promotional activities and materials. Promotional communications, whether in Chinese or English, should have medical clearance or, when appropriate, clearance by the responsible person before their release. The responsible person must have appropriate scientific or healthcare qualifications.

When package inserts are printed in Chinese and English, the information imparted in both languages should be the same.

Promotional material, such as mailings and medical journal advertisements, should not be such as to disguise its real nature.

No pharmaceutical product shall be promoted for use in any city until the requisite approval for marketing for such use has been given in the city. However, this provision is not intended to abridge the right of the scientific community and the public to be fully informed concerning scientific and medical progress. It is not intended to restrict a full and proper exchange of scientific information concerning a pharmaceutical product, including appropriate dissemination of investigational findings in scientific or lay communications media and at scientific conferences. Nor should it restrict public disclosure to stock holders and others concerning any pharmaceutical product as may be required or desirable under law, rule or regulation.

Promotion should be capable of substantiation either by reference to the approved labeling or by scientific evidence. Such evidence should be made available on request to healthcare professionals. Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the inquiry.

All printed material (including journal advertising and Internet posting) which is issued for promotional purposes by the manufacturer or with his authority should include the following:-

Except for pharmaceutical products where use entails specific precautionary measures, reminders need not necessarily contain all the above information, providing that the generic name of the product is given and that a form of words is used which indicates clearly that further information is available on request. Reminder promotion is considered to be that for a product which has been on sale in a city for a period of not less than 12 months. The word ‘new’ in relation to a product, indication or presentation should only be used during the first 12 months promotion of that product, indication or presentation.
Where a claim for ‘newness’ is made the provisions of Clause 4.1 must be adhered to in relation to the claim.

Promotional material should conform, both in text and illustration, to canons of good taste and should recognise the professional standing of the recipients.

Where appropriate, for example, in technical and other informative material, the date of printing or the last review should be stated.

In a multi-page advertisement, only one page need include the information required by Clause 4.1. of the code; provided that each of the other pages (expect the page on which, or facing which, the information is printed) includes a reference, indicating on which page that information appears.

The same requirements shall apply to electronic promotional materials as apply to printed materials. Specifically, in the case of pharmaceutical product related websites:

Symposia, congresses and the like are indispensable for the dissemination of knowledge and experience. Scientific objectives should be the principal focus in arranging such meetings. Any hospitality offered should be reasonably related to the scientific agenda and shall not be inconsistent with this Code.

Symposia, congress and other communications means
When a pharmaceutical company or association sponsors a symposium, congress or other promotional, medical/health care or educational programme (an “Event”), other than a breakfast, lunch or dinner Event of no more than 3 hours in duration covering a clear scientific agenda, a minimum of twothirds (2/3) of the time (calculated from the official start to finish of the Event agenda for each day) shall be devoted to the scientific agenda, which shall be prepared and distributed to participants before the Event. In addition:

Entertainment

Sponsorship

Member companies may sponsor healthcare professionals to attend Events provided such sponsorship is in accordance with the following requirements:

Medical representatives should be adequately trained and possess sufficient medical and technical knowledge to present information on the company’s products in an accurate, ethical and responsible manner.

Medical representatives should at all times maintain a high standard of ethical conduct in the discharge of their duties.

The requirements of the Code which aim at accuracy, objectivity, fairness, balance and good taste apply to oral presentations as well as printed or electronic material.

Unfair or misleading comparisons or comparisons implying a therapeutic advantage which is not in fact justified should not be made by medical representatives.

Medical representatives should take adequate precautions to ensure the security of medical products in their possession. They should also report to their company any information which they receive on the use of products and particularly reports of side effects.

Companies should prepare detailed briefing material for medical representatives on the technical aspects of any product which the medical representative is to promote.

The system of remuneration of representatives should not be such as to adversely influence the proper prescribing of pharmaceutical products by the physician.

Medical representatives should not copy and distribute to healthcare professionals detail briefing material which can be training material or in-house and internal memo product material for promotion purposes without the prior approval of the responsible person in the company – see Section 3.9.

The distribution of product samples is intended for the use of physicians to gain patient experience with a particular drug, each sample pack shall be clearly indicated (i.e. physician sample, not for sale) The frequency and volume of samples provision should be reasonable given the doctor’s experience with the products and in any event, limited both in size and face value. Under no circumstances shall samples be included or used as part of any sale and purchase transaction of any products with any healthcare professional.

Samples shall only be given out in accordance with applicable policies of healthcare institutions (e.g. Hospital Authority)

All samples sent by post should be packed up as to be reasonably secure against the package being opened by young children, and should be of quantities small enough not to be dangerous to children.

Where samples of products restricted by law to supply on prescription or are classified as “poison” are distributed by a representative, the sample should be handed directly to the doctor or given to a person authorised to receive the sample on his behalf. A receipt bearing doctor/dentist/pharmacist’s signature must be obtained for the quantity of samples supplied.

All samples (poisons) should be stored in a locked and secure area and someone should be assigned to be responsible for the procedures relating to the storage and balance of samples. Companies should keep proper records and sample receipts so as to show a reconcilable balance.

Inappropriate financial, material or personal benefits (such as theatre, concerts, sporting events and festive gifts), including inappropriate or lavish hospitality, should not be offered to healthcare professionals to influence them in the prescription of pharmaceutical products.

Text, reference-books, magazines, journals, or other items, scientifically and/or medically-related and/or educational in nature, may only be given to hospitals or private group practices when they serve a genuine educational purpose are provided on infrequent basis and limited to HK$5,000 per hospital department or group practice per year. Maximum expenditure of these items per company should be in a modest amount in a calendar year.

Gratuitous payments in cash or cash equivalents (such as gift certificate) must not be offered to healthcare professionals under any circumstances.

Methods used for marketing research should never be such as to bring discredit upon, or to reduce confidence in, the pharmaceutical industry. The following provisions apply whether the research is carried out directly by the company concerned or by an organisation acting on the company’s behalf.

Marketing research should not in any circumstances be used as a disguised form of sales promotion and the research per se should not have as a direct objective the influencing of the opinions of the informant.

The identity of an informant should be treated as being confidential, unless he has specifically agreed otherwise. In the absence of this agreement it follows that the information provided (as distinct from the overall results of the research) should not be used as the basis upon which a subsequent approach is made to that informant for the purpose of sales promotion.

Precautions should be taken to ensure that no embarrassment results for informants following on from an interview, or from any subsequent communication concerning the research project.

Requests from individual members of the public for information or advice on personal medical matters must be refused and the enquirer recommended to consult his or her own doctor.

Information about medicines which is made available to the general public either directly or indirectly must be factual and presented in a balanced way. It must not raise unfounded hopes of successful treatment or be misleading with respect to the safety of the product.

This fifteenth Edition of the Code shall take effect on April 1, 2011 and supersedes previous editions.

The complaint procedure has been established to provide a mechanism for dealing with breaches of the Code after they have occurred. However, the Code has an equally, if not more important role in encouraging the implementation and monitoring of improved standards for marketing practices in order to prevent the errors which lead to breaches of the Code.

The Code is administered by a Code of Practice Committee which the Executive Director shall invite 3 members, include Directors/General Managers/Managing Directors of members companies.
Provided that they have valid reasons/justification, the two companies involved in the complaint have the right to reject an individual member to be included in the panel within 7 days after the member is selected.
If, after best efforts, the two parties and the Executive Director still cannot reach an agreement on the jury composition, the Executive Director will elevate the issue to the Board of Directors for final resolution.
The Committee shall have the authority to appoint the Chairman of the Committee. Decisions are made by a simple majority of the Committee, with the Chairman having a casting vote.

If a party to the complaint is dissatisfied with the decision of the Code of Practice Committee, it may request the Code of Practice Committee to review its decision. Any party requesting a review of a decision of the Code of Practice Committee shall notify the HKAPI President in writing within 30 days of receipt of the Code of Practice Committee’s decision.

If no request for a review of the Code of Practice Committee’s decision is made within the period specified in Section 12.3, the decision of the Code of Practice Committee shall be final and binding, and adherence to the decision shall be a condition of continued membership of the HKAPI.

Where a party requests for a review of decision of the Code of Practice Committee as aforesaid, the Executive Director shall select 4 members from member companies and 1 outside expert to convene a Review Committee to review the matter.
Decisions are made by a simple majority of the Committee, with the Chairman having a casting vote.
The cost of such an outside expert shall be borne by the company judged to be in the wrong whether it be an unsuccessful complainant or the company which is found to have breached the Code.

The Review Committee may conduct its review in any manner it thinks fit, the final decision is made by a simple majority. The Review Committee shall render a decision within 30 days of receipt of the request for a review and promptly notify the HKAPI President and the parties to the review of its decision, and the reasons therefor, in writing and by registered mail.

If a party is dissatisfied with the decision of the Review Committee, either party involved in the complaint may refer the complaint to arbitration by notifying the HKAPI President in writing within 14 days of receipt of the Review Committee’s decision.

If no request for arbitration is received within the period specified in Section 12.7 the decision of the Review Committee shall be final and binding, and adherence to the decision shall be a condition of continued membership of the HKAPI.

The arbitration tribunal shall be constituted as follows:

The arbitration tribunal may conduct its proceedings in any manner it thinks fit. The arbitration tribunal shall render a decision within 30 days of the date it commences deliberation of the complaint (which date shall not be later than 7 days after the arbitration tribunal has been constituted) and shall promptly notify the HKAPI President and the parties to the arbitration of its decision and the reasons therefor, in writing and by registered mail. The decision of the arbitration tribunal shall be final and binding, and adherence to the decision shall be a condition of continued membership of the HKAPI. Each party shall bear the costs and expenses of the representative selected by it. The costs and expenses of the chairman of the arbitration tribunal shall be borne by the losing party.

Where the complainant and/or the infringing company is a non-member of the HKAPI, the matter will be referred to the Board of Directors for a decision on whether to impose the penalties referred to in Section 12.11.(a).

Where the company acknowledges that it has acted in breach of the Code, information is required on the action that has been taken or will be taken to remedy the matter.
Where the allegations are rejected, the reasons for rejection must be clearly stated and, where appropriate, supporting data (e.g. scientific evidence to support claims which have been questioned) should be provided.

The Members agree that they shall follow the local dispute resolution procedures in Section 12 of the Code to adjudicate on any local dispute or complaint in relation to violation of the Code that may arise, and the Code shall have exclusive jurisdiction over such local dispute or complaint between Members.

Notwithstanding Clause 12.15, on local issue that is not stipulated in or regulated by the Code, and/or international issue that goes beyond the boundaries of one local country: (1) the Members may refer such issue to IFPMA for dispute resolution if it cannot be resolved within HKAPI despite reasonable effort being made; and/or (2) HKAPI may refer such matter to IFPMA for adjudication in its own initiative.

The Code is administered by a Code of Practice Committee which the Executive Director shall invite 3 members, include Directors/General Managers/Managing Directors of members companies
Provided that they have valid reasons/justification, the two companies involved in the complaint have the right to reject an individual member to be included in the panel within 7 days after the member is selected.
If, after best efforts, the two parties and the Executive Director still cannot reach an agreement on the jury composition, the Executive Director will elevate the issue to the Board of Directors for final resolution.
The Committee shall have the authority to appoint the Chairman of the Committee. Decisions are made by a simple majority of the Committee, with the Chairman having a casting vote.

The Committee shall render a decision within 30 days of receipt of the complaint with supporting documentation and shall promptly notify the parties of its decision in writing and by registered mail.

Any party requesting a review of a decision of the Code of Practice Committee shall notify the HKAPI President in writing within 30 days of receipt of the Committee’s decision.

Where a party requests for a review of decision of the Code of Practice Committee as aforesaid, the Executive Director shall select 4 members from member companies and 1 outside expert to convene a Review Committee to review the matter.
Decisions are made by a simple majority of the Committee, with the Chairman having a casting vote.
The cost of such an outside expert shall be borne by the company judged to be in the wrong whether it be an unsuccessful complainant or the company which is found to have breached the Code.

The Review Committee shall render a decision within 30 days of receipt of the request for a review and promptly notify the parties of its decision in writing and by registered mail.

Any party may refer the complaint to arbitration by notifying the HKAPI President in writing within 14 days of receipt of the Review Committee’s decision if a party is dissatisfied with the decision.

The arbitration tribunal shall render a decision within 30 days of the date it commences deliberation of the complaint (which date shall not be later than 7 days after the arbitration tribunal has been constituted) and shall promptly notify the parties to the arbitration of its decision in writing and by registered mail. Each party shall bear the costs and expenses of the representative selected by it. The costs and expenses of the chairman of the arbitration tribunal shall be borne by the losing party.