The medical profession in Singapore is ethically governed by the Singapore Medical Council (SMC) Ethical Code and the Singapore Medical Association (SMA) Ethical Code. The pharmaceutical industry in Singapore is ethically governed by the Singapore Association of Pharmaceutical Industries (SAPI) Code of Marketing Practices.

This first joint document of the SMA and SAPI outlines the common ethical principles and practice in the relationship between the medical profession and pharmaceutical industry. The Principles aim to harmonise the ethical issues and dilemmas. The Practice establish the working guidelines, bringing the two organisations together in resolving the ethical conflicts which may arise from time to time.

This document will serve as a reference, for both individual doctors and pharmaceutical companies. It marks the beginning of the close and long-term collaboration between SMA and SAPI, in ensuring the highest level of ethical standards and integrity in the medical profession and the pharmaceutical industry in Singapore.

This paper is the output of the deliberations of the Joint SMA-SAPI Committee which has considered the following documents: the SMA Ethical Code, SMC Ethical Code, SAPI Code of Marketing Practice, and the Academy of Medicine Position Paper on "Pharmaceutical Companies and Doctors in Singapore".

1.1 The medical profession and the pharmaceutical industry are important partners in the delivery of healthcare to patients and the public. The medical profession is expected to place patients' health and welfare above financial or commercial gains. The pharmaceutical industry is expected to invest in research and development, to develop new and improved treatment options for the benefit of patients and market them ethically.

1.2 In the relationship between the medical profession and the pharmaceutical industry, strict and professional conduct is necessary to prevent abuses. This relationship must always be seen to be impartial, honest and in compliance with the SMA Ethical Code, SMC Ethical Code and the SAPI Code of Marketing Practices. This is to ensure that patients and public's interests are always upheld.

1.3 The medical profession at large and the individual physician in particular must assure and demonstrate to the patient and public that the medical treatment offered is the most appropriate for the patient (considering benefits, side-effects and costs) and not primarily influenced by commercial or financial gains. The physician must not compromise nor be regarded by others as likely to have compromised their independent professional judgement in prescribing.

1.4 Public confidence and patients' trust in the healthcare delivery system can only be preserved by:

a) responsible prescribing by the physician based on scientific and clinical integrity and,

b) responsible marketing by the pharmaceutical industry.

1.5 Physicians must ensure their professional judgement and impartial clinical assessment of drugs is not impaired by the receipts of gifts, hospitality, travel grants nor research grants.

1.6 Educational medical meeting sponsored by the pharmaceutical industry must always preserve scientific and educational aims foremost. The level of accompanying hospitality should not exceed the level which the physicians might normally adopt when paying for themselves.

1.7 Scientific research carried out in collaboration with the pharmaceutical industry must be of high scientific merit, properly planned, approved by an ethics committee and professionally executed. Proper accounting procedures are to be adopted with independent audit and fulfilling all legal requirements.

1.8 Conflict of interests, if any, must be declared by speakers, researchers, medical institutions and pharmaceutical companies at meetings, presentations and in publications.

2. PHARMACEUTICAL MARKETING PRINCIPLES

2.1 Legal Regulations

2.1.1 There are established regulations, namely the Medicines Act of 1975, which controls and advises on the promotional activities of pharmaceutical companies, including direct-to-consumer advertising, where permitted.

2.1.2 Guidelines for promotion and advertisements for pharmaceutical products directed to the healthcare professions fall within the scope of the SAPI Code of Marketing Practices but advertising directed to the general public of self medication products is covered by Medicines Act of 1975 and, SAPI OTC Medicine Code of Advertising and Promotion Practices.

2.1.3 With regard to product information on labelling, packaging, leaflets, data sheets and in advertisements, the Medicines Act 1975 has specifications on the format and content of the information to be communicated.

2.2 Standards of Promotion

2.2.1 Promotional materials for pharmaceutical products should be accurate, fair and objective and presented in such a way as to conform not only with legal requirements but also with high ethical standards and to be in good taste. Claims should not be stronger than what scientific evidence warrants. Every effort should be made to avoid ambiguity.

2.2.2 Companies should deal objectively with requests for information made in good faith and should provide data which are appropriate to the source of the enquiry.

2.3 Scientific Evidence

2.3.1 Prescribing information in promotional materials should be based on an up-to-date scientific validation and should not be incorrect or misleading. Scientific data to support the claims and recommendations for use should be made available, on request, to healthcare providers. Prescribing information in packaging insert should be approved by the Drug Administration Division (DAD), Ministry of Health.

2.3.2 Companies should produce data on request to support their claims irrespective of whether or not the data are public domain but are not required to substantiate indications 'or use w ic are a rea y approved by DAD, Ministry of Health. Normal considerations relating to confidentiality of information should apply.

2.3.3 Data from in vitro and animal tests should be clearly indicated as such and not be cited in such a way as to be incorrect or misleading.

2.4 Disguised and Misleading Promotion

2.4.1 Promotional material, such as mailings and medical journal advertisements, must not disguise their real intent. An example of disguised promotion is an advertisement in a journal which appears to be part of the editorial content.

2.4.2 Post-marketing and surveillance studies should be conducted scientifically. Where these studies have little or no scientific basis, they should not be used as a means to promote a product and influence physicians.

2.5 Training and Responsibilities of Medical Representatives

2.5.1 Medical representatives must be adequately trained and possess sufficient medical and technical knowledge to present information on their company's products in an accurate, responsible and ethical manner. They must also feed back to their company, from contacts in the medical and allied professions, information which they receive on the use of products, particularly reports of side effects.

2.5.2 The system of remuneration for medical representatives should not adversely influence the promotion of pharmaceutical products to the medical profession. The provisions relating to remuneration should ensure that no incentives are provided that would lead to unethical behaviour of representatives.

2.6 Symposia, Congresses, Media Interviews and Other Means of Verbal Communication

2.6.1 Symposia, congresses and oral presentations are important for the dissemination of knowledge and experience. Scientific objectives should be the principal focus of such meetings. It is increasingly recognised that such events are being organised by professional conference organisers who are appointed by the pharmaceutical companies and/or medical societies. In this regard, the company or medical society should ensure that hospitality is consistent with such scientific objectives. The cost of organising such events should be kept modest and in keeping with the dignity of the pharmaceutical industry and the medical profession.

2.6.2 The principal aims of media interviews are to inform and educate the public on the advances of medicine, which are of public interest. Physicians participating in media interviews must ensure that they are fully proficient with the subject under discussion and present a comprehensive, balanced and objective view. Where there are conflicts of interests, the physicians should declare them at the beginning of the media interview. The physician is recommended to use generic names of products and refrain from appearing to endorse any particular product. Basically, the pharmaceutical industry and the physician must be aware of the potential risks of misinterpretation, misquotation and even misinformation, and should therefore take the necessary steps to reduce these.

2.7 Sponsorship

2.7.1 Where a pharmaceutical company or a medical association sponsors a symposium, congress or other medical/health care or educational programme, the main focus should be scientific.

2.7.2 The fact of sponsorship by the company or association should be clearly transmitted to all the participants, before and during the proceedings. Printed, audio-visual or computer-based material arising from such meetings should accurately reflect the presentations and discussions.

2.7.3 Entertainment or other hospitality and any gifts to members of the medical and allied professions should be secondary to the main purpose of the meeting and should be kept to a modest level.

2.7.4 If the programme is accredited for postgraduate medical education by a medical or other professional organization, responsibility for the programme content remains with the organization responsible for obtaining accreditation for the meeting. Industry support should be disclosed.

2.8 Hospitality

2.8.1 Extravagant or inappropriate hospitality should not be offered to healthcare professionals to influence them in the prescription of pharmaceutical products. Making hospitality or other benefits conditional upon prescribing performance is unacceptable.

2.9 Samples

2.9.1 Samples, clearly identified as such, may be supplied to the prescribing physicians to familiarize them with the products. They should not be sold.

2.10 Consultancy

2.10.1 A medical consultant is defined as a medical practitioner in a contractual relationship to provide medical expertise to a pharmaceutical company. Such a consultant is entitled to remuneration. Where attendance of medical congresses is part of the stipulated contract, it would be appropriate for the medical consultant concerned to receive reasonable allowances for travel, lodging and meal expenses.

3. THE INDIVIDUAL DOCTOR AND PHARMACEUTICAL COMPANIES

3.1 Gifts

3.1.1 Any gift accepted by physicians should primarily benefit patients and be related to the physician's work. Gifts should not be solicited. Cash payments as incentives for prescribing are unacceptable. Gifts should not be of substantial value such that they obligate the physician and improperly influence responsible prescribing. The public disclosure of receipts of such gifts should not create embarrassment.

3.2 Promotional Items

3.2.1 Promotional items of insignificant value, provided free of charge, are acceptable where they are related to the physician's work and entail a benefit to patients.

3.3 Educational Material

3.3.1 Text or reference-books/information, and other educational materials may be given to the physicians if they serve a genuine educational function.

3.4 Travel Grants

3.4.1 Individual doctors receive help or invitations from pharmaceutical companies to travel overseas to attend medical conferences. It is recognized that such conferences with their learning experiences are important for doctors to keep abreast with rapid changes in medicine.

3.4.2 The criteria for offering and acceptance of such travel grants include:

i. the subject of the Conference is directly related to the doctor’s work and appropriate for the specially or the practice of the doctor concerned;

ii. the doctor should make the best use of such travel grant to maximise his/her medical learning experience.

3.4.3 Travel grants should not be offered or accepted if they are:

i conditional upon the physician's past or present prescribing habits;

ii. attached to any obligation to prescribe certain products.,

iii. additional holidays (such as pre or post conference tours) or entertainment;

iv. for travel expenses for accompanying persons.

3.4.4 Medical institutions and societies which coordinate in offering travel grants are encouraged to draw up open and clear criteria for such awards (e.g. based on merit, presenting a paper, chairing scientific sessions, research interest or other equitable criteria).

3.4.5 Any support to individual healthcare practitioners to participate should not be conditional upon any obligation to promote any medicinal product;

3.4.6 Payments of reasonable honoraria and reimbursement of out-of-pocket expenses, including travel, for speakers/presenters are customary and proper;

3.4.7 The individual doctors and medical societies who have received travel grants and pharmaceutical companies which have offered such travel grants should register the travel grants, the conference name, the city/country of the conference and the total amount of the grant with the SMA and SAPI Ethics Committees respectively. The two Ethics Committees should regularly exchange such registered information. Such a Register of Travel Grants is to ensure transparency and appropriateness in offering and accepting travel grants.

3.5 Support For Research or Clinical Studies

i. It is appropriate for doctors conducting research or clinical trials to receive funds and/or supplies from the relevant pharmaceutical company. Such research or clinical trials must always be approved by a research ethics committee and comply with the Ministry of Health's Guidelines for Good Clinical Practice.

ii. The use of such funds should be accompanied by statements of actual expenditure and disbursements. Such statements should be available for independent audit.

iii. It is also appropriate for such doctors to receive travel grants to attend conferences relevant to their area of research (as speaker or delegate);

iv. Offers and acceptance of research grants should not be conditional upon the purchase of medical drugs or equipment.

v Any communication pertaining to the results of such research must be accompanied by a declaration of conflict of interest.

4. PHARMACEUTICAL RELATED CME

4.1 When a pharmaceutical company invites an expert (whether local or foreign) to address the medical community on advancements or studies on drug therapy, several areas of conflict may arise.

To reduce the conflicts of interest and to increase the objectivity of the lecture, the following guidelines are suggested:

i. Such talks are best organised through a registered and recognised academic or professional medical society or institution.

ii. The medical body should only receive a financial grant equal or proportional to what is necessary in organising the meeting (e.g. invitations, publicity, rental of hall, etc.).

iii. Before organising the meeting, the medical body is recommended to:

a. Vet the curriculum vitae of the speaker to assess his suitability,

b. Ensure the speaker declares his conflict of interest in writing,

c. Ensure that the contents of the lecture are vetted for objectivity and comprehensiveness by members well versed on the subject.

d. Award CME points only if objectivity and relevance are established. Lectures not meeting the criteria should not be awarded CME points.

iv. Where a speaker is from a pharmaceutical company or a foreign speaker, invitation to a local discussant (a member of the local medical community who holds expertise or experience on the topic) to give a local perspective should be encouraged. The discussant should have access to the lecture materials in advance.

v At the beginning of the Lecture, the Speaker, the Discussant and the Chairman should declare their conflict of interests, if any.

vi. The presentation of gifts or tokens of appreciation by pharmaceutical companies or the medical societies to speakers, chairmen and discussants at the end of CME talks is not essential.

vii. The medical academic community and the pharmaceutical industry should regularly organise seminars that would inform and equip doctors on methods of objective assessment of pharmaceutical products.

viii. Hospitality associated with the CME should be modest and dignified.

4.2 Product Talks

4.2.1 Pharmaceutical companies can organise marketing talks about their new products. Doctors are free to attend such talks. However, doctors are encouraged to analyse critically the information presented. These talks may not qualify for CME points. They must comply with the Ethical Codes of the SMC, SMA and SAPI. However, this is a potential "slippery slope situation".

5. PUBLIC MEDICAL TALKS

5.1 Where pharmaceutical companies assist in conducting public/ patient disease-awareness programs, the information disseminated should be objective, comprehensive, balanced, and accurate. Such activities are best organized under the auspices of appropriate medical bodies/societies.

5.2 Where it is permitted by law for the health professionals to communicate directly with patients regarding their prescription of medicine, all such information should be accurate, fair and not misleading. The forms in which the information is disseminated in, to the public, may include patient package inserts, leaflets and booklets etc., made available to inform patients about products prescribed or recommended by health professionals.

5.3 The aim of these talks is to inform and educate the public so as to enable them to:

a) understand the medical issues involved, including signs and symptoms of medical conditions, the available treatments and prevention;

b) learn to cope with and manage their own medical conditions;

c) help family members cope with medical problems and;

d) enable the public to become better informed in medi @ decision making,

5.4 The subject of the talks should be of public interest. Promotion of the following should be avoided:

a) forms of treatment that are unproven or controversial

b) non-established medical therapy or investigations,

5.5 The speakers should address the topic in its broadest sense covering all aspects, being comprehensive, non-biased and meet the needs of the public. Speakers should not have financial or other interest beyond the need to educate the public,

5.6 The pharmaceutical companies involved should observe the following:

i. Product names are not displayed - Medicines Act forbids display of product and brand name,

ii. For the sake of transparency, names of pharmaceutical companies should appear on invitation cards and publicity materials,

iii. Distribution of brochures and door gifts bearing names and logos of pharmaceutical companies and logos are allowed,

iv. Not to advertise directly or indirectly pharmaceutical agents, devices and medical investigating devices to the public unless they are meant for home use.

5.7 Such talks are best organised through registered medical societies. The organising body (medical society or hospital) must:

i. Ensure that speakers and pharmaceutical companies declare their conflict of interest, if any.

ii. Vet for comprehensiveness and ensure that speakers avoid biases in their talks.

iii. Avoid using such public talks as money-making ventures either from the pharmaceutical company or from the participants.

iv. Not allow public talks to be used primarily as a means of attracting patients or gain other commercial advantage for the individual or the institution.

5.8 In organising public talks, the public interest should be upheld foremost. All aspects of medical ethics must be complied with as stipulated in the Ethical Codes of SMC, SMA and SAPI, and requirements of the MAAU regulations.

5.9 Where talks refer to unregistered products, this must be clearly stated.

6. SCIENTIFIC PAPERS/POSTER PRESENTATIONS AT MEDICAL CONFERENCES

6.1 The aim of a scientific paper/ poster presentation is to objectively present scientific evidence with regard to the efficacy of the drug/ device understudy.

6.2 The speaker should declare clearly his financial interest, or lack thereof, in the drug/ device under investigation at the outset of his oral presentation, or as a footnote in his poster presentation.

6.3 The speaker should also declare any financial assistance received i.e research grants, travel allowances etc from any commercial sources.

This policy provides guidelines for evaluating and accepting offers of gifts, hospitality and sponsorships by vendors/suppliers to all members of the HCS Group.

2. OBJECTIVES

2.1 To provide a consistent, open and transparent system for use by all members of the HCS Group to process and approve/reject offers by vendors/suppliers of gifts, hospitality and sponsorships to their staff and/or the institution,

2.2 To protect staff from allegations of misconduct by disgruntled vendors/suppliers, especially staff who are perceived to be in a position to influence the institution's decision on selection and procurement of drugs, medical, surgical and other supplies as well as equipment, instrumentation and other assets.

2.3 To provide a consistent and objective framework to ensure staff integrity in their dealings with vendors/suppliers.

3. GUIDELINES

3.1 Gifts

1 . All perishable gifts shall be declared to the Head of Department (HOD)/Unit and shared with colleagues (foodstuff except liquor which is treated as non-perishable) andlor displayed in public areas (e.g. flowers).

2. All non-perishable gifts shall be declared to the HOD and forwarded to the Human Resource Department (HRD) for safekeeping and subsequent use as prizes for institutional functions such as annual dinner and dance, family day etc.

3. The CEO/MD may approve the retention of personalised nonperishable gifts by individual recipients upon payment of not less than 25% of the prevailing market price (where known) or the assessed market value based on valuation by the Gift Assessment Panel and/or a department as directed by the CEO/MD.

4. Gifts with no market value such as diaries, desktop organisers and other promotional tokens (notepads, stickers, book marks etc) bearing the name/logo of a vendor/supplier that are given to all customers in the ordinary course of business need not be declared.

3.2 Hospitality

1 . Invitation to lunch, dinner etc should generally be discouraged. Where this is in the course of normal business transactions, not lavish, and there is no perceived obligation to the host, the invitation may be accepted. This should be disclosed to the HOD/next level of authority and made public.

2. Sponsorship of receptions, overseas speakers (accommodation, airfare) etc for local scientific meetings, professional conferences, continuing medical education (CME) programmes etc shall not be actively solicited. Acceptance of offers of hospitality for such functions shall be selective, and spread across a number of vendors/suppliers to avoid any perceived undue obligation to any single party.

3.3 Sponsorship for staff training and development

1 . All offers of sponsorship covering fees and charges, accommodation, per diem, airfare and other related costs for staff to:

a) attend local/overseas professional conferences and seminars as speakers, chairmen and/or participants, as well as formal training courses in specific areas of specialisation and/or

b) undergo training related to acquisition of capital equipment and/or IT/medical systems as well as overseas site visits to evaluate such equipment/systems shall be directed to the institution without naming particular beneficiaries in the area(s)of training sponsored and considered for acceptance or otherwise on the merits of each case.

2. In general a staff member shall not receive more than one sponsorship per year from any single sponsor unless specifically approved by the CEO/MD.

3. In general a staff member shall not receive more than two sponsorships per year from different sponsors. Medical staff shall generally not accept more than three sponsorships per year from different companies unless otherwise approved by the Medical Board.

4. All sponsorship moneys (where applicable) shall be credited to a central account to be managed by the institution for disbursement to the most deserving candidates based on the prevailing policy guidelines on staff training and to meet specified training needs.

5. Where the sponsorship is offered in kind (e.g. accommodation and airfare), the vendor/supplier shall declare the value of the sponsored items to the institution.

6. The value of sponsorship offered to the selected candidate(s) shall be subject to the prevailing terms and conditions offered by the institution to all other candidates sponsored internally by the institution irrespective of the actual value of the sponsorship offered by vendor/supplier. Any excess funding shall be credited to the institution's Endowment Fund, Departmental Fund andlor institution as decided by the CEO/ MD; or returned to the sponsor.

7. A sponsored candidate may be provided with additional financial support by the institution to top up any shortfall

between the value of the sponsorship provided by a vendor/ supplier and the quantum normally granted by the hospital for similar activities/training programme.

8 All sponsored employees shall be barred from participating in any product review and/or tender committees for a period of one year from the date of receipt of their sponsorships where these involve the vendor(s) 1 supplier(s) who has provided them with the respective sponsorships. This shall not apply to staff who are involved in clinical trials and expected to present the results at various forums.

9. Sponsorship offers by professional societies shall be considered separate from this Policy and decided upon by the relevant authorities within each hospital/institution.

4. PROCEDURES

4.1 Each member of the HCS Group shall adopt this set of guidelines as the framework to formulate a set of standard operating procedures for compliance by their own staff with regard to the declaration, processing, and acceptance or otherwise of all offers of gifts, hospitality and sponsorships by vendors/suppliers.

4.2 The CEO/MD may at his discretion delegate the authority for approval of acceptance or otherwise, of all offers of gifts, hospitality and/or sponsorships to designated members of his staff. All delegations shall be properly authorised and documented, with the appointees fully apprised of this set of guidelines. This is to facilitate auditing.

4.3 This set of guidelines shall be used in conjunction with the individual institution's prevailing policy guidelines on training and development of medical and non-medical staff.

4.4 All offers from vendors/suppliers and subsequent disposal of gifts/sponsorships in kind, and/or disbursement of funds received from the sponsors, shall be properly documented and subject to audit.


1 Aug 2000