ADOPTED BY THE MEDICAL AND DENTAL PROFESSIONS BOARD AS BEING APPLICABLE TO DOCTORS, DENTISTS AND MEDICAL SCIENTISTS

INTRODUCTION

1. The Medical and Dental Professions Board holds the view that a health care professional such as a medical practitioner, dentist and medical scientist, should at all times act in the best interest of the patient and place the clinical need of the patient paramount. To this end, a health care professional should always try to avoid potential conflicts of interests and maintain professional autonomy, independence and commitment to the appropriate professional and ethical norms. Any conflicts of interests or incentive or form of inducement which threatens such autonomy, independence or commitment to the appropriate professional and ethical norms or which does not accord first priority to the clinical need of a patient, is unacceptable. The ownership and use of high technology equipment creates a special problem, not only because of inappropriate use by health care professionals not duly qualified, but also due to overservicing by appropriately qualified health care professionals. In general, problems related to the usage of high technology equipment is already covered by the relevant stipulations of this policy statement. It needs to be emphasised, however, that overservicing of whatever nature is unacceptable.
2. In this policy statement, the Medical and Dental Professions Board seeks to identify those incentive schemes and forms of inducement which it finds unacceptable. It must be clearly stated that the perverse incentives or potential conflicts of interests set out in this document should not in any way be regarded as an exhaustive list. The principles underlying these listed perverse incentives will apply in every case of alleged unprofessional conduct on the part of a health care professional and where applicable will form the basis for an investigation by an appropriate health care authority or the Board.
3. The policy statements pertaining to perverse incentives as contained in this document shall be applicable to health care professionals in both the public and private sectors.
4. It should further be noted that in terms of this policy statement, it would be an offence either to offer an inducement or to accept one.
5. In addition to any action which the Medical and Dental Professions Board might take in terms of other legislation that governs the Board, the Board may, at its own discretion and where it believes such action to be warranted, lay a charge against any person(s), or corporate body(ies) or other legal entity in terms of the Corruption Act, 1992 (Act No. 94 of 1992), should the actions or omissions of such person(s), body(ies) or other legal entity be in breach of the provisions of the said Act.

2.  DEFINING OF CONCEPTS
For the purpose of this policy statement, the following concepts will have the meanings as indicated below, unless the context otherwise indicates. It should be noted that these concepts have not been defined for legal purposes, but merely to clarify the meaning of the policy statement. It should further be noted that some of these definitions have been based on various pieces of legislation, in particular definitions contained in the draft of the South African Medicines and Medical Devices Regulatory Authority Act, 1998 (Act No. 132 of 1998):

1. "Advertise" in relation to any health establishment or orthodox medicine, complementary medicine, veterinary medicine, medical device or scheduled substance or health related product or health related service, means any written, pictorial, visual or other descriptive matter or verbal statement or reference in respect thereof -
   1. appearing in any newspaper, magazine, pamphlet or other publication; or
   2. distributed to members of the public; or
   3. brought to the notice of members of the public in any manner whatsoever,

   which is intended to promote the sale of that orthodox medicine, complementary medicine, veterinary medicine, medical device or scheduled substance or health related product or to attract patients to any particular health establishment or health related service.

2. "Complementary medicine" means any substance, or mixture of substance, which -
   1. originates from a plant, mineral or animal, and which may be, but is not limited to being classified as herbal, homeopathic, ayurvedic or nutritional; and
   2. is used or intended to be used for, or manufactured or sold for use in, or purported to be useful in, complementing the healing power of a human or animal body or for which there is a claim regarding its effect in complementing the healing power of a human or animal body in the treatment, modification, alleviation or prevention of a disease, abnormal physical or mental state or the symptoms thereof in a human being or animal; and
   3. is used in, but not limited to, the disciplines of Western herbal, African traditional, traditional Chinese, Homeopathy, Ayurveda, Unani, Antroposophy, Aromatherapy and Nutritional supplementation; or
   4. because of its origin, intended use or use in a discipline, is determined by the Authority, by notice in the Gazette, to be a complementary medicine.
3. "Endorse" means any action whereby a person or body attaches approval to or sanctions any health establishment or orthodox medicine, complementary medicine, veterinary medicine, medical device or scheduled substance or other health related product or health related service with a view to encouraging or promoting the preferential use or preferential sale thereof for the purpose of financial gain or other valuable consideration.
4. "Health establishment" means an institution, facility, building or place where persons receive treatment, diagnostic or therapeutic interventions or other allopathic or complementing health services and it includes facilities such as a clinic, mobile clinic, hospital, community health centre, maternity home or unattached delivery suite, convalescent home, consulting room, dispensary of health related treatment or aids and appliances, first aid station, orthopaedic workshop, dental laboratory or workshop, ambulance, unattached operating theatre, sanatorium, laboratory, pharmacy, occupational health clinic, radiological clinic, and health spa or hydro.
5. "Health related product" means any commodity other than orthodox medicine, complementary medicine, veterinary medicine, medical device or scheduled substance which is produced by human effort or some mechanical, chemical, electrical or other human engineered process for medicinal purposes or other preventive, curative, therapeutic or diagnostic purposes in connection with human health.
6. "Improper financial gain or other valuable consideration" means money, or any other form of compensation, payment, reward or benefit which is not legally due or which is given on the understanding, whether express, implied or tacit, that the recipient will engage or refrain from engaging in certain behaviour in a manner which is either -
   1. illegal; and/or
   2. contrary to ethical or professional rules; and/or
   3. which, in the opinion of a the Medical and Dental Professions Board, may adversely affect the interests of a patient or group of patients,
      
      in order to procure some direct or indirect advantage, benefit, reward or payment for the person offering or giving the said money, compensation, payment, reward or benefit.
7. "Medicinal purposes" in relation to a scheduled substance, means the purpose of treatment or prevention of a disease or some other definite curative or therapeutic purpose, but does not include the satisfaction or relief of a habit or a craving for the substance used or for any other scheduled substance, except where the substance is administered or used in a hospital or similar institution maintained wholly or partly by the Government or a provincial administration, or approved for that purpose by the Minister.
8. "Orthodox medicine" or "Medicine" means any substance or mixture of substances intended to be used by, or administered to human beings, for any of the following therapeutic purposes, namely --
   1. treating, preventing or alleviating symptoms of disease, abnormal physical or mental state or the symptoms thereof;
   2. diagnosing disease or ascertaining the existence, degree or extent of a physiological condition;
   3. otherwise preventing or interfering with the normal operation of physiological function, whether permanently or temporarily and whether by way of terminating, reducing, postponing or increasing or accelerating the operation of that function.
9. "Medical device" or "device" means any instrument, appliance, material, machine, apparatus, implant or diagnostic reagent or any other article, whether used alone or in combination, including software necessary for its proper application used for or purporting to be suitable for use or manufactured or sold for use in or on a human or animal body -
   1. in the diagnosis, prevention, monitoring, treatment or alleviation of disease; or
   2. in diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; or
   3. in investigation, replacement or modification of the anatomy or of a physiological process; or
   4. in the diagnosis of pregnancy, or the control of conception or termination of pregnancy,
      
      and which does not achieve its principal intended action in or on the human body by chemical, pharmacological, immunological or metabolic means, but which may be assisted in its function by such means.
10. "Overservicing" means the supply, provision, administration, use or prescription of any treatment or care (including diagnostic and other testing, medicines and medical devices) which is medically and clinically not indicated, unnecessary or inappropriate under the circumstances or which is not in accordance with the recognised treatment protocols and procedures, without due regard to both the financial and health interests of the patient.
11. "Promote" means any action taken by a person(s) or body or allowed to be taken by such person(s) or body to further or to encourage the preferential use of any health establishment or orthodox medicine, complementary medicine, veterinary medicine, medical device or scheduled substance or health related product or health related service or to further or to encourage the preferential sale of any such product or service for the purpose of financial gain or other valuable consideration: This definition does, however, not prohibit the normal practice of those professions where, in terms of their scopes of practice, it is appropriate to sell at market related prices.
12. "Health care professional" means any person registered in terms of the applicable Act which governs the functioning of any of the Councils that form part of the Forum of Statutory Health Councils. This includes persons registered by the Medical and Dental Professions Board.
13. "Scheduled substance" means any medicine prescribed under section 31 of the South African Medicines and Medical Devices Regulatory Authority Act, 1998 (Act No. 132 of 1998). (At present still to be the Medicines and Related Substances Control Act, 1965 (Act No. 101 of 1965)).
14. "Spouse" means a person's partner in marriage and includes for the purpose of this policy statement, a person with whom another person lives as if they were married or with whom one habitually cohabits.
15. "Trade" means an act or instance of buying, selling or purchasing goods and services for the purpose of financial gain or other valuable consideration.
16. "Veterinary medicine" means any substance or mixture of substances intended or manufactured for use in connection with animals for diagnosis, treatment, alleviation, modification or prevention of disease or unhealthy physical conditions, for the improvement of growth, production or working capacity, for the lasting capacity of carcasses, for curing, correcting or modifying behaviour or for humane euthanasia, but does not include foodstuffs.

3.  POLICY STATEMENTS
The following is not permissible for any health care professional, nor is it ethical for any health related body to encourage a health care professional to engage in the following acts:

4.  OVERSERVICING
Engage in any activity or action that could be regarded as overservicing

5.  MANUFACTURING
Either manufacture or to participate in the manufacture, for commercial purposes or trade, of orthodox medicine, complementary medicine, veterinary medicine, medical device or scheduled substance or health related product, except where such medicine or device or substance or product forms an integral part of the normal scope of practice of a health care profession or where explicit permission was granted to a health care professional by the Board to manufacture or to participate in the manufacture of such medicine, device, substance or product.

6.  ADVERTISING
Advertise or endorse or encourage the use of any health establishment or orthodox medicine, complementary medicine, veterinary medicine, medical device or scheduled substance or health related product or health related service in a manner that unfairly promotes the practice of a particular health care professional or a health care facility for the purpose of improper financial gain or other valuable consideration.

7.  PREFERENTIAL USAGE OR PRESCRIPTION
Engage in or advocate the preferential usage of any health establishment or medical device or health related service or prescribe any orthodox medicine, complementary medicine, veterinary medicine or scheduled substance, if any improper financial gain or other valuable consideration is derived from such preferential usage or prescription or the advocacy of preferential usage by the health care professional, unless entitled by law.

8.  REFERRAL
Self-referral
Self-referral of clients or patients to any health establishment in which the health care professional or a close family member or business associate has a financial interest or potential conflicts of interest (e.g. X-ray facilities, Cathlab, Pathlab, or other such services) if such referral would constitute overservicing.

Other referral
Referral of clients or patients to any health establishment or to other health care professionals if such referral would constitute overservicing.

9.  TECHNOLOGICAL EQUIPMENT

1. The use of high-technological equipment has become and integral part of healthcare and has made a significant contribution to the rendering of accurate and high standards of healthcare in modern times.
2. New technological equipment is being introduced by manufacturers on an ongoing basis and a niche in clinical medicine is subsequently being sought in respect thereof. Aggressive marketing campaigns have, as a result, become rife.
3. Technological equipment should only be owned and used by a health care professional if it forms an integral part of the scope of practice of that health care professional and on condition that the health care professional concerned has received appropriate training in using and managing such equipment.
4. Overservicing by healthcare professionals in whatever form, is in direct conflict with clause 3.1 of this policy statement.

10.  SHAREHOLDING

1. A professional relationship is based on trust and the interests of the patient or client are paramount. Clinicians frequently have to advise patients to be admitted to hospital or to undergo particular tests or procedures. Any suspicion that such advice could be influenced in part by the clinician's own financial interest, will undermine that relationship of trust. Furthermore, overservicing by ordering or providing more tests, procedures or care than is strictly necessary, is a common problem in modern medicine. It is, therefore, morally hazardous for a health care professional to refer patients to a facility or for a procedure in which that professional has a financial interest. All health care professionals have an obligation to help to reduce this moral hazard and to protect the professional relationship and the long term interests of the professions.
2. The intention is to reduce perverse incentives and, therefore, the Medical and Dental Professions Board will be expected to enforce these guidelines on ownership of shares in a reasonable manner. For example, ownership of a few shares in a publicly listed company which itself owns some of the shares in a private hospital group, is unlikely to act as a significant incentive to refer excessively to a particular hospital. However, regular referral of patients to a hospital by a health care professional who, for example, owns 10% of the shares in that hospital is clearly a matter of concern. Similarly, referral of patients to a facility in which a health care professional or his family have been offered and have accepted free shares, is totally unacceptable.
3. It needs to be emphasised again that the intention is to address perverse incentives, for example overservicing and not to interfere with the rights of health care professionals. For example, a retired health care professional who owns a substantial percentage of shares in a hospital or health care facility in which he or she has shares or who practices in a different professional field than what is provided by the hospital or health care facility in which he or she has shares, might not derive any direct financial gain from such hospital or health care facility. It would, therefore, not be required of such a health care professional to declare his or her shares. It will, therefore, not be permissible for a practising health care professional to -
   1. receive or acquire shares or any financial interest free of charge, or at a price which is less than the market value, in any undertaking which renders health care services or which sells, manufactures, markets or distributes any product which is used in health care;
   2. own shares or any financial interest in an undertaking which is not a company listed on any Stock Exchange, except in accordance with (c) below;
   3. own shares or any financial interest in any undertaking other than a company listed as described in paragraph (b), unless the following criteria have been met.
4. Where the health care professional wishes to acquire shares or any financial interest in an undertaking, whether a body corporate or not, the following applies:
   1. The arrangement in terms of which the shares or any financial interest in an undertaking, whether a body corporate or not, which renders or provides healthcare services, are acquired, is reduced to writing and signed by all of the parties to the transaction; and furthermore, that the document thus signed by the parties concerned, contains the following information, namely the number and present value of the shares held; the name and address of the undertaking in which the shares are held; the number of shares held as a percentage of the total number of shares issued; the circumstances in which the shares were acquired (e.g. were they purchased or is the health care professional a founder member of the undertaking, were they granted free of charge by the undertaking concerned or at a reduced rate; were they granted on an understanding of certain performance on the part of the health care professional); the length of time for which the shares have been held.
   2. The written document referred to in paragraph (a) is submitted by the health care professional concerned to the Medical and Dental Professions Board together with an application in the prescribed form for approval of the ownership of the shares or other financial interest by the said health care professional.
5. Where the health care professional has acquired shares in a health care undertaking prior to the coming into force of this policy and the acquisition of such shares was not previously approved by the Medical and Dental Professions Board acting in accordance with any law or ethical or professional rule, the health care professional shall -
   1. submit a written application to the Medical and Dental Professions Board detailing the number and present value of the shares held; the name and address of the undertaking in which the shares are held; the number of shares held as a percentage of the total number of shares issued; the circumstances in which the shares were acquired (e.g. were they purchased or is the health care professional a founder member of the undertaking, were they granted free of charge by the undertaking concerned or at a reduced rate; were they granted on an understanding of certain performance on the part of the health care professional); the length of time for which the shares have been held;
   2. if there is a written document reflecting the nature of transaction in terms of which the shares in the undertaking were acquired, furnish a certified copy of such document together with the application referred to in paragraph (a);
   3. supply together with the application referred to in paragraph (a), details of any relationship or association, other than that of shareholder, which that health care professional has with the undertaking in which the shares are held. For example, the shareholder may also conduct a practice from the premises of the undertaking, or be a tenant of the undertaking, or be the landlord of the undertaking, or be a director or member of the undertaking or a participant in the undertaking, etc.;
   4. furnish details of any additional reasons or motivation which may support the ownership of shares in the undertaking by the health care professional, including, for example, any barriers to overservicing which may exist; the interests or needs of the community served by the health care professional; the interest of the health care professional, other than financial, in owning the shares in the undertaking; the absence of any other party interested in owning the shares; the absence of perverse incentives for the health care professional; etc.;
   5. via the application referred to in paragraph (a), obtain the approval of the relevant professional body of his or her ownership of the shares in question, failing which the health care professional shall divest himself or herself of ownership of the said shares within a period of three years as from the date of such failure.
6. Health care professionals in rural areas and in areas where there is a severe lack of health care facilities could submit, subject to the conditions as spelt out in 3.7.4, a motivated application to own shares in or to establish a private hospital or clinic where such need existed or arises.
7. A health care professional who has, subject to the above conditions, been given permission to have a financial interest in a private clinic or hospital and who wishes to refer his or her patients to such a clinic or hospital should display a conspicuous notice in his or her waiting room indicating that he or she has a financial interest in such clinic or hospital.

11. RENTALS

1. Pay rentals in lease agreements between health care professionals and health establishments which are not market related or are at preferential rates.
2. Should a health establishment or service wish to rent its consulting rooms at a particular rate, such rental must, however, not be conditional on the health care professional to achieve a certain turnover, nor may it be selectively applied.

12. COMMISSION

Accepting commission
Accept commission or any financial gain or other valuable consideration from any person(s) or body or service in return for the purchase, sale or supply of any goods, substances or materials used by the health care professional in his or her practice.

Paying commission
Pay commission or render any financial gain or other valuable consideration to any person for recommending patients.

13. CHARGING OR RECEIVING FEES
For referring patients
Charge a fee or receive any financial gain or other valuable consideration for referring patients for participating in drug trials or other research trials of a similar nature.

For seeing representatives
Charge a fee or receive any financial gain or other valuable consideration for seeing a medical representative.

For services not personally rendered
Charge or receive fees for services not personally rendered by either a health care professional himself or herself or by an unregistered person in his or her employ, except for services rendered by another health care professional or person registered in terms of the Health Professions Act, 1974 (Act No. 56 of 1974), that regulates the particular profession, with whom the health care professional is associated as a partner, shareholder or locum tenens.

14. SHARING OF FEES
Share fees with any person or health care professional who has not taken a commensurate part in the service for which the fees are charged.

15.  CONTRACTS

1. Enter into a contract to work in a particular health establishment or service on the understanding that a health care professional generates a particular amount of revenue for such health establishment or service.
2. A health establishment or service that equips a theatre, ward or other facility for a specific health care professional according to his or her specifications, may enter into a contractual agreement with such health care professional on the condition that such health establishment or service may not stipulate any turnover targets for the health care professional concerned.

16.  CONTINUING PROFESSIONAL DEVELOPMENT
With regard to the matter of continuing professional development, the Medical and Dental Professions Board wishes to state the following:

Collaborative efforts
Historically there has been a close collaboration between health professionals and the pharmaceutical and health supply industry which extended particularly to continuing professional development. Health care is to a large extent self-governing and practitioners must ensure that their participation in such collaborative efforts is in keeping with their duties towards patients and society.

Educational needs of targeted group
Continuing professional development activities should address the educational needs of the targeted health care group.

Health care provider organisations
The decision on content and choice of continuing professional development activities, as well as funding arrangements lies ultimately with the health care provider organisations such as professional associations, its branches and groups who should not be in a position of conflict of interest by virtue of any relationship with the funding body. The organisers may acknowledge financial or other aid received, but should not identify any specific products. Generic names of products should be used rather than trade names in the course of continuing professional development activities.

Funding
Funds for continuing professional development activities should preferably be in the form of an educational grant payable to the health care provider organisation arranging the activity.

Travel, lodging and other expenses with regard to the attendance of CPD events
No travel or lodging costs or other expenses should be paid by the industry for individual health care professionals to attend a continuing professional development event. Scholarships, grants or other special funding, to permit students and other deserving health care professionals to attend continuing professional development activities are permissible, provided the funds are paid to the organisers for disbursement. The organisers may extend reasonable honoraria and imbursement for travel, lodging and meal expenses to speakers. The principal event should at all times centre around education and not around meals, entertainment or other hospitality, the cost of which should not exceed that level which the recipients might reasonably be expected to incur for themselves under similar circumstances.

Travel, lodging and other expenses with regard to the attendance of international conferences
It is a well established practice and an acknowledged fact that practising health care professionals and educators should be exposed to new knowledge and insight into their respective professions and/or disciplines by the attendance of international conferences, either locally or overseas. It is, however, also of utmost importance that young and upcoming health care professionals and educators and those from disadvantaged backgrounds be given an equal opportunity to expand their knowledge and understanding with regard to their respective professions and/or disciplines by the attendance of such international conferences.

It will, therefore, be permissible for companies to sponsor delegates to attend international conferences, either directly or through professional associations/societies, with the proviso that a fair and transparent process should be followed in the election and sponsoring of delegates to attend such events, especially with regard to the attendance of such conferences by young and upcoming health care professionals and educators and those from disadvantaged backgrounds.

Such sponsorships should furthermore be earmarked for specific educational events/conferences and not for holiday purposes.

Distinction between education, training and product promotion
A distinction should be made between education and training on the one hand and product promotion on the other. Practitioners cannot earn continuing professional development points for attending product launches or other product promotion events. No travel, lodging or other expenses of health care professionals should be paid for attendance of product promotion events or product launches. Modest meals may be provided.

Issued 04/02/2003