16 February 2009 SUBMISSION BY THE SOUTH AFRICAN MEDICAL DEVICE INDUSTRY ASSOCIATION (SAMED)

Transcription

1 16 February 2009 SUBMISSION BY THE SOUTH AFRICAN MEDICAL DEVICE INDUSTRY ASSOCIATION (SAMED) To The Registrar, Health Professions Council of South Africa, P.O. Box 205, Pretoria 0001 (for the attention of the Senior Manager: Professional Boards) on 1. Booklet 7: GUIDELINES ON OVERSERVICING, PERVERSE INCENTIVES AND RELATED MATTERS (SECOND EDITION) 2. Booklet 2: ETHICAL AND PROFESSIONAL RULES OF THE HEALTH PROFESSIONS COUNCIL OF SOUTH AFRICA AS PROMULGATED IN GOVERNMENT GAZETTE R717/2006, (SECOND EDITION) SAMED Reg nr. 2002/005232/08 Tel: Fax: PO Box , Benmore, 2010, South Africa 52 Thembi Place, Calderwood Road, Lonehill Directors: T.M. Vogt (Chief Operating Officer), M.J.F. Howe-Ely (SAMED Chairman), R.D. Crawford (SAMED Vice Chairman), M. Brand, M.G. Burgess, L.J. Curran, A.H. Denoon, W. Flowers, G.R. John, R.A. Marconi, R.J. Millar,, M. Pearce, G. Stier, G.D. Young (SAMED Treasurer) Page 1

2 Index Page 1. Introduction 3 2. Comment on Booklet Comment on Booklet 2 15 Page 2

3 1. Introduction The South African Medical Device Industry Association (SAMED) is a voluntary organisation that represents the interests of the Medical Device Industry in South Africa. SAMED supports the initiative taken by the Registrar of the Health Professions Council of South Africa with regard to a call for comment by stakeholders on the various guidelines for good practice in the healthcare professions. SAMED s comments have been cross referenced to the clauses as numbered in the two booklets in question. SAMED respectfully requests that the recommendations proposed in this submission be given due consideration, and requests that SAMED be afforded the opportunity to verbally present to the HPCSA on the contents of this submission. Yours sincerely Tanya Vogt Chief Operating Officer SAMED Tel Fax tanya@samed.org.za Page 3

4 2. Comments on Booklet It should further be noted that in terms of these guidelines, it is an offence either to offer a perverse incentive or to accept one. 2. Defining of Concepts It should further be noted that some of these definitions have been based on those in certain Acts of Parliament - in particular the definitions contained in the draft of the South African Medicines and Medical Devices Regulatory Authority Act, (Act No. 132 of 1998). 2.5 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 Health Professions Council of South Africa. The term also includes registered student health care practitioners. The wording suggests this only applies to healthcare professionals. SAMED suggests this clause define from who and to who i.e. it should be extended to: to the trade and from the trade (medical device suppliers) Act No. 132 of 1998 never came into being. It should be changed to read Act 101 as amended. SAMED suggests aligning 2.5 with 2.6 i.e. definition of health care professional to include health care practitioner. It is also suggested that only health care professional be used subsequently in the document. 2.6 Health care practitioner means any person registered with the HPCSA. 2.9 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: Does this include the trade? SAMED suggests this clause must state from any party Contrary to ethical or professional rules and/or Which ethical or professional rules are implied here? SAMED suggests that the implied rules be listed Which, in the opinion of the HPCSA, may adversely affect SAMED is concerned that basing a decision on an opinion is providing the Page 4

5 the interests of a patient or group of patients, HPCSA too much power e.g. the HPCSA might rule that an otherwise illegal action is acceptable i.e. what informs such an opinion. SAMED suggests the following rewording:.affect the interests, both medical or other, of a patient or group of patients, And adding an additional clause i.e Irrespective of patient outcome HCP may not receive financial gain of any type Medical 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: In the diagnosis, prevention, monitoring, treatment or alleviation of disease; or In diagnosis, monitoring, treatment, alleviation of or compensation for an injury or handicap; or In investigation, replacement or modification of the anatomy or of a physiological process; or 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: and device has the same meaning. SAMED suggests the definition of a medical device be aligned with the Medicines and Related Substances Bill, as amended i.e. "..any instrument, apparatus, implement, machine, appliance, implant, in vitro reagent or calibrator, software, material or other similar or related article: (a) intended by the manufacturer to be used, alone or in combination, for human beings for one or more of the specific purpose(s) of: and Diagnosis, prevention, monitoring, treatment or alleviation of disease Diagnosis, monitoring, treatment, alleviation of or compensation for an injury, Investigation, replacement, modification, or support of the anatomy or of a physiological process Support or sustaining life Control of conception Disinfection of medical devices Providing for information for medical or diagnostic purposes by means of in vitro examination of specimens derived from the human body (b) which does not achieve its primary intended action in or on the human body by pharmacological, immunological or metabolic means, but which may be assisted in its intended function by such means". Page 5

6 2.14 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 Promote means any action taken by a person or body or allowed to be taken by such person 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 practice of those professions where, in terms of their scopes of practice, it is appropriate to sell such product or service at market related prices. SAMED suggests the following rewording (see underlined text): Overservicing means the supply, rental, 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. And the addition of the following clause after overservicing i.e Underservicing e.g. where a surgeon is forced by medical aids to use cheaper products more often or where a doctor is induced by medical aids to comply with medical aid requirements e.g. the medical aid compels the HCP to work at a particular hospital or use a medical aid preferred product and in return the surgeon is given a certain top fee i.e. paying surgeons more to use the product or work in particular areas. SAMED questions the potential for perversity here. Ultimately medical aids make more money because they are able to reduce their benefits, thus reducing the cost of medical aid and getting more members SAMED suggests the addition of the following text (see underlined): This definition does, however, not prohibit the practice of those professions where, in terms of their scopes of practice, it is appropriate to sell such product or service at market related prices, provided application has been made to the HPCSA and special permission given. SAMED assumes this clause relates specifically to dispensing doctors. However this could provide a loophole for doctors to sell devices. It is requested that the HPCSA consider the difference between dispensing and commercialising a product. E.g. surgeon buys product e.g. hip implant, artificial breast, bariatric surgery and then sells to patient Scheduled substance means any medicine prescribed under section 31 of the South African Medicines and Remove reference to Act 132. Act No. 132 of 1998 has not yet been brought into effect and at present the Medicines and Related Substances Control Act (Act Page 6

7 Medical Devices Regulatory Authority Act (Act No. 132 of 1998). No. 101 of 1965 as amended) is still in force 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 Trade means an act or instance of buying, selling or purchasing goods and services for the purpose of financial gain or other valuable consideration. SAMED suggests the following additional clause i.e. potential means of doing business should not only be limited to spouses but also to: immediate family members, or a trust linked to a trading company from which the practitioner and his or her immediate family members, spouse or life partner may benefit. HCP s shall not, hold any shares or be part of any business which is not a listed entity or participate in the manufacture for commercial purposes, or in the sale, advertising or promotion of any medicine or medical device or in any activity which amounts to trading in medicine or medical devices to the public or keeping an open shop or pharmacy, and excludes: (a) situations where the practitioner is by law allowed to sell and dispense devices and/or medicine, subject to the provisions of rule 23(5); (b) situations where such family member, spouse or life partner is bona fide employed in the device industry and there is no perverse relationship between the industry player and the practitioner through the employment of such family member, spouse or life partner Trade means an act or instance of buying, selling or purchasing goods and services from any source for the purpose of financial gain or other valuable consideration. Page 7

8 2 OVERSERVICING, PERVERSE INCENTIVES AND RELATED MATTERS The following acts or omissions are not permissible for any health care practitioner, nor is it ethical for any health related body to encourage health care professionals to engage in any of them: The following acts or omissions are not permissible for any health care practitioner / health care professional, nor is it ethical or legal (where governed by legislation) for any health related body to encourage health care professionals to engage in any of them: SAMED suggests the incorporation of a definition of health related body i.e. any body or organisation whose business is health related matters. This includes, but is not limited to: Medical Aids, Medical Administrators and Funders, Trade, Trade Associations, MCO s, Consultants etc, 3.1 OVERSERVICING Health care practitioners shall not: Health care practitioners / Health care professionals shall not: Refer a patient to another health care practitioner / health care professional for a service or a procedure that is neither indicated nor scientific or has been shown to be ineffective, harmful or inappropriate through evidence-based review. [Note: Over servicing by ordering or providing more tests, procedures or care than is strictly necessary, is common problem in modern medicine. Health care practitioners / health care professionals must therefore not engage in any act that would constitute over servicing of patients] Refer a patient to another health care practitioner / health care professional for a service or a procedure that is neither indicated nor scientific or has been shown to be ineffective, harmful or inappropriate through evidencebased review. [Note: Over servicing by ordering or providing more tests, procedures or care than is strictly necessary, is common problem in modern medicine. Health care practitioners / health care professionals must therefore not engage in any act that would constitute over servicing of patients]. 3.2 MANUFACTURING Health care practitioners shall not manufacture or participate in the manufacture for commercial purposes or trade, of orthodox medicine, complementary medicine, veterinary medicine, a medical device or a scheduled substance or a health related Health care practitioners / health care professionals shall not manufacture, distribute or participate in the manufacture or distribution, for commercial purposes or trade, of orthodox medicine, complementary medicine, veterinary medicine, a medical device or a scheduled substance or a health related product, except where such medicine or device or substance or product forms an Page 8

9 product, except where such medicine or device or substance or product forms an integral part of the normal scope of practice of the health care practitioner concerned or where explicit permission was granted to a health care professional by the HPCSA to manufacture or to participate in the manufacture of such medicine, device, substance or product. 3.3 ADVERTISING Health care practitioners shall not 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 practitioner or a health care facility for the purpose of improper financial gain or other valuable consideration. integral part of the normal scope of practice of the health care practitioner concerned or where explicit permission was granted to a health care professional by the HPCSA to manufacture, distribute or to participate in the manufacture or distribution of such medicine, device, substance or product. SAMED suggests this section be reworded in such a way as to ensure the prevention of possible commercial gain. i.e. HCP s should be prohibited from selling a device they may have manufactured or invented. They should only be able to obtain royalties on the device and may not use the device exclusively (i.e. only that and no other device) on their patients. Health care practitioners / Health care professionals shall not 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 practitioner or a health care facility for the purpose of improper financial gain or other valuable consideration. Page 9

10 3.4 PREFERENTIAL USAGE OR PRESCRIPTIONS Health care practitioners shall not engage in or advocate the preferential use 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. 3.6 TECHNOLOGICAL EQUIPMENT Health care practitioners shall only own and use technological equipment if it forms an integral part of their scope of practice and on condition that the health care practitioner concerned has received appropriate training in using and managing such equipment Health care practitioners / health care professionals shall not over-use equipment for procedures, tests and other applications that are not indicated, scientific or based on evidence. This constitutes overservicing and is prohibited Health care professionals shall not use technological equipment, health care products or devices for profiteering and must refrain from charging patients fees for the use of such products or devices that are not market related. Health care practitioners / Health care professionals shall not engage in or advocate the preferential use 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 practitioner / health care professional - unless entitled by law Health care practitioners / health care professionals shall only own and use technological equipment if it forms an integral part of their scope of practice and on condition that the health care practitioner concerned has received appropriate training in using and managing such equipment Health care practitioners / health care professionals shall not over-use equipment for procedures, tests and other applications that are not indicated, scientific or based on evidence. This constitutes overservicing and is prohibited Health care practitioners / health care professionals shall not use technological equipment, health care products or devices for profiteering and must refrain from charging patients fees for the use of such products or devices that are not market related. 3.7 SHARE HOLDING It is unethical for a health care practitioner to refer patients to a facility or for a procedure in which such practitioner has a financial interest. All health care practitioners have an obligation to avoid this conflict of interest, and to protect the professional relationship and It is unethical for a health care practitioner / health care professional to refer patients to a facility or for a procedure in which such practitioner has a financial interest. All health care practitioners / health care professional have an obligation to avoid this conflict of interest, and to protect the professional relationship and the long term interests of the Page 10

11 the long term interests of the health care professions. health care professions In acquiring shares a health care practitioner shall not: In acquiring shares a health care practitioner / health care professional shall not: SAMED suggests the addition of a clause to this section, the intention being to prevent practitioners from trading in devices under the guise of trusts, closed corporations or family owned companies i.e A health care practitioner / professional and his or her immediate family members, spouse or life partner, or a trust linked to a trading company from which the practitioner / professional and his or her immediate family members, spouse or life partner may benefit, shall not, hold any shares or be part of any business which is not a listed entity, participate in the manufacture or distribution for commercial purposes, or in the sale, advertising or promotion of any medicine or medical device or in any activity which amounts to trading in medicines or medical devices to the public or keeping an open shop or pharmacy, and excludes: (a) situations where the practitioner / professional is by law allowed to sell and dispense devices and/or medicine (b) situations where such family member, spouse or life partner is bona fide employed in the device industry and there is no perverse relationship between the industry player and the practitioner through the employment of such family member, spouse or life partner. 3.9 COMMISSION Accepting commission Health care practitioners shall not accept commission or any financial gain or other valuable consideration from any person or body or service in return for the purchase, sale or supply of any goods, substances or materials used by the health care SAMED suggests the following additions and amendments: Accepting commission Health care practitioners / health care professionals shall not accept commission or any financial gain or other valuable consideration from any health related body (which will be defined under definitions section to include medical device and IVD establishments) person or body or Page 11

12 professional in his or her practice. service in return for the purchase, sale or supply of any medical devices, goods, substances or materials used by the health care practitioner / professional in his or her practice Paying commission Health care practitioners shall not pay commission or render any financial gain or other valuable consideration to any person for recommending patients. SAMED suggests the following addition, see underlined text: Health care practitioners / health care professionals shall not pay commission or render any financial gain or other valuable consideration to any person for recommending patients CONTINUING PROFESSIONAL DEVELOPMENT 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, their 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. SAMED seeks clarity on who is referred to here? I.e. a clear definition of a healthcare provider organisation is requested. SAMED suggests the following additions, see underlined text: 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 or via the healthcare organisation to whom the practitioner belongs. In the event that a HCP needs to be reimbursed directly for costs incurred, such Page 12

13 reimbursement shall be supported by original documentation e.g. invoices, receipts etc 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 practitioners to attend a CPD event. Scholarships, grants or other special funding, to permit students and other deserving health care professionals to attend CPD activities are permissible, provided the funds are paid to the organisers for disbursements. 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 at which the recipients might reasonably be expected to incur for themselves under similar circumstances. SAMED seeks clarity that this clause applies only to local events and suggests the following amendments / additions: No travel or lodging costs or other expenses should be paid by the industry for individual health care practitioners to attend a local CPD event. Scholarships, grants or other special funding, to permit students and other deserving health care professionals to attend CPD activities are permissible, provided the funds are paid to the organisers for disbursements. (What if the organisers are the company arranging the workshop? Will this be acceptable?) 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 at which the recipients might reasonably be expected to incur for themselves under similar circumstances. SAMED questions the realism of this clause i.e. it is doubtful that doctors and / or nurses, other than speakers, actually attend if their travel etc is not paid for. For state employees payment for sponsorship shall be paid only via the service providers i.e. airline, hotel, congress organiser Distinction between education, training and product promotion SAMED suggests that this clause should only apply to local events and that medical device companies should be allowed to pay for international travel and lodging for doctors to attend product launches. The reasoning here is that many devices are very large equipment and some cannot be moved. It may not warrant the supplier bringing it all the way to SA if they are not assured of selling it. For example: radiology equipment or a digital theatre. Page 13

14 4. Accountability Mention is made of an annexure, but this appears to be missing. Health care practitioners who decide not to follow the guidance in this Booklet (including the Annexure), must be prepared to explain and justify their actions and decisions to patients and their families, their colleagues and, if necessary, to the courts and the HPCSA. Ethical guidelines for good practice in the health care professions The following Booklets are separately available: Booklet 7: General ethical guidelines for health researchers SAMED is unsure whether this title is correct and suggests that it should read: Booklet 7: Guidelines on overservicing, perverse incentives and related matters (second edition) Page 14

15 3. Comments / Suggested Amendments to Booklet 2 SAMED suggests the addition of the following clause, after clause 23 and before clause 24 pertaining to medical devices 24. Medical Devices 24. (1) A practitioner shall not participate in the manufacture for commercial purposes, or in the sale, advertising or promotion of any medical device or in any other activity which amounts to trading in medical devices. (2) A practitioner shall not engage in or advocate the preferential use or prescription of any medical device, if any valuable consideration is derived from such preferential use or prescription. (3) The provisions of subrules (1) and (2) shall not prohibit a practitioner from - (a) (b) (c) (d) owning shares in a listed company; manufacturing or marketing medical devices whilst employed by a medical device concern; whilst employed by a medical device concern in any particular capacity, performing such duties as are normally in accordance with such employment; or dispensing in terms of a licence issued in terms of the Medicines and Related Substances Act, (4) A practitioner referred to in subrule (3) shall display a conspicuous notice in his or her waiting room and also, if appropriate, verbally inform his or her patient about the fact that he or she - (a) (b) owns shares in a listed public company which manufactures or markets the medical devices prescribed to such patient; or is in the employ of the medical device concern which manufactures such medical device(s). (5) A practitioner may prescribe medical devices: Provided that such practitioner has ascertained the diagnosis of the patient concerned through a personal examination of such patient or by virtue of a report by another practitioner under whose treatment such patient is or has been. (6) In the case of a patient with a chronic disease the provision of subrule (5) shall not apply. Page 15