CPD Meetings
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STANDARD OPERATING PROCEDURE SPONSORING OF CONTINUED PROFESSIONAL DEVELOPMENT MEETINGS OF THE SOUTH AFRICAN SOCIETY OF PSYCHIATRISTS |
| Introduction This document serves the purpose to guide members and sponsors of the South African Society of Psychiatrists (SASOP) regarding Continued Professional Development (CPD) meetings. The Ethical Codes and Acts that govern these activities as well as the sponsorships of such activities should be interpreted to ensure that the spirit and the letter of these codes and acts are followed. The relevant acts are the Health Professions Act, Act No. 56 of 1974 and all the amendments, Regulations and Ethical Codes of Conduct , and the Medicines and Related Substance Control Act, Act 101 of 1965 and all its amendments, Regulations and Codes of Conduct2 . 1 Ethical guidelines for good practice in medicine, dentistry and the medical sciences; The Medical and Dental Professions Board of the Health Professions Council of South Africa has embarked on a project to bring together ethical and professional guidelines for doctors (medical practitioners), dentists, and medical scientists. The following Booklets are separately available: Booklet 1: General ethical guidelines for doctors, dentists and medical scientists Booklet 2: General ethical guidelines for health researchers Booklet 3: Ethical and professional rules of the Medical and Dental Professions Board Booklet 4: Professional self-development Booklet 5: Guidelines for making professional services known Booklet 6: Guidelines for the management of health care waste Booklet 7: Policy statement on perverse incentives Booklet 8: Guidelines for the management of patients with HIV infection or AIDS Booklet 9: Guidelines on research and clinical trials involving human subjects Booklet 10: Research, development and use of the chemical, biological and nuclear capabilities of the State Booklet 11: Guidelines on keeping of patient records Booklet 12 : Canvassing of patients abroad Booklet 13 : National Patients' Rights Charter Booklet 14 : Confidentiality: Protecting and providing information Booklet 15 : Seeking patients' consent: The ethical considerations Act 101 of 1965 as amended by: The Drugs Control Amendment Act 29 of 1968, The Drugs Control Amendment Act 88 of 1970, The Drugs Laws Amendment Act 95 of 1971, The Drugs Control Amendment Act 65 of 1974, The Medicines and Related Substances Control Amendment Act 19 of 1976, The Health Laws Amendment Act 36 of 1977, The Medicines and Related Substances Control Amendment Act 17 of 1979, The Medicines and Related Substances Control Amendment Act 20 of 1981, The Transfer of Powers and Duties of the State President Act 97 of 1986, The Businesses |
| Ethical guidelines for the good
practice in Medicine, Dentistry and the Medical Sciences as
published by the Health Professions Council, apply. The Policy
statement on Perverse Incentives (Booklet 7) has specific
relevance.
(Quoted in blue for reference purposes) The Code of Practice relating to the Marketing of Medicines in South Africa as published by the Medicines Control Council has specific relevance. This has only been published in a draft format. (Quoted in green for reference purposes) As the two documents did not concur on certain issues, the 'stricter' of the two documents should be adhered to, to maintain the highest standard of ethical practice for both the Health Professionals and the Sponsors. Sponsors in this context refer to the Pharmaceutical Industry. Health Professionals refer to members of SASOP. The acts and the ethical rules regulating the sponsorship of CPD meetings are "not set in stone" and could change in the future. This document attempts to set the highest legal and ethical standards for both the Health Professionals and the Pharmaceutical Industry in an attempt to self regulate rather than interpret laws, regulations and ethical rules and is proactive rather than reactive. CPD meetings organized by SASOP
Standard Operating Procedure (SOP) The following SOP needs to be followed regarding the sponsoring of CPD events: (Events and meetings have been divided into three categories for easy reference)
Promotional meetings: Procedures for promotional meetings:
"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." 6 "Companies, organizations or individuals are permitted to provide appropriate hospitality to members of the health professions and appropriate administrative staff in association with scientific and promotional meetings, scientific congresses and other such meetings. The level of hospitality offered must be appropriate and not out of proportion to the occasion and the costs involved must not exceed that level that the recipients would normally adopt when paying for themselves. It must not extend beyond members of the health professions or appropriate administrative staff." 7 National CPD Meetings Procedures for National CPD Meetings:
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.” 9 “Companies, organizations or individuals are permitted to provide appropriate hospitality to members of the health professions and appropriate administrative staff in association with scientific and promotional meetings, scientific congresses and other such meetings. The level of hospitality offered must be appropriate and not out of proportion to the occasion and the costs involved must not exceed that level that the recipients would normally adopt when paying for themselves. It must not extend beyond members of the health professions or appropriate administrative staff. Supplementary information – Clause 17.1 Note 1 Hospitality and Meetings, including CPD events – Companies, organizations or individuals must take cognisance of the provisions of the Policy Statement pertaining to perverse incentives and related mattes as published by the Health Professions Council. The provision of hospitality may, in certain circumstances, include the payment of reasonable, actual travel costs for delegates to attend meetings within the Republic of South Africa. Such payment of travel expenses and the like for persons accompanying the delegate is not permitted. The payment of reasonable honoraria and reimbursement of out of pocket expenses, including travel, for the speakers, is permissible. 9 Ethical guidelines for good practice in medicine, dentistry and the medical sciences; The Medical and Dental Professions Board of the Health Professions Council of South Africa; Booklet 7: Policy statement on perverse incentives Pharmaceutical Companies, other organizations or individuals may appropriately sponsor a wide range of meetings. These range from small lunchtime audio-visual presentations in a group practice, hospital meetings and meetings a t post graduate education centers, launch meetings for new products, management training courses, meetings of clinical trialists, patient support group meetings, satellite symposia through to large international meetings organized by independent bodies with sponsorship from pharmaceutical companies, other organizations or individuals. With any meeting, certain basic principles apply:
The provisions of this and all other relevant clauses in the Code apply equally to meetings and courses organized or sponsored by pharmaceutical companies, organizations or individuals which are continuing professional development (CPD) approved. The fact that a meeting or course has CPD approval does not mean that the arrangements are automatically acceptable under the Code. The relevant provisions of the Code and, in particular, those relating to hospitality, must be observed. A useful criterion on determining whether the arrangements for any meeting are acceptable is to apply the question would you and your company b willing to have these arrangements generally known? The impression that is created by the arrangements for any meeting must always be kept in mind. Meetings organized for groups of doctors, other health professionals and/or for administrative staff are wholly or mainly or a social or sporting nature is unacceptable. Meetings organized by pharmaceutical companies, other organizations or individuals, that involve South African health professionals at venues outside South Africa are not necessarily unacceptable. There have, however, to be valid and cogent reasons for holding a meeting at such venues. As with meetings held in South Africa, in determining whether such a meeting is acceptable or not, consideration must also be given to the educational programme, overall cost, facilities offered by the venue, nature of the audience, hospitality provided and the like. As with any meeting, it should be the programme that attracts delegates and not the associated hospitality or venue. Clause 17.1 – Note 2 Certification of Meetings Companies, organizations or individuals must ensure that all planned meetings are checked to see that they comply with the Code. Companies, organizations or individuals, must have a written document that sets out their policies on meetings and hospitality and the association allowable expenditure. In addition, meetings that involve travel outside South Africa must be formally certified as set out in Clause 12.2 (or 12.1) of the Code. (Promotional material must not be issued unless its final form, to which no subsequent amendments will be made, has been certified by two persons on behalf of the company or by the individual, in the manner provided by this clause. Each company or individual should have a standard Operating Procedure for this process, which must be available for audit by the Medicines Control Council or the Authority.) (One of the two persons on a company, or the individual, must be a registered medical practitioner or a responsible pharmacist or, in the case of a product for dental use only, a registered medical practitioner, a responsible pharmacist or a dentist. The other must be an appropriate senior official of the company.)” 10 International CPD Meetings Procedures for International CPD Meetings:
“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.” 13 “Companies, organizations or individuals are permitted to provide appropriate hospitality to members of the health professions and appropriate administrative staff in association with scientific and promotional meetings, scientific congresses and other such meetings. The level of hospitality offered must be appropriate and not out of proportion to the occasion and the costs involved must not exceed that level that the recipients would normally adopt when paying for themselves. It must not extend beyond members of the health professions or appropriate administrative staff. Supplementary information – Clause 17.1 Note 1 Hospitality and Meetings, including CPD events – Companies, organizations or individuals must take cognisance of the provisions of the Policy Statement pertaining to perverse incentives and related mattes as published by the Health Professions Council. The provision of hospitality may, in certain circumstances, include the payment of reasonable, actual travel costs for delegates to attend meetings within the Republic of South Africa. Such payment of travel expenses and the like for persons accompanying the delegate is not permitted. The payment of reasonable honoraria and reimbursement of out of pocket expenses, including travel, for the speakers, is permissible. Pharmaceutical Companies, other organizations or individuals may appropriately sponsor a wide range of meetings. These range from small lunchtime audio-visual presentations in a group practice, hospital meetings and meetings a t post graduate education centers, launch meetings for new products, management training courses, meetings of clinical trialists, patient support group meetings, satellite symposia through to large international meetings organized by independent bodies with sponsorship from pharmaceutical companies, other organizations or individuals. 13 Ethical guidelines for good practice in medicine, dentistry and the medical sciences; The Medical and Dental Professions Board of the Health Professions Council of South Africa; Booklet 7: Policy statement on perverse incentives With any meeting, certain basic principles apply:
The provisions of this and all other relevant clauses in the Code apply equally to meetings and courses organized or sponsored by pharmaceutical companies, organizations or individuals which are continuing professional development (CPD) approved. The fact that a meeting or course has CPD approval does not mean that the arrangements are automatically acceptable under the Code. The relevant provisions of the Code and, in particular, those relating to hospitality, must be observed. A useful criterion on determining whether the arrangements for any meeting are acceptable is to apply the question would you and your company b willing to have these arrangements generally known? The impression that is created by the arrangements for any meeting must always be kept in mind. Meetings organized for groups of doctors, other health professionals and/or for administrative staff are wholly or mainly or a social or sporting nature is unacceptable. Meetings organized by pharmaceutical companies, other organizations or individuals, that involve South African health professionals at venues outside South Africa are not necessarily unacceptable. There have, however, to be valid and cogent reasons for holding a meeting at such venues. As with meetings held in South Africa, in determining whether such a meeting is acceptable or not, consideration must also be given to the educational programme, overall cost, facilities offered by the venue, nature of the audience, hospitality provided and the like. As with any meeting, it should be the programme that attracts delegates and not the associated hospitality or venue. Clause 17.1 – Note 2 Certification of Meetings Companies, organizations or individuals must ensure that all planned meetings are checked to see that they comply with the Code. Companies, organizations or individuals, must have a written document that sets out their policies on meetings and hospitality and the association allowable expenditure. In addition, meetings that involve travel outside South Africa must be formally certified as set out in Clause 12.2 (or 12.1) of the Code. (Promotional material must not be issued unless its final form, to which no subsequent amendments will be made, has been certified by two persons on behalf of the company or by the individual, in the manner provided by this clause. Each company or individual should have a standard Operating Procedure for this process, which must be available for audit by the Medicines Control Council or the Authority.) (One of the two persons on a company, or the individual, must be a registered medical practitioner or a responsible pharmacist or, in the case of a product for dental use only, a registered medical practitioner, a responsible pharmacist or a dentist. The other must be an appropriate senior official of the company.)” “All meetings that involve travel outside South Africa which is sponsored for the professionals or appropriate administrative staff, must be certified in advance in a manner similar to that provided for by clause 12.1 The certificate for the meetings involving travel outside South Africa must certify that the signatories have examined all the proposed arrangements for the meeting and that in their belief the arrangements are in accordance with the relevant advertising regulation and the Code” 15 12.1 Promotional material must not be issued unless its final form, to which no subsequent amendments will be made, has been certified by two persons on behalf of the company or by the individual, in the manner provided by this clause. Each company or individual should have a Standard Operating Procedure for this process, which must be available for audit by the MCC or the Authority. One of the two persons in a company, or the individual must be a registered medical practitioner or a responsible pharmacist or, in the case of a product for dental use only, a registered medical practitioner, a responsible pharmacist or a dentist. The other must be an appropriate senior official of the company. 16 Other relevant information “Collaborative efforts 14 The Code of Practice relating to the Marketing of Medicines in South Africa; Medicines Control Council 15 The Code of Practice relating to the Marketing of Medicines in South Africa; Medicines Control Council 16 The Code of Practice relating to the Marketing of Medicines in South Africa; Medicines Control Council 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.” 17 “Payment may not be made to doctors or groups of doctors, either directly or indirectly, for rental of rooms to be used for meetings. Supplementary information – Clause 17.2 – Payment of Room Rental This provision does not preclude the payment of room rental to postgraduate medical centres and the like. Payment of room rental to doctors is not permissible even if such payment is made to equipment funds or patients' comforts funds and the like or to charities or companies. When meetings are sponsored by pharmaceutical companies, other organizations or individuals, that fact must be disclosed in the papers relating to the meetings and in any published proceedings. The declaration of sponsorship must be sufficiently prominent to ensure that readers are aware of it at the onset. Attention is drawn to Clause 7.9, which requires that all material relating to medicines and their uses that is sponsored by a pharmaceutical company, other organizations or individuals must clearly indicate that it has been sponsored by that company. It should be noted that where companies are involved in the sponsorship and/or distribution of reports on meetings or symposia etc. these reports may constitute promotional material and thus be fully subject to the requirements of the Code.” 18 17 Ethical guidelines for good practice in medicine, dentistry and the medical sciences; The Medical and Dental Professions Board of the Health Professions Council of South Africa; Booklet 7: Policy statement on perverse incentives General procedures
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