|
|
|
Website sponsored by
an unrestricted educational grant |
 |
|
|
|
|
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
- A Biennial National Congress organized by the National
Congress Committee under the leadership of the National
Congress Convener. The National Congress Convener is also in
charge of the coordination of all other congresses organized
by SASOP. This congress is mostly co-sponsored by the World
Psychiatric Association.
- A Biennial Psychopharmacology Congress every alternative
year organized by the Biological Special Interest Group and
the relevant Congress Committee. This congress is organized
in association with the World Association of Biological
Psychiatry.
- Other congresses organized by the relevant Special
Interest Groups.
Act 71 of 1991*, The
Medicines and Related Substances Control Amendment Act 94 of
1991, The General Law Amendment Act 49 of 1996, The
Abolition of Restrictions on the Jurisdiction of Courts Act
88 of 1996, also amended by The Medicines and Related
Substances Control Amendment Act 90 of 1997 and Act 59 of
2002 Medicines and Related Substances Amendment Act, 2002
and the publication of the Amended regulations to the Act on
the 02nd May 2002
3. 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
4.The Code of Practice relating to the Marketing of
Medicines in South Africa; Medicines Control Council
- Monthly regional CPD meetings organized by the relevant
Subgroups in the various regions.
- Yearly Symposia, Forums and Workshops, Journal Club
meetings, Case presentations organized by the relevant
groups.
- Journal Club meetings, Case presentations and other
meetings organized by the relevant groups.
- Co-sponsored World Congresses and Symposia.
- Other meetings.
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
- National CPD Meetings
- International CPD Meetings
Promotional meetings:
Procedures for promotional meetings:
- A clear distinction should be made between educational
and promotional meetings at the start of planning a meeting.
- Promotional meetings can not be combined with any
educational meetings.
- All procedures related to the promotion of medicines in
South Africa as described in the draft Code of Practice
relating to the Marketing of Medicines in South Africa ,
should be followed by the sponsor of the meeting.
- No CPD points can be awarded for promotional meetings.
- No travel, lodging or other expenses can be paid to
health professionals for promotional events.
5 The Code of Practice relating to the
Marketing of Medicines in South Africa; Medicines Control
Council
- Modest meals may be provided and excludes anybody beyond
the professional or appropriate administrative staff.
- SASOP and all its Subgroups, Task Teams, Divisions and
Special Interest Groups can not be involved in the
organizing of such events.
"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:
- A National CPD Meeting refers to a meeting that is
arranged by and attended by National delegates and is
not arranged by and attended by International
delegates.8
(Still awaiting final confirmation from the HPCSA regarding
the definition of National and International CPD Meeting.)
6 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
7 The Code of Practice relating to the Marketing of
Medicines in South Africa; Medicines Control Council
8 Personal e-mail from the Health Professions Council of
South Africa, on the 11 December 13:45 from Mr Danie Kotze
Head of the Professional Boards of the Health Professions
Council of South Africa in reply to an e-mail sent to the
HPCSA on the 10th December 2003 at 14:22 from Dr Eugene
Allers, President of SASOP.
“Dear Mr Kotze; As per our telephonic conversation this
afternoon, it would be appreciated if you could clear the
following with Advocate B. Mkhize:-
The South African Society of Psychiatrists (SASOP) is busy
drafting Standard Operating Procedures (SOP) for sponsoring
of CPD events as well as conferences. These SOP's will serve
the function to advise professionals to behave in an ethical
manner regarding sponsorship of events as well as to guide
sponsors to adhere to ethical rules. To be able to draft a
document we need the following clarification:-
a. In booklet 7 on perverse incentives paragraph 3.13
mentions is made of international conferences - local and
international. We need a definition of international
conference as it seems that in this document no
international conferences could be locally and
internationally. We presume from this document an
international conference will refer to international
delegates speaking and/or attending the conference where
local will refer to events with only local doctors.
- No travel, lodging or other expenses with regard to the
attendance of the meeting can be paid directly to the
individual health care professional to attend the CPD event.
This includes the payment of travel expenses, lodging and
meal expenses and honoraria to speakers at the event.
- Scholarships, grants or special funding can be paid to
the organisers of the CPD meeting into the SASOP bank
account or other specific bank account for the meeting for
the organisers of the meeting to disburse.
- The organisers of the meeting will disburse the funds
mentioned above to students and other deserving health
professionals in the following manner:
- Sponsorships will only apply to paid-up Full members
or paid-up Associate members, Honorary members, Life
members, paid-up International Full members, paid-up
International Associate members of SASOP or speakers at
CPD meetings.
- A list of all the paid up Associate members of SASOP
registered as registrars in Psychiatry (Master's
students in Psychiatry) must be obtained from the SASOP
office by the organisers. For regional meetings,
regional lists must be obtained as well as a detailed
list of all other members of SASOP.
- All students in Psychiatry (i.e. Master's and
Doctoral students) in need of sponsorships should, in
writing, apply, with a motivation, and proof of
membership to the organisers of the meeting for
sponsorship.
b. Act 90 in article 21c "instruct
the MCC" to draft a Code of Practice related to the
marketing of medicine in South Africa. A draft has been
formulated but unfortunately this draft differs from the
perverse incentive document that events or conferences
are either called inside or outside of South Africa. The
sponsoring of international conferences as mentioned in
your document is clearly different from other
non-international events, either local or international,
where as in the Act 90 document mention is only made of
inside or outside the Republic.
We need clarification on this as our SOP and the
pharmaceutical SOP must coincide to make this document a
practical working document.
We thus need advice as to draft our SOP in accordance
with the HPCSA Act as well the Medicine and Related
Substances Control Amendment Act (Act 101 of 1965, Act
90 of 1998 and Act 59 of 2002).
Could you please advise before Friday, 12:00 (as we have
a major meeting planned for that day to give guidance
regarding the above legal issues). Yours sincerely; DR
EUGENE ALLERS; President: SA Society of Psychiatrists
“Dear Adv Mkhize (CEO of the Health Professions Council
of South Africa); My reply to the request of Dr Allers
was as follows: International conferences refer to such
events being arranged and attended by representatives
from all over the world – not only South Africa. These
events could be arranged in South Africa or outside the
borders of South Africa. Could you please confirm or
provide your view on the matter; Thank you; Danie
- A percentage of the sponsorship, determined by the
organisers of the meeting, must be allocated to students
and/or previously disadvantaged members not fulfilling
the criteria for “deserving”. This percentage would vary
from meeting to meeting. This must be determined as
early as possible.
- All members deserving of sponsorship should apply in
writing to the organisers of the meeting. Applications
should include:
- Personal details and a CV.
- Details of the meeting to be sponsored.
- Motivation for sponsorship.
- Proof of membership.
- Criteria for deserving:
- Members assisting in the management of the
organisation and the promotion of the discipline of
Psychiatry.
- Senior Psychiatrists that have promoted the
discipline of Psychiatry and has rendered a service
to Psychiatry for some time.
- Active members of the Society that have assisted
in the management, the organisation and attended
meetings on a regular basis.
- Members that have been actively involved in
their own original research and presentations to
promote the discipline of Psychiatry.
- Members that have published peer reviewed
articles or that have presented peer reviewed
presentations at meetings.
- Members that have been regular speakers at
meetings and that have been actively involved in the
Continued Professional Development in Psychiatry of
other health professionals.
- Members that have been presenters of posters at
meetings.
- Members should share knowledge with other health
professionals and should after sponsored meetings
organise and present the knowledge gained at the
sponsored meeting with other health professionals at
SASOP organised regional or national meetings. This
could be decided at the time of the allocation of
the sponsorship and should be measurable.
- Previous sponsorship should always be considered
as an exclusion criteria for members, to ensure that
others also be considered for sponsorship.
- A full Curriculum Vitae could assist in the
allocation of sponsorship as it could assist in
determining the merit of certain members as well as
identify specific interests of certain members to
attend certain important meetings that could relate
to their interest and expertise.
“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.” 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 meeting must have a clear educational content;
- The hospitality associated with the meeting must be
secondary to the nature of the meeting, must be appropriate
and not out of proportion to the occasion, and
- Any hospitality provided must not extend to spouses and
other persons unless that person is a member of the health
professions or appropriate administrative staff and
qualifies as a proper delegate or participant at the meeting
in their own right.
- Spouses and other accompanying persons, unless qualified
to as above, may not attend the actual meeting and may not
receive any associated hospitality at the company's expense;
the entire costs which their presences involves are the
responsibility of those they accompany.
- Administrative staff may be invited to meetings where
appropriate. For example, receptionists might be invited to
a meeting in a general practice when the subject matter
related to practice administration.
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:
- An International CPD Meeting refers to a meeting that is
arranged by and attended by International delegates
as described by the Health Professions
Council of South Africa and outside of South Africa as
described by the Medicines Control Council . To make this
document workable, an International Meeting is defined for
the purposes of this document as a meeting that is
arranged by and attended by international delegates and is
outside of South Africa.
- Travel, lodging or other expenses with regard to the
attendance of the meeting can be paid directly to the
individual health care professional to attend the CPD event.
This includes the payment of travel expenses, lodging and
meal expenses and honoraria to speakers at the event.
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 as well
as students and other deserving health professionals.
10 The Code of Practice relating to the
Marketing of Medicines in South Africa; Medicines Control
Council
11 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
12 The Code of Practice relating to the Marketing of
Medicines in South Africa; Medicines Control Council
- The prescribed procedures in companies for sponsoring of
delegates to international meetings must be followed as
described in the Act.
- Scholarships, grants or special funding can be paid into
the SASOP bank account or other specific bank account for
international meetings for SASOP to disburse.
- SASOP will disburse the funds mentioned above to young
and upcoming health care professionals, educators and those
from disadvantaged backgrounds, students and other deserving
health professionals in the following manner:
- Sponsorships will only apply to paid-up Full members
or paid-up Associate members, Honorary members, Life
members, paid-up International Full members or paid-up
International Associate members of SASOP.
- A list of all the paid up members of SASOP must be
obtained from the SASOP office.
- All students in Psychiatry (i.e. Master's and
Doctoral students) in need of sponsorships should, in
writing, apply, with a motivation, and proof of
membership to the organisers of the meeting for
sponsorship.
- A percentage of the sponsorship, determined by
SASOP, must be allocated to students, young and up and
coming professionals, educators and/or previously
disadvantaged members not fulfilling the criteria for
“deserving”. This percentage would vary from meeting to
meeting. This must be determined as early as possible.
- All members deserving of sponsorship should apply in
writing to the organisers of the meeting. Applications
should include:
- Personal details and a CV.
- Details of the meeting to be sponsored.
- Motivation for sponsorship.
- Proof of membership.
- Criteria for deserving:
- Members assisting in the management of the
organisation and the promotion of the discipline of
Psychiatry.
- Senior Psychiatrists that have promoted the
discipline of Psychiatry and has rendered a service
to Psychiatry for some time.
- Active members of the Society that have assisted
in the management, the organisation and attended
meetings on a regular basis.
- Members that have been actively involved in
their own original research and presentations to
promote the discipline of Psychiatry.
- Members that have published peer reviewed
articles or that have presented peer reviewed
presentations at meetings.
- Members that have been regular speakers at
meetings and that have been actively involved in the
Continued Professional Development in Psychiatry of
other health professionals.
- Members that have been presenters of posters at
meetings.
- Members should share knowledge with other health
professionals and should after sponsored meetings
organise and present the knowledge gained at the
sponsored meeting with other health professionals at
SASOP organised regional or national meetings. This
could be decided at the time of the allocation of
the sponsorship and should be measurable.
- Previous sponsorship should always be considered
as an exclusion criteria for members, to ensure that
others also be considered for sponsorship.
- A full Curriculum Vita could assist in the
allocation of sponsorship as it could assist in
determining the merit of certain members as well as
identify specific interests of certain members to
attend certain important meetings that could relate
to their interest and expertise.
“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 meeting must have a clear educational content;
- The hospitality associated with the meeting must be
secondary to the nature of the meeting, must be appropriate
and not out of proportion to the occasion, and
- Any hospitality provided must not extend to spouses and
other persons unless that person is a member of the health
professions or appropriate administrative staff and
qualifies as a proper delegate or participant at the meeting
in their own right.
- Spouses and other accompanying persons, unless qualified
to as above, may not attend the actual meeting and may nor
receive any associated hospitality at the company's expense;
the entire costs which their presences involves are the
responsibility of those they accompany.
- Administrative staff may be invited to meetings where
appropriate. For example, receptionists might be invited to
a meeting in a general practice when the subject matter
related to practice administration.
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
- A person responsible for CPD activities within the
groups of SASOP organizing the meeting is appointed to take
responsibility for the CPD activities and the organizing of
such activities within the rules pertained in this document.
This person will be the responsible person and will take
full responsibility to ensure that the meeting is organized
and sponsored in the correct manner according to this
document.
- The content and the purpose of the meeting have been
determined by the relevant organization, Subgroup, Special
Interest Group, Task Team and Division of SASOP and are
clearly set out in the first announcement of the meeting or
in the invitation to the meeting. (If the meeting is held
for promotional purposes, this must be clearly set out in
the announcements or the invitations to the meeting and
SASOP and its subgroups, task teams, special interest groups
or divisions can not be at all involved in the organization
of such a meeting. Hospitality for such a meeting is
permissible but no CPD points can be earned for the
attendance of such a meeting. No travel, lodging or other
expenses of health care professionals should be paid for the
attendance of product promotion events or product launches.
Modest meals may be provided. No action to encourage or
promote the preferential use or preferential sale of any
health establishment or orthodox medicine or complementary
medicine on veterinary medicine of medical device of
scheduled substance of other health related product of
health related service may be taken by any member of SASOP
for the purpose of financial gain of other valuable
consideration. This pertains to the promotion or endorsement
of the above.)
- The speakers have been agreed upon and approved by the
executive or convener or organizing committee of the
relevant groups within SASOP and announced prior to the
meeting in the final program.
- All the organization of the meeting be done by the
relevant group within SASOP. If the relevant group does not
have the infrastructure to organize such meeting or chooses
to the appointment of an outside organization for an agreed
fee, they should do so to organize the meeting. Sponsors
should not be involved in organizing the meeting. Sponsors
though can be asked to help with certain tasks determined be
the organizers of the meeting.
18 The Code of Practice relating to the
Marketing of Medicines in South Africa; Medicines Control
Council
- Space for advertising could be sold regarding the
printing of advertisements in the announcements. These
announcements are then seen as promotional material and are
thus fully subject to the requirements of the Code.
- Place for stands can be sold as part of the sponsorship
of the meeting.
- The prices of the stands be clearly advertised and all
the sponsors should be given equal opportunities to purchase
the stands.
- Other promotional material is allowed ie. Pens, Mineral
water etc
- In cases where only one sponsor will sponsor the
meeting, the meeting can not be held as part of a marketing
or advertising drive of the sponsor and the organizers must
ensure that the meeting is balanced and fair and represents
all views on the subject on discussion at the meeting. (See
promotional meetings above) Particular care should be given
to such meetings to ensure the above. No reference should be
made to any product and only generic names should be used in
the presentations. Products of the sponsor can only be
advertised in designated areas that do not interfere with
the content of any presentation.
- No material related to the sponsors can be placed on any
presentation including logos, company branding or special
backgrounds to the presentations.
- All presenters must disclose all financial support
related to that specific presentation at the onset of the
presentation.
- No employee of a company can give a presentation unless
specifically invited to present at a meeting and the
presenter shall disclose all financial assistance to that
presentation as with all presenters.
- No payment may be made to SASOP or its Subgroups,
Special Interest Groups, Task Teams or Divisions, either
directly or indirectly, for rental of rooms to be used for
meetings. Congress registration fees should be sufficient to
cover the cost of the venue for the meeting. Hospitality
does not include the payment of the venue for the meeting.
- All advertisements and promotional material is subject
to the requirements of the Code.
- The meeting has a budget and that the budget is adhered
too.
- A person responsible for the funds (treasurer) of the
meetings must be appointed within SASOP to take
responsibility for the accounting of the funds and prepare
the documents to be audited.
- The funds must be administered separately until the
final accounts have been paid and the last money collected
as sponsorships or registration fees and the balance sheet
closed.
These SOP should be read in conjunction with all the documents
referred to in this document.
|
|
|
