E-drug: South Africa News (cont'd)
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Perhaps you had all better see the Executive Summary of the Report,
so you can form your own opinion of the media articles about the
matter. The full report is available at the following website:
http://www.healthlink.org.za/hlink/info/medicine/content.htm
Best regards,
Professor R S Summers
Head, School of Pharmacy
MEDUNSA
South Africa
The Medicines Regulatory System in South Africa:
Review and proposals for reform.
24 March 1998
Prepared for the Minister of Health by
Prof Graham Dukes
Dr Suzanne Hill
Prof Rob Summers
Dr Wilbert Bannenberg
with the support of
Dr Ian Roberts
Dr Ayanda Ntsaluba
Mr Bada Pharasi
Department of Health, South Africa.
Reproduction and commercial distribution of this report is prohibited
without written agreement of the Department of Health.
EXECUTIVE SUMMARY
Background
In January 1998, the Minister of Health requested a Team, consisting of
four members independent of the current drug regulatory system and
three representatives from the Department of Health and the Ministry,
to review the existing process for the regulation of medicines in South
Africa and to make recommendations on this and a number of closely
related issues. The need for a review had been identified by all
parties involved in the regulatory process, and the South African Drug
Action Program had assisted in identifying and appointing appropriate
external consultants. The Review Team took an entirely independent
approach, involving wide consultation, numerous written submissions,
and examination of comparable systems in other countries. This
summary outlines the principal findings and recommendations.
Findings
Established by law in 1965, the Medicines Control Council of South
Africa has in the past been well regarded internationally for its
approach to the regulation of medicines. It has developed sufficient
capacity to ensure that medicines marketed in South Africa are
carefully evaluated in terms of their quality, safety and the
acceptability of the claims made for them. Working alongside the
Council, a well-managed inspectorate has been developed which, despite
limited resources, has done much to ensure compliance with the
standards set by law and regulation. Such strengths of the present
system must be maintained and further developed in the future.
The Review Team has however also identified a series of shortcomings
in drug regulation which have developed, particularly in more recent
years. In particular:
- there has often been a failure of communication between the
Medicines Control Council, policy makers, administrators, the general
public and the pharmaceutical industry. This failure has led to
misunderstanding and mistrust, with the Council mainly coming into
the limelight when disputes arise
- confusion has developed as to division of responsibility for policies
on the one hand and technical matters on the other
- the existing administrative system is no longer adequate for the
complex management and massive data handling which a national
regulatory system requires
- the drug knowledge and experience required to support the system
have long been concentrated in too few academic centres. This
makes it difficult for the system to adapt to the current need to
involve all population groups and a wider range of experts; it also
leads to decisions essentially being taken in sub-groups when a
wider discussion is called for.
- no adequate rules have been implemented to avoid the risks posed
by conflict of interest, particularly where commercial interests do
not run parallel with those of the community at large. Both groups
and individuals face such risks.
Alongside these defects in the operation of the system created in 1965,
it must be realized that the legislation of that date no longer fully
meets the country's needs. In particular, it does not provide for the
currently widespread popular use of non-orthodox (complementary and
traditional) medicines, which need to be approached in an appropriate
manner consistent with the public health interest and public demand.
Recommendations
As is commonly the case, it is more effective to replace a defective
older system with a new one than to adapt what currently exists. The
new structure can incorporate electively all those elements of the older
system which are functioning well, and can recruit many of its
experienced staff and advisers; those who are likely to experience
difficulty in radical change can be invited to take up other tasks in
the public health sector.
Salient recommendations on specific matters are as follows:
1. The Inspectorate of Medicines should continue in place, but with
a greater degree of autonomy and more adequate resources, which can
be derived largely from fees.
2. The present Medicines Control Council (MCC) should cease to
exist. By the end of 1998 an entirely new Medicines Regulatory
Authority should be brought into operation, having a simplified
structure based on successful models used abroad. By charging
appropriate, yet still reasonable, fees for handling applications to
register drugs, the Authority will be largely financially independent. It
will have the right to retain its own revenue; a small contribution from
government funds will ensure that the Authority is not entirely
dependent on fees from commercial sources.
3. Within the Medicines Regulatory Authority two channels for new
drug approval will be created. A first Expert Technical Committee will
assess orthodox (science-based) medicines; the Committee will apply
standards similar to those used up to the present but will engage a
wider range of experts in its work. A second Expert Technical
Committee, comprising experts in the various fields of complementary
and traditional medicines, will assess applications for products in these
classes, recognizing that their use rests primarily upon a desire to
follow either traditional teaching or particular schools of treatment;
this Committee's principal concern will be with product quality, the
avoidance of misleading labelling and the need to prevent the sale of
unsafe products.
4. The two Committees will effectively take their own decisions.
However, a multidisciplinary Board charged with the Management of the
Authority will be authorised to question and refer back once only for
reconsideration any decision which may appear technically incorrect. It
may also rescind any decision in the event of procedural error.
5. More generally, the Board of the Medicines Regulatory Authority
will ensure that the Authority is well managed, sufficiently supported
by a Technical Secretariat to ensure efficient operation, and interprets
the law in the public interest at all times. The operation of the
Authority will be open and democratic, with adequate opportunity for
appeal against its decisions. It will also report regularly to the
professions and the public media on its progress. By maintaining
appropriate international contacts, the Authority can be expected to
benefit from the activities and experience of reputable foreign
agencies, avoiding the need to repeat in South Africa regulatory work
which has been undertaken competently elsewhere.
6. The Review Team points out that regulation comprises only part
of the national effort required to ensure that drugs are appropriately
used. Proposals are made to develop strong independent channels of
drug information, to improve emergent knowledge of drug risks and to
examine and approve proposals for trials of drugs in human subjects.
The Review Team also points to the need for thorough studies of drug
use, so that patients can be more rationally treated and waste avoided.
7. Although the present legislation will need further revision to
provide for the new approach, the laws relating to human medicines
will never be ideal as a basis for handling issues which lie strictly
outside this field. Special provisions are therefore recommended to deal
with veterinary drugs, to promote the safety of cosmetics, and to
ensure that information on risks posed by medical devices and
materials is made known to those who need it.
8. The system proposed here will deal only with technical issues.
Matters of policy involving drugs will lie exclusively with the Minister,
advised by the Department of Health. Consideration should however be
given to the creation of a standing policy advisory body to the
Minister to ensure further progress in this complex field.
9. To ensure a smooth transition to the new system, a number of
immediate steps are proposed by the Review Team. They include
suspension of the work of the existing Medicines Control Council and
the institution of a temporary Council to handle ongoing work and lay
the basis for operation of the new system before the end of the
current year.
The Review Team is confident that these changes are feasible. They
will result in the emergence of a medicines control system attuned to
the special needs of the people of South Africa.
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