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 selectively 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:

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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.