Our medicines regulatory authority: plans for reform in South Africa
One of the most important building blocks of any effective health system is a fully-functional medicines regulatory authority. In South Africa, this structure, established by an act of parliament, is entrusted with ensuring that the medicines made available in our country are safe, of good quality, and can be expected to have the effect for which they are indicated.
South Africa first established a medicines regulatory agency in the mid-1960s, in response to the thalidomide disaster. Thalidomide was a medicine marketed to pregnant women which had not been adequately tested for safety. Only when it was used by large numbers of women, particularly in Europe, did it become apparent that the medicine had very serious adverse effects on the growing foetus. The South African Parliament passed the Medicines and Related Substances Control Act in 1965. This Act — often referred to as Act 101 of 1965 — has been amended many times since that year. However, the basic structure of the drug regulatory system remains the same.
Act 101 created a statutory council to be known as the Medicines Control Council (MCC). The MCC has been housed within the National Department of Health ever since. Department employees provide the secretariat for the council and also staff the inspectorate that visits pharmaceutical manufacturers and distributors.
However, the members of the council itself are not full-time staff of the Department of Health. The Minister of Health can appoint no more than 24 members of the council, each for a maximum of two five-year terms of office. Council members are selected mainly from universities and research institutions in South Africa, although civil servants may also be appointed. Every appointee must be a South African citizen who is permanently resident in the republic. No council member may be an unrehabilitated insolvent, disqualified from practising a health profession, or employed in the pharmaceutical industry.
Critically, the power to make decisions about the registration of drugs is vested in the council, not the secretariat. A series of expert committees supports the council, but these can only make recommendations. The final decisions lie with the council as a body. Their decisions are then implemented by the Registrar of Medicines, who occupies a post within the National Department of Health and also manages the MCC secretariat. The council meets every six weeks. Their decision-making capacity is hobbled by the part-time nature of the structure and by the competing demands on members’ time.
In 2008, a ministerial task team presented a report on the MCC and secretariat that made recommendations for a new regulatory authority for health products. These recommendations — known widely as the Green-Thompson report — were then incorporated into an amendment to the Medicines and Related Substances Act, and passed by parliament in late 2008. Although the Act was assented to by the President in April 2009, it has yet to be promulgated (formally declared). Once brought into effect by promulgation, the Act will replace the MCC with the South African Health Products Regulatory Authority (SAHPRA). SAHPRA will be an organ of state, but one that will operate outside of the existing public service.
The new authority, which is expected to be in place by April 2013, will be led by a Chief Executive Officer (CEO) with the authority to appoint and supervise the staff of that body. SAHPRA and the CEO will report to the Minister of Health. The Act will also allow the CEO to appoint committees “to investigate and report to the authority on any matter within its purview”. In addition, the Minister will be able to appoint a committee of not more than five members to advise on corporate governance, but not on applications for registration.
A full-time commitment
Most importantly, decision-making power will be vested in the authority, not in the part-time experts who may be called upon to advise. This change will be the most fundamental. Many more will be needed to address the shortcomings identified in the Green-Thompson report. It will be vital to ensure that the CEO of SAHPRA has sufficient well-qualified staff to perform the tasks required of an effective drug regulatory authority. The decision-making process in SAHPRA will be similar to that used by the US Food and Drug Administration. The body will have to raise much of its funding in the form of user fees from companies applying to register health products.
In March 2012, the Director-General of Health published a draft bill that would amend some of the elements put in place in 2008. The period allowed for comments has passed, but this bill has yet to be formally introduced in parliament. The draft bill appears to refocus some sections on the regulation of medicines. It also broadens the scope of the authority to include regulation of foodstuffs and cosmetics, and presumably, disinfectants. In addition, the authority will have to regulate medical devices, including in vitro diagnostic tests.
However, many practical details are still missing from the draft bill. These include the size of SAHPRA, the structures to be put in place – including advisory committees – and how decisions will be taken and documented. A team led by external consultants is dealing with these organisational issues. As yet it has not communicated widely on the specifics.
Globally, medicines regulatory authorities are trying to achieve greater transparency in their operations, while continuing to protect the commercially sensitive information submitted to them by manufacturers. This will be one of the major challenges to face SAHPRA. It will inherit a 1965 secrecy clause, which is out of step with modern practice and out of line with the constitutional demands of post-apartheid South Africa.
SAHPRA will need to set up a clear operating procedure that draws on the knowledge of external advisers with years of experience. It will then need to make their recommendations public. In this way the regulatory decisions of the authority will be seen to be supported by evidence. The organisation must attract the staff it will need to eliminate the backlogs and inefficiency that have plagued the MCC, but also to maintain the confidence of health professionals and the public. Without such confidence, many health policies will be impossible to implement. The National Health Insurance scheme, for instance, will require access to affordable, quality medicines.
By Andy Gray
Andy Gray is a senior lecturer in the Department of Therapeutics and Medicines Management at the University of Kwazulu-Natal’s Nelson R. Mandela School of Medicine.
A description of the way medicines are developed, registered and used in South Africa can be found in the book “Health and Democracy”, which is available on the SECTION27 website at http://section27.org.za.dedi47.cpt1.host-h.net/wp-content/uploads/2010/04/Chapter13.pdf or can be ordered from SECTION27 at 011 356 4100.