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HEALTH PORTFOLIO COMMITTEE
27 March 2001
MEDICINES CONTROL COUNCIL: BRIEFING
Chairperson: Dr S A Nkomo
The Chairperson of the Medicines Control Council briefed the Committee. The MCC registers new medicines, both generic and complementary. It does clinical trials of drugs as well as the very important adverse event drug monitoring.
It is vital that developing countries do clinical trials. The focus of new medicines is to treat "diseases of the rich". The industry invests where there is the greatest possibility of profit. Consequently, research into local diseases needs to be done locally and clinical trials must be very rigorous. South Africa is an ideal place for clinical trials to be done since it has strong academics and institutions, the diseases of both the rich and the poor as well as a favourable exchange rate.
Companies that pay for drug trials want the drugs to be tested on people of European origin since these drugs are being for developed for European markets. It is to South Africa's benefit to get data on the effects of medicines on black people since the majority of the population of this country is black. To do so is not to exploit the black population but to gather data that will be useful in developing effective medicines.
It is possible for a drug's approval to be "fast-tracked". Some of the factors taken into account are the reasons for speeding up the process, if the drug is essential or a therapeutic breakthrough or potentially life-saving. The criteria for fast-tracking are very clear. In terms of cost, she said a drug may be fast-tracked if cost saving is in the interests of public health. The primary focus of the MCC is always to protect public health.
The Chairperson of the Medicines Control Council (MCC), Professor Helen Rees, briefed the Committee. The main aim of the MCC is the safety, quality and efficacy of medicines. The focus of the Council is primarily technical and scientific but is also concerned with the public environment. Until recently, the Council had seventeen members; it now has 24.
The MCC registers new medicines, both generic and complementary. It also has a new mandate for African traditional medicines, medical devices and new veterinary medicines. It does clinical trials of drugs as well as the very important adverse event drug monitoring. This is very serious; in the United States, adverse effects of medicines are the third or fourth most common cause of death in hospitals. Professor Rees reminded the Committee that we only know of a drug's safety in the conditions of its clinical trials. Different effects can emerge when a drug is in use. Professor Rees gave the example of viagra, which was found in the United States to be dangerous when used with heart medicine.
The work of the MCC is divided between committees; these include clinical, biological, pharmaceutical and analytical, scheduling, adverse drug monitoring, veterinary and veterinary policy. Two new committees are African traditional drugs and complementary medicines. The committees are made up chiefly of academics. An inspectorate does supporting work. Professor Rees emphasised the MCC is essentially a technical and scientific body. It is not explicitly political.
One of the main problems in the MCC is the backlog of medicines to be registered. Also, the process of registration was inappropriate in that different committees would approve different aspects of a drug at different times. A drug was never considered in a holistic way. Professor Rees advocates for a more integrated view of what medicine is being registered. The process was ad hoc, rather than rigorous. Complementary medicines were badly registered in that there was no strong legal framework and there was nothing for African medicines. Inspectors are also an important part of the MCC, although how they do their work is changing since their powers were found to be unconstitutional.
The MCC is overseen by Act 101 of 1965. Medicines were different then; for example, there were no complementary medicines and no clinical trials. Accordingly, these are not mentioned in Act 101. In addition, the penalties the Act metes out for violations are weak. Sentences are inadequate. For example, there was a pharmacist in Gauteng selling a powerful steroid creme as a skin lightener. This is ruinous to the skin. Although he was properly brought to court and convicted, his penalty was only a fine of R500. Professor Rees says the penalties of the Act are not "fierce enough".
Another of the MCC's current problems is its budget. Salaries at the MCC are low. This means the most highly qualified people may go where they will be better remunerated for their work. There is also no comprehensive training of MCC staff. In addition, the level of science skills in South Africa is not high. It takes years for a newcomer to gain a level of expertise. The professor did emphasise, however, that the current staff at MCC are highly qualified and dedicated professionals.
Budget allocation from the Department of Health for the MCC increased this year. The current Directorate will become a Chief Directorate. Activities will be more centralised. The MCC is looking to transform its membership, as well as committee membership.
The registration process for new medicines is changing so that it will be done in a more integrated fashion. The backlog is being tackled by making a realistic timeline and sophisticated information processes are being used.
Approval of clinical trials is not medical approval. It is, by necessity, faster. In South Africa, it now takes about eight weeks.
The registration of complementary medicines is different than that of orthodox medicines. Complementary medicines involve different treatment and their efficacy involves a different philosophical paradigm. They have different levels of diagnosis and intervention. But complementary medicines cannot be assumed to be safe.
(Q) Ms Baloyi (ANC) asked if the short time for clinical trials allowed for all the necessary checks to be done. She also asked why so many clinical trials are done here in South Africa. She wondered if South Africans, as citizens of a developing country, were serving as "guinea pigs" for medical testing. Ms Malumise (ANC) amplified this question, asking why the black population, and particularly black women, were used as "guinea pigs".
(A) Professor Rees responded it is vital that developing countries do clinical trials. The focus of new medicines is to treat, for lack of a better term, "diseases of the rich". This covers the medicinal needs of about ten percent of the world's population. The "diseases of the poor" are not researched. The industry is reluctant to invest where there is little possibility of profit. Consequently, research into local diseases needs to be done locally and clinical trials must be very rigorous.
South Africa is an ideal place for clinical trials to be done since it has strong academics and institutions. South Africa is also anomalous in that it has the diseases of both the rich and the poor. In addition, the exchange rate of the rand makes South Africa a favourable location for clinical trials. A clinical trial needs two approvals before it can take place, one prescribed by Act 101 and the other by an ethics committee. The MCC takes both science and ethics into account. Professor Rees said the two are inseparable.
Professor Rees finally said South Africa is "far ahead" in terms of clinical trials and the protection of human subjects. Candidates have to justify why they want to do a clinical trial in South Africa and show sensitivity to the local environment.
(Q) Dr Jassat (ANC) asked if the computer situation at the MCC had improved. He had heard that a lot of the Council's work was being done manually. He also asked if, in the case of drugs that already received the approval of the American Food and Drug Administration (FDA) were subject to the full process of testing in South Africa.
(A) Professor Rees agreed about the computer shortage, saying budget constraints included infrastructure constraints. Communication needs to be strengthened, she said.
A drug's approval elsewhere is taken into account, but this does not mean automatic approval in South Africa. The needs in South Africa and the MCC's interpretation of information are different here.
(Q) Dr Gous (NNP) asked if price is ever a consideration in the testing and approval of new medicines. He asked if approval could be "fast-tracked". He also asked if, in view of the current backlog, a requirement of re-registration every five years is viable. He asked how effective the inspectors are. He had heard there was a vehicle shortage. Finally, he asked if Professor envisaged either new legislation or amendments to Act 101.
(A) Professor Rees said it is possible for a drug's approval to be "fast-tracked". Some of the factors taken into account are the reasons for speeding up the process, if the drug is essential or a therapeutic breakthrough or potentially life-saving. The criteria for fast-tracking are very clear. In terms of cost, she said a drug may be fast-tracked if cost saving is in the interests of public health. The primary focus of the MCC is always to protect public health. The motivation for the fast-tracking of fluconozol, for example, was price. It was reviewed when fluconozol was made available free by the drug company Phizer.
As for a requirement to re-register a drug every five years, Professor Rees said it has not been discussed. The backlog is not for new products, but is an inherited one.
The professor agreed the inspectorate is very important and is currently a concern of the MCC. It needs to be strengthened. The borders of South Africa are porous and more inspectors are needed.
As for new or amended legislation, Professor Rees said she is the wrong person to ask. This question should be addressed to the Minister of Health or the Director General. The MCC operates under Act 101.
(Q) Dr Rabinowitz (IFP) asked if approval of a drug is influenced by government policy. She mentioned nuviropen and misaprostel as examples. She also asked about the issue of counterfeit drugs. About African traditional medicines, she said many bodies are now doing work in this area and asked if there was co-operation so the work can be co-ordinated.
(Q) Ms Dudley (ACDP) asked about the current status of nuviropen.
(A) Professor Rees said the data on nuviropen is favourable. A single dose to a pregnant mother and a single dose to the child prevents the transmission of HIV from mother to child by 50 percent. However, there are other significant factors. For example, subsequent transmission can occur after birth through breastfeeding. Or mortality rates rise when a mother who bottle feeds does not have enough money to purchase milk. A single dose of nuviropen can also result in a high resistance rate to the drug. Eighteen research sites are being approved for the testing of nuviropen and many women will be participating.
The patent for misaprostel has now expired so generic versions will be available. It is a simple drug and therefore affordable. The ideal is that the drug will be registered.
As for the problem of counterfeit drugs, Professor Rees said this is a worldwide challenge. The World Health Organisation estimates about five percent of drugs on the market are counterfeit. The definition of "counterfeit" is broad and can range from substances that are not medicine at all and generic versions of medicines. Counterfeit drugs are another good reason to strengthen the inspectorate.
(Q) Ms Baloyi asked who sits on the committee for African traditional medicines.
(A) Professor Rees responded it is a new committee with people with knowledge of traditional African medicines as well as people with scientific knowledge.
(Q) Ms Cupido (DP) asked about asked if ayurvedic medicines are included in the category of traditional medicines.
(A) Professor Rees responded ayurvedic medicines are part of the process and the MCC receives assistance from those who are knowledge in the use of these medicines.
(Q) Dr Gous asked if time lines or cut off dates were causing South Africa to "lose out" on international drug trials. He also asked if South Africa is a "dumping ground" for counterfeit drugs.
(A) Professor Rees responded eight weeks is "pretty good"; not as short as some places and not as long as others. South Africa, she said, will never have an FDA. There is no budget for such an entity. However, it can do the job but not in one week. But is does stick to its promised time of eight weeks. She said she often heard it said that South Africa is "losing out", but when asked to give examples when this has actually happened, there are only one or two instances.
The professor agreed that places can become "dumping grounds" for counterfeit drugs. The law deals with orthodox medicines, but not complementary medicines. Even the United States have not found a way to deal with this problem, she said. This is why South Africa is pushing for registration.
Professor Rees also commented that companies that pay for drug trials want the drugs to be tested on people of European origin since these drugs are being for developed for European markets. The companies want data on how their products affect white people. But it is to South Africa's benefit to get data on the effects of medicines on black people since the majority of the population of this country is black. To do so is not to exploit the black population but to gather data that will be useful in developing effective medicines.
The meeting was adjourned.
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