Sunday Times (Johannesburg) - July 17, 2005
Buddy Naidu

THE minister of health plans to take control of the registration of medicines and medical trials to be carried out in the country.

The Sunday Times has established that the department has outlined changes that will drastically clip the wings of the Medicines Control Council (MCC), whose functions include the testing and evaluation of medicines and approval of clinical trials.

The council is an independent body that ensures all medicines sold and used "are safe, thera-peutically effective and consistently meet acceptable standards of quality".

Now Health Minister Manto Tshabalala-Msimang wants to set up the Medicines Regulatory Authority under the direct control of herself and her director-general, Thami Mseleku.

Critics say it is an "inappropriate attempt" by the government to centralise power.

One of the concerns is that it would allow politicians to make key scientific decisions. Another is that it represented a "radical about-turn" by the government, which has been trying to change and strengthen the function of the council since the late 1990s.

Health department spokesman Sibani Mngadi was unable to confirm the department's plans, but admitted discussions about the council "and how it's been positioned" had taken place.

"There's always been a feeling ... that all the structures under the health department need to be able to be geared up towards the new era where we expand access to healthcare [and] access to medicines," he said.

The Sunday Times has established that the government believes the council is ineffective and has little knowledge of national healthcare policies.

This follows public disputes between the health ministry and the council over testing of the Aids drug Virodene and, more recently, the testing and availability of antiretrovirals.

The government also questioned the validity of antiretrovirals when the council had already approved these.

The new plan could affect the access to drugs, particularly antiretrovirals and may even give the minister a stronger hand in dictating medicine prices.

It is understood that the intention is to ensure the government takes full responsibility for all medicines.

The Medicines and Related Substances Control Act allows only the minister to, among other things, approve appointments, establish licensing conditions and deal with law enforcement.

It also allows the minister to intervene in matters of public interest.

The Medicines Regulatory Authority will, according to the proposal:

* Enable the minister and director-general to make and implement decisions;

* Employ people full time unlike the council; and,

* Comprise several advisory committees, with the council being one of them.

But a former registrar of the council, Professor Johann Schlebusch, said the government should not politicise a scientific institution.

"The moment you do that you cannot apply good science."

He said it was bemusing that the council could be accused of "inhibiting government policy".

"The MCC cannot play a role in government policy on healthcare. They simply evaluate and regulate products and ensure they are made available."

He said there must have been "conflict" within the council that could have precipitated such a radical move by the department.

Former senior council employee Seemole Mohoto, who helped draft the ill-fated SA Medicines and Medical Devices Regulatory Authority Bill, insisted that state machinery could not run a scientific body.

"If they're doing it in good faith then it may enable them to access drugs of public interest and control the prices of these drugs. It also gives them the muscle to bargain and negotiate."

But he described the situation as a "time bomb" because it would give too much power to too few individuals.

Former council chairman Professor Helen Rees was unaware of the move, but said that the proposal was a radical departure from what has been discussed since the late 1990s.

"There needs to be a real injection and strengthening of the infrastructure [of the council] instead," she said.

The president of the Pharmaceutical Society of SA, Clive Stanton, said the government was trying to control all healthcare.

The Pharmaceutical Society is currently embroiled in a Constitutional Court battle with the health department over dispensing fees for pharmacists.

Stanton said: "If we talk about the decision by the minister [then] I would like to see the minister's scientific credentials. The same goes for the director-general."

He said the establishment of an Medicines Regulatory Authority would give the government "a stronger hand" with regards to medicine pricing.

The editor of the SA Medical Journal, Professor Dan Ncayiyana, said the testing of medicines and its approval "can only be done by an autonomous body".

If the Cabinet approves the proposal, the minister is expected to make provisions for such a body in the next financial year.

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