Almost four year wait for the approval of some antiretroviral: When will the MCC's problems be dealt with?

This year's budget made substantially more money available for antiretrovirals. But this is of no use if we do not have access to the drugs we need to buy. A reply to a Democratic Alliance (DA) parliamentary question shows that the Medicines Control Council (MCC) has not yet approved applications for nine antiretrovirals - although some of these applications were made almost four years ago.

South Africa's MCC once had an international reputation for speed, efficiency and quality, but it has become increasingly inefficient and for many years it has been denying South Africans access to new treatments because of the enormous delays in getting drugs approved.

The DA calls on Health Minister Aaron Motsoaledi to explain how he is going to move this massive obstacle in the fight against Aids.

According to the reply, nine ARVs are still awaiting approval. While the health department refused to give the names of the drugs, the applications were made in, respectively:

·         April 2006;

·         September 2006;

·          January 2007;

·          June 2008;

·          January 2008;

·          January 2008;

·          1-2 January 2008;

·          February 2009; and

·          August 2009.

These drugs are likely to be fixed dose ARVs, where two or more drugs are combined in one pill. This makes dispensing the medication much simpler, particularly in the context of the vast number of patients in South Africa's ARV programme.

They may also be some of the newer medications which are increasingly being needed as resistance to older drugs develops.

The most recent application was made in August of last year, and even that application has been waiting for seven months. No application should have to wait for more than six months, particularly not for drugs which have already been approved across the rest of the world.

It has for many years been reported that the MCC is moribund; that phones don't get answered, documents get lost, people do not respond to messages and lethargy and incompetence prevails. We cannot allow people to lose their lives because of an ineffective organisation.

Statement issued by Mike Waters, MP, Democratic Alliance shadow minister of health, March 11 2010

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