Opposition blasts about turn on medicine registration system
The Democratic Alliance said it was appalled by the Health Committee’s decision, ‘after what seems to have been an instruction from Health Minister Manto Tshabalala-Msimang’, to effectively reinstate a two-tier system for approval of medicines.
‘By allowing political considerations to be imposed on medicines evaluation, the committee is endangering health care for all South Africans,’ said DA health spokersperson Mike Waters.
The current law requires that medicines be evaluated only on the basis of their quality, efficacy and safety. No political considerations come into it.
The Health Department recently attempted to change this by allowing the Health Minister to make a final decision on medicines approval.
In public hearings on the Bill numerous organisations described the problems that this would create for access to medicines, and the Health Committee finally vetoed the proposal.
‘Now, after a summons to Luthuli House, the committee has back-tracked, and in fact made the situation even worse,’ Waters claimed.
He said an appeals process has now been created whereby anyone will be able to appeal against a scientific decision made by the Authority on political grounds – which include the public health interest, economic interests, and ‘access to health care by vulnerable groups’.
‘This is in fact worse than the original draft from the Health Department, because now any individual ‘ rather than the only the minister alone – may exploit political considerations to hold up or stop the approval of a medicine,’ he said.
Waters said this would open up medicines approval to many vested interests.
He said for example Dr Rath would be able to claim, on grounds of public health, that AIDS does not exist and an AIDS drug should not be approved. The Manufacturer of a particular medicine would be able to complain about a competitor’s product on grounds of economic interests. Anyone suffering from a rare disease might be denied access to a life-saving drug on the basis of ‘economic interests’.
‘It is, quite frankly, absurd that anyone should be able to influence the scientific process of evaluating a medicine on grounds that have nothing to do with its medical efficacy. We are disturbed by yet another attempt on the part of the Health Minister to place herself in absolute control of the health care system, and by so doing, stifle a system that every South African depends on,’ said Waters.
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