Medicines legislation could face court action

Government will face a barrage of litigation if amendments to the Medicines Act currently before Parliament were not revised, MPs heard on Tuesday.

Briefing the National Assembly’s health committee during Parliamentary hearings on the amendments, the Pharmaceutical Industry Association of South Africa (PIASA) opposed proposals that the health minister should be in charge of the registration of new medicines.

PIASA representative Abeda Williams said the proposals could lead to “significant delays”, thereby exposing the government to litigation from people in urgent need of medicines.

According to the proposals, the health minister is required to approve all new medicines, and could decline to register products even if they had passed clinical tests.

“This will cause enormous delays and as PIASA we believe the decision should be a one-step process based on science,” she said.

Williams said SA should draw lessons from what is currently happening in Brazil, where the government was being taken to court by citizens who accuse the state of failure to register essential medicines on time.

The Brazilian government had adopted the same module that is being proposed in the measure.

While PIASA was in favour of the restructuring of the Medicines Control Council (MCC) and the establishment of a new medicines control authority, it was opposed to the two-stage application process that new medicines had to be subjected to before being approved for sale to the public.

The Treatment Action Campaign (TAC) and the Aids Law Project also opposed the proposal, threatening to take legal action if the measure was passed in its current form.

“If passed in its current form .... it will go to litigation,” Jonathan Berger of the ALP said. - Sapa



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