Tamar Kahn - Science and Health Editor, Business Day
The bills original two-tier system ran into fierce opposition from industry and activists during public hearings earlier this month. They said it would allow unfettered political interference in the proposed Health Products Regulatory Authoritys decisions on whether to allow new products on the South African market.
The authority will replace the Medicines Control Council (MCC), and oversee medicines, medical devices, and foodstuffs containing drugs.
The bill originally provided for the authority to assess the safety, efficacy and quality of new medicines and devices, and then refer certified products to the health minister for further scrutiny. The minister would be given the power to decide whether or not to register them on ill-defined grounds such as public interest.
MPs across the political spectrum yesterday backed committee chairman James Ngculus proposal to ditch these provisions. The state law advisers office was instructed to redraft the bill so that the power to register medicines would rest solely in the hands of the authority.
MPs also agreed to introduce measures to allow aggrieved parties to lodge appeals with the health minister if their applications to register new products were rejected.
The minister would then be obliged to appoint an independent committee to consider their appeals within a time frame still to be determined.
The development was hailed widely as one that would strip politics out of the science of assessing whether medicines were safe, effective and of appropriate quality.
We welcome the decision to implement a single registration system where the minister cannot decide which medicines can or cannot be registered, Treatment Action Campaign spokeswoman Leslie Odendaal said.
The Democratic Alliances Mike Waters said the committees decision would avert a chaotic situation in medicines regulation where medicines were denied to South Africans for political reasons.
The MCC is in desperate need of reform. Its antiquated structure creates enormous delays in approvals, (denying) South Africans access to life-saving drugs, he said.
Pharmaceuticals Made in SA spokesman Stavros Nicolaou said: Our preference was for registration that stuck to scientific criteria, evaluated by people with competence.
We didnt want politicians getting involved. The Pharmaceutical Industry Association of SA and Innovative Medicines of SA (Imsa), which represent multinational drug makers, welcomed the committees decision cautiously, saying it would like to see the details of the new draft before being completely reassured.
Imsa said that a separate decision by the committee to introduce provisions in the bill that would compel the authority to draw up rules specifying timelines for applications to register new products was also an important development. It gave the industry some standards against which to measure the authority by.
The MCC does not commit itself to deadlines, and usually takes more than two years to approve new drugs.