Medicines bill clause slammed

by Slindile Khanyile Durban Anyone in South Africa can oppose the registration of new medicines if they feel it would not be in the public interest or the country’s economic interest, or vulnerable groups would not have access to the drugs. This is a consequence of a new clause added by the parliamentary portfolio committee on health to the Medicines and Related Substances Amendment Bill. James Ngculu, the committee’s chairman, confirmed yesterday that the committee had added the clause. He rejected suggestions by the Democratic Alliance (DA) that this was the committee’s way of reinstating the two-tier registration system that was removed last week. “The DA has not explained what it means,” he said. “This is an appeal process which exists in any institution because sometimes people may be aggrieved by a certain decision and you cannot always say to people they must go to court.” At present new drugs are evaluated only on the basis of quality, efficacy and safety. When the bill was initially released, it said the SA Health Products Regulatory Authority would handle certification while the health minister would be in charge of registration. Before approving registration the minister would consider whether the product was in the public health interest, the economic interest in relation to health policy, and the strategic interest in relation to policy. She would consider the need and desirability for such a product and generally, whether the public would be best served by the registration. Industry players opposed this aspect of the bill. The portfolio committee was applauded last week when it ordered the department of health to remove this clause. Mike Waters, the DA’s spokesperson on health, said his party was appalled and considered the move a reinstatement of the two-tier system. “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,” Waters said. “Now, after a summons to Luthuli House [ANC headquarters] the committee has back-tracked and made the situation even worse.” Giving reasons for different criteria in the appeals process than those used in certification, Ngculu said: “There has to be a basis for appealing. People can’t just appeal willy-nilly. There will be timelines.” He said the meeting at Luthuli House was simply to discuss the national health insurance scheme. The appeal must be made within 30 days of the certification decision and a ruling on it will be made within a month. Vicki Ehrich, the chief operating officer at the Pharmaceutical Industry Association of SA, said her organisation’s position was that medicines should be registered on the basis of safety, efficacy and quality. The association would be very concerned if other factors, that had potential to limit access to medicines, were considered. There have been many complaints about the Medicines Control Council, which took two to three years to approve drugs, and between six months and a year to give clinical trials a green light. This is considered to be a reason the country has less than 1 percent of global pharmaceutical market share. Dinesh Bheema, the director for medical and new business development at Sandoz South Africa, said there was an overwhelming rejection of the two-tier system. It could not work “no matter how we disguise it. The process should be kept plain and simple, and we must do it like the rest of the world does it”. Ngculu said the committee was considering moving deliberations on the National Health Amendment Bill to next year, but a final decision had not been made.