Pat Sidley

The Government's AIDS policy appeared to be in tatters yesterday as Gauteng's African National Congress (ANC) premier, Mbhazima Shilowa, announced far-reaching plans to deal with the epidemic, and party bosses grappled with the issue until late last night. Former president Nelson Mandela attended a meeting of the ANC's national working committee yesterday afternoon, intending to raise his concern about government's AIDS policy, which has drawn international criticism. After the meeting, ANC spokesman Smuts Ngonyama acknowledged that AIDS had been discussed, but said Mandela agreed that government and the ANC were on the correct path. Shortly before the meeting, at the opening of the Gauteng legislature's session, Shilowa said that the antiretroviral drug Nevirapine would be supplied to HIV-positive pregnant women in all public hospitals. He committed R30m to the programme. Rape victims would also receive antiretrovirals at provincial facilities, he said. Gauteng's move seen as a shift in political commitment and policy within the ANC's ranks drew praise from AIDS activists and opposition parties. Shilowa's announcement makes Gauteng the third province to decide to provide the drugs, after Western Cape and KwaZulu-Natal, and the only one ruled outright by the ANC to do so. Gauteng had been supplying the drug at several sites assisted by the team at Chris Hani Baragwanath hospital, which supplies the drug to HIV-positive pregnant women throughout Soweto. Shilowa said that the plan was to ensure pregnant women throughout Gauteng accessed the full package of care within a reasonable distance from their homes. After consulting experts locally and internationally, Mandela stepped into the AIDS fray recently, believing government policy needed to be addressed. He told the Sunday Times at the weekend that he would meet the ANC yesterday, a meeting that lasted the afternoon. A second meeting, without him, was scheduled to take place later. According to Ngonyama, the meeting at Luthuli House did not specifically discuss Mandela's statements reported at the weekend. He said the issue was discussed more broadly. Mandela left before the meeting was over. (Source: Business Day, 19 February 2002)

Tacit agreement for the wider use of Nevirapine by SA's nine provinces appears to have been reached at a top-level meeting of provincial MECs for health and the national health minister. After the two-day meeting at the end of last week, insiders believe the door is now open to those provinces wishing to roll out further sites to provide the anti-AIDS drug to do so. Both the science and activist communities have expressed disappointment at the lack of clear policy directing health departments in all provinces to provide the drug Nevirapine to HIV-positive pregnant women wanting it. They have noted with alarm that there is nothing to compel those provinces that do not want to expand the provision of the drugs to do so. Health department insiders close to the meeting say there was little resistance from MECs wanting to provide an expanded programme and only two provisos were outlined. These were: programmes should be implemented taking cognisance of lessons learned from research sites and that sufficient resources to sustain a programme should be available when deciding to start dispensing the drug. A statement released at the end of the two-day meeting gave details of the number of women receiving counselling, testing and treatment and raised some of the known problems, like the adequacy of counselling. It did not specify whether or not the programmes should be expanded, but mentioned instead that a balance needed to be struck between the expansion in some areas, or rectifying problems where they occur. The largest problem encountered, according to the health department sources was in the area of counselling. (Source: Business Day, 4 February 2002)

Proposals to relax some of the patent provisions on pharmaceutical drugs meant to deal with pandemics, such as HIV/AIDS, tuberculosis and malaria, have been met with scepticism. The proposals, which will be tabled by the US and several other western countries at the World Trade Organisation (WTO) meeting to be held in Doha, Qatar, later this week, offer to extend the window on full compliance of all pharmaceutical-related Trips (trade-related aspects of intellectual property rights) provisions for 10 years till 2016 for the least developed countries. This means that sub-Saharan countries which break patents will be allowed a five-year grace from prosecution when dealing with HIV/AIDS, infections related to AIDS, and other health crises, such as malaria and tuberculosis. Multinational pharmaceutical companies, whose interests have traditionally been well protected by western governments, particularly the US government, are greeting the move with caution. It seems SA makers of generics too will have to wait until the meeting in Doha is over before they assess whether their ability to copy patented drugs has been meaningfully enhanced. Global drug companies and diplomatic sources say the move is meant to seek out some form of middle ground between the position taken by developed countries and the position sought by poorer nations. Developing countries would like to be able to override patents for public health needs when they see it as necessary. Developed countries, and drug companies do not wish to see their patents eroded in this fashion. Jamie Love of Washington's Consumer Project on Technology, which fights for generic copies of drugs to be more widely available, says the moratorium on the dispute settling provisions of the WTO is to be welcomed, but he points to other problems. Countries classified by the United Nations as least developed do not include SA, Brazil, India, Thailand or Kenya. These are the countries where generics would make competition and bring down the price of medicine. (Source: Business Day, 7 November 2001)

Prices for AIDS drugs will become more affordable with the announcement this weekend of two initiatives aimed at cutting the cost of the most frequently prescribed antiretrovirals. Multinational pharmaceutical company GlaxoSmithKline (GSK) said yesterday it was granting a voluntary licence to local firm Aspen Pharmacare to produce AZT and 3TC - as well as the combination pill Combivir exclusively for the public sector. The deal also obliges Aspen to pay 30% of the net sale price to non-governmental organisations dealing with HIV/AIDS. At the same time Cipla-Medpro, the local associate of Indian pharmaceutical manufacturer Cipla, has submitted a complaint to the Competition Commission alleging that GSK and Boehringer Ingelheim abused their patents. Cipla manufactures Nevirapine, an antiretroviral drug that helps to prevent the mother-to-child transmission of HIV. Cipla-Medpro CEO Jerome Smith said late last night that the complaint might now have to include Aspen Pharmacare. The only real market in SA for antiretroviral drugs has been in the private sector as government has consistently refused to provide the life-prolonging drugs to public sector patients who could not afford them. GSK has kept the lucrative - albeit small - market that includes medical aid schemes and larger buyers, like mining or manufacturing companies like Ford or DaimlerChrysler. The Cipla action is groundbreaking and challenges the way the patents have been used by both companies to keep drug prices high. Cipla has chosen to challenge the patents through the commission initially, but it will use the Patents Acts if necessary. Cipla's complaint says that the patents and licence-holders qualify as a dominant firm in terms of the Competition Act, and claims that they have abused that dominance. James Love, director of the Washington-based consumer project on technology, believes that GSK needs to be challenged further on its drug policy for the private sector, and says that the competition which the Cipla action will bring, will see prices lowered further. (Source: Business Day, 8 October 2001)

The Medical Research Council (MRC) was free to release its controversial report on the number of South Africans dying as a result of HIV/AIDS, the cabinet said yesterday. Government has been accused in recent weeks of keeping the report from the public because of dramatic revelations in it about the fatality rate as a result of AIDS. The report's results were in sharp contrast to the 1995 figures used by President Thabo Mbeki in a letter to Health Minister Manto Tshabalala-Msimang, in which he asked her whether the spending priorities of her department were correctly focused. The statement released yesterday said the (cabinet) meeting had also examined the report of the MRC on the impact of HIV/AIDS on adult mortality in SA. The meeting noted the interdepartmental task team and Statistics SA expressed concern on the methodology and findings of the report. Chief government spokesman Joel Netshitenzhe said cabinet had decided the MRC could release its report and Stats SA would explain its reservations. Stats SA released a statement later saying it had difficulty with the MRC's contention that 40% of adult deaths were as a result of HIV/AIDS. It said there was a wide range of reasons for the gaps in knowledge about HIV/AIDS. For example, HIV/AIDS is not a notifiable disease. Therefore it is difficult to trace the disease and its manifestations from its origin. Stats SA said the antenatal clinic tests used to establish HIV prevalence in the population were not necessarily a representative sample. (Source: Business Day, 11 October 2001)

Health Minister Manto Tshabalala-Msimang and the health MECs in all nine provinces are to defend the court action launched by the Treatment Action Campaign (TAC) and hundreds of doctors to force them to provide antiretroviral treatment to HIV-positive pregnant women in the public health system. The TAC and doctors sent a letter of demand followed by court papers asking the national health ministry and provinces to supply the antiretroviral drugs or details of a plan to do so. Government was given until yesterday to say if it would defend the action. Western Cape, which has a plan in place, is defending the action but notified Tshabalala-Msimang its approach would be different. A spokesman for health MEC Nick Koornhof said last night that the province would have preferred it had the TAC not included it in the action as it had a plan in operation to provide the treatment. The province would use its own team of lawyers and would likely try to avoid being lumped into the same action with the other respondents. A similar approach seemed possible from Gauteng, which, while defending the action, has written a letter explaining its own rollout for the provision of treatment. Earlier in the year, Gauteng launched the rollout of its plan, making it clear it intended to give treatment more widely than the provision of two sites would allow for. It has become clear that the court case and the issue of the provision of antiretroviral treatment are dividing the public health system. (Source: Business Day, 13 September 2001)

While changes in the law prompted mainly by the Medicines Act and its proposed regulations (and to some extent changes to the pharmacy profession) will be good in parts for the local pharmaceutical industry, it nevertheless has several concerns about the law and its regulations. The concerns would ring familiar to most who watched the pharmaceutical giants square up to government in Pretoria earlier this year: the importation of drugs; the proposed pricing committee; and the single exit price. For those not well versed in that court case and the law, the single exit price has been a hot potato proposed and dropped and reinstated over many years. It would see one price of a drug at the factory exit. The way it has been cast in law would ensure that no matter what the size of the purchase the price would be the same. Unlike every other industry, a larger volume bought would not be able to trigger a discount. The move was inspired by a need to inject transparency into medicines pricing and a need to remove a range of corrupt practices in the industry (known as perverse incentives) and would go hand in hand with a pricing committee. The pricing committee would ideally see to it that there was transparency and rationality to pricing policy. But the industry fears price controls. Of the drugs that flow through medical aid societies, some 19% in rand value are generics. In volume the amount goes up to 27%, according to Fiona Robertson of the Board of Healthcare Funders that represents the medical aid industry. She believes prices are at least 50% higher than they should be, partly because there is no real incentive to prescribe or reimburse generics. And the system currently buffers the higher prices of generics. There is little proper competition, but that will change if legislators have the effect they desire, but parts of the local industry are unconvinced it will. Several groups, including local industry body the National Association of Pharmaceutical Manufacturers, have proposed an enforceable code of ethics with a pricing committee, instead of the current single exit price. The health department faces a mountain of submissions from interested parties on its proposed regulations, which range from pharmaceutical groups to retailers and users like hospitals. (Source: Business Day, 23 August 2001)

The Treatment Action Campaign (TAC) and close to 100 paediatricians have asked the health department to make Nevirapine available in all public health hospitals for HIV-positive pregnant women. The department has until the end of this week to reply, or it faces legal action likely to take the form of a Constitutional Court challenge. The issue has thrown up the fact that many healthcare professionals within the health department have been frustrated by the lack of progress in supplying the drug, proven to be cost-effective as a means of reducing the transmission of the virus from mothers to their babies. Mark Heywood of the TAC confirmed yesterday that the letter had been sent and that the matter would go to court if a satisfactory answer was not received by Friday. Heywood said the drug was registered with the Medicines Control Council, was known to be effective and safe, and there was no reason doctors in the public health system should not give the inexpensive drug to pregnant HIV-positive women. He said about 75000 babies are born HIV positive every year. This is about 30% of the babies born to HIV-positive mothers. He said it was likely if the drug was widely available, at least 20 000 more babies would be born HIV negative. It is the knowledge that HIV can be prevented for these babies, but is not, that is causing division within the health department, according to several well-placed sources. (Source: Business Day, 31 July 2001)

SA is about to allow the importation of traditional Indian medicines, after the introduction of a process of listing the medication at the Medicines Control Council. This is according to Precious Matsotso, the chief director of medicines in the health department, who, along with the Medicines Control Council officials and other colleagues, recently visited India. The move could also lead to the importation of the Chinese medicines. The process will allow the importation of Chinese medicines too. Many natural or health products, or traditional health products, are sold in this country without regulatory approval provided they make no medicinal claims. However, Indian products, like Ayurveda, in these categories have thus far been banned. Registers will be open for ayurvedic practitioners, naturopaths, osteopaths, phytotherapists (who used to be known as herbalists), Chinese medicine and acupuncture practitioners, therapeutic aromatherapists, therapeutic massage therapists and therapeutic reflexologists. India has a well-developed system of traditional medicine, which has been integrated into the regulatory system along with modern medicine. Traditional medicine and health systems in India have some 400000 practitioners who have been trained in regulated institutions since the introduction of regulations some decades ago. It also has around 200 000 older practitioners who were practising before the introduction. India's system of drug regulation in this area includes pharmacopoeia laboratories, which develop and test standards for drugs, she says. India also has a Medicinal Plants Board. (Source: Business Day, 23 July 2001)

The private hospital industry, the largest buyer of medicines after the state, has questioned whether the controversial Medicines Act will drive down the costs of drugs. The Medicines Act, recently the subject of court action, was introduced as a mechanism to make medicines more accessible to South Africans. Rick Hogben, Afrox Healthcare CEO, told delegates at the Conference of Healthcare Funders yesterday that private hospitals were philosophically opposed to parts of the new law, and called for private hospital access to the state tender system as a more effective way of cutting medicine costs. The price of the drug was only one factor influencing the eventual cost. Among the ignored cost drivers was utilisation. Hogben said factors like which product was selected, its quantities, and where and when it was used were equal or greater determinants of the rising costs of pharmaceuticals. He questioned the need for any legislative controls on pricing, citing Afrox's extensive database as evidence that ethical drug manufacturers (those that have to be prescribed) had kept their prices down relative to the depreciation of the rand against the dollar. He said the consumer price index (CPI) for the past year was 6,4%, the rand had depreciated against the dollar by about 18% over the same period and the prices of ethical drugs to Afrox had increased by about 10%, showing restraint on the part of manufacturers. Earlier, Fiona Robertson, the BHF's chief tariff officer, told delegates that of all medicines prescribed in SA, only 20% were generics, the rest originals. Bada Pherasi, former chief director of medicines in the health department outlined the government's reasons for introducing changed medicines legislation. Consumers, Pherasi said, had for too long had to adapt to the needs of healthcare providers. The relationship between the healthcare industry and consumers was too unregulated. (Source: Business Day, 10 July 2001)