Always in the way

Thursday, 28 August 2008 15:18

South Africa is a country beaming with potential and a guiding light in democratic unity, as well as medical advancements in the fight against HIV/Aids. It is estimated that of the 39.5 million people living with HIV worldwide, in 2006 more than 63% were from sub-Saharan Africa. In 2005, about 5.54 million people were estimated to be living with HIV in South Africa, with 18.8% of the adult population and about 12% of the general population affected. In a country where so many people are fighting the pandemic daily, the government and medical community are under constant pressure to initiate a cure for this debilitating disease. As of yet, no miracle cure has come to light; however, significant advances are indeed evident in the form of numerous antiretroviral (ARV) drugs. Much has been debated in recent times over the distribution, as well as the costs of these; however, it seems things are not quite at the level they should be. In fact, in 2006, former US president Bill Clinton, a frontrunner in the fight against HIV/Aids, announced that his foundation had negotiated major price discounts on Aids tests and drugs with companies from five countries, including India and China. This deal reduced by 30% or more the cost of already cut-price products offered in most developing nations. At this stage, there were already more than one million people receiving treatment, with growing challenges to keep costs affordable as they reached out to millions more in need. On the medication side, the focus was on slashing prices of drugs used on patients who have become resistant to first-line medications. In this agreement, it was also decided that four companies – three from India and one from South Africa – would offer the second-line ARV drug Efavirnez for $240 per patient per year, representing a 30% price cut. While it seems that these were indeed positive steps in the fight against the virus, there have been numerous technicalities resulting in these ARVs being prevented from reaching distressed patients. One of the main issues causing delay is the fact that one of the drugs in question, Efavirnez, has not been licensed, leading to the Treatment and Action Campaign (TAC) launching a complaint to the Competition Commission. In South Africa, all medicines go through strict checks by the Medicines Control Council (MCC) to ensure that they are safe and effective and when the medicine passes all the required checks, a product licence is granted, allowing the medicine to be utilised in the treatment of specific medical conditions. For a product to be licensed, it has to meet certain criteria: • It should be proven to work for the illnesses for which it was developed. • It should not have too many side effects or risks. • It should be made to the highest of standards. This is certainly not a unique case, as witnessed by the Aids Law Project (ALP). In September 2007, the ALP submitted a memorandum to the Office of the Presidency setting out various issues that they believe should be considered by the government in preparing for and running the 2008 ARV medicine tender. The ALP’s memorandum explained their concerns with the ARV tender that the State has put out, identifying problems with: • Type and quantity of ARV medicines to be procured; • Contract period; • Legislative requirements (relating to registration and licensing concerns); • The cost of local production; and • Adverse drug reactions and numerous others. The TAC and ALP have publicly united and voiced their belief that the State would be in a stronger position to secure the right medicines at the right prices if the tender took their concerns into consideration. Efavirenz is commonly sold under the brand names Sustiva and Stocrin and is used as part of highly active ARV therapy in the treatment of HIV/Aids. It is used in combination with other ARV agents as part of an expanded regimen to prevent HIV transmission. Efavirenz was combined with other pharmaceutical elements to provide highly active ARV therapy (HAART) in a single tablet taken in a 600mg dosage once a day. It results in a simplified drug regimen for many HIV/Aids patients and the fact that this drug has not yet been licensed, is a cause of major concern for millions of Aids sufferers across the country. Due to a technicality of effectively licensing this product in South Africa the drug cannot be distributed for effective use. On 7 November 2007, the TAC lodged a complaint to the Competition Commission against MSD and Merck over their failure to license this key ARV on reasonable terms. Within this complaint lie numerous concerns, amongst them that the ARV tender specifications appear to have been decided in the absence of consultation with experts regarding a range of relevant issues. These include appropriate drug regimens, the latest available evidence on treatment options, as well as an analysis of treatment outcomes. Another noteworthy point put forward in the complaint was the clear lack of consultation which appears to have resulted in the ARV tender specifications anticipating lower patient demand than contemplated by the targets of the national HIV & AIDS and STI Strategic Plan for South Africa, 2007-2011 (NSP). It is hoped that by bringing this issue to light in the form of an official complaint to the Commission, as this might speed up the process with regards to getting this much-needed drug licensed and distributed amongst suffering patients eligible to undertake treatment. The ARV tender represents big business for pharmaceutical firms, as South Africa has the highest number of HIV infections in the world, and ambitious targets exist to provide more than double the roughly 400 000 patients already receiving ARVs from the public sector in the next few years. The 2004 tender allowed for companies to bid, providing they had applied to register their drug with the MCC, South Africa’s regulatory authority. The new tender, however, excludes companies from bidding to supply drugs that have not completed MCC registration by 20 March, the date when submissions were due. Long delays in registering new drugs have prompted calls by the Joint Civil Society Monitoring Forum (JCSMF), a body made up of health, human rights and law organisations, for the government to waive the process for drugs already registered by rigorous regulatory bodies such as the US Food and Drug Administration and the World Health Organisation. The fears of both the ALP and TAC were indeed justified in that they were concerned that the tender’s strict registration requirement would result in many drugs still awaiting registration not making the cut. The argument that both the TAC as well as the ALP are pushing for greater ARV access is that competition between generic drug manufacturers offers the best hope of further driving down ARV prices. According to researchers, however, South Africa’s patent laws do not favour such competition. Other developing nations, such as Brazil and Thailand, have taken advantage of exemptions in international intellectual property law that allow developing countries to license generic manufacturers to produce essential drugs, regardless of patent restrictions. However, South Africa’s Patent Act favours patent protection, thus significantly slowing the production of these essential drugs. The ALP has fought patent restrictions on ARVs by using South Africa’s constitution to file complaints against pharmaceutical companies with South Africa’s own Complaints Commission, an approach that has achieved a number of successes, with several of the companies agreeing to issue voluntary licences to generic manufacturers. So with all this infighting within the South African Aids sector, where does this leave South Africa’s progression in the fight against HIV/Aids in the form of ARVs? With South Africa being the world’s leader in HIV/Aids, this brings with it a heavy burden to provide ARVs adequately to those in need. According to the ALP, more than 500 000 South Africans currently require ARVs with less than half that number receiving the medication – and despite substantial increases in public funding for ARVs. Recently, the Inter Press Service (IPS) reported that a government fact sheet issued in November 2005 entitled “Implementation of the Comprehensive Plan on Prevention, Treatment and Care of HIV and AIDS” noted that 85 000 people were receiving ARVs in the public health sector by September last year. According to pre-set benchmarks for South Africa, this marked a shortfall of some 300 000 in terms of the targets global health authorities had set themselves. Paediatricians and children’s rights activists are particularly concerned that very few children are accessing treatment and estimates are that at least 50 000 children currently require ARVs, but that only about 10 000 are receiving them. Zackie Achmat of the TAC has also caused ripples amongst the international HIV/Aids community by publicly stating that lack of funding is not the main obstacle to ARV provision. According to further research into this issue, it was noted that in a 2005 update for the ‘three by five’ initiative, the World Health Organisation (WHO) commended South Africa for committing a billion dollars up to 2008 for increasing ARV treatment, which was by far the largest budget allocation of any low- or middle-income country. (The ‘three by five’ programme was started in 2003 by the World Health Organisation and the Joint United Nations Programme on HIV/AIDS, whereby it aimed to have three million people in low- and middle-income states on ARVs by the end of 2005.) Achmat openly states that the ARV issues lay elsewhere and his opinions are widely known in that he regards the largest problem we have in South Africa is that it has a president who doesn’t believe that HIV causes Aids. Mbeki has drawn fire for questioning whether HIV causes Aids; something the TAC believes has undermined efforts to distribute ARVs effectively. Another issue causing apprehension, is the point at which sufferers gain access to ARV treatment. A patient embarks on ARV treatment when a count of their CD4 cells, which regulate the immune system, dips below a certain level. The count falls as CD4 cells come under attack from HIV, making the body increasingly susceptible to opportunistic infections. In South Africa, ARVs are offered to those with a CD4 count of below 200. Achmat, who is HIV positive himself, takes issue with this, as he argues that a 200 CD4 cell count is too late. He criticises this level in comparison to that of Botswana, who start treatment at 350. In addition, if there is any resistance to initial treatment, one has to go for the second line of ARVs, which becomes increasingly expensive. This is an issue that the South African medical community is going to have to evaluate and decide upon prior to effective ARV treatments being rolled out at a mass-effective level. Another element halting progression in this battle is the unorthodox views held by South Africa’s health minister Manto Tshabalala-Msimang. Last September Mbeki came under massive scrutiny in his praise of Tshabalala-Msimang’s stance on Aids, much to the world’s dismay. The TAC stated that the minister’s failings included: the slow provision of drugs to prevent HIV-positive mothers passing on the virus to their child; delays in providing ARVs to people with Aids; and her department’s failure to provide proper levels of staffing and expertise. The minister’s backward stance to ARVs reached a peak at last year’s international Aids conference in Canada last year when she made plain her mistrust of ARV medicines. She has praised the value of natural herbs such as lemons, garlic, olive oil and beetroot. South Africa’s stand included garlic and other foodstuffs, prompting international scientists to write a joint letter of protest to Mbeki. Positive change was seen during a period when deputy health minister Nozizwe Madlala-Routledge took charge. During that time, she joined forces with civil society and Aids activists to draw up an ambitious five-year plan to halve the number of new infections and provide care and treatment to 80% of those in need by 2011. But Mbeki swiftly dismissed Madlala-Routledge, because she went on an unauthorised trip to an Aids vaccine conference in Spain and did not work as part of a team. Activists are convinced, however, that she was victim of a political vendetta orchestrated by her boss, the minister. While infighting is the last thing South Africa needs in the battle against HIV/Aids, this is a positive step in that HIV/Aids patients are finally standing up against profit-driven pharmaceutical brands in this global challenge. While the South African public is often inundated with messages of prevention being the ultimate cure, the country cannot afford to turn its back on those victims already suffering the effects of HIV. It is essential that drugs such as Efavirnez, that can be instrumental in halting the progression of HIV/Aids, are immediately licensed and openly distributed to those patients in need. In an age increasingly driven by profit, it is imperative that developing nations suffering the most from this virus, such as South Africa, lead the way in both prevention as well as treatment in the form of ARVs, if an effective cure is ever to result. The South African government and medical community needs to stand back and effectively alter current patenting laws in order to mount a challenge efficiently in the fight against HIV/Aids and, in turn, shape South Africa’s current HIV/Aids landscape for the better. Adam Currie

Last Updated on Thursday, 08 April 2010 12:46