Equitable access: Scaling up HIV/AIDS treatment in developing countries

There is no reason to remain silent or polite about the more than 8,000 people we lose to AIDS every day. We must strive collectively to make effective HIV/AIDS treatment a reality for the millions of people who need it.
For many years, Médecins Sans Frontières (MSF) has been caring for people living with HIV/AIDS in developing countries. Since 2001, MSF has been providing antiretroviral treatment to patients with HIV/AIDS in Cambodia, Cameroon, Guatemala, Honduras, Kenya, Malawi, South Africa, Thailand, Uganda and Ukraine. Our experience has demonstrated that providing effective treatment is not only feasible in resource-poor settings, but has concrete clinical benefits and dramatic effects on the lives of individuals and their communities. However, while we know that treatment is possible, scaling up to national level has only been successfully implemented in a handful of countries. Time to scale up HIV/AIDS treatment in developing countries 95% of the 40 million people who have HIV/AIDS worldwide live in developing countries. Yet in July 2002, the World Health Organization (WHO) estimated that, in developing countries, only 230,000 of the 6 million people who would need antiretroviral drugs (ARVs) are receiving them. The greatest obstacle to access is lack of money. The Global Fund to fight AIDS, tuberculosis and malaria clearly illustrates the extent of the funding deficit: by July, only US$2.08 billion had been pledged. US$700-800 million will be available for disbursal in 2002 - less than a tenth of what is estimated to be required each year to tackle AIDS alone. Donors have skirted their responsibilities and repeatedly broken promises made over the last two years. The first proposal of the European Commission for 2003 budget was an allocation of 35 million, which would represent close to a 50% cut from the previous year. Scaling up will not be possible without increased international aid. Where political will is matched with funding, the fortification of health care systems and the wide availability of affordable medicines, countries can achieve dramatic results with their HIV/AIDS treatment programmes. This is already the case in Brazil. Other countries, including Cameroon, Uganda, Botswana and Thailand are beginning to scale up. With a concerted effort and sufficient international support, many countries confronted with low or medium prevalence levels, such as those in Eastern Europe or Central America, would be able to move toward universal coverage. Instead, many HIV/AIDS endemic countries who are developing their own objectives for increasing access face stalled implementation because of lack of domestically allocated and donor funds. Moving towards equitable access MSF supports an 'Equitable Access' approach to keeping down the price of drugs, where policies are implemented to ensure that the price of a drug is fair, equitable and affordable, both to individuals and the health systems that serve them. Equitable pricing is based on the principle that the poor should have access to, and pay less for, essential medicines. To ensure this, developing country patients and communities, governments, UN agencies and the newly established Global Fund to Fight AIDS, TB and Malaria must all participate in encouraging purchases from the lowest cost reliable supplier through competition and local production. WHO and UNICEF should offer technical support, including pre-qualification of medicines, bulk purchasing and assistance in overcoming patent barriers to access more affordable medicines. Stimulating generic competition An important element of equitable pricing is generic competition, a strategy that has proven to be the most effective means of lowering drug prices. During the last two years, originator companies have only consistently cut the prices of their drugs when faced with generic competition and international public pressure. This is clearly illustrated in the figure below, which shows the effects of generic competition on the world prices of the ARV triple combination stavudine (d4T) lamivudine (3TC) nevirapine (NVP). While in May 2000, originator prices were over US$10,000 per person per year, by July 2002, they had dropped to just over US$700 ppy. Lowest world prices per patient per year for stavudine (d4T) lamivudine (3TC) nevirapine (NVP)
Although generic competition is a critical factor in reducing prices, it cannot stand alone as a strategy. There is an urgent need to develop a more systematic, transparent approach to differential pricing of originator products combined with an increased access to generic products. For developing countries that do not have strong regulatory authorities, creating a reliable process to assess the quality of generics of HIV/AIDS related medicines may be difficult. For this reason, WHO's pre-qualification system is an essential service. When countries are forced to buy drugs at a premium from originator companies because they do not have systems to assure quality of generics, drug prices are kept artificially high. Pre-qualification facilitates the ability of poor countries to pursue the best offers on the world market. The Global Fund has officially announced that until 2004, it will not only authorise payment for WHO prequalified drugs, but also for generics approved by national authorities. Differential pricing Differential pricing policies refer to the lowering of prices by drug makers for lower-income markets. In the past, differential pricing has been successfully implemented for vaccines and oral contraceptives, with drugs costing as much as 200 times less for poor countries. So far, the most publicised effort to reduce prices has been the industry-led Accelerating Access Initiative (AAI). In the AAI, UNAIDS and WHO help countries develop HIV/AIDS plans and play a facilitator role between countries and companies to negotiate discounted prices. But in this system, companies are free to set the rules, and they offer very different levels of discounts to selected countries and types of purchasers. Country eligibility restrictions for these prices also vary widely between companies. Unfortunately for people with HIV/AIDS in Central America, for instance, originator drug companies have decided, with the exception of Merck, to handle discounts on a case-by-case basis. The governments of Guatemala and Honduras, who have chosen to buy exclusively from originator companies, are as a result paying 75-99% more than MSF, which uses generics for its pilot projects. So far only Merck has a published price for mid-level countries, such as Ukraine and Guatemala. For products from other companies, these countries must negotiate on a case by case basis. The case of Roche While other multinationals participating in the Accelerated Access Initiative have dropped their drug prices 87-92% for least developed countries compared to French and Swiss prices, Roche's best price for Viracept( (generic name: nelfinavir) is only 40% less than their Swiss price. According to its own policy 'Roche is committed to providing HIV medication to the 63 countries in sub-Saharan Africa and the Least Developed Countries (LDCs) at sustainable reduced prices and has pledged not to profit from its HIV portfolio in these countries.' However, there are many examples where Roche charges LDCs much more than the price they announced publicly for Viracept( (e.g. US$4,124 per patient per year in Cameroon rather than the US$3,171 announced). And there are many examples where Roche charges developing countries more than the developed: Viracept( is sold to the MOH of Guatemala at US$8,358 per patient per year, and to the Ukraine at US$7,110. In Switzerland, it is available at US$6,060 per patient per year. UNAIDS and WHO, which have been helping countries negotiate within the context of the AAI, have now changed their policy and are actively encouraging the involvement of generic companies. In addition to encouraging competition where possible, WHO needs to replace ad hoc multinational reductions with an international approach that specifies levels of reductions and ensures that all developing countries benefit from reduced prices. Making use of the Doha Declaration on TRIPS and public health At the 4th Ministerial Conference of the World Trade Organisation (WTO), in Doha in November 2001, 142 countries adopted a Declaration on the TRIPS Agreement and Public Health, which firmly placed public health needs above commercial interests. Although the Declaration is a strong political and legal document, countries will only benefit if they enact pro-public health intellectual property rights legislation and start routinely issuing compulsory licence provisions to encourage the availability of more affordable medicines. One year later, the significant progress is at risk of being compromised in favour of the industrial interests of developed countries. A key issue remained unresolved in Doha could potentially hamper poor countries access to medicines. In 2005, once the TRIPS Agreement is fully implemented, countries such as India and Thailand which produce generic medicines and export them to other developing countries may no longer be able to do so for new drugs. This is because the TRIPS Agreement limits compulsory licences 'predominantly for the supply of the domestic market'. How will countries that do not have the capacity to produce themselves find suppliers of affordable medicines after 2005, when producing countries must become TRIPS-compliant? Along with WHO, the European and Belgian parliaments, the French government and other NGOs, MSF is supporting a patent exception rule to allow countries to produce for export in order to fulfil a compulsory licence or a health need in a country that does not have production capacity, but the US and the EU are opposing such a solution. In addition, the US is attempting to undo the gains in Doha through negotiations on bilateral and regional trade agreements, such as the Free Trade Area of the Americas (FTAA). It is clear in information in the FTAA negotiating objectives of the US, for example, that the US is pushing to impose 'TRIPS-plus' requirements, and that these standards directly contradict the spirit and letter of the Doha Declaration. Regional and local production through licensing and technology transfer The capacity to produce quality ARVs exists today in many developing countries. Brazil and Thailand have dramatically increased affordability of ARVs by producing within government manufacturing organisations. Existing capacity should be enhanced, and used to produce the drugs that are needed. This can be achieved through voluntary licensing agreements with originator companies, or compulsory licensing if multinationals choose not to cooperate. Action needed now AIDS is the world's most disastrous pandemic and it requires bold unhesitating action. There is no reason to remain silent or polite about the more than 8,000 people we lose to AIDS every day. We must strive collectively to make effective HIV/AIDS treatment a reality for the millions of people who need it. To reach the millions in need, governments and the international community must immediately scale up treatment. This can be done by taking measures to continue bringing down the price of AIDS medications, significantly increase funding, introduce easier-to-use combinations of drugs, and support and carry out operational research to adapt care models to resource-poor settings.