World AIDS Day 2002 Briefing Paper
HIV/AIDS Treatment is feasible in developing countries – Where is the political will to scale up?
95% of the 40 million people who have HIV/AIDS worldwide live in developing countries. Yet an estimated 6 million people in developing countries are in immediate need of life-sustaining antiretroviral therapy (ART), and only around 300,000 are receiving them.
For many years, Médecins Sans Frontières (MSF) has been caring for people living with HIV/AIDS in developing countries. Medical projects include prevention efforts, voluntary counselling and testing, psychosocial support, and prophylaxis and treatment of opportunistic infections. Some of these programmes focus on reducing the transmission of the virus from pregnant mothers to their children. Starting in 2001, MSF has also been providing antiretroviral treatment to patients with HIV/AIDS in Cambodia, Cameroon, Guatemala, Honduras, Kenya, Malawi, South Africa, Thailand, Uganda and Ukraine. We now treat almost 2,200 patients in these countries, including 100 children. In the next year, MSF will double its intake of patients in existing projects, and will open new projects in Burkina Faso, Burma, Ethiopia, Indonesia, Laos, Mozambique, Peru, Rwanda, Zambia, and Zimbabwe.
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. Consolidated data from seven MSF projects in South Africa, Malawi, Kenya, Cameroon, Cambodia, Thailand and Guatemala showed that, among the 743 patients followed, the probability of survival was 93% at six months . At six months, patients who were weighed had gained an average of 3kg; patients who had CD4 cell counts taken had an increase of 104 cells/mm3 on average. And in the three projects that systematically tested viral load at six months of treatment, 82% of patients showed undetectable levels of virus in their blood (<100 copies/ml). Compliance rates were also impressive, with 95% of patients reporting taking their medicines properly at six months. In addition to the clinical benefits of providing ART, the provision of treatment has also strengthened prevention efforts by, for example, providing an incentive for people to come forward for voluntary counselling and testing, promoting openness about HIV and reducing stigma. For example, in the MSF project in Khayelitsha township in South Africa, ART increased the voluntary HIV testing and counselling uptake from less than 1,000 in 1998 to over 12,000 in 2002 .
While we know that treatment is possible, scaling up to national level has only been successfully implemented in a handful of countries.
Obstacles to access
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: as of October 2002, only US$2.1 billion had been pledged– a fraction of the estimated amount required each year to tackle AIDS alone. A recent analysis of country pledges examined how closely country contributions matched their share of the total need. The three wealthiest countries – the US, Japan and Germany – all contributed 7% or less of their share. The UK contributed 13%, France 11%, Switzerland 4%, and Austria, Denmark and Finland, 1%. If the countries had all funded at the level required to make up US$9 billion, it would have represented a mere 0.035% of each country’s Gross Domestic Product (GDP).
Donors have skirted their responsibilities and repeatedly broken promises made over the last two years. The US has pledged US$200 million to the Global Fund to Fight AIDS, TB and Malaria in 2003, for example, representing just one-sixth of what the Global Fund itself estimates is needed for that year. No US funds have yet been appropriated for 2003. Meanwhile, the initial 2003 European Commission proposal for the EU Programme for Action called for a 50% cut from the 2002 allocation to the Global Fund.
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. In Brazil, for instance, universal access to free AIDS treatment led to a 54% reduction in AIDS deaths between 1995 and 1999 , and government savings totalled US$472 million between 1997 and 1999, thanks to prevented hospitalisations and a reduction in the burden of opportunistic infections. Other countries, including Cameroon, Uganda, Senegal, 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. In some high prevalence countries, a more incremental approach will be needed.
Moving towards equitable access
Drug budgets constitute a significant part of overall programme costs. For this reason, MSF supports the implementation of “Equitable Access” to keep drug prices down. Equitable pricing is based on the principle that the poor should have access to, and pay less for, essential medicines. Drug prices must be fair, equitable and affordable, both to individuals and the health systems that serve them. To ensure this, drugs must be bought from lowest cost reliable suppliers 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 figure 1 at the back of this document, 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 per person per year. In the meantime, generic prices sloped down to US$209 per person per year. To reduce prices further from current levels, it is essential to increase competition further up the line, i.e. between raw material manufacturers, which are still primarily in monopoly positions.
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.
No single strategy will be sufficient to achieve and sustain equitable drug prices. Rather, what is needed is a comprehensive system of mutually supportive strategies that include generic competition, a systematic, transparent approach to differential pricing, bulk procurement, and local production.
Differential pricing policies refer to drug makers’ price reductions for those countries classified as Least Developed (UNCTAD classification) and medium Human Development Index (UNDP classification). 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 paying up to twice as much more than MSF, which uses a mix of generics and originator products in its pilot projects.
UNAIDS and WHO, which have been helping countries negotiate within the context of the AAI, have now started encouraging the involvement of generic companies. In addition to encouraging competition where possible, WHO needs to replace ad hoc price reductions from originator companies 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 the TRIPS Agreement and Public Health
At the 4th Ministerial Conference of the World Trade Organisation (WTO) in Doha in November 2001, 142 countries adopted an historic Declaration on the TRIPS Agreement and Public Health, which firmly placed public health needs above commercial interests in international trade negotiations. 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 licences to ensure the availability of more affordable medicines.
One year after the Doha Declaration, this advance is at risk of being compromised in favour of the economic interests of developed countries. In particular, the key issue of “production for export”, which 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 will no longer be able to do so for new drugs. The Doha declaration granted least developed countries the option of a ten-year extension to the TRIPS implementation deadline, which means that they would not be obliged to provide patent protection for pharmaceutical products until 2016, and can therefore use generic versions of antiretrovirals and other news drugs. But how will these countries find suppliers of generics after 2005, when the producing countries must become TRIPS-compliant? Unless an export exception is allowed, non-producing countries will have only a theoretical right to use affordable generic medicines – in practice, they will not have access to them.
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 supply countries that cannot manufacture their own pharmaceutical products. However, 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). The US is pushing to impose “TRIPS-plus” requirements, which 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 them locally within government manufacturing organisations. Local production is a long-term, sustainable strategy that has the added benefit of stimulating the economic development and autonomy of developing countries. Existing production 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 originator companies choose not to cooperate – and technology transfer. In practice, a patent-holder is more likely to grant a voluntary licence if a country has a strong compulsory licensing system. Under TRIPS, developed countries are obligated to transfer technology to least developed countries.
Adapting treatment to clinical reality
There is an urgent need to simplify treatment and monitoring protocols for resource-poor settings. This entails the quick introduction of affordable monitoring tools and fixed-dose, once-a-day formulations, as well as operational research to explore adapting treatment to clinical reality.
Fixed-dose combinations (FDCs)
FDCs can improve compliance and avoid development of resistance, and are recommended by the WHO’s 12th Expert Committee on the Use of Essential Medicines. Ongoing pharmaceutical industry development focused on the needs of people with HIV/AIDS in the US and Europe will lead to new combinations that could potentially be used in developing countries. Of particular interest are the ongoing studies of once-a-day formulations. and single once-a-day formulations being approved. Generic producers of ARVs are particularly well placed to develop fixed-dose combinations of recommended regimens. In fact, the only currently affordable fixed-dose formulations in developing countries are being produced by generic manufacturers. MSF supports WHO’s call to make once-a-day fixed-dose combinations of ARVs available at US$70 per patient per year.
Moving toward a simplified approach
On a parallel track to new formulation development, institutions and physicians working in resource-poor environments should be supported to develop simplified treatment protocols. Research focused on ways to better use clinical markers to reduce dependence on biological monitoring should be supported, for example. At the same time, tests that require less investment and operator expertise, such as Dynabeads and TRAx CD4, should be further developed.
Among the additional research priorities, there is an urgent need for paediatric formulations adapted for use in developing countries. For example, syrups are often very difficult to store and are packaged in a manner that makes dosing complicated. Solid dosage formulations are often not available in strengths designed for children. One example is the antifungal drug fluconazole, which does not exist as a syrup and is difficult to dose with available capsule strengths.
It is not an option to rely exclusively on the private sector, which has no incentive to adapt treatments to developing countries. Researchers in developing countries, along with groups of people living with HIV/AIDS, must have the support of their governments and the international community to further define and implement a research agenda.
Additional challenges to scaling up
Clearly, there are numerous barriers to scaling up access to treatment in poor countries that are beyond the scope of this document, including those related to weak health systems and poor access to health care in general. But two additional factors contribute to the current bottleneck: insufficient training of health care workers and the lack of support for local NGOs and associations of people living with HIV/AIDS.
In addition to increased political commitment from donor countries and developing countries to address the needs laid out above, several other strategies are needed to scale up treatment in resource-limited settings. These include large-scale training initiatives for nurses, counsellors, medical officers, physicians and other care providers, and supporting community mobilisation. Led by people living with HIV/AIDS, local initiatives should provide treatment, carry out HIV/AIDS educational programmes including “treatment literacy” components, and develop advocacy initiatives to strengthen the role of people living with HIV/AIDS in formulating and implementing national and international AIDS programmes and policies.
An example of local mobilization, the Pan-African HIV/AIDS Treatment Access Movement (PATAM) was launched in August 2002 to mobilise communities, political leaders and all sectors of society to ensure access to ARV treatment as a fundamental part of comprehensive care for all people with HIV/AIDS in Africa. Local and regional networks such as PATAM and its member organisations should be supported.
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 significantly increase funding, continue bringing down the price of AIDS drugs, introduce easier-to-use combinations of drugs, support and carry out operational research to adapt care models to resource-poor settings, train health-care workers, and strengthen local and regional NGOs and networks of people living with HIV/AIDS.