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Access to Essential Medicines by Veevek Thankey
There are more than 1.7 billion people worldwide, most of whom are living in developing states, which lack regular access to essential medicines. This dearth of basic medicines contributes greatly to the unnecessary death of millions of children and adults each year, from a short list of preventable diseases. Underlying the specific constraints to access to medicines and health care are the social and cultural conventions that can disproportionately prevent women, children, ethnic minorities, and other marginalized populations from gaining access to the larger health system. According to the World Health Organisation (WHO), essential medicines “are those that satisfy the health care needs of the majority of the population; they should therefore be available at all times in adequate amounts and in the appropriate dosage forms, and at a price that individuals and the community can afford.” These essential medicines are used against diseases and infections that are outlined by the WHO, and examples include: cardiovascular disease, gastrointestinal disorders, HIV/AIDS, preventable diseases, reproductive health, and vitamin deficiencies to name a few. Also, the Working Group on Access to Essential Medicines of the Task Force on AIDS, Malaria, TB, and Access to Essential Medicines, under the aegis of the UN Millennium Project, has defined ‘access to essential medicines’ as “the proportion of population with access to affordable, essential drugs on a sustainable basis is the percentage of the population that access to a minimum of 20 of the most essential drugs…and having drugs continuously available and affordable at public or private health facilities or drug outlets that are within one hour’s walk of the population.” In terms of geographic and demographic distribution, together, the people of India and the African continent account for 53% of the world’s population without access to essential medicines. Of that, 38% of those without access to essential medicines live in India. In Latin America, many States offer universal coverage for antiretroviral treatment, however, Brazil remains the only State with a large population to have achieved universal access to AIDS treatment. In Brazil, the most populous State in the region, the national prevalence level is below 1% but it is home to more than 1 in 4 of all those living with HIV. In other areas of the world, Botswana remains the only State in Africa to adopt a policy of making antiretroviral therapies available to all who need them. A handful of companies in southern Africa have announced schemes to provide antiretroviral therapies to workers and some family members. That being said, only a fraction of the millions of Africans in need of antiretroviral treatment are receiving it. The issues surrounding the lack of essential medicines, as outlined by the UN Millennium Project, are common to many States. The first issue, which is delineated into four sections, is barriers to existing medicines. The first section of that is the inadequacy of States to make commitments in making healthcare a priority from “national to the local levels.” Donor programs can often skew or limit national governments’ abilities to set health policy and debt servicing and loan conditionality from international financial institutions can further limit government responsiveness to basic social service needs of their respective citizens. The second section highlights the inadequacy of human resources. Inadequate pool of allied health professionals and medical professionals threaten to undermine efforts in strengthening health systems and improve the deliverance of health care. The Project also highlights retention plans and compensation schemes for States losing health care workers to satiate health needs from developed States. The third section examines the role of the international community and its role regarding development. The last section that makes up barriers to existing medicines is the lack of coordination of international aid. The other major barrier is barriers to development of affordable new medicines, which examines the role of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) agreement and the lack of incentives to promote research and development of medicines and vaccines to address health concerns of developing States. Following the full implementation, as of January 1, 2005, of the World Trade Organisation’s (WTO) TRIPS agreement in India and other developing States not yet granting pharmaceutical patents, access to affordable new drugs is expected to become more difficult. From 2005 onwards, all new drugs are subject to at least 20 years of patent protection practically everywhere except in least developed States. Patent rules may also hamper the development of fixed-dose combinations – the three-inone pills that have helped simplify patients’ lives – when patents on the different compounds are held by different companies. Although these pills are currently what approximately 70% of all HIV/AIDS patients take as firstline treatment, patent rules in India will make such combinations difficult, if not impossible, to produce in the future. The source of many vital existing medicines for developing States without productive capabilities will be fully subject to TRIPS provisions. Also, there are concerns about the WTO’s decision regarding a waiver for TRIPS Article 31(f), which would allow a compulsory license to be issued by the State in need and by the State that can produce the medicine for export, would be too much of a burden for developing States to exploit. Furthermore, the growing number of bilateral and regional trade agreements with major trading partners, such as the United States of America and the European Union, may often contain provisions that limit developing States’ use of existing flexibilities under TRIPS to protect public health. More recently in July 2005, the Group of Eight committed to universal access to treatment for AIDS by 2010. Since the issues surrounding barriers to access of essential medicines and health care have many aetiologies, a single solution to improve the current situation is improbable as it needs to be complemented by others. The UN Millennium Project highlights the need for States to examine their national medicines policy and strategies founded on the essential medicines concept, which is outlined by the WHO. Access to medicines has always been an important concern in health development, policymaking and programming. However, to date, the world remains a long way from attaining equitable access within developing States, let alone across regions. Thirty years ago, medicines policy was a technical discourse mainly among UN agencies, ministries of health and international experts. However, the growing AIDS pandemic has galvanized discussions about access to treatment. The UN, donors, recipient governments, and suppliers are being pressured by a growing global network of public interest non-governmental organisations and civil society groups that need medicines and access to health care but are unable to get them. Médecins Sans Frontières (MSF) has been campaigning since 1999 to find solutions towards lowering the prices of existing medicines, to bring abandoned drugs back into production, to stimulate research and development for diseases that primarily affect the poor, and to overcome other barriers to access. MSF has been analyzing the drug markets for quite some time and at the most recent 3rd International AIDS Society conference in Rio de Janeiro, Brazil, in July of 2005, and it was a common theme that action was needed to tackle the resurgence of AIDS drug pricing crisis. First, medicines only available from one single producer are still very expensive. For example, the differential price accorded by GlaxoSmithKline for abacavir is over US $800 per patient per year. Second, prices announced by pharmaceutical companies are often not available in reality, because companies have not registered or marketed the drugs in States eligible for differential pricing. Third, some companies do not offer discounts to middleincome States, as this is the case of lopinavir/ritonavir in Thailand and Ukraine, where MSF programs pay US $4,000 to 6,000 per patient per year for this one drug alone. To put these prices in perspective, MSF currently pays less than US $250 per patient per year for WHOprequalified first-line triple combinations sourced from Indian generic producers. In 2000, OXFAM also launched a major access to medicines campaign and Third World Network played a key role in developing technical assistance to developing States on how to formulate pro-public health intellectual property legislation as they become TRIPS compliant. It is quite apparent that the emergence of a strong and ongoing global advocacy NGO network on access to essential medicines and health care has been a crucial boost to increase access in developing States. The impact of the network has been felt especially at the international policy levels in new ways. At the State level, NGOs have catalysed and empowered citizens to engage in the political and policy process in new and important ways within the health sector. Furthermore, many well-established NGOs, such as the International Federation of Red Cross and Red Crescent Societies, are involved in advocacy on health and medicine issues and in providing health care in developing States. The largest health-related public-private partnership is the Global Fund to Fight AIDS, Tuberculosis, and Malaria. It was created as a financing mechanism for Statelevel efforts to combat AIDS, tuberculosis, and malaria. It is an independent entity, governed by a board of directors that include representatives from donor States, the UN, civil society and NGOs, and the private sector. This Fund provides needed financing for medicines purchases that States otherwise could not afford. Secondly, it has outlined very specific criteria for States to meet concerning procurement, supply and distribution of medicines to help ensure that quality medicines are being bought and that those medicines get to the people who need them. In turn, these requirements are hoped to be prerequisites for governments to improve their current regulatory, procurement, supply and distribution systems, all of which are key to improving access to essential medicines and health care for their respective populations. Indeed, the need for access for essential medicines and health care is an important one. Access to supplies of medicine and health care for all, especially for those people who have been traditionally marginalized, is indicative of a much more profound, positive, and socially transformative process. No single institution, organisation, industry, or level of government can make this happen alone. Even though the complexities and intricacies are almost overwhelming, the international medical community must be able to deal with this burgeoning issue.
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