WHO Essential Medicines List at 25 years - Access to essential medicines of the future

Click on image for full size In 1990, a new sleeping sickness drug came onto the market that was so effective it was dubbed 'the resurrection drug'. We were suddenly full of hope for our patients. But our hope was short-lived: the medicine was far too expensive. And five years later, the drug companies had stopped production, because the drug wasn not profitable enough.
Why a campaign for access to essential medicines? Over the last 25 years, Médecins Sans Frontières (MSF) has been a keen supporter of the WHO Essential Medicines List and, more broadly, an advocate of access to essential medicines. In 1999, MSF launched the Campaign for Access to Essential Medicines. Let me explain the initial motivation for our campaign: A few years ago, MSF medical teams treating patients suffering from sleeping sickness felt they were doing a useful job, mainly because almost no-one else was caring for these people. Admittedly, the drug they used, melarsoprol, an arsenic derivative, killed 5% of their patients. But this was a lot less than the 100% who died if left untreated. Then, in 1990, a new sleeping sickness drug came onto the market that was so effective it was dubbed 'the resurrection drug'. We were suddenly full of hope for our patients. But our hope was short-lived: the medicine was far too expensive. And five years later, the drug companies had stopped production, because the drug wasn not profitable enough. Some of us were upset by this situation, both within MSF and elsewhere. We were upset by other things too: the extortionate prices of new antibiotics and antiretrovirals, for which there were no alternatives because of patents; and the fact that almost no new research was being conducted into medicines for tropical diseases. Lining up all these elements, we saw that this was no longer simply about medicine, but about the fundamental inequity in the way the world is organised. The Access Campaign aims to improve the lives of people in developing countries by questioning an organisation of the world that has negative consequences on the health of so many. Let me now expand on three concepts that are key to the future of access to essential medicines: justice, the right of access to essential medicines as a human right, and essential medicines as a public good. Click on image for full size People's unequal access to essential treatments is due simply to the fact of being born in Mozambique, in Bolivia, or in Switzerland. But what it signifies is that millions of lives are considered of less value than a 'fistful of dollars'.
Justice Throughout the 20th century, there was spectacular progress in medicine and pharmacology. But not everybody benefited from this progress. One of the most telling examples is that 95% of all people with HIV/AIDS don't have access to life-saving antiretroviral treatment. The basic problem, and the one that remains the most important to combat, is poverty. The solutions lie in the long term. But while waiting for better days to come, children, women and men are dying in large numbers every day. They die despite the existence of treatments and preventive measures that could save or protect them. People's unequal access to essential treatments is due simply to the fact of being born in Mozambique, in Bolivia, or in Switzerland. But what it signifies is that millions of lives are considered of less value than a 'fistful of dollars'. We must seek to humanise globalisation, and fight to implement the imperative of justice through universal access to essential medicines. Access to essential medicines as a fundamental human right Access to care and medicines can be a question of life or death for an individual. It figures among the highest priorities of people living in the developed world. But in developing countries, governments lack the means, and often also the interest, to bring about real improvements in the living conditions of their fellow citizens. This is why access to essential medicines must be defined as an individual human right, a right that those in political power are obligated to guarantee. Essential medicines as a public good The accumulation of knowledge and technology over the last century has given us power over health. To a great extent, health no longer seems something dependent only on fate or chance, but an objective, even a right. Some medicines are essential because they change the 'health destiny' of individuals, and even save lives. These essential medicines and treatments should be regarded as belonging to a common human heritage - public goods to which individual access should be ensured by all countries. Click on image for full size The list must include new medicines which improve treatment effectiveness and - of particular importance to resource-poor settings - simplify treatment protocols. Even if they are expensive.
Over the last twenty-five years, the WHO Model List of Essential Medicines has been one of the most important public health tools to increase access to medicines and promote their rational selection and use. It has helped gain international acceptance for the concept of essential medicines as a powerful way to promote health equity. My fellow presenters have spoken more comprehensively about these achievements. But I would like to address what challenges remain. I have presented the philosophy of the project. But what specific actions must now be taken to guarantee a just and equal access to essential medicines? Future challenges for access Some essential medicines still not included on the list Recent revisions to the way the Essential Medicines List is composed have sought to make it a fairer and more effective tool: previously, some drugs were not included because they were simply too expensive. According to the new definition, price is not a reason for exclusion. Thanks to this, 12 antiretroviral drugs have been included. But the change is still far from being fully implemented. For many recent antibiotics for instance, such as cephalosporins, quinolones and the new macrolides, high cost remains an obstacle. The list must include these and other new medicines which improve treatment effectiveness and - of particular importance to resource-poor settings - simplify treatment protocols. Even if they are expensive. It is the duty of WHO and its member states to ensure that the world's inequalities are not replicated in the very system that it has set up to redress them. Click on image for full size People's unequal access to essential treatments is due simply to the fact of being born in Mozambique, in Bolivia, or in Switzerland. But what it signifies is that millions of lives are considered of less value than a 'fistful of dollars'.
Overcome intellectual property barriers to access In recent years, the magnitude of the AIDS crisis has drawn attention to the grave inequity in access to AIDS medicines and, in parallel, the potential negative effects of trade agreements on the availability of medicines. Patents on AIDS drugs and other recent medicines translate into high prices worldwide, with the direct result that people in developing countries cannot afford to save their own lives. We are advocating for a combination of long-term, sustainable strategies to lower drug prices. They include encouraging generic competition, promoting the use of TRIPS safeguards, global procurement and local production. This figure shows how powerful generic competition can be. Between May 2000 and July 2002, the price of this triple therapy dropped from over US$10,000 to less than US$300. This is a crucial tool to increase access to essential medicines in developing countries. It must be protected. TRIPS safeguards such as compulsory licensing can be used to overcome barriers to access. They are also a strong negotiating tool - a perfect illustration of this arose last October: during the anthrax scare, the Canadian and US governments used the threat of compulsory license to force Bayer to dramatically lower the price of ciprofloxacin. The Doha Declaration on TRIPS and public health has given us hope that, in theory at least, the system can protect developing countries' access to essential medicines. But countries must now be supported by WHO and partners to implement the declaration through national legislation that prioritises patients over patents. In all debates and negotiations on trade and intellectual property issues, WHO must stand very firmly as the advocate for health and equal access to essential medicines. Address the crisis in R&D for medicines for developing country diseases Another major challenge is that the present system for research and development does not adequately address health needs in developing countries. In the last 25 years, pharmaceutical R&D has produced almost 1,400 new medicines. Only 1% were aimed at tropical diseases, despite the significant disease burden represented by these diseases. If it is to continue improving and expanding its List, WHO must also address this crisis. WHO is in a pole position to lead a needs-driven essential medicines research agenda, supported by national governments. And pharmaceutical companies' should have the moral obligation to invest into it a part of their profits. Click on image for full size When people's lives are at risk, WHO and member states have an obligation to impose solutions, even if they contradict the direct interest of commercial entities. We cannot accept the sick logic that says "he who cannot pay, dies".
Maintain the production of essential drugs and secure the market Experience has shown that we cannot rely on profit-oriented private companies to continue production of developing country treatments or develop new ones. To ensure continued and improved access, WHO must ensure the production of essential medicines is maintained and the market secured. At the beginning of my speech, I talked about sleeping sickness patients, and the abandoned production of the drug that could save them. This story had a good ending: together with WHO, we placed enormous pressure on the companies and obliged them to restart production of eflornithine and guarantee supply of sleeping sickness drugs for five years. Patients treated by MSF and others in Angola or Sudan are now benefiting directly. When people's lives are at risk, WHO and member states have an obligation to impose solutions, even if they contradict the direct interest of commercial entities. We cannot accept the sick logic that says "he who cannot pay, dies". Conclusion While many in the world still lack effective access to essential medicines, the work done by WHO and its partners has helped to bridge the gap. However, gaining acceptance of access to medicines as a human right remains a challenge. It will require strong leadership at international and national level. We, as MSF, have a fundamental role to play in convincing political decision-makers in developed and developing countries, as well as company directors and shareholders, that globalisation can be more humane, and that it is in our mutual interests that it should become so.