Trading Away Access to Medicines - Revisited: How the European trade agenda continues to undermine access to medicines | Pharmaceutical Drug

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Insufficient innovation and a lack of access to affordable medicines are major barriers to achieving the right to health in low- and middle-income countries. This paper argues that European Union trade policies should not be used to bolster pharmaceutical companies
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  JOINT AGENCY BRIEFING PAPER 29 SEPTEMBER 2014 Medicine being sold at a local market in Mozambique. (Photo: Tineke D'haese/Oxfam) TRADING AWAY ACCESS TO MEDICINES  –  REVISITED How the European trade agenda continues to undermine access to medicines Insufficient innovation and a lack of access to affordable medicines are major barriers to achieving the right to health in low- and middle-income countries. The lack of a vaccine or treatment for the deadly Ebola virus highlights the need for new ideas on how to finance pharmaceutical research and development (R&D). Trade policies should not be used as a tool to defend the status quo, which rewards research with monopolies. Instead, innovative models that create new, affordable medicines should be supported. Members of the new European Parliament and EU Member states must ensure that the incoming European Commission defends a trade and R&D model that is coherent with its development and public health objectives. This should begin by ensuring that the ‘ regulatory harmonization ’  to be enshrined in the Transatlantic Trade and Investment Partnership will not lock in regulations that serve corporate over public interests, and set new global standards that will later be imposed on developing countries.  2 SUMMARY The failure of the current pharmaceutical research and development (R&D) system is revealed by the World Health Organization (WHO) alert about the lack of effective medicines to address antimicrobial resistance 1 , and the absence of a treatment for the deadly Ebola virus that is ravaging communities in West Africa at the time of writing. While low- and middle-income countries (LMICs) have been suffering from a lack of access to medicines for years, European public health systems have become unable to bear the burden of expensive new medicines. The rise of non-communicable diseases (NCDs) is affecting all people, but is more acutely hitting developing countries that are still struggling with the unfinished business of communicable diseases. Meanwhile, European health systems, badly hit by austerity measures, are under pressure to deliver more with less money, against a backdrop of rising medicine prices. The European Union (EU) could play a leading role in improving pharmaceutical innovation and access to medicines around the world. However, the European Commission (EC) has implemented a trade agenda that favours the commercial interests of the multinational pharmaceutical industry over the health of people in LMICs. Such trade policies have triggered an outcry from European citizens, experts and organizations, who are asking for the public interest to be prioritized in trade discussions. Unfortunately, the EC appears to remain deaf to this call, and is currently negotiating the highly controversial Transatlantic Trade and Investment Partnership (TTIP), a free-trade agreement (FTA) that could negatively impact European citizens including via increasing medicine prices. That the TTIP is being negotiated behind closed doors, and has been captured by the industrial lobby, is to the detriment of the public interest. It is time for the Directorate-General for Trade (DG-Trade) in the EC to change its approach to trade and innovation, and put people‟ s health before multinational companies‟ profits. The increasing disease burden on LMICs One third of the world‟s population    –  over 2 billion people  –  do not have regular access to the essential medicines that they need. 2  Nowhere in the world is the lack of access more problematic than in LMICs, where new or adapted medicines and vaccines to treat some of the world‟s deadliest diseases are unavailable or unaffordable. Although treatment for HIV/AIDS has improved, in LMICs, about 7 million people still do not have access to anti-retroviral medicines. This problem will only worsen, given that the 35 million people who are infected with HIV will need treatment at some point. 3  Similarly, 75 percent of the estimated 150  – 180 million people infected with hepatitis C live in LMICs. A new hepatitis C treatment (sofosbuvir, marketed as Sovaldi) recently came onto the market at the prohibitive price of $84,000 for a 12-week treatment. 4 NCDs, such as   3 cancer and diabetes, are also increasing suffering throughout the developing world. Making generic medicines widely available is key to meeting these challenges. Generic competition  Although generic competition would be the most effective way to lower medicine prices in a sustainable way, patents and other forms of intellectual property (IP) protection impede this, and keep prices high. The governments and citizens of LMICs cannot cope with the high prices of needed medicines without sacrificing other basic necessities. 5 Even a slight price increase may result in life-saving medicines becoming unaffordable for the many. 6 Global intellectual property rights The patent system, globalised under the Agreement on Trade-Related  Aspects of Intellectual Property Rights (TRIPS), 7  is the dominant incentive framework for the development of new medicines. Given that its incentive structure is driven by profits, the system favours commercial interests over public health concerns, and tends to prioritise short-term maximisation of returns to shareholders. It does not focus on producing medicines that actually meet public health needs (e.g. antibiotics) at a price that societies can afford in the long term. 8 Lower-income countries lacking profitable pharmaceutical markets suffer the most from this system. 9   New innovation models Evidence suggests that stronger IP protection does not lead to greater innovation and affordable prices. 10  Therefore, public institutions and even some parts of the pharmaceutical industry are exploring new approaches to biomedical innovation, such as collaborative and open knowledge. Meanwhile, the EU and the WHO have recognised the need for new approaches to innovation that do not rely on the patent system, and break the link between the costs of R&D and the price of medicines. The EU trade agenda In its trade policies, however, the EU continues to push for a range of IP measures that support the pharmaceutical industry‟s commercial interests, and damage opportunities for innovation and access to medicines in LMICs. These measures include: 1. Introducing TRIPS-plus provisions, i.e. rules included in trade agreements that exceed WTO obligations; 2. Exerting pressure on LMICs to prevent the use of TRIPS public health safeguards and flexibilities to reduce medicine prices; 3. Using technical assistance programmes to further export excessive IP standards.  4 Growing medicine inequalities in the EU The ongoing Transatlantic Trade and Investment Partnership (TTIP) negotiations between the EU and the US are considering a number of clauses that could negatively af  fect Europe‟s public health. EU health systems which are already impacted by the high prices of new medicines and austerity measures can no longer bear huge medicines costs. TTIP could worsen this already sensitive situation. At odds: the EU ’s  trade, health and development policies The EU, under the Treaty of Lisbon, has committed to the principle of „ health in all policies ‟, 11  which guarantees that a „ high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities ‟. 12  The Treaty also stipulates that all external policies of the EU should be coherent with its development objectives. 13  Despite this, DG-Trade, lobbied by the pharmaceutical industry, implements policies that reverse those that improve access to medicines in LMICs, as well as in the EU, in contradiction to the EC‟s pro-public health policies. Such activities have provoked an outcry from the EP, academics, civil society and some trade partners, 14  and led to harsh criticism from UN commissions and the Vatican. 15 Recommendations to improve innovation and reduce medicine prices Oxfam International and Health Action International Europe demand a U-turn on trade and R&D policies over the next five years. DG-Trade should stop considering trade policies as a tool to protect the commercial interests of EU industries, and collaborate more closely with other Directorate-Generals and EU institutions to ensure coherence with public health and development objectives. EU institutions and Member states should honour their commitments to ensure access to medicines and needs-driven innovation by promoting alternative R&D models. To improve innovation and access to medicines, Health Action International and Oxfam International recommend that: 1. The EU ensures its trade policy aligns with its development and (global) health objectives . In particular it should: a. Not introduce TRIPS-plus and investment protection measures in FTAs that are detrimental to access to medicines, and/or which limit the public-health policy space. b. Actively support governments that make use of legal TRIPS safeguards and flexibilities to protect and promote public health. c. Ensure that the TTIP agreement does not jeopardise access to medicines in Europe and beyond.  Among the most damaging concessions developing countries make in regional and bilateral agreements are those enhancing the monopolies on life-saving medicines, which reduce access and affordability and those that provide excessive legal rights to foreign investors, limiting the policy space for nations to promote sustainable and inclusive development. Holy See, statement to 9th WTO Ministerial Conference in Bali, 3  – 6 December 2013 16  
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