It has been almost twelve years since the Doha Declaration on the TRIPS Agreement of the WTO clarified the sovereignty of states in determining domestic public health over international trade policy. This landmark decision armed developing countries in the World Trade Organization with essential legal tools to challenge the intellectual property claims made by pharmaceutical companies and thus obtain otherwise unaffordable medications for their populations.
And yet, despite this apparent victory in the name of global health, the last decade has been fraught with intense conflict between corporations, civil society groups and states. With so-called ‘TRIPS-Plus’ measures underpinning bilateral free-trade agreements (in other words, exceeding the intellectual property protection requirements of the original TRIPS Agreement and restricting developing countries’ means of bypassing them), rich nations such as the United States have been complicit in the subjugation of public health in developing countries to the interests of their own industries. They have routinely used their trading power to bully concessions from the governments of poor nations, such as extended patent terms and increased data exclusivity measures, effectively maintaining the bloated monopoly prices of patented medicines by diminishing the capacity for generic medicines to enter the market. Such agreements are found in China’s WTO accession terms and the Central American Free Trade Agreement (ibid.).
With the focus of discourse on intellectual property rights and trade, a deeper, more systemic problem in pharmaceutical R&D has been overlooked: that of innovation. This manifests itself in a number of ways. Primarily, the lack of market incentive has led to a historical pattern of disease neglect in drug development. Just 1% of global pharmaceutical R&D investments are for neglected and tropical diseases (Rottingen et al, 2013), despite the great need for new treatments for diseases such as leishmaniasis or Chagas’ disease which destroy the lives of millions of people in the developing world. Related to this is Big Pharma’s potentially catastrophic aversion to participate in the antibiotic arms race (Nathan, 2004); something that threatens to throw mankind back to a past era of mass mortality and morbidity from infectious diseases.
The market failure inherent within the traditional pharmaceutical R&D business model is now being felt by rich countries as well, with spiralling drug prices forcing a change in drug procurement policy. In the US, 78% of all retail drug prescriptions dispensed in 2010 were for generic drugs, up from 49% in 2000 (WHO, 2012). Risk-averseness has led to a proliferation of patented ‘me-too’ drugs which offer no significant therapeutic benefit beyond existing medications, and which are associated with aggressive marketing efforts (including distortion of data and bribing of doctors) to win a share of the market niche previously occupied by the original ‘breakthrough’ drug. On top of the monopoly price that their patent confers, the marketing costs associated with ‘me-too’ medications are passed on to the consumer (Correa, 2002). When the purchasing body is a western government in the throes of austerity and declining healthcare budgets, a number of new patented medications have become unaffordable. For example, in the UK, NICE decided that Bayer’s antineoplastic agent, Nexavar®, would be unavailable for prescription on the NHS because it was not cost-effective enough in the treatment of liver cancer, at a monthly cost of around GBP 3,000 (BBC, 2013).
The landscape appears to be changing even further. Wikileaks recently revealed a draft of the Intellectual Property chapter of the Trans-Pacific Partnership (TPP), a free-trade agreement between eight countries with one-third of the world’s population (Guardian, 2013a). This agreement, being drafted by corporate leaders in complete secrecy, would give corporations the power to directly sue governments for enacting policies (including public health measures) seeking to reduce the provisions of intellectual property protection in the public interest. Not only this, but it would extend intellectual property protection to TRIPS-Plus levels, and would make patentable previously unprecedented areas of innovation, including surgical techniques (Guardian, 2013b). As a treaty, the TPP would require signatory governments to make their domestic law compliant with its provisions - a move which would undo much of the progress made in the last decade in the name of access to medicines and the human right to highest attainable standard of health.
It is against the backdrop of such an adverse regime that access to medicines advocacy groups such as Universities Allied for Essential Medicines (UAEM) continue to make progress, with one of the most recent advances being to successfully advocate for the adoption of a Socially-Responsible Licensing policy on intellectual property (including therapeutic agents) developed by University College London, the latest in a series of public research institutions to do so. This will make UCL’s discoveries and developments more accessible to those in the world who most need them.
On the weekend of January 25-26, UAEM will be hosting at UCL in London their national conference with workshops and talks from leading experts in the field of access to medicines, including Nobel Laureate Sir John Sulston, Katy Athersuch from the MSF Access campaign, and Director of Knowledge Economy International, James Love. The event will be an excellent opportunity for those interested to learn about the most current and pervasive issues surrounding access to medicines, and what the future holds.
Tickets for and further information about the event are available here.