The WTO Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) set global minimum standards for the protection of intellectual property, substantially increasing and expanding intellectual-property rights, and generated clear gains for the pharmaceutical industry and the developed world. In this fifth paper in The Lancet Series on Trade and Health, Prof Richard Smith, London School of Hygiene and Tropical Medicine, UK, and colleagues discusses how TRIPS has led to unequal pharmaceutical trade between developed and developing countries — and what can be done to redress this balance.
In January 1995, the TRIPS agreement established global minimum standards for the protection of intellectual property, including a minimum 20 years' patent protection on pharmaceuticals. Compliance was postponed until 2005 for developing countries and 2016 for least developed countries.
Although TRIPS contains flexibilities to allow some reconciliation of the protection of intellectual-property-rights with public-health needs, more recently developed countries have engaged in bilateral trade agreements termed 'TRIPS-plus', where protection of intellectual-property-rights beyond TRIPS requirements are incorporated in exchange for trade concessions, particularly the promise of free access to markets for agricultural goods.
The authors discuss how developing countries are not making full use of flexibilities built into TRIPS to overcome patent barriers, such as compulsory licences and parallel imports, as happened in Malaysia. They highlight inequalities in power and influence between countries, leaving many poorer nations vulnerable to pressure to protect broad trade and economic interests. Yet widespread misunderstandings also exist, such as the misconception that countries have to declare a national emergency before invoking a compulsory licence. An immediate policy priority is therefore to address these misunderstandings and misperceptions, together with greater support for development within developing countries of legal and technical expertise to incorporate and implement TRIPS flexibilities in national policy.
There are concerns that developing nations trying to implement their TRIPS flexibilities may suffer repercussions from developed countries in bilateral trade agreements. But the authors say that unfettered, TRIPS-plus will lead to further increases in drug prices and market exclusivity, and reduce accessibility to new essential medicines. More studies are needed into the extent to which any perceived benefits under TRIPS-plus outweigh any detrimental effect on public health. Global surveillance of TRIPS-plus agreements is urgently needed.
The authors conclude: "Several other measures can be undertaken or advocated for by the public-health community in this respect. For example, developing countries with substantial markets, such as India, Brazil, and Thailand, could establish precedence by adopting TRIPS flexibilities into national patent laws; south–south partnerships could mitigate resource and capacity constraints; and pharmaceutical companies might recognise that creation and development of these markets is vital to long-term sustainability and growth."
Professor Richard Smith, London School of Hygiene and Tropical Medicine, UK T) +44 (0) 20 7927 2403 E) richard.smith@lshtm.ac.uk
LSHTM Press Office T) +44 (0) 20 7927 2073 E) lindsay.wright@lshtm.ac.uk / gemma.howe@lshtm.ac.uk
For full fifth paper see: http://press.thelancet.com/tradeandhealth5.pdf
Journal
The Lancet