Much of past discussions in the World Trade Organization (WTO) regarding the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have focused on patents and health, and on its impact on access to medicines in particular. During its twenty years of existence, the WTO has, indeed, made significant contributions to this debate: among others, the 2001 Doha Declaration on the TRIPS Agreement and Public Health has clarified a number of important flexibilities in the Agreement and laid the ground for the adoption of an additional flexibility that allows for the grant of special compulsory licences to export medicines. Similarly, the findings of the WTO dispute settlement mechanism have supported countries in implementing certain policy options, such as the regulatory review exception that allows for early generic entry of medicines. Also, WTO Members have been attentive to the needs of least developed countries by granting them an extended transition period with respect to pharmaceutical patents and related clinical data protection until 2033.

More recently, much of the WTO's work in this field has focused on building capacity in a more holistic way, for example through a series of trade and health workshops, as well as through the provision of data and factual information in order to support decision-makers. This evolution towards a more substantive coverage of all trade components that are key to the promotion of public health objectives has been accompanied by an important development regarding the way in which the WTO as an institution covers these issues: it has thus gone a long way from working in silos to what has become today's gold standard, i.e. close cross-divisional coordination with respect to all matters related to trade and health, including through a well-established in house health contact group.

This being the case, as much as the Doha Declaration already placed the TRIPS Agreement in the context of the wider national and international action, there is also firm recognition that the WTO's contribution as a whole will necessarily be restricted to being a part of a much bigger puzzle. In other words, the WTO can bring its expertise to the table with a view to complementing the experience and knowledge that others will have in the other relevant policy dimensions. This is the very reason why, as early as 2010, the World Health Organization (WHO), the World Intellectual Property Organization (WIPO) and the WTO decided to launch a stepped-up programme of trilateral cooperation. The outcomes of this intense trilateral cooperation include a well-received joint study on Access to Medical Technologies and Innovation that was launched by the three organizations in 2013, as well as a series of technical symposia on various topical issues regarding innovation and access in medical technologies.

But cooperation and coherence building cannot and should, of course, not stop there. Quite to the contrary, the input from a wide range of key stakeholders, including other intergovernmental organisations, regional bodies, and national governments as well as industry, civil society, and academia is indispensable in order to effectively achieve the best outcomes for public health.

To name but two recent examples for the much needed broadening of the discussion, the following initiatives deserve to be mentioned here:

• The UN Secretary General has convened a High Level Panel on Access to Medicines in late 2015. The initiative not only emphasizes the importance of building coherence between health, trade and intellectual property, but rightly also adds the human rights law dimension to the mandate of the panel; and
• Following the adoption of the UN Sustainable Development Goals (SDG) in September 2015, the Graduate Institute's Global Health Programme took the unique initiative of bringing together representatives of global health policy think tanks and academic institutions to consider how these bodies could usefully contribute to the implementation of the SDG goals that particularly affect the public health sector. A breakout session on trade and health that was hosted by the WTO provided a welcome opportunity for an initial exchange of views among representatives of intergovernmental organisations and think tank leaders.

Against this background, the way forward clearly lies in continuing efforts to implement a multidimensional, fact-based and coherent approach. To effectively address the twin challenges of incentivising innovation while also enhancing access to medical technologies, a holistic approach is needed more so than ever before in light of the particular challenges that the entire world, not only developing countries, is facing to effectively tackle public health problems. Ideally, such efforts should be coordinated at all levels, i.e. multilateral, regional and national, and involve all stakeholders. Looking at one factor, such as intellectual property rights, or one level, such as the multilateral framework, in isolation is simply not good enough anymore. Working together in a complementary fashion, benefiting from the expertise that each institution or department can bring to the table, is indispensable. To do so, while big steps towards more coherence have been made in recent years, more needs to be done as regards both substance and process.

The steps forward that merit further consideration could include:

• A thorough analysis of trade in pharmaceuticals and how trade agreements can foster such trade. For example, it is striking that the costs at the border to import a container are equal to or above world average in a number of developing countries that are among the net importers of medicines, whereas these costs are well below average in industrialised countries. Similarly, it takes more than 20 days to import a container in many of these countries, as compared to 5 to 8 days in major developed countries. This is an area where the WTO's recently concluded Trade Facilitation Agreement could contribute to facilitating the import of medicines. But it is also an area which demonstrates that more needs to be done to compile data in support of policymakers: currently available data only cover costs and time to import and export goods in general; to get a better picture of what exactly needs to be done to ease the import of medical technologies, collection of data that are specific to the import of pharmaceuticals would be extremely useful. And this equally applies to data in areas covered by other WTO agreements. For example, discussions about the implementation and use of TRIPS flexibilities by WTO Members and their impact could greatly benefit from more systematic monitoring based on agreed, objective indicators.
• An in-depth discussion of the management of intellectual property rights and how adequate management can support access to medicines. Today's debate still seems very much centred on flexibilities in the TRIPS Agreement and the call upon countries to make maximum use of such flexibilities. While such policy options clearly play a critical role in enhancing access to medicines, not enough attention has been spent on the way in which intellectual property rights are applied in practice and whether and what further guidance would be needed in this regard. Next to the framework for voluntary licensing practices, legislation that allocates intellectual property rights from publicly funded research and the way in which technology transfer offices of universities and research institutes manage their intellectual property rights represents but one area which could be covered by such future work.
• Finally, a thorough review of how cooperation and coherence could be extended to include a maximum of stakeholders. Progress has been made inside organisations, breaking the traditional silo mentality, and also regarding cooperation among key multilateral organisations. This said, making the process even more inclusive in Geneva and elsewhere would greatly benefit public health objectives. This does not necessarily mean that all stakeholders have to work as closely together as the WHO, WIPO and the WTO do. As the European Union has demonstrated, there are also ways of working together in inner and outer circles, depending on the expertise and interest of individual stakeholders and not excluding any of them from the process all together. Equally, further consideration should be given as to how this type of cooperation could be mirrored at the regional and national level and how to link efforts made at these different levels closer together.

However, making a multilayer approach like the one sketched out here work in practice represents perhaps the real underlying challenge in the entire debate about innovation and access in the pharmaceutical sector. Strong leadership and close ties are needed to create a sound basis for future cooperation. This is why initiatives like the trilateral cooperation among WHO, WIPO and the WTO, as well as the recent Global Health Programme initiative to involve global health policy think tanks in the debate should be continued and intensified. Pulling these and other strings together will ultimately constitute an important contribution to the achievement of the SDG goals in the field of public health.

Further information

• WHO-WIPO-WTO Study on Access to Medical Technologies and Innovation – Intersections Between Public Health, Intellectual Property and Trade, 2013
• Global Challenges Brief on Trilateral Cooperation, Promoting Medical Innovation and Access, Together, 2015
• WTO Statistical Profiles on Global Value Chains, 2016

Written by Roget Kampf, Counsellor, WTO Secretariat
This contribution has been prepared strictly in a personal capacity. The views expressed are not to be attributed to the WTO, its Secretariat, or any of its Member governments.

Photo: Doc Searls