631. The European Commission takes note of the contribution provided by the Report of the United Nations Secretary-General's High-Level Panel on Access to Medicines.
632. The work conducted by the Panel started from an assumption that there was "policy incoherence between the justifiable rights of inventors, international human rights law, trade rules and public health". As the European Commission already indicated in its written contribution to the Panel, it does not share this assumption, inter alia, because IPRs are also listed in our Charter of Fundamental Rights as being one of them.
633. The Commission shares the Report's acknowledgement that there are many reasons "why people do not get the healthcare they need, ranging from: under-resourced health systems, a lack of sufficiently qualified and skilled healthcare workers, inequalities between and within countries, exclusion, stigma, discrimination and exclusive marketing rights". Other important problems are global medicines shortages and stock-outs.
634. This is why, in its written contribution to the Panel, the Commission encouraged it to adopt a holistic approach to the problem of access to medicines that could result in a valuable contribution to the wider debate.
635. However, due to its limited mandate, the High-Level Panel has focused its proposals exclusively on addressing an alleged conflict between a research and development model that partially relies on IPRs and the possibility of providing affordable medicines. In doing so, it has missed an opportunity to advance more balanced, comprehensive and workable solutions to the problem of access to health. The Commission would also highlight that no conclusions could be reached with the support by all Members of the Panel, as demonstrated by the dissenting opinions attached to this Report., which are no less than nine.
636. The European Union is committed to increasing access to affordable medicines and to finding solutions to the world's pressing public health challenges and inequities. In line with the 2010 Communication and Council Conclusions on "the EU role in Global Health", the EU pursues a rights based approach to health. Strengthening all areas of a health system, including the availability of qualified health workers, the provision of affordable medicines and the adequate financing of the sector, is central to moving towards universal health coverage with quality health services accessible and affordable for all. The quality and integrity of the pharmaceutical distribution chain is also essential to improving public health.
637. The challenge is to strike the right balance between the need to promote and finance the research of new and better medicines for all, ensuring that medicines are accessible and affordable to those in need, while guaranteeing the sustainability of health systems. We believe that these goals are not contradictory and must be pursued jointly.
638. The current innovation model, including the role of trade related to IP, has delivered consistent progress in global public health, leading to key new and improved treatments as well as much extended life expectancy, both in developed and developing and least developed countries. This model already integrates a variety of tools such as incentives for innovation based on intellectual property, on public and private financing and awards or on public research. Such variety is necessary to address situations where there is a functioning market and those where there could be market failures.
639. The Report underplays the fact that the development of new drugs requires significant investment and long-term research, coupled with clinical trials and regulatory approval procedures. The exclusive right conferred by a patent is an important incentive for innovator pharmaceutical companies to make the necessary investments into that research and development. Without incentivizing the innovator pharmaceutical companies to invest in research, the sustainable development goal of ensuring healthy lives and promoting well-being for all, including achieving universal health coverage, would be severely undermined.
640. Several of the issues covered in the Report's recommendations are addressed in EU legislation, as well as EU and Commission policies and actions, including at multilateral level. To name a few examples: the Commission is a major funder of research and innovation for poverty-related and neglected diseases and for new antibiotics. In the previous intervention yesterday, I took your time and bored you with my exhaustive reading of these programmes, but there was a reason for that. We are talking here about concrete issues and concrete programmes helping countries sitting in this room and financed by real money. At the WHO, the EU supports the implementation of the WHO global strategy and plan of action on public health, innovation and intellectual property, including the development of the Global Observatory on Health Research and Development. In the area of trade, the EU ensures that its free trade agreements are consistent with the Doha Declaration and it has supported the extension of the drug patent exemption for LDCs. As part of its health policy, the EU adopted new legislation to ensure that all clinical trials to be conducted in the EU will be registered in a publicly accessible EU database (Regulation (EU) No 536/2014).
641. However, several other recommendations in this Report are not in line with the EU rules and practices and thus cannot be supported. This is, in particular the case for the proposals to revise the Paragraph 6 Decision or the areas of the TRIPS Agreement relating to patentability criteria, as well as the recommendation to create additional structures at UN level on the issue of health technology innovation and access for mechanisms to supervise the functioning of other international organizations.
642. To conclude, I would just like to say that any future activities at the UN level or at the WTO regarding these issues should be conducted on the basis of a much broader understanding of the complex issues involved.
