24 October 2016
We, Members of the European Parliament Working Group on innovation, access to medicines and poverty-related diseases (EPWG), would like to express our strong support for the findings and recommendations of the recently released report prepared by the High-Level Panel on Access to Health Technologies1, convened by the United Nations Secretary-General.
In accordance with Article 168 of the Treaty on the Functioning of the European Union, a high level of human health protection shall be ensured in the definition and implementation of all Union policies and activities. We recognize the challenges caused by high-prices of medicines and lack of public health-driven innovation in Europe and around the world –as highlighted by the exorbitant price of hepatitis C treatments and the lack of innovation in new antibiotics– and support the need to take concrete actions at the European and global level as recommended by the UN High Level Panel report.
Specifically, we support the following concrete recommendations included in the UN report:
– Governments and the private sector must refrain from explicit or implicit pressure or other strategies that undermine the right of governments to use TRIPS flexibilities. It is imperative that governments commit, at the highest political levels, and fully respect the letter and the spirit of the Doha Declaration on TRIPS and Public Health, and refrain from any action that will limit the implementation and use of TRIPS flexibilities. The European Parliament firmly restated this recommendation in its resolution on a new strategy for trade and investment adopted on 5 July 20162.
– Governments engaged in bilateral and regional trade negotiations, including investment treaties, should ensure that these agreements do not include provisions like TRIPS-plus demands that interfere with the governments’ obligations to fulfil the right to health.
– Governments, the biomedical industry, institutional funders of healthcare and R&D and civil society, should implement new models for financing and rewarding health research and development (R&D) to ensure that resulting medical technologies will be affordably available and appropriate to public health needs.
– Delinkage of the cost of R&D from product price can play an important role to reduce the costs of development, make products more affordable, and get new products to patients faster.
– Governments should require manufacturers and distributors of health technologies to disclose to drug regulatory and procurement authorities information pertaining to (i) The costs of R&D, production, marketing and distribution of health technology being procured or given marketing approval with each expense category separated; and (ii) Any public funding received in the development of the health technology, including tax credits, subsidies and grants.
– Good governance, strong and concrete accountability mechanisms and greater transparency are decisive. Transparency is necessary to hold governments, the private sector and other stakeholders accountable for the impact their actions have on access to health technologies.
We call therefore on the European Parliament initiative report on EU options for improving access to medicines and more broadly the European Union to fully welcome the UN Secretary General High Level Panel Report, acknowledge the usefulness of the recommendations above and start a process to facilitate the implementation in order to ensure both innovation and affordable and suitable access to the needed innovative medical tools, in Europe and beyond.