In February, trade negotiators from the EU and the US met in Brussels for the twelfth round of negotiations on the Transatlantic Trade and Investment Partnership (TTIP) – behind closed doors. Among other things, they discussed an EU proposal on regulatory cooperation on Generic Medicines. The negotiations could have dramatic impacts on affordability and accessibility of medicines in Europe, depending on whether the negotiators prioritise public health goals. Is the negotiators’ main objective to open up the transatlantic pharmaceutical market for companies or to ensure affordable medicines prices?

by Zoltán Massay-Kosubek

Medicines in International Trade Agreements

The pharmaceutical sector is significant for both international trade and public spending. An OECD report estimates EU pharmaceutical spending amounted to around €190 billion in 2010, almost 1.5 % of Gross Domestic Product (GDP). It is vital to ensure coherence between public health and international trade policies. The Doha Declaration on the WTO Agreement on Trade-Related Aspects of IPRs (TRIPs) and public health adopted on 14 November 2001 recognises concerns over the relationship between protection of Intellectual Property Rights (IPR) and the impact on medicine prices.

The EU’s global health strategy of 2010 states that the EU’s trade policy should ensure more effective use of the TRIPs- provisions to increase the affordability and access to essential medicines. The EU should continue to ensure that bilateral trade agreements avoid clauses which may undermine access to medicines. Generic competition and rational use of medicines are of major importance to ensure the sustainability of healthcare systems.

What is at stake for medicines in TTIP?

The TTIP negotiations include a focus on pharmaceuticals. Although there are some touted benefits as regards technical cooperation, the EU position on pharmaceuticals and even the new EU proposal on cooperation on generics fail to guarantee that increased coordination will result in cheaper medicines for health systems and better access for patients. The public health community remains concerned that pricing and reimbursement measures may be included in the future scope of TTIP negotiations. Pharmaceutical and health aspects are missing from the EU position on IPR too. In addition, it is not clear whether the ongoing negotiations on the EU Trade Secrets Directive will affect the availability of clinical trials data.

How should trade policy improve universal access to affordable medicines?

EPHA is supporting a civil society call to action on access to medicines in TTIP. We believe that trade policy should avoid maintaining the current ineffective and costly research and development (R&D) system that encourages unaffordable prices and restricts access to patients. By putting public health at the forefront of their negotiating priorities, the EU should ensure that trade policy contributes an R&D system that and delivers medicines that are universally accessible and more affordable.

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