EU Policy in Action: In Whose Interests?

A divergence between policy and action in political decision-making often occurs both at the national and the EU level. Medicine policy in the EU represents an example of such incoherence and therefore more should be done in order to ensure EU policies match its actions.

A short introduction to the seminar, presented by Jim Murray, former Director of European Consumers’ Organisations (BEUC), explained how large, complex and multi-national organisations with great economic resources influence and shape food and medicines’ political agendas. The challenge was not to "demonise" but to counteract in order to align public policy more closely to the public or common good food and medicines are.

Panel 1: Unwrapping the Pharma Package: What’s in it for Consumers?

The first part of HAI Europe’s seminar was dedicated to bringing a better understanding of the EU Pharma Package (presented by Mr Jorg Schaaber from the International Society of Drug Bulletins), in particular in relation to its impacts on consumers.

Ms Barbara Mintzes from the University of British Columbia talked about the "information to patients’ directive" - a proposal for legislative change currently being discussed in the EU, that would allow for several forms of advertising of prescription-only medicines to the public, an activity prohibited under the current directive 2001/83/EC, article 88. The presentation reviewed European and international evidence-based experience with advertising of medicines to the public and serious public health and consumer rights problems it raises. Furthermore, the seminar discussed an issue of pharmacovigilance (presented by Ms Florence Vandevelde from La Revue Prescrire). In relation to that, it was said that the EU’s recent proposed legislative changes would pose a serious regression in the protection of European citizens. Concerns were raised regarding:

 the spread of weak marketing authorisation practices, using post-authorisation safety studies and "risk management" programmes that would eventually allow insufficiently evaluated medicines to reach the market;
 the dissemination of data on adverse drug reactions, where the responsibilities for data collection and interpretation are left to pharmaceutical companies, would be ambivalent and "inviting" pharmacovigilance decisions being delayed to public disclosure;
 the increased financial and intellectual dependency of health authorities on pharmaceutical companies, would possibly lead to secrecy and increasingly biased decision-making processes.

Panel 2: Trading Away Access to Medicines

During the second part of the open seminar the discussion was focused on how the EC’s intellectual property rights (IPRs) policy adversely affects access to medicines in developing countries and is incoherent with EU development policy and the EU’s own domestic efforts to improve access to medicines within its own borders. Representatives of Oxfam International and HAI Europe presented civil society concerns, lack of global innovation policy and spending by the EU that has not yet recognised nor sufficiently addressed the public health needs of developing countries. In particular, a concrete example of the EU trade negotiations with the Andean countries, including IPRs (in terms of Trade-Related Intellectual Property rules) and how it would affect (impact assessment) public health (by access to medicines) in the countries of concern. All of the issues in question were outlined in the recently published report "Trading Away Access to Medicines: How the European Union’s trade agenda has taken a wrong turn." The news story about the publication is to be found on action for Global Health’s website.

Both panels ended up with an open discussion between the panellists, invited respondents from respectively DG Enterprise, BEUC, DG Trade and Medecins Sans Frontieres, as well as participating CSOs. In particular, a controversial presentation given by a representative of DG Trade evoked a lot of debate amongst the attendees. DG Trade seems to hold a short-sighted vision for EU trade issues, without any perception of its global relations and consequences, falsely self-prizing itself for putting innovation, research and development at the heart of its actions. Yes, possibly within the EU borders. No, not when it comes to the developing world with its health problems neglected and its research under-funded.

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Action for Global Health related articles

Trading Away Access to Medicines: How the European Union’s trade agenda has taken a wrong turn.