Prescrire International - Free Special Edition - 2022

The Innovative Medicines Initiative: a European public-private partnership that mostly benefits Big Pharma

● The Innovative Medicines Initiative (IMI), a public-private partnership set up in 2007 between the European Commission and the European Federation of Pharmaceutical Indus tries and Associations (EFPIA), has received over two billion euros in public funding. ● After ten years of operation, the heads of the IMI congratulated themselves on “a unique model of collaboration” that had played its role to the full, for the benefit of patients’ health. ● Theauthorsof a report by twohealth-focused non-governmental organisations (NGOs) are nowhere near as enthusiastic. They describe a skewed, opaque partnership that benefits the pharmaceutical industry. Inparticular, the indus try used the IMI to lobby regulatory agencies and patients, and to shape the rules to favour its own interests. ● These twoNGOs express the hope that this typeofpartnership, withnoconditions imposed on companies to ensure affordable access to health products derived from subsidised research, will not be replicated in “Horizon Europe”, the European research and innovation framework programme for 2021-2027. I n 2007, a European regulation created a public-­ private partnership called the “Joint Technology Initiative on Innovative Medicines” (IMI) (1). Its founding members were the European Commission and the European Federation of Pharmaceutical In dustries and Associations (EFPIA), with both parties represented equally on the governing board ( a )(1). The official objective in creating the IMI was to improve the drug development process, so that the pharma ceutical sector could produce safer, more effective new drugs in the long term. The IMI’s short-term aims included: fostering a coordinated approach to support research and development at a “ pre-competitive ” stage and determining priority areas; increasing in vestment in biopharmaceutical research; and pro moting the involvement of small and medium-sized enterprises (SMEs) (Art. 2 of the Regulation) (1). In 2018, after 10 years of operation, and with over €2 billion of public money spent, the heads of the IMI described its achievements enthusiastically as “ 10 years of breakthroughs (...) bringing about a

healthier future for us all ” (2). They congratulated themselves on “ a unique model of collaboration ” and a partnership that has contributed “ to more rapidly bringing new products or treatments to market for the benefit of patients ” (2). Not everyone shared their enthusiasm, as shown in a report produced by two non-governmental organisations (NGOs): Corporate Europe Observa tory and Global Health Advocates ( b )(3). This detailed, well-referenced report is based in particular on documents obtained from the European Commission by invoking the European regulation on access to documents held by European institutions. It goes beyond the official line, offering insights into who benefited the most from this public-private partner ship. This independent review of the IMI is especial ly interesting given that “Horizon Europe”, the Euro pean research framework programme for 2021-2027, includes its supposed successor: the Innovative Health Initiative (4). The European Community’s financial contribution was supposed to cover the running costs and research funding granted following “ open and competitive calls for proposals ” (Art. 5 of the Regulation). The EFPIA’s contribution was supposed to be at least equivalent to that of the European Union, but in the form of resources (non-monetary, in-kind contribu tions) provided by its members (1). A skewed, opaque partnership. The IMI, initially intended to continue until late 2017, went through two stages: IMI-1 from 2008 to 2013, and IMI-2 from 2014 to 2020 (1,5). a- The European Federation of Pharmaceutical Industries and Associ ations (EFPIA) represents European pharmaceutical companies. Its members include 36 national associations and 39 pharmaceutical companies (ref 11). b- CorporateEuropeObservatory(corporateeurope.org) isaresearch and campaign group working to expose the privileged access and influence enjoyed by corporations and their lobby groups in shaping European policy. It is funded through donations and by foundations with no links to European corporations or institutions. Global Health Advocates (ghadvocates .eu) or Action Santé Mondiale A one-way public-private partnership

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Full review(4 pages) available to subscribers at english.prescrire.org ▶ Translated from Rev Prescrire January 2022 Volume 42 N° 459 • Pages 63-66

Prescrire Int • April 2022

Page 16 • Prescrire International Special Edition 2022