Report slams big pharma influence in EU-funded project
A new NGO report has sharply criticised the EU-funded Innovative Medicines Initiative (IMI) as favouring Big Pharma over small businesses, particularly when it comes to IP.
The new report carries a scathing evaluation of the IMI, which was established in 2008 to improve levels of competition in the European biopharmaceutical industry.
Structured as a public-private partnership (PPP), IMI is jointly funded by the European Commission (the EU’s top executive body), and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
But according to the report, jointly published this week by the NGOs Global Health Advocates (GHA) and Corporate Europe Observatory (CEO), the IMI is, in reality, “more private than public”, and dominated by big pharma interests.
This is allegedly to the detriment of small-to-medium-sized enterprises (SMEs), who are listed on IMI’s website as a “key player” of the public-private coalition.
The history of IMI has so far been divided into three programmes. The current phase, IMI2, began in 2014 and will end this year. IMI2 has focused on research for next-generation vaccines, medicines, and treatments, such as antibiotics.
The GHA-CEO report found that participation of SMEs in IMI has “dropped sharply” in IMI2 (by up to 30% when measured in 2017), partly because of “the way big pharma dominates the research agenda, and is able to prevail in negotiations over the resulting IP”.
In 2017, an expert group led by French biophysicist André Syrota prepared an interim evaluation of the first two years of IMI2 for the European Commission, including feedback from SMEs.
The interim evaluation found that SMEs did not have the “financial and human resources” to compete with big pharma in complex IP negotiations.
While IMI2’s IP policy was seen as an improvement on the more imbalance regulations of its predecessor, SMEs are still at a significant disadvantage to larger pharmaceutical companies, the report found.
One of the main barriers for SMEs, both the interim evaluation and the new NGO report have found, is the lack of any option for exclusive rights on specific projects.
The interim report recommended that negotiations for exclusive rights on certain research products be allowed to facilitate greater SME engagement in IMI2.
But according to the NGOs, this proposal was not actioned by the Governing Board, and reforms to the IP policy were opposed by EFPIA.
IMI has responded to the report in an open letter: “Overall we are disappointed that the authors have missed the opportunity to contribute to a constructive debate on IMI and health PPPs. We regret the fact that the report targets isolated challenges that IMI has faced and turns them into generalities in order to dismantle the integrity of the programme.”
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