October 14, 2011
I spent an interesting morning last week in the European Parliament at a presentation of the Innovative Medicines Initiative. IMI is a joint undertaking between the European pharmaceutical association EFPIA and the EU to carry out projects, mostly in pre-competitive research, to help develop new and innovative medicines. (New medicines are not necessarily innovative – many are so-called “me-too” drugs.)
The EU has put up Euro 1 billion from the research budget. Pharmaceutical companies contribute a similar amount “in kind”. Projects usually involve companies working with universities, research institutes, public bodies and non-profit bodies, including patient organisations in some cases.
I was glad to see that a number of projects involved companies pooling data (e.g. on depression and schizophrenia) that was previously subject to strict commercial confidentiality. Done properly, data pooling should lead to better science and better medicine.
Four projects aim to improve education and training, including the development of postgraduate courses in Advanced Safety Sciences and in Pharmacovigilance.
A billion Euros is a lot of public money, and the value of the IMI project will depend crucially on a number of factors. The greatest danger of course is that it will be excessively influenced by an industry agenda, focusing on a medicine and drug-based approach to health, at the expense of non-drug therapies and policies.
Independence is also crucial in developing education and training initiatives. Pharmacovigiliance is a critical element in health policy, and in medicines regulation where pharmaceutical companies are the main regulated entities. (Should banks fund university courses on financial regulation?)
There is also the question of who benefits from publicly funded research – will the results of IMI research be open to all? IMI has rules on intellectual property. Companies who bring private data to a project will retain their rights to that data. The IP rights for key results generated by a given project will belong to the participants in that project, but with an obligation to license those rights on reasonable terms. Other incidental results, not central to a given project, will belong to the participant(s) who developed the results. The IP rules do not conform to the principle that publicly funded research results should be available freely to all. Companies are not philanthropists and I suppose they would not participate if the results were to be available without charge to all.
Participants potentially stand to gain from the IP rights to the results of each project. I may be wrong on this but it seems to me that the EU will not gain directly from future license revenue if any, despite contributing up to half the money for the research.
There is an argument that research grants of this nature (and size) are little more than corporate social welfare, subsidising an already rich industry or, worse, paying for something that industry would otherwise have done for itself. That danger certainly exists, in this instance as in others, but I am not against cooperation with industry or the public funding of pre-competitive research in proper cases. I would like to see more funded research on alternatives to medicines and, above all, on how science is made, published, promoted and used in relation to medicines. Research in this area is unlikely to be industry funded.
There is one IMI project that I will follow with special interest – the IMI-funded European Patients Academy on Therapeutic Innovation, EUPATI. Led by the European Patients Forum in partnership with seven pharmaceutical companies and others, the project aims to improve “understanding of pharmaceutical research and development among patients, carers and other interested lay people across the European Union” and to address “…the lack of societal awareness of the complexity of new drug development…” END