Brussels, 4 December 2013
Subject: Open letter on governance and intellectual property in the Innovative Medicines Initiative 2 (IMI2)
Dear Mr Strohemeier,
I am writing to you in your capacity as the Chair of the Innovative Medicines Initiative’s (IMI) Governing Board. As I am the Shadow-Rapporteur for the Greens/EFA group on the Regulation on IMI2, I would like to share my concerns on the Commission’s proposal and the general management of the initiative and to ask you to take concrete action to address these issues.
The IMI2 is a Joint Technology Initiative (JTI) that aims at improving the drug development process by supporting more efficient research and development cooperation among academia, small and medium enterprises (‘SMEs’) and the biopharmaceutical industry, in order to deliver better and safer medicines for patients. The IMI2 can only be successful in achieving its objectives to bridge gaps in the development process for vaccines, medicines and treatments and tackle Europe’s growing health challenges if a certain number of criteria are met, namely good governance and collaboration. For any public-private endeavour to be successful, the public and private sectors should balance each other in terms of priority and strategy setting. I believe that with increased leadership and oversight from the side of the European Commission IMI2 could better address market failures, bottlenecks in products development, and existing public health needs at EU level and globally. This will be a building block to reinforce cooperation with other European and international initiatives in the field of health R&D, for example the WHO Consultative Expert Working Group on Research and Development Financing and Coordination (CEWG) and the European & Developing Countries Clinical Trials Partnership (EDCTP).
The Greens in the European Parliament also regret that the Commission proposal for the IMI2 does not include provisions to enhance good governance and transparency of the initiative, which emerged as one of the challenges during the first and second Interim Evaluation of IMI. It would be especially important to ensure inclusiveness in the process to identify priorities and define IMI agenda by allowing a central role for the advisory boards, namely the Scientific Committee, the States Representative Group and the Stakeholder Forum.
To fulfill the objective of meeting unmet public health needs, intellectual property (IP) rights will have a crucial role in terms of accessibility to medical innovation, as well as access to research data. There have been complaints in the past from academics, small and medium enterprises, and non-governmental organisations that the vague and unclear guidance from the IMI on intellectual property favours the industry, and particularly big industries. As a result, this becomes an obstacle to negotiate project agreements. Using public money to create a final product that is privatised by the industry partners is not an acceptable way of spending public money, especially when it comes to the health and lives of European citizens.
It is disappointing to see that the legislative text does not contain clear provisions on the dissemination, exploitation, and accessibility of data and research products. What is even more unfortunate among what came out of the trilogue negotiations on the Rules of Participation is that IMI2 is the only public private partnership that has an exemption on open access, exploitation and dissemination rules. Fair access and IP rules are fundamental to avoiding delays, bottlenecks in product development, unnecessary duplication, as well as ensuring the affordability of the end products. The sharing of data is essential to establishing an open scientific, collaborative partnership between the public sector, industry, SMEs, academia and civil society.
The intellectual property rules and governance mechanisms are crucial for an IMI2 that would both be more accountable and enhance excellence in science. I expect that the Governing Board of IMI will formulate concrete measures to ensure transparency and access to research results and knowledge. You can count on support of the European Parliament to achieve an accountable and inclusive IMI2 that delivers breakthroughs to meet public health needs.
I look forward to a fruitful and constructive dialogue with you in the future.
Yours sincerely,
Michèle Rivasi, MEP (Greens/ EFA)
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