Introductory text

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1290/2013 of the European Parliament and of the Council of 11 December 2013 laying down the rules for participation and dissemination in ‘Horizon 2020 — the Framework Programme for Research and Innovation (2014-2020)’ and repealing Regulation (EC) No 1906/2006^f1, and in particular Article 1(3)(b) and points (i) to (vii) of Article 1(3)(c) thereof,

Whereas:

Regulation (EU) No 1291/2013 of the European Parliament and of the Council^f2 establishes the Framework Programme for Research and Innovation (2014-2020) (Horizon 2020) and provides for the involvement of the Union in public-private partnerships, including in joint undertakings, in key areas where research and innovation can contribute to the Union's wider competitiveness goals and help tackle societal challenges.

Participation in indirect actions under Horizon 2020 should comply with Regulation (EU) No 1290/2013. However, in order to take into account the specific operating needs of joint undertakings established pursuant to Article 187 of the Treaty in the area of innovative medicines, the power to adopt acts in accordance with Article 290 of the Treaty was delegated to the Commission for the duration of Horizon 2020 with a view to allowing funding bodies established under Article 187 of the Treaty to limit the eligibility for funding to specific types of participants and to adopt specific intellectual property rules.

The Innovative Medicines Initiative Joint Undertaking was set up by Council Regulation (EC) No 73/2008^f3 for a period up to 31 December 2017 in order to foster collaboration between all stakeholders such as industry, public authorities (including regulators), organisations of patients, universities and clinical centres and to improve the efficiency and effectiveness of the drug development process with the long term aim that the pharmaceutical sector produce more effective and safer innovative medicines.

Specific operating needs, substantiated by the aim of the Innovative Medicines Initiative (IMI) to bring together large industrial partners with non-profits, public entities or other entities and to maximize exploitation of project results which could bring medicines to patients faster, have been identified as referring to eligibility for funding and intellectual property rules. The Innovative Medicines Initiative 2 Joint Undertaking set up by Council Regulation (EU) No 557/2014^f4 should continue to provide funding to entities such as micro, small and medium-sized enterprises, secondary and higher education establishments, and non-profit organizations, therefore a derogation from Article 10(1) of Regulation (EU) No 1290/2013 is necessary.

Specific operating needs have been identified regarding intellectual property rules in the context of the Innovative Medicines Initiative 2 objectives, in order to achieve an open innovation model, a dynamic system of knowledge sharing providing wider possibilities to create and exploit the knowledge resulted from the IMI projects and wide access of participants, affiliates and third parties to this knowledge, with the ultimate goal of speeding up the development of diagnostics and medical intervention for patients' benefit, including by stimulating clinical, translational research and clinical trials, in particular in the areas of public health interest and high unmet medical need, as identified in the World Health Organisation priority medicines report issued on 9 July 2013^f5. Those conditions should apply to all participants in order to protect their background, results and sideground. It is appropriate to allow for the transfer and licensing of results and background and for access rights to the results and background of other participants in order to allow research to be carried out. It is appropriate in that context to differentiate, in the context of exploitation, between research use and direct exploitation. Those conditions should also take into account the participants' prior obligations, while providing for potential direct exploitation of results, including clinical trials on the results per se. In order to widely exploit results and facilitate the delivery of innovative medicines to patients and to improve drug research and development, it is necessary to establish derogations from Articles 41 and 44 to 48 of Regulation (EU) No 1290/2013,

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