EUROPEAN PHARMA R&D (RSFF)

The project concerns the promoter’s R&D for new generics and biosimilars. It includes investments in research, development, clinical trials and regulatory approval.

The project will contribute to private sector investments in R&D, located in Hungary, the Netherlands, the UK and Israel, thus meeting the orientations that underpin the Lisbon’s Council decision and the Bank’s Knowledge Economy (i2i) Initiative. The promoter’s collaboration with smaller companies, in particular in the biotechnology industry, adds to the diffusion and transfer of knowledge across Europe; the partnering with companies and Contract Research organisations (CROs) helps to translate knowledge into new products. Thus, EIB financing of the R&D development costs corresponds with the Community’s role to encourage Research and Technological Development, as defined in Article 163 of the EC Treaty and with the “Common Interest” criterion retained for the Treaty’s Article 267 point (c), i.e. the Bank’s financing activities under the Knowledge Economy (i2i) Initiative: (i) research & development and (ii) innovation. In addition, the project is eligible under the Risk Sharing Finance Facility (RSFF).

As a substantial part of the project is located in a convergence area in Hungary, the project is also partly eligible under the Treaty’s article 267 point (a) convergence. The part of the project that is located in Israel is eligible under the Bank’s mandate for the country.

The R&D activities encompassed within this project will not materially change current R&D practices and will be carried out within existing facilities, mostly in the EU and Israel, making use of existing laboratories, pilot plants, clinical centres etc. Thus an EIA according to the EU Directive 97/11 as amended by Directive 2003/35 or according to the local legislation in a non-EU country is not required. Compliance of R&D activities with relevant EU legislation will also be verified during appraisal.

The Promoter is a private company not operating in the Utilities sector, and is thus not covered by EU Directives on procurement. Procedures followed will be verified during appraisal.