Action n° 6: To promote, in a staged approach, unprecedented collaborative research and development efforts to bring new antibiotics to patients by: Launching rapidly with EFPIA[12], within the IMI-Joint Undertaking, a programme for research on new antibiotics aimed at improving the efficiency of research and development of new antibiotics through unprecedented open sharing of knowledge. Establishing an overarching framework agreement with the industry, defining objectives, commitments, priorities, principles and modes of action for public-private collaboration in a longer term perspective. Mobilising adequate resources, within IMI in pa ...[+++]rticular (and its possible successor), FP7 and in the longer term the forthcoming research and innovation programme 2014-2020 (Horizon 2020), in order to support research and development work, based on criteria and modalities adapted to the specific needs and challenges of antibiotic development. Use the flexibility in the current pharmaceutical legislation to give rapid authorisation to new antibiotics and work with stakeholders and the Member States' authorities towards the establishment of adequate market and pricing conditions for new antibiotics. Ensure conditions for and implement fast track procedures for the marketing authorisation of new antimicrobials.

The rapporteur would also like to thank for their valuable contributions the following non-institutional stakeholders who have communicated their positions and views on the proposed Directive: The European Patients Forum (EPF), the European Organisation for Rare Diseases (EURORODIS), the European Federation of Pharmaceutical Industry Associations (EFPIA), the European Confederation of Pharmaceutical Entrepreneurs (EUCOPE), the European Generic Medicines Association (EGA), GlaxoSmithKline, Celgene, the European Social Insurers Platform (ESIP), the Représentation des institutions françaises de sécurité sociale auprès d ...[+++]e l'UE, The Alliance for cost-efficiency in healthcare (COSTEFF), Prescrire and Health Action International - Europe.

The European Federation of Pharmaceutical Industries and Associations (hereinafter referred to as EFPIA) took the lead in establishing the European Technology Platform on Innovative Medicines under the Sixth Framework Programme.

- develop a Healthcare and Pharmaceuticals process involving Member States, industry and other health stakeholders to promote corporate responsibility, improve access to medicines, and strengthen the competitiveness of the pharmaceutical industry.

These specialists shall take active steps to compile information concerning the onset of adverse reactions to the new medicinal products, interacting continuously with all the actors involved (undertakings, pharmacists, doctors, specialists) and with patients" associations.

making publicly available in an ad hoc Register in accordance with Regulation (EC) No 1049/2001, assessment reports, summaries of product characteristics, labels and package leaflets or inserts for these medicinal products; establishing that the labels and package leaflets or inserts are written in simple, clear language comprehensible to the public and that they are scientifically accurate, and periodically checking the effectiveness of the medicinal products in cooperation with undertakings, patients" associations and health-care professionals (doctors and pharmacists);