The EU Parliament adopted on 2 March a non-legislative Report on EU options for improving access to medicines.
More than a year after the Socialists & Democrats (S&D) Political Group of the EU Parliament initiated work on a document on EU options to improve access to medicines, the final, non-legislative Report was adopted with a large majority in Plenary, on 2 March. From a pessimistic view of the current situation, antagonising the pharmaceutical and biotech industry, with numerous data and information errors, the Report has shifted to a much softened and balanced analysis of the situation, aiming to guarantee better and timelier access to medicines whilst preserving public health systems across Europe and safeguarding the industry’s competitiveness and cutting-edge innovation.
The 20-page document acknowledges inter alia:
- The pivotal role of the industry in access to medicines and the essential need to preserve European innovation; but calls for caution in the granting and application of IP Rights
- the delays caused by national re-assessments of criteria already evaluated by the EMA
- the need for fast-access and short-trials for unmet medical needs
- the issues of parallel trade and shortages
It also calls for:
- more preventive and holistic healthcare
- improved multi-stakeholder collaboration (early dialogue; EU cooperation on HTA)
- patient inclusion in research and clinical trials
- more transparency, regarding pricing, R&D costs, clinical data
- fostered development of, and patient access to ATMPs
- an enabling environment for generics and biosimilars
- a common definition of “added therapeutic value” (HTA) and innovation, agreed between the EU Commission and Member States
- annual reports on medicine shortages across the EU
- a report every 5 years, written by the Commission access to medicines in the EU
Though the Report has no legislative bearing, it will likely be referenced in future discussions to present the EU Parliament’s position on Access to Medicines and Pricing, such as the WHO Fair Pricing Forum (9/10 May, Amsterdam) or the OECD Report expected for the end of 2017.