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EU Semester Country Specific Recommendations: More Efficient Medicine Policies Needed for Patient Access


23 May 2017


Health & Consumers


·         The 2017 European Semester Country Specific Recommendations highlight the inefficiencies in several European healthcare systems particularly regarding the low access to medicines for patients.

·         Generic and biosimilar medicines provide an outstanding opportunity to improve access to safe and effective medicines through efficient medicines policies.

·         Medicines for Europe country recommendations promote sustainable medicines policies to improve patient access to gold standard treatment.


The European Semester Country Specific Recommendations show that healthcare systems need to improve in terms of efficiency.  The EU commitment to ensuring equity of access to healthcare is challenged by the limited financial capacity of governments to cover growing demand for healthcare services. Generic and biosimilar medicines provide the greatest opportunity to improve access to safe and effective medicines through efficient medicines policies. 

Governments should adopt medicines policies that support the use of generic and biosimilar medicines to generate the sustained benefits of competition over the long-term. Short-sighted and radical cost-containment measures (such as External Reference Pricing (ERP), single winner tendering, payback/clawback policies and mandated price cuts), endanger medicines supply reliability and ultimately patient health, as is underlined in the Commission’s assessment of the situation in Romania.

Adrian van den Hoven, Director General at Medicines for Europe commented that “The OECD[1], the European Commission[2],[3] and the European Council[4] have highlighted the importance of the timely availability of generic and biosimilar medicines for healthcare systems. In this light, Medicines for Europe has developed a set of Country Recommendations for France, Italy, The Netherlands, Spain, Portugal, Bulgaria and Ireland to help the EU and member states develop effective policies that support access to medicines for patients”.

To fully realise the potential of generic and biosimilar medicines, European governments should encourage competition from generic and biosimilar medicines based on four overarching recommendations as well as specific measures for each country:

·         Ensure a predictable market environment for a stable supply of medicines.

·         Implement clear incentives to stimulate the use of generic and biosimilar medicines.

·         Increase regulatory efficiency to promote high standards while reducing red tape.

·         Support Supplementary Protection Certificate manufacturing waiver to promote a strong manufacturing base in Europe.

More details on the Medicines for Europe recommendations can be found here.


[1] OECD, Fiscal Sustainability of Health Systems: Bridging Health and Finance Perspectives, 2015

[2] Investing in Health, 2013, DG SANCO, European Commission,

[3] DG ECFIN and Economic Policy Committee (Ageing Working Group), Joint Report on Health Care and Long-Term Care Systems & Fiscal Sustainability, 2016,

[4] Council conclusions on strengthening the balance in the pharmaceutical systems in the EU and its Member States -


About Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members employ 160,000 people at over 350 manufacturing and R&D sites in Europe, and invest up to 17% of their turnover in medical innovation.

Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at and on Twitter @medicinesforEU.