One of the objectives of the EU pharmaceutical strategy is to ensure that patients have access to affordable medicines and that health systems remain financially sustainable. It expresses the key challenge and opportunities as follows:
‘Great progress has been made on human health in the European Union in recent years, with average life expectancy at birth in the EU having increased by 3.3 years since 2002. New medicines, vaccines and treatments have helped to tackle some of the leading causes of disease and life threatening illnesses.
At the same time, though we are experiencing a period of rapid change and innovation, many patients do not benefit from that innovation, because medicines are either unaffordable or unavailable. And there is greater awareness of the need to ensure that our use of pharmaceuticals is sustainable.’
Costly medicines are a growing challenge for national budgets as well as for individual patients. New medicines come with an increasingly high price tag, and their added therapeutic benefit is sometimes not proportionate to their additional cost and their effect on the patient’s overall cost of treatment.
What is the Strategy proposing to improve affordability?
- Revising the pharmaceutical legislation to make it more conducive to competition and reinforce affordability in the EU pharmaceuticals market - 2022
- Develop cooperation in a group of national competent authorities, based on mutual learning and best-practice exchange on pricing, payment and procurement policies, to improve the affordability and cost-effectiveness of medicines and health system's sustainability, including on cancer treatment – 2021-2024. See the meetings of the National Competent Authorities on Pricing and Reimbursement and Public Healthcare Payers (NCAPR)
- Working with EU countries on non-legislative ways to improve transparency, such as guidelines on how to calculate the R&D costs of medicines - 2021-2024
- Assessing national health systems and issuing country-specific recommendations to ensure their accessibility, efficiency and sustainability – yearly European Semester cycle of economic policy coordination
Further actions on affordability
Ensuring the transparency of national decisions on e.g. medicine prices and reimbursement, in line with the Transparency Directive (Council Directive 89/105/EEC) while respecting EU countries’ competence to set their own prices for medicines as long as they comply with (procedural) requirements.
Cooperation with the OECD
With the financial support of the EU health programme, the Organisation for Economic Cooperation and Development (OECD) has carried out work to identify how to better manage the pharmaceutical budget, increase the efficiency of pharmaceutical spending and better prepare for changes in the market.
- More information on OECD’s work on addressing the challenges of access to medicines
Under this EU-funded project, EU countries work together to build and maintain a database of national medicine prices and pricing regulations. The purpose is to prevent any unintended negative effects on access to care created by international price benchmarking rules.
- More information on the EURIPID project
A biosimilar is a biological medicine that is highly similar to another, previously approved biological medicine. As these medicines increase treatment options for patients, the Commission supports cooperation between EU countries to help incorporate biosimilars into national markets as part of its policy to improve patients’ access to affordable medicines and ensure the sustainability of healthcare budgets.
The Commission provides information to:
- all stakeholders: on the scientific concept, approval process, safety and efficacy of biosimilar medicinal products (2013)
- patients: on biosimilar medicines (2016)
- health professionals: new information guide (prepared with the European Medicines Agency - 2017) and a joint statement on interchangeability (issued by the European Medicines Agency and the Heads of Medicines Agencies - 2022).
In addition, IQVIA (formerly QuintilesIMS) produces annual reports on the impact of increasing competition on biosimilars in Europe, for which it consults with national authorities, payers, patients, healthcare professionals and pharmaceutical companies.
Reports and workshops on biosimilar medicines
- 2022 - Report and sixth Multistakeholder Event
- 2021 - Report
- 2020 -Report
- 2019 -Report and fifth stakeholder conference
- 2018 -Report and fourth stakeholder conference
- 2017 -Report and third stakeholder conference
- 2015 - 2016 - Combined report and stakeholder workshops
Previous studies and related documents
- Study on optimising public procurement of medicines
- Opinion on Innovative payment models for high-cost innovative medicines
- Factsheet on improving access to innovative medicines
- Access to health services in the European Union - Final opinion
- Study on enhanced cross-country coordination in the area of pharmaceutical product pricing
- External reference pricing of medicinal products: simulation-based considerations for cross-country coordination
- EU Pharmaceutical expenditure forecast