The cost- effective use of medicines is an essential component under the EU Agenda on effective, accessible and resilient EU health systems. As seen through the lens of health systems, a comprehensive view on pharmaceutical policies is necessary to gain a deeper understanding of relevant factors that influence patients’ timely access to affordable and effective medicines. Such an approach comprises both “pre-launch” activities, implying a forward-looking perspective on new medicines in development and “post-launch” activities, touching on pricing/value-for-money and the appropriate use of medicines.
Breaking down barriers for patients in the EU
There is limited EU competence in the organization and delivery of the national healthcare services, in particular in pricing and reimbursement of medicinal products , but many EU Member States have committed to work together in a number of aspects and on a voluntary basis, as reflected in a number of Council Conclusions. Key elements are improved cooperation, evidence generation, pooling of international expertise and knowledge sharing to minimize any unintended effects that current national policies may have in terms of medicines’ accessibility throughout the EU.
Overall, strengthening capacities of the EU health systems would assist them to address future waste in pharmaceutical spending and to improve patients’ access to life saving medicines.
Over the last years, the European Commission has contributed by carrying out a number of supportive activities to complement Member States’ voluntary work and took initiative to study the economic impact of the various pharmaceutical incentives on innovation, availability and accessibility. The European Commission is currently evaluating the functioning of the EU legislation on medicines for children and rare diseases; the evaluation should be due in the second half of this year.
Support to OECD work on access to medicines
With the financial support of the EU Health Program, the OECD (Organisation for Economic Co-operation and Development) has undertaken several projects to further identify avenues to increase pharmaceutical expenditure efficiency and better prepare to changes in the market. This work is exploring further policy options as suggested in the OECD report Pharmaceutical Innovation and access to medicines. The work brings together governmental experts from the area of pharmaceuticals with the following key deliverables:
- Using routinely collected data to inform pharmaceutical policies
- Country fiches on routinely collected data to inform pharmaceutical policies
- Better anticipating pharmaceutical market dynamics
- Country fiches on market dynamics
- Building capacities for improved pricing and reimbursement negotiations
- Addressing challenges in access to oncology medicines
More information on OECD work addressing the challenges of access to medicines
Supporting cooperation on reference pricing methods and the set-up by the Member States of guidelines to mitigate unintended negative effects of international price benchmarking rules on access to care.
- Guidance document on a coordinated approach of national authorities regarding the use of external reference pricing to avoid/mitigate negative impact for patient access to medicines (March 2019)
Expert Panel Opinions
- 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
Previous EU Health Programme studies
- 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
Health systems performance assessment
Contributing to the European Semester process and the State of Health cycle, which assesses the performance of the health systems and the cost-effectiveness of pharmaceutical expenditure. Apart from possible country specific recommendations, the work can unlock potentials for the EU Member States for ad- hoc technical support and access funding instruments.