The research-based pharmaceutical industry has a vision for a healthier future for Europe. At the heart of this is prevention, innovation, access to new treatments and better outcomes for patients. How can we address barriers to achieving this?
Across Europe there is a stark variation in speed of access to new medicines for patients in different countries. Today, patients in Germany are able to access new medicines in 133 days after they have been approved by the European Medicines Agency, while patients in Romania have to wait an average of 899 days.
Data published by EFPIA also show significant disparities in terms of availability of innovative medicines, not just speed of access, with less than 30% of centrally approved products available in smaller and Eastern European Member States. This stands in stark contrast to availability rates of up to 92% in Germany and 46% on average in the European Union.
For patients, health systems and industry, the situation is untenable. Underpinned by strong and predictable Intellectual Property Rights, we are on the cusp of a scientific revolution in treatment options. After years of research and development in areas of unmet need by companies like Lilly, we believe innovative medicines should reach patients as quickly as possible. We believe it’s time for change and in April 2022 EFPIA published new proposals including a commitment to file for pricing and reimbursement in all Member States as soon as possible, a portal to assess progress and barriers, and a framework for equity-based tiered pricing, to contribute to level the playing field for speed of access across Europe.
Taking action on access
EFPIA member companies have put forward this series of proposals which should dramatically increase the availability of innovative medicines in EU countries and decrease the time patients must wait for new medicines by several months.
Companies have committed to file for pricing and reimbursement in all EU countries as soon as possible, and no later than two years from the central EU marketing authorisation, provided local systems allow it. The commitment is designed to help deliver faster, more equitable access to medicines for patients across Europe.
This commitment is supported by the launch of a portal where marketing authorisation holders can provide timely information on the timing and processing of pricing and reimbursement applications in the EU-27 countries. Bringing greater transparency to specific barriers and delays will help us find solutions in partnership. Further details of both the commitment to file and the portal are included in a new position paper Addressing patient inequalities in Europe.
Innovation in pricing mechanisms
In addition to a fairer system for patients, EFPIA is opening a conversation on the potential for a more equitable system for EU Members States where the value-based price of innovative medicines is allowed to vary between countries depending on their economic level and ability to pay. A new discussion document entitled A Shared Approach to Supporting Equity-based Tiered Pricing’ sets out the key features of an equity-based tiered pricing system, anchored in the principle of solidarity between Member States and enshrined in the EU treaties. A key objective is to seek to address the current access lag in smaller and Eastern Member States.
Delivering the proposed equity-based approach requires the European Commission and EU Member States to amend external reference pricing systems and implement mechanisms to prevent unintended consequences from internal trade in medicines.
We see this as a balanced and holistic approach to tackling a long-standing problem. It brings greater transparency to barriers and delays, as well as supporting novel pricing mechanisms that can spare patients undue delays in accessing medicines they need. Together with EMA reform, the implementation of the EU HTA regulation, the Clinical Trials Information System and other initiatives that shorten time and broaden access for patients, we can create a step-change in the access landscape for patients across Europe.
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