6th EPHA Universal Access and Affordable Medicines Forum

• Milka Sokolović | Director General – European Public Health Alliance 

• Sarah Garner | Senior Policy Advisor, Access to Medicines and Health Products, WHO Regional Office for Europe

New antibiotics are needed as part of the toolbox to address increasing antimicrobial resistance (AMR). Equally important is to ensure timely access to existing antibiotics along with stewardship measures to ensure they are used prudently.

In the proposed revision of the EU pharmaceutical legislation, the EC has put forward a proposal to create a new pull incentive to spur the development of new antibiotics. However, as argued by EPHA1 and by 14 member states2, the transferable exclusivity extension (voucher) would create a very costly, non-transparent and indirect pull incentive to spur the development for new antibiotics.

This session will discuss more effective and fairer alternative incentives that could address both the lack of new antibiotics and the availability of old ones, such as those identified in a report for the EU HERA and proposed by member states. They include initiatives such as market entry rewards, a guaranteed minimum turnover per Member State, and providing milestone-based R&D payments. 

• Helle Aagard | ReAct – Action on Antibiotic Resistance
• Dimitri Eynikel | EU Policy and Advocacy Advisor, Médecins Sans Frontières | Doctors Without Borders – Access Campaign
• Dr Dimitra Panteli | Programme Manager and Senior Health Systems Analyst – European Observatory on Health Systems and Policies
• Dr Rosa Castro | Senior Advocacy Officer at DSW (Deutsche Stiftung Weltbevölkerung)

What is the real R&D cost for a new medicine? And when a medicine has been developed with the public funding’s support, should companies be able to freely choose the price that extracts the higher profit for them?

Fair prices for medicines have been defined as “justifiable, predictable and cost-effective within the aims and priorities of the healthcare systems and the available budget”.3 This requires consideration of the needs of patients and health systems, the affordability of treatments and the balance between the cost of bringing a product to market and its final price.

Hence, transparency of pharmaceutical R&D costs is a necessary step towards fair(er) prices. Without a clear understanding of the costs to develop a new medicine, the quest for fair prices remains elusive.

The revision of the EU pharmaceutical legislation has opened the opportunity to request information from pharmaceutical companies about the public funding contributions they have received for the development of a new medicine. However, the proposed text is limiting the disclosure of information to direct public contributions. A too narrow scope for this obligation risks being incomplete at best or counterproductive at worst.

This session will convene experts from different areas to discuss ways forward to improve transparency of pharmaceutical R&D costs in the context of the revision of the EU pharmaceutical legislation.

• Anna Prokupkova | Health Policy Advisor – Greens/EFA Group at European Parliament
• Dr Javier de la Cueva | Lawyer specialised in free intellectual property licenses
• Anne Hendrickx | Advisor in the Research department of Solidaris (Belgian mutual fund), Fair pricing calculator
• Suzannah Chapman | Health Policy Analyst, Health Division, Directorate for Employment, Labour and Social Affairs – OECD

• Milka Sokolović | Director General – European Public Health Alliance