Rome Joint Statement — Awareness and Concerns on Issues Related to Access to Affordable Medicines

In June 2022, the members of the European Alliance for Responsible R&D and Affordable Medicines gathered in Rome to analyze the current public health scene and discuss potential solutions to the most important challenges. In light of public health outbreaks in the European Union (EU), such as COVID-19 and Monkeypox, the urgent global need for medical tools such as vaccines and revision of the EU pharmaceutical strategythe Alliance stressed the need to ensure that people have access to the medicines they need and calls for an R&D system that focuses on health needs and provides medicines and other health technologies that are safe, effective, universally accessible and affordable.

In this context, and with the sole aim of promoting public health from a patient-centred perspective, the Joint Rome Declaration calls on global, European and national policy makers to:

  1. Securing available, affordable and accessible medicinesin particular by ensuring that the review of EU pharmaceutical legislation is transparent, addresses adequate patient access and prioritizes public health and patients’ needs;
  2. Use incentives for new antibiotics that decouple the cost of R&D investment from price and sales volume while adopting an end-to-end approach and avoiding the creation of new market-based incentives (such as transferable exclusivity cheques);
  3. Setting higher standards for patentability at the European Patent Office ensuring that patents are issued for genuinely new and truly innovative medicines;
  4. Remove legislative and regulatory barriers to the use of TRIPS flexibilities such as compulsory licensing or parallel imports from EU legal frameworks;
  5. Promote transparency of R&D and other costs as well as net drug prices, as well as public and private funding for pharmaceutical R&D across the entire value chain to restore balance in the pharmaceutical sector;
  6. Ensuring transparency and accountability of political decisions in key institutions such as the European Medicines Authority (EMA) and the new European Health Emergency Group Preparedness and Response (HERA);
  7. Commit public funds to support a needs-based approach to pharmaceutical R&D and address unmet needs and introduce effectively enforceable conditions for public R&D funding to hold the pharmaceutical industry accountable;
  8. To prevent drug shortages and reduce their impact on patients and healthcare providers by strengthening oversight of key raw materials and priority APIs as well as finished pharmaceutical products;
  9. Ensure the co-creation of European pharmaceutical policies by facilitating the meaningful involvement of patients, consumers, healthcare professionals and civil society;
  10. Strengthen existing legislation on human rights obligations pharmaceutical companies regarding access to medicines in the EU.