In June 2022, the members of the European Alliance for Responsible R&D and Affordable Medicines gathered in Rome to analyse the current public health scene and discuss potential solutions to the most prominent 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 the revision of the EU Pharmaceutical Strategy, the Alliance highlighted the need to ensure that people have access to medicines they need and call on for an R&D system that is driven by health needs and delivers medicines and other health technologies which are safe, effective, universally accessible and affordable.
Within this context, and with the sole aim of fostering public health from a patient-centred perspective, the Joint Rome Declaration calls global, EU, and national policymakers to:
- Secure available, affordable and accessible medicines, including by ensuring that the revision of the EU pharmaceutical legislation is transparent, addresses adequate patient access, and prioritizes public health and patients’ needs;
- Use incentives for new antibiotics that delink the cost of investment in R&D from the prices and volume of sales while adopting an end-to-end approach and avoiding the creation of new market-based incentive (such as transferable exclusivity vouchers);
- Set higher standards for patentability at the European Patent Office to ensure that patents are granted to truly new and genuinely innovative medicines;
- Remove legislative and regulatory obstacles to the use of TRIPS flexibilities such as compulsory licenses or parallel imports from EU legal frameworks;
- Promote transparency of R&D and other costs as well as net prices of medicines, as well as rack public and private funding for pharmaceutical R&D across the full value chain to restore balance into the pharmaceutical sector;
- Ensure transparency and accountability of political decisions at key institutions such as the European Medicines Authority (EMA) and the newly formed European Health Emergency Preparedness and Response (HERA);
- Commit public funds to support a needs-driven approach to pharmaceutical R&D and address unmet needs and introduce effectively enforceable conditions to public R&D funding to hold the pharmaceutical industry accountable;
- Prevent medicine shortages and reduce their impact on patients and healthcare providers by strengthening monitoring of key starting materials and priority APIs as well as finished pharmaceutical products;
- Ensure the co-creation of European pharmaceutical policies by facilitating the meaningful involvement of patients, consumers, and healthcare professionals and civil society;
- Strengthen existing legislation on the human rights duties of pharmaceutical companies in relation to access to medicines in the EU.