Europe’s COVID-19 battle: Ensuring the supply of medicines and the continuity of clinical trials
As many countries in Europe near the peak of the COVID-19 pandemic, EFPIA member companies are continuing to work around the clock to increase capacity and ensure the supply of critical medicines to patients across Europe. In fact, increases in capacity was one of the first actions undertaken by pharmaceutical manufacturers, as part of their pandemic preparedness plans, activated back in January. However, we are witnessing a significant increase in demand in some European countries, that in some cases can reach many times the normal levels.
On the call with Commissioner Kyriakides and Commissioner Breton held on 17 April, EFPIA welcomed the Commission’s guidance to member states on the optimisation of supply of medicines for COVID-19, as well as underlining the need to continue to address stockpiling and exports bans, provide more information from Member States to forecast demand for medicines in line with their patients’ needs and ensure optimal and timely supply of medicines to all Member States and to work collaboratively to support the continuation of clinical trials across Europe.
Export bans restrictions and requisitioning of medicines continue to exist across the EU in countries such as Belgium, Hungary, or Portugal. Such export bans are particularly challenging for companies who have their multi-market distribution warehouses in those countries, from which they serve all of Europe, or even parts of Africa. We understand each Member State’s desire to ensure the availability of necessary medicines for their population. However, the supply chain is designed to work across borders. No one country can meet all its needs on its own, and through restrictions, countries risk isolating themselves and their citizens from the global supply network. The consequences of export bans are directly detrimental to the availability of medicines for patients across the EU and globally, as well as risking retaliatory measures from other regions that could impact timely availability of medicines for European patients.
As our industry works globally to develop diagnostics, vaccines and treatments for use in the fight against COVID-19, we need to ensure that wherever successful tools are developed, we avoid any unilateral decisions by governments that could negatively impact on the supply of essential new vaccines, diagnostics and treatments. COVID-19 is a global pandemic and requires a global response. We call upon the Commission to establish a sustained dialogue with relevant governments to avoid any such ‘knee-jerk’ reactions, irrespective of where the innovator company or manufacturing sites of any future vaccines or treatments are located.
Critical to our efforts to meet the needs of patients is accurate forecasting data on the patient demand for medicines. We urgently need detailed modelling data from the European Centre for Disease Control. In the meantime, to be proactive, EFPIA members are examining the modelling exercise conducted by the Institute for Health Metrics and Evaluation (IHME). COVID-19 has put immense strain on Europe’s intensive care units, including the demand for medicines used in critical care. As these are mainly generic medicines, EFPIA supports the project initiated by Medicines for Europe and its members to try to assess the total demand for ICU medication needed in hospitals across the EU as well as to gather supply and capacity data from manufacturers of these medicines under close supervision by European Commission Directorates General for Competition (DG COMP) and Health (DG SANTE).
Many thousands of patients across the EU take part in over 4000 clinical trials of new medicines across many therapy areas. In our interactions with the patient community, they have repeatedly underlined the impact of the COVID-19 on clinical trials, critical to future advances in patient care. EFPIA welcomes upcoming guidance on the continuation of clinical trials, currently under review by the European Commission.
As an industry we continue to stand shoulder to shoulder with citizens, patients, health systems, Member States and the EU Institutions in tackling the COVID-19 emergency. Our commitment to that fight have been made publicly available in the European research-based pharmaceutical industry’s commitment to tackling COVID-19, endorsed by the EFPIA Board and #WeWontRest in the fight against COVID-19.