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No further excuse to delay digital regulatory infrastructure for medicines after COVID-19 pandemic


19 Feb 2021


Health & Consumers

Medicines for Europe calls on Heads of State and Governments to apply the lessons learned from the COVID-19 pandemic to build a more robust European crisis preparedness system and to enhance European solidarity.  This unpreceded public health crisis has highlighted long-standing issues: a low level of crisis preparedness, a lack of cooperation and coordination with stakeholders and insufficient market demand predictability that can impact product supply.

Early in the Covid-19 outbreak, the EU policy response to the massive surge in demand for ICU and other medicines was undermined by unilateral decisions to close internal EU borders, to hoard critical medicines and other supplies, and to disrupt transport and logistics.   Europe’s solidarity was affected  and European patients suffered the consequences. The industry adhoc ICU project helped address  these gaps with the support of the Commission, EMA and national agencies and delivered lessons learned which cannot be ignored.  To prevent this happening in future, we need systemic changes to enable clear and comprehensive crisis preparedness plans that can be rapidly deployed where there are serious threats to public health. The EU needs swift and direct two way communications and cooperation between EU Institutions and agencies, the Member States and relevant stakeholders, including medicine manufacturers, to coordinate an effective crisis response and to address potential supply bottlenecks. This cooperation needs to be  based on data and evidence, and reported to national authorities via an interoperable and digitalised reporting system connected with EMA, so as to enable fast informed discussions between all parties, on matters such as major health crisis.

The crisis has indeed exacerbated longstanding issues related to lack of digitalisation in healthcare, including regulatory processes for the approval and maintenance of medicines. We now know that robust and harmonised digital regulatory systems for addressing challenges such as  shortages of medicines can make a tangible difference in handling health emergencies. This should be reflected in the European Medicines Agency legislation. Digital solutions in the regulatory field can bring us much-needed flexibility,  a rapid response to a fast-changing environment and enable regulatory authorities to monitor and promptly react to major health events. We also underline the importance of EU-industry coordination in a crisis, which is absent from the draft legislation. Medicines cannot manufacture themselves to meet a surge in demand.

Although we are still in the midst of the COVID crisis it is crucial to act now. Together, Europe can build a fairer and more resilient system for its citizens. The European Health Union and the proposals for Regulation are the first steps to fulfilling this aim.

Medicines for Europe

Medicines for Europe represents the generic, biosimilar and value-added medicines industries across Europe. Its vision is to provide sustainable access to high quality medicines, based on 5 important pillars: patients, quality, value, sustainability and partnership. Its members directly employ 190,000 people at over 400 manufacturing and 126 R&D sites in Europe and invest up to 17% of their turnover in R&D investment. Medicines for Europe member companies across Europe are both increasing access to medicines and driving improved health outcomes. They play a key role in creating sustainable European healthcare systems by continuing to provide high quality, effective generic medicines, whilst also innovating to create new biosimilar medicines and bringing to market value added medicines, which deliver better health outcomes, greater efficiency and/or improved safety in the hospital setting for patients. For more information please follow us at and on Twitter @medicinesforEU.