On March 11, the European Commission presented the much-anticipated Critical Medicines Act, a proposal aimed at strengthening the resilience and autonomy of the EU’s pharmaceutical supply chain. The European Brain Council (EBC) welcomes this initiative as an important step toward a stronger, more innovative, and competitive Health Union, particularly in light of increased geopolitical challenges and international tensions, as well as ongoing efforts to meet Sustainable Development Goal #3.

Recent health crises, including the COVID-19 pandemic, have highlighted the bloc’s reliance on external actors for essential medicines, a dependency that has led to an increasing number of shortages. Ensuring a secure and sustainable supply of medicines is vital for all European citizens, including the millions living with brain disorders, neurological and mental alike.

A staggering treatment gap in the management of brain disorders persists, despite them being the leading cause of disability and the second leading cause of death in the world. This treatment gap affects between 30% and 80% of people living with a brain disorder, neurological and mental, despite efficient medicines being available on the market [1]. A recurring issue lies in the capacity for patients to adhere to treatment, particularly in the case of disorders with acute phases (e.g. migraine or severe mental disorders such as psychosis or schizophrenia) or conditions whose progression needs to be slowed down (e.g. Parkinson’s Disease or Multiple Sclerosis). In light of these high unmet medical needs, addressing disruptions in the pharmaceutical supply chain is therefore critical in ensuring people living with brain condition have access to critical medicines.

EBC welcomes some of the Critical Medicines Act’s key provisions, such as:

  • The recognition of orphan drugs as critical medicines, a long-standing demand of the patient community,
  • Strengthened cooperation between Member States through mechanisms such as joint procurement and the establishment of a Critical Medicines Coordination Group,
  • The acknowledgment of medicines production and supply as a strategic priority for the EU’s industry, competitiveness, and public health.

While EBC supports these advancements, we will closely monitor the implementation of the Critical Medicines Act, with particular attention to:

  • Financing mechanisms that do not divert resources from existing programmes and funding instruments (such as Horizon Europe, EU4Health or the Cohesion Fund for instance),
  • Ensuring patient and stakeholder involvement in both the implementation and monitoring phases,
  • Enhancing data sharing and collaborative efforts to monitor and prevent future medicine shortages,
  • Developments around a strategic EU stockpile of medicines to improve preparedness and response.

EBC remains committed to working with policymakers and all stakeholders to ensure that the Critical Medicines Act delivers on its promise of a more secure, sustainable, and patient-centered pharmaceutical landscape in Europe. However, a thriving European research and innovation ecosystem remains a prerequisite to secure the pharmaceutical supply chain, close the treatment gap and address the growing burden of brain disorders. This can only be achieved through increased funding for R&D and greater collaboration (within Europe and beyond), which would rely on the design of an ambitious stand-alone 10th Framework Programme for Research and Innovation.

 

[1] Policy White Paper: Towards Optimizing Research and Care for Brain Disorders.