The COVID-19 crisis exposed the vulnerabilities of national healthcare systems and highlighted the importance of health policies that truly address the needs of European citizens. The European Commission’s proposal for an EU Health Union, put forward in November 2020, represented a welcome response to reinforce the EU’s health security framework and crisis preparedness.
With strengthened mandates for the European Centre for Disease Control and Prevention (ECDC) and European Medicines Agency (EMA) and a brand-new European Health Emergency Preparedness and Response Authority (HERA), Europeans should expect more coordinated monitoring and response to public health threats and better management of medical product shortages in the future.
We are far from a fully integrated Health Union however, and there is no room for complacency. As millions face the worst cost-of-living crisis in nearly 40 years, public health once again risks falling victim to economic downturn. Budget cuts risk further deteriorating patients’ access to healthcare and social services while poorer households struggle with food and housing insecurity at a scale not seen in many decades. A perfect recipe for failing the patients of today and the many more patients of tomorrow. That is, unless the pandemic’s wake up call for people-centred health systems continues to resonate and European countries leverage every opportunity to coordinate their efforts.
It is against this backdrop that the EU is revising its pharmaceutical legislation for the first time since the early 2000s. For patients, this is a once-in-a-generation opportunity to enshrine patients’ involvement across the lifecycle of medicines and improve – to the extent possible given limited EU competences – access to safe, effective, and high-quality medicines across the EU. The Commission proposed some positive developments in this sense. EPF welcomes the inclusion of patient representatives in the EMA’s Committee for Medicinal Products for Human Use (CHMP) and strengthening of patients’ representation at the Pharmacovigilance Risk Assessment Committee (PRAC). This is an important milestone in the years-long journey of recognising the value patients bring to the medicines’ development and regulatory processes. Moving forward, their participation in the CHMP’s scientific working groups and in the Coordination Group for Mutual Recognition and Decentralised Procedures also needs to be formalised. As patients are asked to contribute more, ensuring appropriate compensation and training of patient representatives becomes more pressing. A legal definition of “patient organisations” and specific measures to support their sustainability would make a considerable difference in this regard.
The proposal’s focus on speeding up regulatory approval and incentivising the launch of new medicines in all 27 EU member states also represents a positive step towards a true single market for medicines.
Unacceptable disparities persist. It can take years for patients to access some medicines in some countries after the granting of the EU marketing authorisation, if they can access them at all.
Of course, more accountability is needed at all levels, especially as regards member states’ compliance with legal deadlines for pricing and reimbursement decisions1. Another important element is the adaptation of the regulatory framework to innovation, as well as the introduction of new regulatory procedures and pathways for promising new therapies. While regulatory flexibilities should not undermine patients’ safety, they have the potential to speed up patients’ access to life-saving products.
Other aspects of the Commission’s proposal, however, can be further improved. The “elephant” in the proposed directive is of course the definition of “unmet medical needs”. Whether a static definition of such a key concept should be set in law is questionable, as it may become outdated faster than the legislation is implemented. If the legislation is to include a framework for assessing unmet patient needs, it must be defined in full cooperation with patients. Only patients can ensure that research and development of new medicines targets the most needed medicines from their perspective. Unmet patient needs are not just about morbidity and mortality, they encompass considerations of quality of life, disease severity, available treatment options – including convenience, adequacy, availability, etc.
Only patients can define what added therapeutic value means from their lived experience. Not everything “new” is innovative, and patients’ involvement throughout the medicines’ lifecycle is the key to prioritising those products that make a tangible, positive difference to them.
Access to high-quality, patient-centred, and timely healthcare, including medicines, is a fundamental right of patients. For many patients living with chronic diseases, medicines are an essential aspect of treatment and therefore, this new legislation is crucial. It should constitute another building block of a true EU Health Union, equipped with the right resources and instruments to address systemic challenges such as access to quality care, inequalities, healthcare digitalisation, and tackle non-communicable and communicable diseases alike. We will continue to advocate for patients’ full involvement in the development and implementation of the EU health agenda and for healthcare systems that meet all patients’ needs.
1 Council Directive 89/105/EEC of 21 December 1988 relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of national health insurance systems.