Lessons learned? The EU on its way to a new approach in pharmaceutical regulation. Feedback from CEE countries to the EU Strategy.
Many EU initiatives have seen the light of day in recent months to renew EU policy and regulation in the pharmaceutical sector. All of them will form bricks to build a stronger European Health Union.
Initiatives include, e.g.:
• to establish a new institution on EU levels – the Health Emergency Preparedness and Response Authority;
• to create a European Health Data Space;
• to adopt a Health Technology Assessment Regulation;
• to contribute to the European Pillar of Social Rights;
• to align the pharmaceutical sector to other EU projects.
In addition, at the end of 2020 the EU initiated the renewal of the Pharmaceutical Strategy for Europe, revising pharmaceutical legislation to address potential weaknesses with the following major goals:
• delivering for patients – unmet medical needs and unequal access to medicines for patients across the EU;
• a competitive and sound legislative framework to quickly respond to innovation and enabling digital transformation;
• enhancing resilience – securing supply of environmentally sustainable medicines and enhancing EU health crisis mechanisms.
The Pharmaceutical Strategy and the Combined Evaluation Roadmap/Inception Impact Assessment draws conclusions not only from application of current EU pharmaceutical legal acts but also from issues experienced during COVID-19.
Initial feedback from all interested persons was collected by the end of April 2021.
Different opinions were received from pharma associations and institutes of CEE countries with generally positive feedback to the initiatives as such.
However, many opinions stress the fact that inequalities in access to medicines and affordability will not be resolved solely by EU regulation since they also originate also from the size of markets, national regulations (especially pricing & reimbursement), national timelines and readiness of national health systems. This was stressed by the Romanian Association of International Pharmaceutical Producers, the Polish INFARMA, and the Lithuanian Free Market Institute.
The AIFP of the Czech Republic suggests that the legislative framework should allow policy adaptions at a later stage without the need to revise the whole legislation anew.
Suggestions from the lessons of COVID-19 include enhancing the process of resource allocation, reforming procurement, rationalizing stockpiling away from uncoordinated national stockpiling demands, and use of data from national databases due to the Falsified Medicines Directive.