As the European Union advances a series of major health and industrial reforms, Poland has voiced support for new legislation aimed at strengthening biotechnology, pharmaceutical resilience and medical device regulation across the bloc.
Poland’s health ministry told Euractiv it broadly supports the direction of both the proposed European Biotech Act and the Critical Medicines Act, while calling for further technical work on several elements of the legislation.
“Poland supports the goal of strengthening security of supply and rebuilding production capacity in Europe,” the ministry said.
Focus on resilience and production
The ministry stressed that pharmaceutical security was one of the key health priorities during Poland’s presidency of the Council of the European Union in the first half of 2025.
The Critical Medicines Act could play an important role in reducing Europe’s dependence on external suppliers by encouraging the relocation of active pharmaceutical ingredient (API) production to Europe, the ministry noted. It could also support pharmaceutical investment and strengthen emergency stockpiles.
EU institutions reached a provisional political agreement on the Critical Medicines Act in May. The legislation is designed to reduce medicine shortages and reinforce manufacturing capacity for critical medicines and their ingredients within the bloc.
The Polish government also underlined the importance of ensuring that the new rules are applied consistently across all member states.
“We emphasise the need to ensure uniform application of the legislation throughout the European Union in order to limit the risk of divergent interpretations and implementation at the national level,” the ministry said.
Support for biotech, caution on details
Warsaw has also expressed support for the broader European Biotech Act, which aims to strengthen the EU’s biotechnology and biomanufacturing sectors and improve the bloc’s global competitiveness.
At the June meeting of EU health ministers, member states endorsed the Council’s negotiating position on the directive component of the package and held a policy debate on the regulation establishing a framework for strengthening European biotechnology and biomanufacturing.
Poland supports the overall direction of the initiative but considers some aspects sufficiently complex to require further detailed analysis before final adoption.
The discussion comes as Brussels seeks ways to close the innovation gap with the United States and China in strategically important sectors, including biotechnology, pharmaceuticals and advanced manufacturing.
Simplifying medical device rules
Poland also backed efforts to reduce regulatory burdens for medical devices and in vitro diagnostics, arguing that companies need more predictable and coherent legal frameworks.
The issue forms part of a broader EU effort to simplify existing legislation, which industry stakeholders say creates administrative complexity and can delay market access.
This is in light of longstanding concerns over the implementation of the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), including bottlenecks in notified body capacity, lengthy certification procedures and the risk of certain products being withdrawn from the market.
The proposed legislative path has been largely welcomed by industry stakeholders. The European Federation of Pharmaceutical Industries and Associations (EFPIA) has repeatedly called for a more competitive regulatory and investment environment, warning that Europe risks losing pharmaceutical and biotech investment to other regions unless it improves conditions for innovation and manufacturing.
While legislative negotiations continue, Poland’s position reflects a broader tension at the heart of EU health policy: how to strengthen industrial competitiveness and strategic autonomy without fragmenting the single market through uneven national implementation.
For Warsaw, the challenge will be ensuring that new rules not only support innovation and investment but also translate into tangible improvements in supply security and consistent application across member states.
[VA, BM]