New European plan for biotechnology and medicines strengthens innovation, production, patient access, and the strategic autonomy of the European Union.
The Minister of Health Adonis Georgiadis, from the Council of Health Ministers of the EU in Luxembourg, placed at the center of the European debate the need for access to medicines to be treated henceforth as a matter of strategic autonomy, resilience, and European security, at a time when Brussels is pushing for far-reaching reforms in biotechnology, pharmaceutical production, and medical devices, with the aim of strengthening innovation, reducing dependence on third countries, and accelerating the transfer of scientific advances to the market for the benefit of patients.
Adonis Georgiadis also participated in the Council of Health Ministers of the European Union Member States held in Luxembourg, where, among other things, he emphasized that access to medicines is now a matter of strategic autonomy, resilience, and European security.
Progress in the negotiations
In particular, among the topics discussed at the Council was the amendment of the Directives concerning the placing on the market of genetically modified microorganisms in the European Union and their use in the processing of solid foods(the “Biotech I” Directive), an exchange of views on the Regulation on the European Biotechnology Act I and how it can strengthen health biotechnology in the EU.
In addition, progress was reviewed regarding the negotiations on the Regulation amending Regulations 745 and 746/2027 on medical devices and in vitro diagnostic medical devices, while the policy on “Strengthening Europe’s Pharmaceutical Resilience and Strategic Autonomy” was also discussed.
The Cypriot Presidency strengthened the provisions regarding the processing of transplants
In his remarks, the Minister of Health supported the Council’s general approach to the Directive (Biotech I Directive), emphasizing that the Cypriot Presidency strengthened the provisions specifically regarding the processing of transplants.
Regarding the Regulation on the promotion of biotechnology and biomanufacturing in the Union, he emphasized that Greece considers the European Biotechnology Act a key strategic initiative for strengthening Europe’s leading position in biotechnology and biomanufacturing in the health sector. “At a time of intensifying global competition, biotechnology is not only a driving force for growth and innovation, but also a critical pillar of Europe’s health security, resilience, and strategic autonomy.” At the same time, he explained that, while Europe continues to excel in scientific research and faces a persistent gap between scientific excellence and commercial success, many innovations are ultimately developed, manufactured, and marketed outside the Union.
The new legislation must help reverse this trend, emphasizing that the European Biotechnology Act represents a unique opportunity to strengthen Europe’s global competitiveness, while ensuring that scientific and technological progress delivers tangible benefits for patients and citizens.
To achieve this goal, the Regulation should cover the entire biotechnology value chain, from research and clinical development to manufacturing, market launch, and patient access. Europe must become a place where innovative companies can grow, invest, and manufacture, while ensuring that patients benefit more quickly from cutting-edge technologies.
Actions Across Three Key Pillars
In this context, actions are proposed across three key pillars, as stated by the Minister of Health:
First, regulatory simplification must yield tangible results. Based on initiatives such as FAST-EU and COMBINE, the directive should establish faster, more predictable, and better-coordinated procedures for clinical trials and product development across the Union. Reducing unnecessary administrative burdens, while ensuring the operational sustainability of competent authorities and ethics committees, will enhance Europe’s attractiveness for research and innovation.
Second, Europe must address its structural weaknesses regarding scaling-up funding and industrial development. Stronger support for later-stage financing, strategic investments, and advanced bioproduction infrastructure is essential to help innovative companies remain and grow within the Union. At the same time, we must seize the opportunity to build a stronger biomimetic sector.
Third, the framework for strategic projects should focus on technologies that address unmet medical needs, strengthen security of supply, and enhance Europe’s long-term competitiveness.
Finally, the Minister reiterated that the success of the European biotechnology initiative should ultimately be measured by its impact on patients’ health, emphasizing that true innovation is innovation that reaches patients and improves their clinical outcomes.
Regarding the proposed amendments to Regulations 745 & 746/2017 on medical devices and in vitro diagnostic medical devices, he reiterated that the improved framework, which will address the shortcomings of the previous one, must be agreed upon and adopted as soon as possible, while maintaining high standards of quality and safety, in order to ensure an uninterrupted supply to the market.
A matter of strategic autonomy, resilience, and European security
During the luncheon discussion, Mr. Georgiadis reiterated that he considers access to medicines to be a matter of strategic autonomy, resilience, and European security. He believes that the EU’s key priorities are strengthening European pharmaceutical production, diversifying supply chains, and effectively implementing the Critical Medicines Act and the revised pharmaceutical legislation. At the same time, he emphasized that resilience must go hand in hand with sustainable access to innovation, and that the HTA Regulation can make a substantial contribution to faster patient access to new, clinically effective, and affordable treatments, while developments in pricing policies require close European monitoring, evaluation, and coordination. He advocated for strengthening voluntary cooperation among Member States and keeping the issue of antimicrobial resistance high on the European policy agenda. Finally, he proposed that the issue be discussed on an ongoing basis at upcoming Health Ministers’ Councils.
Furthermore, the Minister of Health reiterated that Article 9 of the Urban Wastewater Directive cannot be implemented as is, until we have a clear picture of the implications for the pharmaceutical sector and patient safety, calling for immediate action.
On the sidelines of the Council of Health Ministers, accompanied by the Secretary-General for Strategic Planning, Health Minister Georgiadis held a bilateral meeting with Crisis Management Commissioner Lahbib, during which he was briefed on the European Commission’s actions regarding the response to the Ebola outbreak in Central Africa. For his part, the Minister reaffirmed Greece’s support for the work of HERA and was informed that a legal provision had recently been enacted to institutionalize the country’s participation in the European
