Greece and Poland Urge Irish EU Presidency to Prioritize Biotech and Medicines Security

As the European Union seeks to bolster its industrial competitiveness and secure its healthcare supply chains against global disruptions, legislative frameworks governing pharmaceuticals and biotechnology have taken center stage. With Ireland commencing its rotating Presidency of the Council of the European Union for the second half of 2026, member states are actively lobbying Dublin to prioritize key legislative files designed to enhance Europe\'s healthcare resilience.

Chief among these advocates are Greece and Poland, who have formally urged the Irish EU Presidency to accelerate work on biotechnology innovation and medicines security. Both nations have highlighted the compounding threats of systemic drug shortages, clinical trial delays, and Europe\'s heavy reliance on third countries for essential pharmaceutical ingredients. This article explores the details of their joint advocacy, the legislative files under review, and the strategic implications for pharmaceutical and medical device companies operating in the EU.

The European Council Presidency Trio and Shared Health Goals

The rotating Presidency of the Council of the EU is structured around "trio" groups to ensure continuity of the legislative agenda over an 18-month period. The second half of 2026 marks the beginning of a new presidency trio comprising Ireland (July to December 2026), Lithuania (first half of 2027), and Greece (second half of 2027). While Poland is not part of this specific trio, it has aligned with Greece to form a strong coalition pressing for health and pharmaceutical reforms during the Irish term.

As part of this collaboration, Greece and Poland have presented a series of priority areas to the Irish health authorities. Greece is focusing heavily on the development of the biotechnology sector, clinical trial efficiency, and manufacturing scalability. Poland, meanwhile, is championing the cause of medicines security, seeking concrete mechanisms to prevent shortages of essential drugs and urging the simplification of regulatory hurdles for generic and biosimilar manufacturers.

Advancing the European Biotech Act

Greece\'s advocacy is heavily focused on the proposed **European Biotech Act**, a legislative initiative aimed at creating a unified, modern regulatory framework for biotechnology across the EU. The Greek government, which is preparing for its own presidency in late 2027, wants the Irish term to lay the groundwork by advancing key negotiations on the act.

The European Biotech Act is designed to address several critical challenges currently limiting biotech growth in Europe, including fragmented national regulations, slow approval timelines for advanced therapy medicinal products (ATMPs), and barriers to securing venture capital. Greece argues that by accelerating this act, the EU can streamline clinical trial authorization procedures, establish harmonized standards for gene and cell therapies, and create targeted tax incentives for biomanufacturing facilities. These measures are seen as essential to prevent European biotech startups from relocating to the United States or Asia, where capital markets and regulatory approvals are often faster.

The official flag of the European Union and the national flag of Ireland displayed outside the European Council building during the Irish Presidency.

Securing Supply Chains: The Critical Medicines Act

While Greece focuses on forward-looking biotech innovation, Poland\'s primary concern lies in the immediate security of the drug supply. Systemic shortages of basic antibiotics, cardiovascular medicines, and oncology treatments have affected pharmacies across the EU, forcing member states to seek emergency imports and coordinate distribution.

Poland has urged the Irish Presidency to make substantial progress on the **Critical Medicines Act**. This proposed legislation aims to establish a secure, localized supply chain for a defined list of essential medicines. Key components of the act supported by Poland include:

• Strategic Stockpiling: Establishing national and EU-level reserves of critical drugs to buffer against sudden manufacturing shutdowns or supply chain blockages.
• Diversification of Production: Providing financial incentives and subsidies to repatriate the production of active pharmaceutical ingredients (APIs) back to European soil. Currently, Europe relies on imports from India and China for over 70% of its raw API requirements.
• Shortage Monitoring: Creating an automated, real-time alert system across EU pharmacies and distributors to report supply issues before they impact patient care.

Regulatory Simplification for Medical Devices (MDR & IVDR)

In addition to pharmaceutical supply chains, both Greece and Poland have highlighted the need for urgent revisions to the **Medical Devices Regulation** (MDR) and **In Vitro Diagnostic Regulation** (IVDR). Since their implementation, these regulations have faced criticism from industry stakeholders for creating complex, costly, and slow conformity assessment processes, which have led to some legacy devices being withdrawn from the European market.

Under pressure from member states, the European Commission has introduced temporary extensions, but Greece and Poland are asking the Irish Presidency to lead negotiations on a more permanent solution. They are calling for a simplified approval pathway for "well-established technologies" (WET) and Class I/II devices, reducing the duplicate clinical testing requirements for existing, safe products. They also advocate for increasing the capacity of designated Notified Bodies to accelerate certification timelines and lower the administrative burden for small and medium-sized medical device enterprises (SMEs).

Comparing Key Legislative Priorities

To summarize the distinct yet complementary focus areas of the two member states lobbying the Irish EU Council Presidency, the table below outlines the primary legislative files and their key objectives: