European leaders on Friday urged stronger coordination between the European Commission, EU member states, and relevant agencies to tackle a fast-expanding illicit drugs market estimated to be worth €31 billion, warning that organised crime networks are increasingly operating across borders and exploiting gaps in enforcement.

The issue was discussed at the level of EU heads of state for the first time, reflecting growing concern over the scale and complexity of drug trafficking across the continent. Officials said the booming market is being driven by the rising availability of new psychoactive substances, evolving smuggling routes, and the use of encrypted communication platforms and online marketplaces that make detection more difficult.

Speaking after the meeting in Brussels, Belgian Prime Minister Bart De Wever said Europe’s major port hubs have become key entry points for illegal shipments, underscoring the cross-border nature of the threat.

“As the home of one of the biggest ports in Europe, my country has gained a simple but central knowledge: organised crime knows no boundaries,” De Wever told reporters. “Therefore, our answer to this threat must not end at the borders.”

EU leaders stressed that tackling the drug trade requires a coordinated, wide-ranging response that goes beyond law enforcement alone. According to the conclusions adopted at the summit, member states must adopt a “whole-of-government and whole-of-society approach” based on evidence, involving action at local, regional, national, European and international levels.

The statement called for improved preparedness, stronger public health protections, enhanced security measures, and expanded efforts to reduce drug-related harm. Leaders also emphasised the importance of deepening cooperation between EU countries and international partners, including initiatives such as the European Coalition Against Drugs and increased collaboration with third countries.

The conclusions further highlighted the need for stronger law enforcement coordination to disrupt trafficking networks and address the growing sophistication of criminal operations. Officials noted that criminal groups are increasingly relying on fragmented supply chains and digital tools, making traditional policing methods less effective without greater cross-border intelligence sharing.

Earlier this month, EU home affairs ministers agreed on implementation steps for the bloc’s drugs strategy covering the period from 2026 to 2030, setting the framework for future policy coordination.

The latest summit marks a shift in approach, with European leaders signalling that the drugs trade is no longer just a criminal justice issue, but also a public health, security, and governance challenge requiring sustained cooperation across the bloc.

EU health ministers remain divided over a proposal to extend market protection for certain innovative medicines, as Brussels seeks to balance industrial competitiveness with patient access and healthcare affordability.

The proposal, part of the wider Biotech Act package, would grant an additional year of exclusivity under Supplementary Protection Certificates for selected treatments. These would apply to medicines containing new active substances, those with different mechanisms of action compared with existing therapies, products tested in more than two EU member states, and drugs with at least one manufacturing step carried out within the bloc.

The European Commission argues the measure is necessary to attract biotech investment, strengthen domestic manufacturing, and prevent pharmaceutical innovation from shifting to other global markets. EU Health Commissioner Olivér Várhelyi defended the proposal, saying that without stronger incentives, many new treatments would not reach Europe until after patent expiry elsewhere.

He also rejected concerns over cost implications, suggesting that greater investment in preventive healthcare could offset long-term spending pressures on national health systems.

However, several member states raised strong objections, warning that longer exclusivity periods could delay the entry of cheaper biosimilar alternatives and increase strain on public healthcare budgets. Critics also questioned whether the proposal sufficiently considers unequal access to medicines across the EU.

Malta highlighted stark disparities in availability, noting that it had access to only 17 innovative medicines approved between 2020 and 2023, compared with more than 150 in Germany and over 140 in Italy. Officials warned that extending monopoly rights could deepen such inequalities.

Estonia echoed these concerns, stressing the need for a balanced approach that considers affordability, accessibility, and the long-term sustainability of national health systems.

Other delegations, including Poland and France, questioned whether the Commission had provided enough evidence to justify the policy shift. Some ministers pointed out that the proposal was not accompanied by a standalone impact assessment and relied instead on broader pharmaceutical sector analysis.

Despite disagreements, there was broad agreement on the need to simplify clinical trial procedures, reduce administrative burdens, and avoid regulatory overlap. Many countries also emphasised the importance of strengthening biosimilar markets, which are seen as critical to lowering drug costs and improving patient access across the EU.

France and several other member states argued that biosimilars play a key role in ensuring system resilience and affordability, particularly for smaller healthcare systems.

The debate reflects a broader fault line in EU industrial policy: how to encourage innovation without undermining access and cost control.

As negotiations continue, attention is shifting to Ireland, which will assume the Council of the EU presidency next. Irish Health Minister Jennifer Carroll MacNeill urged member states to accelerate discussions, citing increasing global competition in biotechnology.

She said the external environment makes rapid progress essential and confirmed that Ireland will prioritise clinical trial reform and measures to strengthen Europe’s biomanufacturing capacity.

MacNeill added that Europe must streamline regulatory frameworks to remain competitive, warning that delays could allow other regions to pull further ahead in biotech innovation.

EU health ministers have agreed on a common position to update biotechnology and organ transplantation rules, as the bloc seeks to strengthen its competitiveness in a sector increasingly dominated by the United States and China.

The agreement, reached on 16 June, forms part of the broader Biotech Act package and focuses on revisions to two existing directives covering genetically modified micro-organisms (GMMs) and organ processing procedures. The reforms aim to make regulatory frameworks more flexible, reduce administrative burdens, and improve cross-border cooperation in medical and scientific fields.

Officials say the changes are intended to help Europe catch up in biotechnology innovation, where global rivals have accelerated investment and development in recent years.

Cyprus Health Minister Neophytos Charalambides, who led the negotiations, said the update reflects scientific and technological advances that have taken place since the original rules were introduced. He described the revision as both a practical adjustment and an ethical necessity, given the pace of change in the sector.

Under the revised approach, EU countries agreed to adjust terminology in the European Commission’s proposal. The term “low-risk GMMs” has been replaced with “GMMs eligible for an expedited procedure”, reflecting a more streamlined approval pathway. In addition, consent for placing certain GMMs on the market may now be valid for up to ten years, instead of indefinitely.

The agreement also introduces provisions allowing personal data processing to be treated as serving the public interest in specific cases, particularly where it supports medical or scientific outcomes.

In the area of organ transplantation, member states agreed to extend the implementation period for updated rules from 24 months to 36 months, giving national health systems additional time to adapt to the new requirements.

While the compromise was largely supported, discussions highlighted continuing tensions within the EU over how to balance innovation with safety oversight. Several member states stressed the importance of maintaining strict ethical safeguards, protecting personal data, and preserving national control over transplant systems.

The agreement among member states allows negotiations with the European Parliament to begin once it finalises its position. Lawmakers in the Parliament’s Health (SANT) and Environment (ENVI) committees are currently reviewing the proposal, with MEPs Adam Jarubas of the European People’s Party and Marta Temido of the Socialists and Democrats leading the process.

Charalambides also suggested that upcoming talks should take into account an opinion issued by the European Data Protection Supervisor in late May, noting that it arrived too late to be fully incorporated into the Council’s position.

As Cyprus concludes its presidency of the Council of the EU, responsibility for advancing the file now passes to Ireland, which will guide the next stage of negotiations between member states and the European Parliament.