Belgium has still to take a definitive position on the Polish Presidency’s compromise proposal for the EU pharmaceutical package, as discussions continue at Council level.

A decision will hinge on multiple strategic, economic, and health-related considerations ahead of a critical COREPER I meeting on 21 May.

“The Belgian position on the Presidency compromise proposal is not definitive yet and will be finalised in accordance with the progress of the discussions within Coreper,” a Belgian government spokesperson told Euractiv.

Several factors will influence Belgium’s final stance. “Belgium will take into account several factors in order to determine its position, including the impact on the pharmaceutical industry, the EU’s strategic autonomy and the impact on our social security system,” the spokesperson added.

Belgium also continues to advocate for a coordinated approach with like-minded member states and is assessing the potential mandate “based on the progress of the discussions in the Council and the support of other Member States.”

Domestic industry concerns

Concerns raised by Belgium’s domestic pharmaceutical sector have not gone unnoticed. “The Belgian pharmaceutical sector has raised concerns about the impact of the reforms on innovation and investment. Belgium recognises the importance of the sector and takes these concerns into account,” the spokesperson confirmed.

Belgium has long supported maintaining a longer regulatory data protection (RDP) period for new medicines, a stance shaped by its strong pharmaceutical ecosystem.

That position has remained consistent since the Commission’s proposal was first introduced, placing Belgium among the group of countries favouring extended exclusivity (the so-called “A-tier”), in contrast with those advocating shorter terms.

At the same time, observers note that Belgium, like other EU countries, is navigating a delicate balance between preserving incentives for innovation and addressing persistent barriers to patient access.

While the country is considered a leader in pharmaceutical research and production, regulatory complexity and delayed reimbursement decisions continue to hinder the timely delivery of treatments to patients.

Amid broader geopolitical shifts, Belgian regulators also acknowledge that external trade dynamics could influence national and EU-level positions on pharmaceutical legislation.

“Tariffs should not have an impact on the pharmaceutical package, but the current geopolitical situation will make the pharmaceutical industry more sensitive to any incentives, which could affect the position of member states,” said a spokesperson of the Federal Agency for Medicines and Health Products.

Council faces high stakes

As reported earlier by Euractiv, the Polish Presidency is aiming to adopt the Council’s position “sooner, rather than later”, ideally before it hands over to Denmark on 1 July.

In remarks reported by Pink Sheet, Lilia Luchianov, a policy officer at the European Commission’s DG SANTE, said that “in the best-case scenario,” trilogues could begin in July and a final version of the legislation could be adopted before the end of the year.

However, she also cautioned that unresolved divisions between member states could delay the process by a full year.

“If member states disagree on some points and they try to fight more on some elements, then it could be delayed,” Luchianov warned, adding: “It’s really like looking into a crystal ball.”

Disagreement over the length of RDP remains one of the most contentious issues, with some countries insisting on a longer exclusivity period, while others push for a shorter one, a split that continues to block consensus in the Council.

U.S. pressure and strategic autonomy

Recent moves by the United States to lower medicine prices have also shifted the tone of the debate in Brussels. The transatlantic developments have served as a wake-up call for some policymakers, renewing calls for greater European strategic autonomy and competitiveness in pharmaceuticals.

At the same time, many stakeholders warn that unless the EU reduces regulatory complexity and improves investment conditions, it risks losing ground to more agile global markets.

Belgium, in particular, faces the challenge of translating its innovation strength into faster and more equitable access for patients.

Informal technical meetings are underway, and a first trilogue could take place as early as the last week of June, if the Council secures a qualified majority in time. The next few days will determine whether the pharmaceutical reform is finalised under the Polish Presidency or postponed into 2026.

[Edited by Vasiliki Angouridi, Brian Maguire]