Belgium leading new ‘one-stop shop’ for medicines, simplifying pharma market

Belgium is leading a new European consortium to streamline the evaluation of health technologies across the European Union.

By streamlining the evaluation of new medicinal products and high-risk medical devices, the simplification aims to ensure faster, evidence-based decision-making and better access to innovative treatments.

The newly formed consortium, comprising 34 health technology assessment (HTA) agencies from 19 EU Member States, will conduct joint clinical assessments and scientific consultations for medicines and medical devices.

This work is being implemented under EU Regulation 2021/2282 on Health Technology Assessment (HTAR), which establishes a permanent EU framework for joint assessments.

Pedro Facon, Vice President of Belgian National Institute for Healthcare and Disability Insurance (NIHDI), highlighted the regulation’s importance to Euractiv: “There is a wealth of information available about the HTA regulation and the reasons why it is truly significant.”

As healthcare innovation accelerates, he noted that new treatments are entering the market faster than ever, thanks to accelerated authorisation procedures.

However, this brings new challenges for payers like NIHDI.

“It’s crucial not only to assess whether a treatment is safe and effective but also to evaluate its relative added value—how much better it is compared to alternatives if they exist and whether the cost is justifiable,” said Facon.

Supported by the European Commission under the EU4Health programme, this initiative marks a milestone in collaborative healthcare policymaking.

New era of EU collaboration

The HTA Regulation (HTAR), which entered into force on 12 January 2025, introduces a framework designed to enhance the efficiency and consistency of health technology assessments across the EU.

Facon also addressed the collaborative nature of the HTA regulation, emphasising the need for shared resources across Member States: “Now, every country faces challenges in having sufficient capacity and expertise to conduct these evaluations.”

“The HTA regulation allows us to address large portions of this collectively at the European level – everything except, roughly speaking, the national willingness to pay.”

This collaborative approach, he explained, enables countries to pool resources, divide the workload, and focus on the most complex therapies.

He remarked: “Initially, we will focus on cancer medicines and advanced therapy medicinal products (ATMPs). Later, this will expand to other medicines and, eventually, to medical technologies.”

To support this legislative innovation, the European Commission has awarded a €35 million framework contract to the consortium, formed under the guidance of the Heads of the HTA Agencies Group (HAG).

This group, which includes members of the HTA Coordination Group, is led by Belgium’s NIHDI. The signing of the framework contract on 22 January 2025 marked a critical milestone in establishing a robust legislative and procedural framework for collaborative HTA in the EU.

“Of course, to ensure this collaboration runs smoothly and that the procedures exist and are carried out efficiently, a kind of coordinating body is necessary,” Facon explained. “It is in this area that the NIHDI, with Belgium, is taking a leading role.”

Robust, evidence-based assessments

Over the next 48 months, the consortium will focus on delivering robust, evidence-based clinical assessments to guide healthcare decision-making across Europe.

By conducting joint HTA reports, Member States can efficiently evaluate the therapeutic value of medicines while fostering transparency and equal access to innovative treatments.

This world-first ‘one-stop shop’ for medicines will significantly reduce duplication.

Pharmaceutical companies will now submit a single application instead of 27, simplifying processes and enhancing the EU’s attractiveness as a global market.

Building on Belgium’s legacy of collaboration

Belgium’s leadership within the consortium is rooted in decades of fostering international collaboration.

Initiatives such as the BeNeLuxA collaboration – uniting Belgium, the Netherlands, Luxembourg, Austria, and Ireland to address medicine pricing and reimbursement challenges – and the Critical Medicines Alliance, which tackled shortages of essential medicines, have laid the groundwork for the EU’s HTA framework.

This extensive experience and strong reputation have established Belgium as a trusted leader in the field.

“This is the result of years of dedication from staff and leadership within NIHDI, as well as political leadership at the ministerial level, both from the previous Minister of Social Affairs, Maggie De Block and the current outgoing Minister of Social Affairs, Frank Vandenbroucke,” Facon told Euractiv.

He emphasised that “while we take on a leadership role, we collaborate closely with other countries and seek support when needed.”

Long-term impact on healthcare systems

This collaboration promises significant benefits for national healthcare systems. By sharing the workload and harmonising methodologies, Member States will save resources and improve the timeliness of assessments.

In addition, the centralised process will enhance collective bargaining power for price negotiations, ensuring sustainable healthcare budgets.

“This is a perfect example of European cooperation that makes the Member States stronger: a joint evaluation of new medicines makes the evaluation better, cheaper, and gives us more leverage during negotiations,” said Belgium’s Frank Vandenbroucke, Deputy Prime Minister and Minister of Social Affairs.

“I’m convinced that it will also contribute to an improvement of our decision-making with regard to the price and reimbursement of medicines, which is key to guaranteeing both the long-term accessibility of new drugs and a sustainable budget.”

[Edited by Vasiliki Angouridi, Brian Maguire]

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Publish date : 2025-02-14 10:59:00

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