Growing geopolitical tensions, persistent medicine shortages, and increasing global competition have quickened Europe’s ambitions to secure its pharmaceutical supply chains.

For Belgian MEP Yvan Verougstraete (Renew Europe Group), relocating pharmaceutical production to Europe is a realistic goal. “But it won’t happen on its own,” he said in an interview with Euractiv.

Verougstraete is Vicfore-Chair of the Committee on Industry, Research and Energy (ITRE) and Substitute on the Committee on Public Health (SANT). “It requires strong political ambition and a real commitment to rethinking our industrial strategy in this area. I certainly won’t let anyone claim that it’s impossible,” he said.

According to Verougstrate, the priority should be to begin with critical medicines, where vulnerabilities in the supply chain are already well known.

Early steps towards reshoring

Some progress has already been made. The construction of an antimicrobial production plant in Austria and a new paracetamol factory in France demonstrate that reshoring efforts are moving from theory to practice.

In March 2024, Sandoz, a generic pharmaceutical and biosimilar company based in Switzerland, opened an antibiotic manufacturing facility in Kundl, Austria.

With this investment, Austria and Sandoz aim to serve more patients with critical antibiotics, produced entirely in Europe.

Similarly, the French government recently announced its support for seven new industrial projects aimed at strengthening the production of strategic medicinal products in France. Among these is Ipsophène, which plans to construct a new paracetamol factory as part of the “France 2030” initiative, reinforcing national production of this essential medicine in France.

“However, these isolated cases need to become part of a broader, long-term industrial strategy,” Verougstraete stressed.

Supply chain deficiencies

Verougstraete advocates for greater cohesion rather than competition among Member States.

“The possibility of joint procurement between several EU countries should be a key consideration in the legislation. We need greater strategic autonomy: reshoring production, multiplying supply chains, establishing strategic stockpiles, and strengthening coordination between Member States. This is a major public health issue.”

The pharmaceutical sector shares the ambition of reinforcing supply chains and fostering local investments. However, industry representatives warn against regulatory measures that could undermine Europe’s attractiveness as a hub for pharmaceutical production.

“As a sector, we welcome ambitions to strengthen supply chains and encourage local investments,” said Caroline Ven, CEO of pharma.be, the Belgian pharmaceutical industry association.

“At the same time, caution is needed when introducing regulations or initiatives that could make Europe less attractive – such as fragmented national strategic stockpiles of medicines or vaccines, or mandatory joint purchasing mechanisms that do not account for differences in national healthcare systems,” said Ven.

For Belgium, tackling medicine shortages is a clear government priority at both the European and national levels.

“The government has committed to cooperating at the European and multilateral levels to facilitate joint negotiations and procurement of hard-to-access medicines,” Ven added.

While pricing and reimbursement decisions remain the competence of individual Member States, Verougstraete believes greater dialogue and cooperation within the EU would provide significant added value.

Belgium commits to pharma security

Verougstraete underscores the government’s firm commitment to strengthening Belgium’s pharmaceutical sector as part of a broader European strategy.

“We ensure that the supply of generic medicines and biosimilars remains sufficiently attractive in the Belgian market through a sufficiently flexible financial framework and incentives to stimulate the market.”

To guarantee supply security, the government is increasing transparency, evaluating pricing mechanisms, and imposing a binding public service obligation on industry stakeholders.

“Efforts are being made to ensure transparency, a thorough assessment of pricing mechanisms, and a binding public service obligation from the various actors, alongside maintaining a list of essential medicines,” Verougstrate remarked

Belgium is also advancing its Medicines Roadmap, designed to streamline the reimbursement process by making it faster, more transparent, and science-driven.

“We are implementing the Medicines Roadmap to ensure a targeted, transparent, and efficient reimbursement process. All submitted requests will be handled appropriately and quickly, tailored to the type of request and based on scientific and economic evidence,” he said.

A standardised assessment model within the Commission for Reimbursement of Medicines (CRM) will align pharmaceutical and economic expertise with KCE (Belgian Health Care Knowledge Centre) guidelines.

Accelerating patient access

Ensuring faster access to medicines, medical devices, and innovative treatments is another key priority.

“Citizens must be able to access medicines, medical devices, and innovative treatments more quickly. Significant steps have already been taken in this regard within the Medicines Roadmap,” Verougstrate added.

The new fast-track and early-access procedure will be monitored and evaluated before 2027, with adjustments made if necessary to maintain both speed and budgetary control.

At the European level, Belgium is actively pushing for joint negotiations and procurement of hard-to-access medicines.

According to Verougstrate, “The government is committed to collaborating at European and multilateral levels to facilitate joint negotiations and the purchase of hard-to-access medicines.”

Belgium is also implementing the EU Health Technology Assessment (HTA) Regulation to enhance access to the latest treatments while reducing bureaucratic barriers.

Fighting AMR

Combatting antimicrobial resistance (AMR) is a top priority for Belgium, which has pledged to support EU-wide initiatives for developing new antibiotics.

“The fight against antimicrobial resistance is a government priority. To develop new antibiotics, Belgium will support European initiatives in this area,” Verougstrate remarked.

Reforms are also underway at the Federal Agency for Medicines and Health Products (AFMPS) to improve efficiency.

“AFMPS operations are being assessed and reformed to ensure the agency improves public service in collaboration with all stakeholders. Its functioning must be maintained within a defined budgetary framework,” he argued.

Boost clinical research

Belgium is also addressing Europe’s declining position in clinical research, particularly in Advanced Therapy Medicinal Products (ATMPs).

“Europe, with Belgium as a frontrunner, is losing ground in clinical research, particularly regarding ATMPs. To maintain its attractiveness for clinical research, Belgium needs a progressive, flexible, and supportive regulatory environment, as well as strong and effective cooperation between relevant institutions,” Verougstrate said.

The government is encouraging the development of a national clinical trial network to keep Belgium at the forefront of medical innovation.

[Edited by Vasiliki Angouridi, Brian Maguire]