Pharma package improvements are needed, says Belgian medicines agency

The Belgian medicines agency, an important stakeholder in revising the European pharmaceutical legislation, is proposing improvements to the EU Pharma Package.

“A reform of the pharmaceutical legal framework was more than necessary. Overall, we are satisfied with the Commission’s proposal, which moves in the right direction on many issues,” Hugues Malonne, CEO of the Belgian Federal Agency for Medicines and Health Products (FAMPH), told Euractiv.

“However, we will suggest several improvements to these texts during the upcoming negotiations,” he added.

FAMPH's pivotal role involves not only coordinating with other relevant administrations but also working closely with Belgium's permanent representation to the EU, a responsibility the agency continued to uphold throughout Belgium's six-month presidency of the EU Council.

Supply chain resilience

FAMHP welcomed the inclusion of a chapter dedicated to supply chain security and combating drug shortages. Malonne stated, “In our view, it is high time to review the existing legislative framework.”

Malonne stressed the European Commission’s proposals are moving in the right direction, but they can still be improved on several points, including the incentives regime, environmental risk assessments, and procedural enhancements.

“The recognition of the Heads of Medicines Agencies (HMA) network is also crucial, with the ultimate goal of ensuring high levels of public health protection and maintaining the quality, safety, and efficacy of medicines.”

Shortages and AMR, high priorities

“Our primary priority is related to our mission: to ensure the quality, safety, efficacy, and availability of medicines and health products from their design to their use. It is essential that patients have appropriate access to safe and effective medicines and health products that meet their needs in sufficient quantities,” said Hugues Malonne.

Addressing drug shortages is, therefore, a key focus. He advocates for a system that strengthens supply chains and their transparency.

Combating antibiotic resistance is also among the agency’s priorities. This global issue significantly impacts society and healthcare systems, requiring concerted efforts at Belgian, European, and international levels. The FAMHP emphasises the need to strengthen European rules regarding the use and prescription of antibiotics and to establish mechanisms to stimulate the R&D of new antibiotics.

Additionally, the FAMHP works closely with the European Medicines Agency (EMA) and the competent authorities of other EU member states. Within the European network, AFMPS has chosen to focus on areas where it can excel, such as vaccines and advanced therapies (ATMPs). This focus aims to address new therapeutic needs and enhance the agency's areas of excellence.

Efforts to achieve consensus

“Of course, with the Presidency of the EU Council, our work was significantly altered. It was no longer a question of expressing a national position on the revision of the European pharmaceutical legislation but rather an opportunity to set priorities through agenda setting. We chose to prioritise articles related to combating drug shortages and incentives for innovation,” said Malonne.

During the six-month term, FAMHP dedicated considerable effort to reaching a consensus among the 26 other member states on the optimal text. The agency played a crucial role in guiding delegates both during and outside meetings of the ‘pharmaceutical products and medical devices’ working group.

This included providing support during technical meetings and assisting in drafting various compromise proposals submitted to the working group.

“Work on these priorities is not finished. However, we feel that we have significantly contributed to improving the text and helping the working group advance on a series of major points,” Malonne noted.

Conditionality of regulatory incentives

Regarding regulatory incentives, FAMHP supports the principle of conditionality. “We believe that incentives should be applied within a legal framework that is clear and predictable, ensures patient access, considers the specific needs of SMEs, guarantees the competitiveness of the European pharmaceutical sector, and ultimately limits administrative burden.

Patient access to medicines is a central concern, which is why we advocate for a simplified system where authorisation holders are rewarded for accelerating patient access to innovative medicines across member states.”

“To accelerate procedures and make medicines available more quickly, many deadlines have been shortened in the Commission’s proposal. While we agree that some lengthy procedures could be expedited, we must consider the feasibility and the impact on the workload of competent authorities. It is crucial to find the right balance, as any decision or opinion related to a medicine can have serious consequences," said Malonne.

Authorities must always have the time and data needed to exercise their prerogatives properly. The safety, efficacy, and quality of medicines must remain paramount,” he added.

Administrative simplification and streamlining procedures are also a priority for the FAMHP, vital for the sustainability of the European regulatory network.

The agency's commitment to these goals is viewed as reflecting its broader mission to ensure the effective availability of medicines and health products while maintaining high standards of public health protection.

[Edited by Vasiliki Angouridi, Brian Maguire | Euractiv’s Advocacy Lab]