European legislative initiatives such as the Biotech Act, the MDR/IVDR revision, the Critical Medicines Act, the new European pharmaceutical legislation and measures relating to online health information will have a significant impact on all stakeholders. The FAMHP provides an update on the current situation.
Even though the initiatives mentioned cover a wide range of areas, they share a common ambition: to strengthen a coherent and workable European regulatory framework that fosters innovation, safeguards patient safety and supports sustainable access to medicines and health products. The FAMHP remains actively committed to developing and implementing Belgium’s positions in European forums, with particular attention to striking a balance between competitiveness, public health, security of supply and the quality of regulation.
Biotech Act: strengthening innovation through coherent regulation
The European Commission presented the Biotech Act I on 16 December 2025 as part of the "Health Package". It consists of one regulation and one directive. The Biotech Act aims to strengthen the European biotechnology sector, with a focus on medicines and health products. This legislation provides for incentives for innovation, support for clinical trials, strategic projects and a more favourable investment climate.
For the FAMHP, the purpose is clear: to support a European framework that is more conducive to biotechnological innovation, while maintaining a high level of safety, scientific rigour and alignment with existing frameworks, and at the same time improving patients’ access to innovative treatments. The FAMHP advocates clearer, more efficient and better-coordinated procedures, particularly for clinical trials and the support given to innovators. The FAMHP also emphasises the need for clear governance and the prevention of any form of regulatory fragmentation.
During the EPSCO Council (Employment, Social Policy, Health and Consumer Affairs Council) policy debate on 16 June 2026 the Member States’ ministers responsible for public health were asked to adopt a general approach to the directive, while the regulation was the subject of a policy debate within. Negotiations on the regulation are expected in the coming months.
MDR/IVDR: targeted amendments to a complex framework
On 16 December 2025, the European Commission presented a targeted revision of the MDR (Medical Device Regulation) and the IVDR (In Vitro Diagnostics Regulation) in order to simplify the framework for medical devices and in vitro diagnostic devices and to make it more predictable.
The FAMHP supports a targeted simplification and modernisation of the system, without compromising the essential requirements relating to clinical evidence, supervision and the liability of market participants. The following six principles are at the core of the FAMHP’s positions:
- proportionality and a risk-based approach,
- legal certainty and predictability,
- scientific integrity and evidence-based decision-making,
Excerpt from the official page. The original is authoritative. Continue reading at FAMHP (Belgian Medicine Agency) ↗