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,
- the sustainability of the system and European competitiveness,
- equal access to the regulatory framework,
- availability and supply security.
In particular, the FAMHP advocates for more harmonised governance at European level, full digitisation and an acceleration of the development of EUDAMED, better integration of cybersecurity and artificial intelligence requirements, and more efficient tools to support innovation and critical or orphan products.
During the technical discussions within the Council progress was made on the scope, governance, notified bodies, classification, post-market surveillance, the obligations of economic operators and the specific provisions for in vitro diagnostic medical devices. On 16 June 2026, a progress report was presented to the EPSCO Council. The forthcoming Irish Presidency of the Council aims to reach a general approach at the EPSCO Council in December 2026.
Critical Medicines Act: a crucial step towards a structural approach to addressing shortages
This proposed regulation aims to strengthen the security of supply of critical medicines in Europe. The regulation focuses on the diversification of supply chains, investment in manufacturing capacity and cooperation between Member States, including through joint procurement. In addition, it introduces resilience requirements in public procurement and coordination at European level through the Critical Medicines Coordination Group.
Belgium had been calling for a Critical Medicines Act since 2023 and has, understandably, advocated an ambitious approach to this issue. In particular, the FAMHP has emphasised the importance of a genuine European strategy for security of supply, of robust resilience criteria in public procurement, of the relevance of multi-award procedures, and of a framework-based yet operational "European preference policy".
In May 2026, the Council and the European Parliament reached a provisional political agreement on the Critical Medicines Act. In June, the COREPER has validated the final text. Formal adoption and implementation will follow in the following months. These new dispositions need to go hand in hand with rapid strategic positioning at national level in order to organise the Belgian coordination, clarify the relevant stakeholders' roles and prepare for participation in future European mechanisms.
European pharmaceutical legislation: towards the final approval of a far-reaching reform
The pharmaceutical package is the first major overhaul of EU medicines legislation since 2004. Its goal is to better address patients’ needs by promoting innovation and competitiveness through incentives for new antimicrobial substances, medicines for rare diseases and paediatric treatments, and by addressing supply security and shortages so that safe, affordable medicines are available in a timely manner throughout the EU. The European medicines legislation reform has taken a decisive step forward with the political agreement reached between the Council and the Parliament in December 2025. The subsequent technical work led to a final agreement on the directive and the regulation, which was reached in early 2026.
The challenge for the FAMHP now lies in transposing the directive into national law and preparing its implementation. Particular attention is being paid to the upcoming delegated and implementing acts, particularly with regard to electronic product information (ePI), regulatory sandboxes and certain new instruments relating to innovation and antimicrobial substances. Belgium emphasises the need for coherent implementation at European level, taking place well in advance to allow for proper national transposition and effective coordination between the competent authorities.
The vote in plenary session and the approval by the Council and the official publication will take place in the following months.
Audiovisual media services: the FAMHP calls for stricter regulation on online health information
The European Commission is evaluating the Audiovisual Media Services Directive (Directive 2010/13/EU) .It is indeed true that the market has profoundly changed since the last revision in 2018.
In its contribution to the consultation on the evaluation and forthcoming revision of the Audiovisual Media Services Directive, the FAMHP calls, among other things, for clear rules on the role of influencers, transparency in commercial communications, and stricter obligations for platforms regarding the removal and traceability of content. This will offer citizens better protection against illegal advertising of unauthorised or prescription-only medicinal products and, more generally, against medical misinformation in digital environments.
This development may lead to a stricter regulatory framework for online communication relating to health products. The FAMHP, in collaboration with the competent authorities will, continues to follow the completion of the European review and the proposals for revision.