Life sciences and healthcare law firms in Belgium

Clinical trials of medicinal products fall under EU Regulation 536/2014, applied through the CTIS portal, with a single assessment procedure combining the Member State assessment and that of the ethics committee. In Belgium the FAMHP is the competent authority and the college established for this purpose coordinates the accredited ethics committees. Belgium has adopted deliberately short assessment timelines to stay attractive, particularly for phase I trials. Medical devices follow a separate regime under the MDR and IVDR.

Two parallel procedures. The maximum price is set by the Minister for the Economy. Reimbursement requires an application to the NIHDI, assessed by the Drug Reimbursement Committee, which weighs added therapeutic value, budget impact and cost-effectiveness. The procedure is bounded by deadlines derived from the Transparency Directive. For innovative products whose value remains uncertain, managed entry agreements allow conditional reimbursement with confidential financial commitments.

Advertising to the public is prohibited for prescription-only medicines. For others it is regulated and, in Belgium, subject to prior control. Advertising to healthcare professionals is permitted but strictly regulated as to content and the benefits that may accompany it: transfers of value to healthcare professionals and organisations are subject to transparency obligations. Non-compliance exposes you to administrative and criminal sanctions, and increasingly to reputational risk.

The MDR requires classification of the device, a quality management system, technical documentation, clinical evaluation, involvement of a notified body for most classes, registration in EUDAMED, unique device identification, and a post-market surveillance system with vigilance obligations. The manufacturer must designate a person responsible for regulatory compliance. In vitro diagnostic devices follow a parallel logic under the IVDR.

Two regimes not to be confused. A novel food, meaning a food without a significant history of consumption in the Union before May 1997, needs prior EU authorisation, a long procedure handled by the Commission with an EFSA assessment. A conventional food supplement requires notification to the Belgian administration before being placed on the market, with specific rules on nutrients, permitted plants and claims. Health claims may only be used if they appear on the authorised EU list.

The food business operator is responsible for the compliance of the products it places on the market and must have a self-checking and traceability system. As soon as it considers a product may be injurious to health, it must withdraw it, inform the FASFC and, if the product has reached consumers, carry out a recall with public information. Speed and documentation of the decision matter as much as the decision itself: they determine how diligence is later assessed.

Hospital tenders and public procurement of medicines combine public procurement law with health regulation, on very short appeal deadlines. Look for a team that practises both, able to act within the standstill period to challenge an award decision. It is worth cross-referencing this category with firms active in public law and administrative litigation.

Legal 500, not us. The tiers shown on this page are the ones Legal 500 publishes for Belgium in Life sciences, reproduced as they stand, with no change to their order or composition. We have not run the practitioner and client interviews that would let us rank firms ourselves: rather than invent an in-house scale that would look like an assessment without being one, we cite the publication that did the work.

By us, on a single criterion: the number of Belgian practice areas in which Legal 500 lists the firm. That figure appears on every card and anyone can recount it. Legal 500 draws no distinction between firms in the same tier; we introduce this order to make the list readable, knowing what it is worth. It measures the breadth of a practice, not the quality of its work: within the same tier, a boutique and a full-service firm are treated as equals by the ranking, and it is the ranking that counts.

They are the two most widely used references on the Belgian market, and they have real value: their teams interview practitioners and clients, year after year, about concrete matters. Their limit lies in how they collect. Listing starts from a submission by the firm: a practice that does not file does not appear, which mechanically under-represents boutiques and firms that do no business development. A Tier 1 tells you a firm is recognised by its peers and clients across a whole area; it does not tell you it is the right one for your matter.

From the Legal 500 index for Belgium, worked through area by area for the 2026 edition: a firm appears here in Life sciences if it is ranked there, at its tier. The direct and accepted consequence: a firm absent from Legal 500 is absent from here, which says nothing about its quality. If you know one that belongs here, write to us. Neither Legal 500 nor Chambers is a partner of this site, and neither endorses its content.