Medicinal products for human use (including biologicals): Volume 1 of the rules governing medicinal products in the European Union (“EudraLex“) was implemented in Belgium. The essential rules regulating those products are included in the act of 25 March 1964 on medicinal products (the “Medicines Act“). Multiple royal and ministerial decrees implement the Medicines Act, including – but not only – the royal decree of 14 December 2006 on medicinal products (the “Medicines Decree“).

Medical devices: Regulation (EU) 2017/745 on medical devices (“MDR“) and regulation (EU) 2017/746 on in vitro diagnostic medical devices (the “IVDR“) are applicable in Belgium. The essential rules regulating those products are included in the act of 22 December 2020 on medical devices (the “MD Act“) and the act of in vitro diagnostic medical devices (the “IVD Act“). Multiple royal and ministerial decrees implement the MD Act and the IVD Act, including – but not only – the royal decree of 12 May 2021 implementing the MD Act and the royal decree of 14 September 2022 implementing the IVD Act. Some medical devices-specific rules are also included in the Medicines Act. Pre-MDR and pre-IVDR legislations may also be relevant, including the act of 15 December 2013 on medical devices, and three royal decrees each implementing the European directives on medical device (decree of 18 March 1999), on active implantable medical devices (decree of 15 July 1997) and on in vitro diagnostic medical devices (decree of 14 November 2001).

Foodstuff: The general food law regulation (EC) No 178/2002 (the “Food Law Regulation“) applies in Belgium. The essential rules regulating those products are included in the act of 24 January 1977 concerning the protection of consumer health regarding foodstuffs and other products (the “Foodstuff Act“). Multiple royal and ministerial decrees implement the Foodstuff  Act, including – but not only – the royal decree of 14 November 2003 on the hygiene of foodstuffs.

Food supplements: Food supplements are pre-dosed foodstuffs, which means that the “horizontal” (general) requirements concerning foodstuffs apply to them, including as regards labelling and advertising. At the European level, there is a framework directive 2002/46/EC for food supplements (the “FS Directive“). At the Belgium level, food supplements are regulated by three specific royal decrees, one for those containing nutrients (royal decree of 30 May 2021), one for those containing plants (royal decree of 30 August 2021), and one for food supplements containing ‘other substances’ (royal decree of 29 August 2021).

Medicinal products for human use: The R&D phase typically begins with extensive preclinical research, followed by clinical trials conducted according to the directive 2001/20/EC on clinical trials (CTD) and subsequently regulation (EU) No 536/2014 on clinical trials (CTR). Local requirements include adherence to specific guidelines issued by the Federal Agency for Medicines and Health Products (FAMHP), Belgium’s regulatory authority for medicinal products. Market approval is obtained through the centralised procedure, decentralised procedure, or mutual recognition procedure outlined in regulation (EC) 726/2004 laying down Union procedures for the authorisation and supervision of medicinal products and Directive 2001/83/EC on the Community code relating to medicinal products for human use (the “Medicines Directive“). Belgium participates in these EU procedures, but local specifics occasionally include additional documentation or requirements specified by the FAMHP. Post-marketing surveillance and pharmacovigilance activities are governed by the aforementioned EU instruments as well as regulation (EU) 1235/2010, which establishes the European Medicines Agency (“EMA“) as the coordinating authority for pharmacovigilance (the “PV Regulation“). The FAMHP oversees post-marketing vigilance activities within Belgium, including monitoring adverse drug reactions and ensuring compliance with reporting requirements.

Medical devices: The R&D phase typically involves conformity assessment procedures according to the MDR for most medical devices, or the IVDR for in vitro diagnostic medical devices. These regulations outline the requirements for clinical evaluation, performance studies, and conformity assessment, where appropriate with notified bodies. Belgium also participates in EU-led collaborative R&D projects and has specific national research funding programs. Market approval for medical devices is obtained through conformity assessment procedures as per the MDR or IVDR. This involves assessing compliance with essential requirements, conformity assessment procedures, and obtaining CE marking. Belgium follows the EU regulations for market approval, but may have additional requirements or documentation specified by the FAMHP, including as regards national languages. Belgium also has specific national provisions regarding the use or delivery of certain types of medical devices in hospital settings or through hospital pharmacies (e.g. implants). Post-market surveillance and vigilance activities for medical devices are governed by the MDR or IVDR. This includes requirements for manufacturers to establish and maintain a post-market surveillance system, report serious incidents, and cooperate with competent authorities. The FAMHP oversees post-market surveillance activities within Belgium. They have issued specific guidance or requirements for medical device economic operators active within Belgium’s jurisdiction, including the obligation to set up a local vigilance contact point.

Prior to introducing their products to the market, manufacturers or distributors of food supplements are required to notify the Federal Public Service Health, Food Chain Safety and Environment (“FPS Health“) in Belgium. This notification includes comprehensive details such as the product’s name, ingredient composition, labelling specifics, and intended use. Food supplements in Belgium are obligated to adhere to a spectrum of regulations, notably including the Food Law Regulation and the aforementioned royal decrees. Stringent labelling standards must be met by food supplement operators, as outlined both in Belgian domestic laws and EU instruments. These requirements encompass the provision of precise details regarding the product’s composition, recommended dosage, usage instructions, and any potential allergens. Manufacturers shoulder the responsibility of ensuring the safety and quality of their food supplement offerings. This entails conducting thorough risk assessments, verifying compliance with permitted ingredients and maximum concentration levels, and implementing robust quality control measures throughout the production process. Marketing vigilance remains imperative for monitoring the safety profile of food supplements post-release. Manufacturers and distributors are mandated to promptly report any adverse reactions or incidents to the competent authorities, such as the Federal Agency for the Safety of the Food Chain (“FASFC“). In the event of any identified safety concerns, appropriate corrective actions must be swiftly implemented.

Medicinal products for human use: Pharmaceutical businesses must establish and maintain a pharmacovigilance system to monitor and report adverse reactions associated with their products, in accordance with the PV Regulation. Holders of marketing authorisations are required to submit post-safety update reports (“PSURs“) at defined intervals, providing comprehensive safety updates on their medicinal products. In Belgium, holders of marketing authorisations are required to report adverse drug reactions (“ADRs“) directly to the FAMHP. This includes serious and non-serious ADRs, as well as any suspected unexpected serious adverse reactions (SUSARs). They must further designate a local contact person responsible for pharmacovigilance activities within Belgium. This individual serves as the point of contact for communication with the FAMHP regarding pharmacovigilance matters. Any updates to the product labelling, including changes related to safety information, must be submitted to the FAMHP for approval. This ensures that the product information provided to healthcare professionals and patients remains accurate and up-to-date. The FAMHP may conduct inspections and audits of marketing authorisation holders to verify compliance with pharmacovigilance requirements and other regulations governing medicinal products. In some cases, the FAMHP may require holders of marketing authorisations to conduct post-marketing studies to further assess the safety or efficacy of their medicinal products in real-world settings.

Medical devices: In line with EU requirements, medical device economic operators operating in Belgium must fulfil ongoing obligations such as post-market surveillance, vigilance reporting, and compliance with any conditions specified as part of the conformity assessment. Manufacturers are required to maintain a quality management system in accordance with the requirements of the MDR or IVDR, depending on the classification of the device. In Belgium, medical device manufacturers are subject to post-market surveillance obligations outlined by the FAMHP. This includes monitoring the safety and performance of medical devices once they are placed on the market and reporting any incidents or deficiencies to the FAMHP. Belgian law imposes specific requirements related to the mandatory registration and notification of medical devices and their economic operators with the competent authorities, such as the FAMHP. Medical device manufacturers operating in Belgium must comply with local labelling and language requirements for product documentation and instructions for use, as specified by Belgian regulations. Belgian regulations stipulate a few additional requirements for the advertising and promotion of medical devices within the country, including restrictions on marketing claims and advertising materials (e.g. as regards implants or reimbursed devices).

Medicinal products for human use and medical devices: The competent authority for medicinal products for human use and medical devices is the FAMHP. The roles of the FAMHP, including its rights (e.g. in the context of inspections) and obligations (e.g. as regards the protection of personal data) are laid down in the sectorial legislation identified under question 1, as well as in the act of act of 20 July 2006 on the establishment and functioning of the FAMHP (the “FAMHP Act“). It is responsible for regulating and supervising the entire lifecycle of these products, from research and development to manufacturing, distribution, and post-market surveillance. The FAMHP evaluates applications for (national) marketing authorisation, conducts inspections of manufacturing facilities, monitors adverse drug reactions, and enforces compliance with regulatory requirements. Additionally, the FAMHP provides scientific expertise, guidance, and information to healthcare professionals, patients, and the public to promote safe and effective healthcare practices.

Food and food supplements: The FPS Health and the FASFC have complementary roles in relation to the surveillance of the food and food supplements market in Belgium. FPS Health is a government department responsible for policy development, regulation, and oversight in various areas, including public health, food safety, and environmental protection. Within the food sector, FPS Health is involved in setting regulations, policies, and standards related to food safety and nutrition. FASFC is an independent federal agency tasked specifically with ensuring the safety of the food chain in Belgium. It is responsible for the control, inspection, and enforcement of regulations governing food safety, from primary production to distribution and consumption. FASFC conducts inspections, sampling, and risk assessments to monitor compliance with food safety regulations. While FPS Health is involved in various aspects of public health and environmental protection, its role in food safety is part of a broader mandate covering multiple areas of health and well-being. FASFC’s mandate is essentially focused on ensuring the safety of the food chain. It has specialized expertise and resources dedicated specifically to food safety and operates independently to carry out its regulatory functions. FASFC has direct enforcement powers and authority to conduct inspections, audits, and investigations to ensure compliance with food safety regulations. It can impose sanctions, such as fines or product recalls, in cases of non-compliance.

The process for challenging regulatory decisions made by competent authorities in relation to medicinal products, medical devices, and food supplements would typically depend on the type of decision issued by the regulator and the company’s intention as regards the decision. Where a competent authority or ministry issues an administrative decision, such decision may be challenged (e.g. to obtain annulation and/or suspension) before the Belgian Council of State in accordance with the timelines and procedural requirements set out in the Council of State regulations coordinated on 12 January 1973. Specific procedural requirements (such as an appeal or a request for hearing before the relevant authority or ministry) may have to be fulfilled before a procedure before the Council of State is being launched, depending on the decision at stake. However, applicable laws and regulations in Belgium do not always impose that an authority or ministry takes a fully-fledged administrative decision and they do not always provide for specific procedural requirements before the relevant authority or ministry. In such cases, regular communication with competent personnel within the regulator or ministry is advisable at an early stage and throughout the regulatory process to optimise outcomes, where possible.

Medicinal products for human use: While EU legislation provides the overarching framework for clinical trials in Belgium (see the European chapter), local Belgium-specific requirements, as enforced by the FAMHP, play a crucial role in ensuring compliance and oversight of clinical research conducted within the country. The application process for conducting clinical trials in Belgium involves submission of a Clinical Trial Application (“CTA“) to the FAMHP. The application must include detailed information about the trial protocol, investigational medicinal product, investigator qualifications, and ethical considerations. Belgium has its own specific requirements for the conduct of clinical trials, which may include additional documentation or procedures beyond those mandated by EU legislation. These requirements are outlined in national laws, regulations, and guidelines, such as the Medicines Act, the Medicines Decree, a general act of 7 May 2004 on experiments on humans, the act of 7 May 2017 on clinical trials of medicinal products (the “CT Act“) and the royal decree of 9 October  2017 implementing the CT Act. Upon submission of the CTA, the FAMHP evaluates the application to ensure compliance with both EU and national requirements. The evaluation process includes review of the scientific merit, ethical considerations, and safety measures of the proposed trial. If the application meets all regulatory requirements, including those specific to Belgium, the FAMHP grants approval for the clinical trial to proceed. However, if deficiencies are identified or if the trial is deemed not to be in compliance with regulatory standards, the FAMHP may request additional information or documentation from the sponsor or may deny approval for the trial to proceed.

Medical devices: The legal framework and regulatory procedures for clinical investigations for medical devices and performance studies for in vitro diagnostic medical devices involve both EU legislation such as the MDR and Throughout the conduct of the clinical trial, sponsors, investigators, and ethics committees must adhere to both EU and Belgium-specific requirements for safety reporting, informed consent, data management, and regulatory reporting. FAMHP guidelines for clinical trials sponsors were last updated on 8 February 2021.the IVDR (see the European chapter), and national specifics. In Belgium, the conduct of such studies is regulated by the MD Act and a royal decree of 18 May 2021 on clinical investigations of medical devices, together with the IVD Act and a royal decree of 25 September 2022 on performance studies of in vitro diagnostic medical devices. A significant number of local specifics apply in combination with the MDR and the IVDR, including as regards the Belgian regulatory pathways (including prior FAMHP validation and ethics committee opinion), initial submissions to the FAMHP, substantial modifications, safety reporting, end of studies, temporary halt and early termination. The FAMHP has enacted specific regulatory and clinical requirements intended for sponsors and sites involved in the conduct of clinical investigations and performance studies. It has enacted criteria for what constitutes additional burdensome or invasive procedures in Belgium, specifies which events are reportable and imposes specific deadlines for each regulatory pathway.

Medicinal products for human use: Belgium does not have a standalone public database specifically dedicated to clinical trials of medicinal products that is separate from EU databases. Clinical trial information for medicinal products conducted in Belgium is typically submitted to and registered in European databases such as the EU clinical trials register maintained by the EMA. Regulatory requirements (including notification and/or prior authorisation and transparency obligations) apply where a clinical trial for a medicinal product is being conducted in Belgium or involves Belgian trial subjects (see question 7).

Medical devices: The European database on medical devices (“EUDAMED“), which is being developed under the MDR and the IVDR will serve as the central repository for information on clinical investigations and performance studies conducted within the EU, including Belgium. Regulatory requirements (including notification and/or prior authorisation and transparency obligations) apply where a clinical investigation or a performance study is being conducted in Belgium or involves Belgian trial subjects (see question 7).

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In line with EU efforts, Belgium has been actively working to streamline and digitize the clinical trial application process to improve efficiency and reduce administrative burden. Belgium is actively exploring the use of electronic informed consent (“eIC“) platforms to facilitate the consenting process for participants in clinical trials. Notably, the Belgian informed consent form working group has issued guidelines for sponsors on the use of the eIC forms in interventional clinical trials in Belgium (30 September 2020). There is also a growing interest in decentralized clinical trials (“DCTs“) in Belgium, which involve conducting trial activities remotely or outside of traditional clinical settings. The FAMHP has commented on the European position on DCTs, including the EMA’s recommendation paper on decentralised elements in clinical trials (13 December 2022). Belgian stakeholders are further exploring ways to incorporate real-world data (“RWD“) and real-world evidence (“RWE“) into clinical trial design and regulatory decision-making processes. Notably, the Belgian association of pharmaceutical companies (“Pharma.be“) is pressing for all stakeholders to contribute to well-informed value decisions, based on optimal access to RWD and acceptance of RWE in order to create better health for patients. These trends and proposals reflect Belgium’s ongoing efforts to modernize and digitize the clinical trial process while ensuring compliance with local regulatory requirements set forth by EU and Belgian laws (see question 7).

Medicinal products for human use: EudraLex Volume 1 and Volume 4 requirements, including directive 2003/94/EC of 8 October 2003 laying down the principles and guidelines of good manufacturing practice in respect of medicinal products for human use (“GMP“), repealed by Directive 2017/1572/EU as regards the principles and guidelines of GMP, are implemented in the Medicines Act and the Medicines Decree. Manufacturers established in Belgium must comply with local GMP regulations, as interpreted by the FAMHP to ensure that medicinal products are consistently produced and controlled according to quality standards. Manufacturers must submit an application for authorisation to the FAMHP, providing detailed information about the manufacturing processes, facilities, equipment, personnel, and quality control procedures. Compliance with GMP standards is assessed by the FAMHP during the authorisation process. The FAMHP also conducts inspections of manufacturing plants to verify compliance with GMP standards and regulatory requirements. Inspections may include assessments of facilities, equipment, documentation practices, and quality control procedures. Once authorised, manufacturing plants are subject to ongoing monitoring and inspections by the FAMHP to ensure continued compliance with regulatory requirements.

Medical devices: The FAMHP ensures the surveillance of medical devices on the Belgian market, among other things through inspections of all actors in the supply chain, from investigators to users, including notified bodies, manufacturers, distributors and hospitals. The FAMHP’s inspections of manufacturing plants for medical devices follows the provisions of the MDR and IVDR regarding market surveillance by competent authorities, as completed by the MD Act, the IVD Act, their implementing decrees, and are in accordance with the surveillance measures described in the FAMHP Act. A number of local requirements are relevant for manufacturers established in Belgium, including those making available medical devices which are not subject to a conformity assessment procedure involving a notified body (such as class I devices) e.g. as regards local registration and EUDAMED registration obligations. The FAMHP reported last year that 92 inspections of medical devices’ manufacturers established in Belgium were carried out by their inspection services during calendar year 2022 (and one additional inspection of a foreign manufacturer).

Medicinal products for human use: EudraLex Volume 1 and Volume 4 requirements, including the guidelines on good distribution practice (“GDP“) of medicinal products for human use and the Medicines Directive’s provisions on wholesale distribution of medicines  are implemented in the Medicines Act and the Medicines Decree. The FAMHP provides Belgium-specific guidance on medicinal products’ GDP regulatory issues such as quality management, personnel, equipment, documentation, operations, complaints, self-inspections, transport and brokerage. Prior registration of wholesalers active in Belgium with the FAMHP is mandatory and multiple obligations apply to them under the Medicines Decree. Those are actively enforced by the FAMHP.

Medical devices: Distributors’ general obligations under the MDR and IVDR requirements are enforced in Belgium in accordance with the MD Act and the IVD Act. The FAMHP provides Belgium-specific guidance on medical devices’ GDP regulatory issues such as quality management system, personnel, documentation, suitable facilities, operations, returns, complaints and recalls, vigilance, delegated activities and internal audits. Prior registration of distributors on the FAMHP generic portal is a legal requirement if they make medical devices available in Belgium. Multiple obligations apply to them under Belgian laws and decrees and compliance with those obligations is ensured by the FAMHP through various enforcement measures such as routine inspections.

Food supplements: Food supplements appropriately notified to the FPS Health (see question 3) may be placed on the market in Belgium by food operators in accordance with the general distribution principles laid out in the Food Law Regulation and the Foodstuff Act. In addition, the food supplements’ royal decrees (see question 1) provide requirements depending on the type of supplement that is being marketed. They further ban the placing on the market of certain products that are either blacklisted because of public health risks or that do not meet the conditions and restrictions provided by them.

Medicinal products for human use: A number of legal instruments establish the framework for pricing negotiations between pharmaceutical companies and the Belgian authorities, as well as the criteria for determining reimbursement eligibility and the reimbursement rates for medicinal products. The act of 14 July 1994 on the compulsory health care insurance and benefits (the “NIDHI Act“) forms the primary legal basis for the reimbursement of medicinal products in Belgium. Additional decrees such as (i) the royal decree of 21 December 2001 on price determination for pharmaceutical products and medicinal products for reimbursement and to their inclusion in the reimbursement system provided for by the NIDHI Act and (ii) the royal decree of 1 February 2018 establishing the procedures, deadlines, and conditions regarding the involvement of the compulsory health care insurance and allowances in the cost of pharmaceutical specialties, outline the procedures and criteria for determining the price of pharmaceutical products and their inclusion in the reimbursement system.

Medical devices: Upon successful application by a medical device economic operator or pursuant to a convention between the NIHDI and healthcare institutions, the NIHDI may also reimburse medical devices and in vitro diagnostic medical devices captured by the NIHDI Act and applicable royal decrees. Full or partial reimbursement may be granted to specific types of devices which meet applicable reimbursement requirements, such as for example (i) implantable medical devices (‘implants’) and invasive medical devices, (ii) certain types of non-implantable devices delivered by pharmacists or other regulated suppliers (e.g. some in vitro diagnostic medical devices such as blood pressure monitors, glucose meters, lancet holders, test strips) as well as certain healthcare services related to their provision (e.g. the dispensing and installation of oxygen gas devices and accessories) (iii) bandaging and services provided by bandage specialists, (iv) mobile health applications (see question 20).

Food and food supplements: The national institute for health and disability insurance (“NIHDI“)  reimburses, either fully or partially, certain types of medical nutrition products. The amount of reimbursement depends on the type of nutrition, route of administration, or pathology. Examples of medical nutrition products reimbursed by the NIHDI include – for example – foods for special medical purposes (FSMPs), parenteral nutrition at home and specialised home nutrition for certain types of patients, breast milks for fragile premature infants and medical nutrition for children with galactosemia. Reimbursement is subject to strict conditions, which depend on the type of product, prescription conditions, the involvement of a mutual insurance and prior authorisation from the mutual insurance’s physician advisor (where required).

Medicinal products for human use: The Medicines Act and a royal decree on medicinal products’ information and advertising provide substantial obligations as regards advertising for medicinal products. Those are complemented or interpreted by guidelines enacted by the FAMHP, Belgian courts’ case law and ethical or deontological codes adopted by local industry associations (see question 22).

Medical devices: The MDR, the IVDR, the Medicines Act and some medical devices decrees described in question 1 regulate the advertising of medical devices in Belgium. These are supplemented or explained by FAMHP circulars, rulings from Belgian courts, and ethical or deontological codes endorsed by local industry associations (see question 22).

Food and food supplements: Advertising for foodstuffs is regulated at Belgian level by the general advertising rules set out under Books VI and XII of the Code of Economic Law as well as the remaining rules in force from the royal decree of 17 April 1980 concerning advertising for foodstuffs, as amended (the “Foodstuff Advertising Decree“). Notably, the Foodstuff Advertising Decree places a ban on claiming that a foodstuff’s composition bear properties that relate to objective or measurable criteria if those cannot be demonstrated. Nutritional and health claims regarding foodstuffs must further comply with regulation (EC) 1924/2006 on nutrition and health claims made on foods (the “Food Claims Regulation“). Promotional efforts regarding food supplements should comply with the Code of Economic Law, Foodstuff Advertising Decree, the Food Claims Regulation, and applicable Belgian and EU provisions on foodstuff (see question 1). The FPS Health has provided further guidelines on this legislative framework, particularly as regards health claims. Examples of such provisions include a general ban on misleading advertising through fair information practices imposed by Regulation (EU) 1169/2011 on the provision of food information to consumers, as well as specific obligations such as (i) avoiding ascribing properties of preventing, treating or curing a human disease, or refer to such properties in the context of food supplements’ advertising and (ii) excluding any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general (per the FS Directive, as implemented locally – see question 1).

In each case, the Belgian reimbursement legislation and general Belgian laws regulating compliant business-to-business or business-to-consumer conduct may provide additional requirements that apply to pharmaceutical companies, medical devices businesses and food operators conducting promotional activities for their products on the local market.

Trademarks: There are three types of trademarks available in Belgium to provide protection to distinctive signs in relation to goods and services related to medicinal products, medical devices and food supplements:

• Benelux trademarks which are organized by the Benelux Convention on Intellectual Property (“BCIP“);
• European Union trademarks which are organized by the regulation (EU) 2017/1001 on the European Union trade mark, and its implementing regulations;
• International trademarks which are organized by the Madrid System.

Additional, albeit limited, requirements regarding the use of trademarks concerning medical devices may be found in the MDR and IVDR – for which we refer to the European chapter of this guide – and the Belgian medical device legislation outlined above.

Patents: Three types of patent protections are available in Belgium that may all apply to inventions related to medicinal products, medical devices, and food supplements.

• National patents which are organised by Book XI of the Belgian code of economic law (the “CEL“);
• European patents which are organised by the European Patent Convention (EPC) to which Belgium is a party;
• Unitary patents which may also be obtained and enforced in Belgium since 1st June 2023, with the entry into force of the regulation (EU) 1257/2012 implementing enhanced cooperation in the area of the creation of unitary patent protection and with the ratification by Belgium of the agreement on a Unified Patent Court (“UPC“).

Medicinal products may also be the object of a Supplementary Protection Certificate (“SPC“), which is governed by the regulation (EC) 469/2009 concerning the supplementary protection certificate for medicinal products. This regulation is mainly complemented in Belgium by Title 2 of Book XI of the CEL.

Provisions of the Medicines Act complement Book XI of the CEL and exempt from patent or SPC infringement those acts that are carried out to perform the studies, tests and trials necessary to obtaining regulatory approval in Belgium or the EU, for generics or biosimilar products for human use (this exemption is known as the “Bolar exemption”).

Design patents are not available as such in Belgium but Benelux designs (regulated by the BCIP), and Community designs (regulated by regulation (EC) 6/2002 on Community designs) are available as far as designs are concerned.

Different actions are available to tackle infringements of a patent in relation to medicinal products and medical devices in Belgium. The pharmaceutical field is well represented in Belgian patent litigation case law, with Belgium tending to be rather favourable to patentees. Case law involving second-medical use patents is however quite limited.

All civil disputes related to patents are handled in first instance by the Brussels Enterprise Court and appellate proceedings are handled by the Brussels Court of appeal. This centralisation of patent cases allows a certain degree of specialisation of the judges, even though most of them have no technical background.

The Belgian part of European patents that have not been opted-out may be litigated either before the national courts or the UPC, while the UPC is exclusively competent for unitary patents. To be noted is that the UPC has a local division in Brussels.

Civil infringement proceedings on the merits are available and Belgian law provides for a regular and an accelerated route, with different timeframes and differences regarding the possibility to obtain compensation for the damage resulting from the infringement. The accelerated proceeding can be initiated before the President of the Brussels Enterprise Court to obtain injunctive relief on the merits, within a shorter timeframe (6 to 10 months in first instance, versus around 18 to 24 months for the regular proceeding).

Both inter partes and ex parte preliminary injunction (“PI“) proceedings are available under Belgian law and allow to obtain interim injunctions pending a decision on the merits. A variety of measures may be ordered by the PI judge to limit, stop, or avoid the damage resulting from the alleged infringement. Injunctive relief may be sought on an ex parte basis in case of extreme urgency if the requested measures are absolutely necessary. The extreme urgency requirement is assessed very strictly and ex parte PIs are exceptionally granted but do occur in the pharmaceutical patent litigation field.

Infringement cases will often start with an ex parte descriptive seizure proceeding which allows the patent holder to collect evidence of an alleged patent/SPC infringement on a unilateral basis. Such request is commonly granted within 2-3 days to one week of the filing of a unilateral request. If granted, a judicial expert is appointed by the court, with as mission to collect evidence of the alleged patent or SPC infringement and scope of the infringement.

In terms of defences, there is no bifurcation in Belgium and the validity of the patent invoked and allegedly infringed will almost systematically be challenged before the competent court seized of the infringement claims. Other defences are available, including (but not limited to):

• The Gillette-defence (or “Formstein defence”) is available in Belgium, and consists in claiming that the alleged infringer merely implements the state of the art, or a non-inventive variant thereof.
• The Belgian research exemption or “exemption for experimental use” is an available defence and has been modified recently to align with the provisions of the agreement on a UPC.
• Specific to the pharmaceutical field, the Bolar exemption allows to carry out the necessary studies, tests and trials to obtain regulatory approval in Belgium or the EU, for biosimilar or generic products for human use. Since 1 June 2023, all acts done for the purpose of evaluating a medicine are now deemed to be done for experimental purposes and do not constitute acts of infringement.

Trademark law plays an important role in regulating parallel imports of pharmaceutical products. Several landmark decisions of the Court of Justice of the European Union have been rendered in this regard, including regarding the repackaging of medicinal products and we refer to the chapter on Europe of this guide on this issue. In addition, potential restrictions on how medicinal products, medical devices, foodstuffs and food supplements may be advertised may also have an impact on the use of trademarks in these fields (see question 14 for a general overview).

The Belgium product liability regime is established by the act of 25 February 1991 on the liability for defective products (the “Product Liability Act“) and implements the principles outlined in directive 85/374/EEC on liability for defective products. A product will typically be considered defective if it does not provide the safety that one is entitled to expect, taking into account all the circumstances, including the product’s presentation, the use to which it could reasonably be expected to be put, and the time when the product was put into circulation. The producer of a defective product can be liable for damage caused by the defect, regardless of whether they acted faultlessly. The term “producer” is defined broadly and may include manufacturers, importers, and anyone who presents themselves as a producer by affixing their name, trademark, or other distinguishing feature on the product. Any injured party should be able to prove a defect in the product, a damage being suffered, and a causal relationship between the defect and the damage. However, the injured party would not need to prove negligence or fault on the part of the producer. A number of exemptions from liability are enshrined in the Product Liability Act, allowing the producer to be exempt from liability in specific circumstances.

The Belgian legislation regulating medicinal products (including biologicals), medical devices, foods, and food supplements provides for sanctions of a criminal and administrative natures ranging from warnings and suspensions, to fines, product recalls or withdrawals and imprisonment sentences. The extent of potential (administrative or criminal) enforcement measures depend on the type of non-compliance, on whether aggravating circumstances may apply, and on the competent authorities’ policies and enforcement level.

Belgium introduced the mHealthBelgium platform in 2018. The platform serves as an online, publicly available registry of digital health applications bearing the CE marking as medical devices. Unlike the mandatory notification requirement on the FAMHP portal (see question 4), app notification on mHealthBelgium is voluntary. No specific public funds were allocated for mHealthBelgium in 2024, but it has been recently announced that the Belgian industry association for medical devices (“beMedTech“) would continue updating the platform.

Further, the NIHDI has established a new procedure for health apps’ reimbursement dossier applications since 1 October 2023. Dossiers are deemed to be evaluated by a multidisciplinary working group within the NIHDI within a maximum of 270 days. To qualify under this new procedure, apps must meet specific criteria, including CE marking as a medical device and allowing patient-healthcare provider interaction for diagnosis, therapy, or remote monitoring. Economic operators, but also scientific associations, professional associations, and hospitals have the opportunity to submit applications to the NIHDI.

Medicinal products for human use: The Medicines Act, the Medicines Decree and the act of 20 December 2019 amending various legislation regarding medicinal products shortages regulate the following situations and impose a number of obligations to pharmaceutical businesses: temporary unavailability,  interruption of marketing, and discontinuation of marketing. Specific measures were passed during the Covid-19 pandemic, such as for example the royal decree of 23 March 2020 on measures to ensure the supply of medicinal products during the COVID-19 pandemic (this decree includes provisions to address shortages of medicinal products and allowed for temporary derogations from certain regulatory requirements to facilitate the rapid production, distribution, and availability of essential medicines).

Medical devices: EU-level measures adopted to avoid the risk of shortages of medical devices, such as regulation (EU) 2023/607 amending the MDR and IVDR, apply directly in Belgium. Additional local measures were also passed during the COVID-19 pandemic to prevent devices’ shortages, including FAMHP guidelines or circulars for healthcare institutions involved in the manufacture of medical devices and their accessories and the reprocessing of medical devices.

Medicinal products for human use: Pharma.be has enacted a code of deontology, last amended on 13 May 2020. The Belgian industry association for over-the-counter medicines (Bachi) has enacted a charter which entered into force on 10 May 2012. The Belgian industry association for accessible medicines (biosimilars and generics) enacted a deontological charter dated 20 September 2018.

Medical devices: beMedTech has enacted a code of ethics, as amended in October 2021.

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Belgium is witnessing a rise in digital health initiatives aimed at modernising the healthcare system. For instance, the eHealth platform in Belgium facilitates electronic data exchange among healthcare providers, enhancing patient care coordination and access to medical information. Additionally, the government has introduced telemedicine reimbursement schemes, allowing patients to consult healthcare professionals remotely, thereby promoting digital healthcare services across the country.

Specific medical devices framework: Belgium is progressively embarking on a legislative shift to separate its medical device regulations from pharmaceutical legislation. This move aims to address the current amalgamation where medicinal products for human use and medical devices are occasionally regulated under the same laws (such as the Medicines Act). By delineating specific regulations for medical devices, Belgium seeks to enhance clarity, streamline compliance procedures, and ensure tailored rules for medical technologies.

Focus on digital healthcare and artificial intelligence solutions: Belgium’s life sciences sector is witnessing a growing emphasis on digital healthcare and artificial intelligence (AI) solutions. Companies and research entities are harnessing technology to enhance healthcare delivery, patient outcomes, and drug discovery processes. Initiatives such as digital health incubators and collaborative research ventures are driving innovation in areas like telemedicine, health data analytics, and AI-driven drug development – and those are progressively backed by industry associations and the evolving reimbursement framework.

Rise in personalised medicine initiatives: Belgium is experiencing a surge in initiatives centred around personalised medicine, aiming to customise medical treatments based on individual patient characteristics. These endeavours leverage advancements in genomics, biomarker exploration, and data analysis to develop precise therapies and diagnostics. Belgian hospitals and research establishments are actively participating in clinical trials and partnerships to advance personalised medicine strategies, laying the groundwork for more targeted and effective healthcare interventions. Additionally, Belgium’s supportive regulatory landscape (including as regards clinical trials) and robust healthcare infrastructure contribute to the adoption and execution of personalised medicine approaches.