Legal & Regulatory > Belgium

On 16 April 2020, a new Act was adopted by the Belgian parliament to increase the transparency of managed entry agreements (‘MEA’) concluded between pharmaceutical companies and the National Institute for Health and Disability Insurance (‘NIHDI’). MEAs stipulate confidential compensation mechanisms for the Belgian government regarding the publicly-listed price and reimbursement basis of the medicine(s) concerned. The Act provides that if the Belgian parliament’s Chamber of Representatives orders a management audit, then the Court of Audit is granted full access to…

On 8 April 2020, the Belgian federal agency for medicines and health products (‘FAMHP’) adopted a consolidated version of its decision (the ‘Decision’) taking the following urgent measures for certain listed medicines (and raw materials) to avoid medicine shortages during the SARS-CoV-2 pandemic:   Wholesalers, full-line wholesalers and manufacturers are obliged to limit their sales to full-line wholesalers and pharmacies for the products concerned to amounts that correspond to the sales for the same period of the previous year increased by a…

With national governments scrambling to take measures in order to counter the Covid-19 pandemic, we are again confronted with the fact that a EU common policy in the healthcare field is quasi inexistent. This is equally so in respect of the pricing and reimbursement of medicines.   While the so-called Transparency Directive 89/105/EEC provides for a limited harmonization of pricing & reimbursement procedures, one however cannot deny a growing tendency of national governments to look beyond their national borders and…

In its ruling of 30 January 2020, the Court of Justice of the European Union (‘CJEU’) has clarified for the first time the criteria governing whether a reverse payment settlement agreement concerning a dispute between the holder of a pharmaceutical patent (‘originator’) and a manufacturer of generic medicines (‘generic’) is contrary to EU competition law. In particular, the Court has provided further guidance on whether and when: (i) originators and generics should be considered as ‘potential competitors’, (ii) a patent…

On 3 February 2020 the Act of 20 December 2019 amending various legal provisions concerning shortages of medicinal products was published in the Official Gazette. Except for Articles 2 and 4, which entered into force on 31 January 2020, the act’s provisions entered into force on 13 February 2020. In our view, the new legislation does not prevent pharmaceutical companies from applying quotas, provided that they do not affect the public service obligation of wholesaler-distributors (also known as full-line wholesalers. In addition, we…

The key facts about regulatory reforms in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. Are there proposals for reform or significant change to the healthcare system? As of recently, attempts have been made to remedy the unavailability of medicines on the Belgian market. The Act of 7 April 2019 on the unavailability of medicines introduced two measures in this…

Keen to learn more about patents & trademarks in Belgium? Read on! Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What are the basic requirements to obtain patent and trademark protection? The Belgian legal framework governing patents and trademarks is enshrined in Book XI of the Code of Economic Law (CEL). A specific framework for Benelux trademarks is provided by the…

The low-down on the situation regarding product liability in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What types of liability are recognized in your jurisdiction? Belgian law distinguishes two types of civil liability: contractual liability and tort liability. Where the first arises from a failure to execute, respect or comply with contractual obligations, the latter arises when certain acts…

A brief overview of the situation regarding traditional medicines and OTC products in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What are the regulatory requirements for traditional, herbal, complementary, or alternative medicines and devices? The Law of 25 March 1964 on the medicines distinguishes between homeopathic medicines, traditional herbal medicines and herbal medicines. All three categories are subject to…

All about marketing, manufacturing, packaging & labeling, advertising in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What is the authorization process for the marketing of new drugs, biologics, medical devices, over-the-counter medications, and other medicinal products? First of all, the medicines must be the subject of clinical trials. These clinical trials must be submitted to the FAMHP and an…

All legal aspects surrounding preclinical and clinical trial requirements in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. Are clinical trials required to be conducted locally as a condition (stated or implicit) for marketing approval? No, clinical trials are not required to be conducted locally to receive marketing approval in Belgium. In order to obtain marketing approval, for new drugs,…

An intro to the legal situation for regulatory, pricing and reimbursement in Belgium. Prepared in association with ALTIUS, a leading law firm in Belgium, this is an extract from The Pharma Legal Handbook: Belgium, available to purchase here for USD 99.   1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? The Federal Agency for Medicines and Health Products (‘FAMHP’) is the competent authority for drugs, biologicals and medical devices in Belgium.…