Born in Lokeren in 1987. Admitted, 2010, Brussels.
University of Ghent (Lic. Jur., 2010), University of Vienna, Austria (Willem C. Vis Moot Court)
Dutch, English and French
Parliament recently adopted a new act to increase the transparency of managed entry agreements (MEAs) concluded between pharmaceutical companies and the National Institute for Health and Disability Insurance. MEAs stipulate confidential compensation mechanisms for the government regarding the publicly listed price and reimbursement basis of the medicines concerned.
The Federal Agency for Medicines and Health Products recently adopted a consolidated version of its decision to take a series of urgent measures for certain listed medicines (and raw materials) to avoid medicine shortages during the COVID-19 pandemic. The measures apply until the end of April 2020 but may be renewed on a monthly basis. This article discusses the measures and their legality under EU law in more detail.
A new act amending various legal provisions concerning shortages of medicinal products was recently published in the Official Gazette. Arguably, 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, the act arguably imposes no general obligation on pharmaceutical companies to supply retail pharmacies directly.
The Federal Agency for Medicines and Health Products recently issued a circular letter reminding the different actors in the Belgian healthcare sector that incentives in the course of public procurement procedures should be considered carefully. Further, the circular letter underlined the risk of contravening the ban on receiving gifts, monetary advantages or benefits and public procurement rules.
A legislative package aimed at fighting falsified medicines will enter into force in the European Union in early 2019. This EU legal framework was transposed into Belgian law through the Medicines Act and the Royal Decree concerning Medicines for Human and Veterinary Use. As a result, pharmaceutical companies will be required to affix a so-called 'anti-tampering device' on all prescription medicinal products to allow verification of whether the packaging has been tampered with.
The government has implemented a strict regulatory framework for genetically modified organism field trials. But what happens when one of the players fails to respect the rules? Does it affect the valid work that has already been done by others? These questions recently arose before the Ghent Court of First Instance in the context of expedited civil proceedings initiated by Greenpeace against the Belgian state.
Preliminary injunctions are rarely granted on an ex parte basis in Belgium and adversarial debates are considered a cornerstone of legal proceedings which can be deviated from only in cases of absolute necessity. However, ex parte interim measures have been granted in at least four patent disputes in Belgium in recent years, which helps to shed light on the circumstances under which patentees can consider them to be a measure of last resort to stop a threat of infringement.
A Belgian court has invalidated Lundbeck's supplementary protection certificate (SPC) for escitalopram, the 'S' enantiomer of its racemate citalopram. The court held that escalitopram is the same product as citalopram, and that the former's SPC did not comply with Articles 3(c) and (d) of EU Regulation 469/2009. The court held that it was in the interests of patients to declare the decision provisionally enforceable.