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.
A pharmaceutical company requested a preliminary injunction against a generic manufacturer based on one of its invalidated supplementary protection certificates. An appeal court granted the injunction, but the generic manufacturer appealed to the Supreme Court. The court's decision is notable for its distinction between the authority and the force of res judicata, and the implications of this distinction for rights holders.
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.
The Brussels Court of Appeal recently ruled that a parallel importer did not properly notify a pharmaceutical trademark holder when it provided a two-dimensional mock-up of the outer packaging, rather than an actual sample, of the repackaged pharmaceutical as it would be presented on sale. The decision provided much-needed clarity, as the first instance court had issued contradicting decisions on the matter.
A number of legislative changes to Book XX of the Code of Economic Law may be required following the adoption of EU Directive 2019/1023/EU on preventive restructuring frameworks. This article focuses on the directive's potential effect on Book XX with regard to debtors in possession, the duration of moratoria, the suspension of enforcement during moratoria, the suspension and termination of ongoing contracts, the cramdown of creditors and the acceptance of reorganisation plans.
The European Court of Justice recently confirmed that the Belgian reorganisation framework infringes the EU Transfer of Undertakings Directive with regard to the transfer of personnel. This judgment looks set to have a significant impact on reorganisation proceedings, with parties more likely to be reluctant to organise a transfer of assets leading to bankruptcies and redundancies.
In an insolvency situation, the fate of ongoing contracts is something to be discussed. Such contracts are often closely linked to the essence of a company's business. For example, for (commercial) leases, a lessor's bankruptcy or a tenant's judicial reorganisation will probably result in discussions about the agreement, its (forced) execution and rental payments. If a company's activities are based on patent or software licences, the effect on these agreements will also be of crucial importance.
The European Court of Justice appears likely to rule that the Belgian reorganisation framework infringes the EU Transfer of Undertakings Directive with regard to the transfer of personnel. If the option to transfer only a portion of staff is no longer available in Belgian reorganisation proceedings, companies will have no choice but to formally file for bankruptcy, which is exactly the issue that the legislature and the labour unions had hoped to avoid when introducing this mechanism into Belgian law.
The former Bankruptcy Statute of 1997 included a principle that a natural person could be discharged of their remaining and outstanding debts – a so-called 'waiver' – at the moment of a bankruptcy's closure. The discharge's beneficial effects were extended to the bankrupt person's spouse. However, for bankruptcies that have happened since 1 May 2018, and so fall under the new legal framework, this situation has changed.