ALTIUS is one of the largest Belgian independent law firms, consisting of approximatively 65 lawyers. Established in Brussels and Louvain-la-Neuve, we advise Belgian and international companies on the legal aspects of their transactions and disputes.Show more
Healthcare & Life Sciences
The Data Protection Authority (DPA) has approved a draft act that would prohibit life and health insurers from processing data from policyholders' health trackers. Notably, data from health trackers and apps can still be used for any other insurance that does not qualify as life or health insurance. However, in its advice, the DPA appears to acknowledge that all data coming from health trackers and lifestyle-related apps is likely to be considered health data.
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.
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.
The Brussels Commercial Court has dismissed Pfizer's misleading claims directed against an advertisement for a generic product marketed by Eurogenerics, as well as Eurogenerics's counterclaim regarding the marketing of Pfizer's own generic product. The court's relaxed views on doctors' awareness of the regulations on reimbursement and their implications will be of interest to pharmaceutical marketeers.
Insolvency & Restructuring
A Supreme Court judgment has clarified that new financing during reorganisation proceedings in principle results in new claims, leading to a privileged status of such claims in the framework of any subsequent liquidation. Further, it confirms that the courts require financing to be actual and new (ie, mere refinancing is insufficient).
The legal form of the actio pauliana offers options for creditors which are confronted with debtors that are disposing of important assets or organising their insolvency. This article reflects on some of the options offered under Belgian law by the actio pauliana, commonly referred to in English as the 'clawback' rules.
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.
The legislature recently took steps to improve the follow-up monitoring of companies in financial difficulty and strengthen the fight against inactive companies. To determine whether companies are in financial difficulty, the courts gather information from various (digital) sources. However, the focus remains on preventive mechanisms – namely, identifying companies in financial difficulty and following up with court action.
The Belgian insolvency law's scope was recently broadened. As of 1 May 2018, all entities that are involved in commercial or entrepreneurial activities can be declared bankrupt (or enter into court-supervised reorganisation proceedings). Discussion has started about whether company administrators can also be seen as being 'involved in an entrepreneurial activity' and thus declared bankrupt.
The digitisation of different insolvency proceedings (ie, bankruptcies, judicial reorganisations and company voluntary agreements) recently reached a new milestone. All new insolvency files must now be commenced through the Central Solvency Register (Regsol) and followed up on the same system. Regsol offers a number of new features, including the electronic storage of insolvency files and a new declaration of debt form.
If reorganisation proceedings are unsuccessful and lead to bankruptcy proceedings, creditors with new claims resulting from services performed during the reorganisation proceedings often find it difficult to receive payment of their privileged claims when they are in competition with a general pledge on the debtor's estate that is held by a bank. The Supreme Court's recent judgment in this regard will help such privileged creditors to receive payment from the bankrupt estate.
The legislature recently took steps to improve the follow-up monitoring of companies in financial difficulty and strengthen the fight against inactive companies. Companies that fail to pay their social security or value added tax debts, file their annual accounts or fulfil other administrative obligations on time will now appear on the radar of the Commercial Court's Investigative Services much earlier. The services' recently extended powers of action could lead to unfortunate surprises for some companies.
Parliament recently voted into law the federal government's proposal to introduce a new chapter on insolvency into the Code of Economic Law. Among other things, the new chapter concerns the potential liability of former directors of a bankrupt company. Some of the new principles already partially existed in Belgian law, but have been amended by the new chapter, which also broadens certain concepts which will thus apply to a wider range of entities.
The Business Continuity Act aims to enable debtors in difficulty to continue their activities by restructuring their debts. One of the proceedings that the act introduced is the reorganisation of debt pursuant to a restructuring plan. The restructuring plan may consist of several measures, including the waiver of certain debts. However, none of these measures (with the exception of a temporary stay on the enforcement of claims) may be imposed on secured creditors, unless they expressly agree to it.
The government recently undertook steps to modernise and broaden its insolvency legal framework and submitted a proposal to Parliament intended to introduce a new chapter to the Code of Economic Law. The proposal will update the Bankruptcy Act and the Business Continuity Act. The government proposal will be discussed in Parliament in the coming weeks and could be accepted before the summer recess.
Franchisees are often unable to fulfil their payment obligations. The special cooperative relationship between a franchisor and its franchisee usually leads to negotiations and contractual agreements between the parties regarding the repayment of accumulated debts. However, the franchisee may still become insolvent. A key question is whether showing leniency in the context of insolvency proceedings will be beneficial or detrimental to a franchisor.
The Business Continuity Act of January 31 2009, amended in 2013, provides for specific (court-supervised) restructuring proceedings, during which the company (or debtor) is protected against its creditors' claims so that it can reorganise its business. For debtors, one of the act's major advantages is its 'open-gate' approach. In essence, this approach means that court protection is granted if the company's continuity is threatened and the debtor files a request in this regard.
Suppliers are often surprised by their customers' insolvency and only at that moment discover that the goods that they delivered are unpaid. Even when a reservation of title has been inserted into the contract, the repossession of goods can be difficult in practice. Measures that can help the recovery process include ensuring that a reservation of title clause is clearly drafted and that each single good is identifiable.
Historically, Belgian insolvency legislation has applied only to entities involved in commercial activities. However, recent jurisprudence and upcoming legislative changes will result in important amendments that are intended to broaden the scope of existing legislation. As a result, entities that are involved in commercial or entrepreneurial activity will be eligible to benefit from bankruptcy legislation.
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.
On 30 July 2018 the Belgian legislature transposed the EU Trade Secrets Directive into domestic law via the Trade Secret Law. The Trade Secret Law is welcomed, as no general regulatory framework regarding trade secrets previously existed in Belgium. It remains to be seen how the law will be used and applied in practice, but it is an essential means in effectively appropriating, protecting and exploiting innovation by providing trade secret holders with the tools to protect valid trade secrets.
The long-awaited amendments to the Benelux Convention on Intellectual Property recently entered into force. The convention offers broader protection to reputed trademarks in opposition proceedings. In addition, an administrative procedure for invalidation and revocation before the Benelux Office for Intellectual Property (BOIP) is now available and the Benelux Court of Justice has become the sole jurisdiction for appeals against BOIP decisions.
In a high-profile trademark infringement case involving Moët Hennessey Champagne Services and a Belgian painter, the courts were asked to strike a balance between the right to property, including intellectual property, and artistic freedom of expression. The decision is expected to set an important precedent on how to strike a fair balance between freedom of speech and the protection of trademarks when these two concepts conflict.