ALTIUS updates

Federal government restricts sale of PPE and medical devices for fighting COVID-19
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 29 April 2020

The minister of economic affairs recently adopted a ministerial decree which restricts the retail and wholesale distribution of certain types of personal protective equipment and medical devices used for treating COVID-19 patients. Further amendments were implemented by ministerial decrees on 27 March 2020 and 7 April 2020. This article provides a short description of the relevant trade restrictions followed by a legal analysis in light of fundamental principles of EU law.

How to introduce a temporary COVID-19 unemployment regime based on force majeure
ALTIUS
  • Employment & Immigration
  • Belgium
  • 29 April 2020

Until recently, when considering implementing a temporary unemployment regime within a company, employers could, depending on their specific situation, apply for the temporary unemployment regime based on either 'force majeure' or 'economic reasons'. The government has implemented a temporary COVID-19 unemployment regime whereby if an employer is faced with temporary unemployment due to the COVID-19 pandemic, this situation is automatically considered to be force majeure.

Medical supplies: public procurement procedures in cases of extreme urgency
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 29 April 2020

The COVID-19 outbreak has created an urgent need for certain goods, including medicines and medical devices. However, do public authorities (eg, hospitals) still need to follow the complete public procurement procedures to procure these urgently needed goods? In cases of extreme urgency, such as that presented by the COVID-19 pandemic, contracting authorities can use the negotiated procedure without publication to place tenders.

New COVID-19 employment measures to respond to economic crisis
ALTIUS
  • Employment & Immigration
  • Belgium
  • 29 April 2020

The government has adopted new socio-economic measures that aim to support the Belgian economy during the COVID-19 economic downturn. Most of the measures seek to encourage individuals to continue working and allow for more flexibility in the way that work can be carried out. This article provides an overview of the different measures that have been approved by the Council of Ministers.

Medicinal product reimbursement during pandemics and budgetary constraints: why quick fixes don't work
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 22 April 2020

The COVID-19 crisis has highlighted the fact that an EU common policy in the healthcare sector is virtually non-existent, especially in respect of medicinal product pricing and reimbursement. This article illustrates the need for national pricing authorities to consider that their policies could have unintended consequences and cross-border effects. Otherwise, national measures risk backfiring, as seems to have happened with the Belgian authorities' most recent attempt at further reducing medicinal product prices.

FAMHP adopts measures to avoid medicine shortages during COVID-19 pandemic
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 15 April 2020

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.

DPA approves draft act prohibiting life and health insurers from processing health tracker data
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 18 March 2020

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.

New act on medicinal product shortages
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 04 March 2020

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.

Incentives and public procurement in the healthcare sector: be careful what you wish for
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 23 October 2019

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.

Anti-tampering devices – fading boundaries of parallel trade?
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 06 February 2019

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.

Invalidated SPC retains prima facie validity in preliminary injunction proceedings
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 25 September 2013

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.

New act reforms Competition Authority
ALTIUS
  • Competition & Antitrust
  • Belgium
  • 06 June 2013

The new Competition Act was recently adopted, which will be included in the new Code of Economic Law. The new act does not affect the substantive law on anti-competitive agreements, abuse of dominant position and merger control; rather, it completely restructures the Competition Authority and introduces a number of important procedural reforms with the aim of increasing the authority's efficiency.

GMO trial gets green light despite formal invalidity
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 08 May 2013

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.

Confidentiality of in-house counsel legal advice protected in competition cases
ALTIUS
  • Competition & Antitrust
  • Belgium
  • 04 April 2013

In a long-awaited decision, the Brussels Court of Appeal has held that advice drafted by in-house legal counsel is to be considered as covered by legal professional privilege when facing an investigation under the Competition Act. The decision allows companies to oppose the seizure of documents drafted by their in-house counsel during dawn raids by the Competition Authority; however, certain restrictions apply.

Mock-ups no proper notification of repackaged pharmaceutical parallel imports
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 13 February 2013

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.

Doctors not easily misled? Brussels court decides on pharmaceutical advertising
ALTIUS
  • Healthcare & Life Sciences
  • Belgium
  • 28 November 2012

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.

Interim order for warehouse operator over dominant position complaint
ALTIUS
  • Competition & Antitrust
  • Belgium
  • 04 October 2012

The president of the Competition Council has ordered Port Real Estate, a warehouse operator in the port of Antwerp, to maintain minimum load-out rates for robusta coffee traded on the NYSE Liffe Exchange in London. The interim order follows a complaint lodged by a UK-based trader in agricultural goods, on the basis of an alleged abuse of dominant position by Port Real Estate.

National Chamber of Judicial Officers subject to competition rules
ALTIUS
  • Competition & Antitrust
  • Belgium
  • 26 April 2012

The Competition Council has ruled that the adoption of a directive by the National Chamber of Judicial Officers - on the fees applicable for so-called 'amicable' (ie, pre-judicial) collection - infringed the Competition Act. Among other things, the council noted that the fact that such officers exercise state authority in some tasks does not preclude the application of competition rules to extra-judicial tasks.

Will new fining guidelines enhance transparency?
ALTIUS
  • Competition & Antitrust
  • Belgium
  • 05 April 2012

New fining guidelines which were recently adopted by the Competition Council aim to improve transparency for undertakings and associations of undertakings under investigation. However, the council clearly retains significant discretion when determining the size of a fine. Among other things, the guidelines leave open the issue of taking compliance programmes into account as a mitigating circumstance.

Supreme Court rules on Honda abuse of dominance case
ALTIUS
  • Competition & Antitrust
  • Belgium
  • 22 September 2011

The Supreme Court has issued a succinct judgment on the scope of the Court of Appeal's powers to overturn Competition Council decisions and the nature of proceedings before the council. This is the latest decision in a case that began in 1995 with complaints filed by 12 independent motorcycle distributors in Belgium against five official importers of motorcycles, including Honda Belgium.

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