On 4 June, the Council of the European Union (Council) adopted its negotiation position on the proposals for a new regulation and directive that make up the so-called ‘pharma package’. The pharma package now moves to the next...more
6/16/2025
/ Biosimilars ,
Data Protection ,
Drug Pricing ,
EU ,
Generic Drugs ,
Healthcare ,
Healthcare Reform ,
New Legislation ,
Pharmaceutical Industry ,
Pharmaceutical Patents ,
Regulatory Reform ,
Regulatory Requirements
In a judgment of 23 December 2024, the Dutch-speaking Enterprise Court of Brussels followed the reasoning of a Dutch court earlier in 2024, ruling that (i) manufacturers are not obliged to provide the reference number of...more
In its two Confédération Paysanne decisions (cases C-528/161 and C-688/21), the Court of Justice of the European Union limited the exclusion of plants and products obtained by new genomic techniques (NGTs) from the...more
9/8/2023
/ Environmental Policies ,
EU ,
EU Directive ,
European Commission ,
European Court of Justice (ECJ) ,
Genetically Engineered Seed ,
GMO ,
Legislative Agendas ,
Life Sciences ,
Proposed Regulation ,
Regulatory Agenda ,
Regulatory Requirements ,
Risk Assessment
On 27 April 2023, the European Commission (the Commission) published its Proposal for a Regulation of the European Parliament and of the Council on compulsory licensing for crisis management (the Proposed Compulsory Licensing...more
In its proposals to revise the general pharmaceutical legislation (GPL) published this week, the European Union (EU) has recognised that the pharmaceutical product lifecycle can have negative impacts on the environment....more
The European Commission has published its long awaited and leaked proposals for a once-in-a-generation revision of the EU general pharmaceutical legislation (GPL)....more
Connected medical devices are used to assist with diagnosing, monitoring or treating a medical condition and thereby facilitate the remote management of a medical condition by healthcare professionals. Such medical devices...more
4/26/2023
/ Algorithms ,
Anticompetitive Agreements ,
Artificial Intelligence ,
Connected Items ,
DATA Act ,
EU ,
General Data Protection Regulation (GDPR) ,
Health Care Providers ,
Health Information Technologies ,
Healthcare ,
Healthcare Facilities ,
Legislative Agendas ,
Life Sciences ,
Machine Learning ,
Medical Devices ,
New Legislation ,
Pharmaceutical Industry ,
Proposed Legislation
The Royal Decree of 19 January 2023 (the Royal Decree) concerning the shortage of medicines (i) details the conditions under which a prior authorisation is required to export medicines aimed for the Belgian market to other EU...more
The European Commission has recently announced its intention to launch a call for evidence and public consultation on a potential new EU regulation concerning the compulsory licensing of patents....more
The Belgian Federal Agency for Medicines and Health Products (the FAMHP) has reviewed its procedure to remove or add patented therapeutic indications or dosage forms from the generic medicines' marketing authorisation (MA),...more
In a new decision dated 24 September 2021, the Belgian Joint Commission's Chamber for Products for Human Use reversed its previous decision dated 27 November 2020, and now considers that oral nicotine pouches do not qualify...more
The European Commission has moved to the next phase in its evaluation of the current EU pharmaceutical legislation and the potential for its reform by opening a 12 week online public consultation....more
As next generation Covid-19 vaccine developers consider whether ethical and practical clinical efficacy trials can be conducted, they might consider whether vaccine efficacy can instead be inferred. We consider the...more
Now that the COVID-19 vaccine contract between the EU and AstraZeneca has been published, we take a look at it and the “Best Reasonable Efforts” provisions....more
On Tuesday, 26 January 2021, Allen&Overy (Belgium) LLP hosted a webinar on the key developments in parallel trade of pharmaceuticals in 2020. In this blog post, we discuss a few key topics and questions raised by the...more
On 23 September 2020, the General Court of the European Union (GC) annulled a decision of the European Commission (Commission) that had withdrawn the orphan drug status of Trecondi (Treosulfan)....more
On 23 June 2017, the Belgian “Sunshine Act” entered into force, requiring life sciences companies to disclose relationships with healthcare actors based in Belgium. Companies in both the pharmaceutical and medical devices...more