Articles for the ‘Healthcare’ Category

Both the Belgian legislator and government have played an active role in 2023 when it comes to pharma legislation, which has led to a number of changes in the legal framework. In this article, we look back and discuss five noteworthy developments in Belgian pharma law.

Despite many initiatives by the (former) Minister of Health, the uptake of biosimilars in Belgium has remained rather low. In this blog, we summarise the new rules, which apply since 2 October 2023. 

During the Covid 19 pandemic, a healthcare compliance “classic” has largely faded into the background: The permissibility of hospitality for healthcare professionals by representatives of the pharmaceutical and medical device industries. After the end of the pandemic, however, face-to-face meetings are coming back to life. And so it is not surprising that the question now also arises again as to whether and to what extent physicians, dentists, pharmacists, nurses, practice staff and other healthcare professionals (“HCPs” for short) may actually be invited to lunch or dinner. Some changes have happened recently, particularly with regard to value limits – including new versions for important codes.

In the ever-evolving world of medical device manufacturing, companies face the difficult task of ensuring innovation and progress every day. However, the pressure to use the latest technologies in healthcare is often in conflict with limited financial resources. In this complex environment, legal problems and risks often arise that can have a direct impact on pharmaceutical and medical device companies, hospitals and healthcare professionals. Pragmatic and safe legal solutions are required to resolve these issues.

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The European Commission published a draft proposal for a revised Product Liability Directive (the “PLD Proposal”) on 28 September 2022, which aims to bring the European Union’s product liability regime ‘up to speed’ with the digital age, circular economy business models and global value chains.This blog focuses on the main changes the PLD Proposal brings and its impact on life science companies.