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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 Advocate General recently gave its opinion in the case No C-473/22 between Mylan AB (“Mylan”) and Gilead Sciences Finland Oy, Gilead Biopharmaceutics Ireland UC and Gilead Sciences Inc (“Gilead”).

The referral was made by the Finnish Market Court in proceedings concerning a claim for damages resulting from an unfounded preliminary injunction (“PI”) issued against Mylan. Under the Finnish system, the liability for such damages is deemed “strict”. In other words, the party that has enforced an unfounded PI is liable for any damages shown irrespective of other circumstances such as the level of care it has taken when evaluating the likelihood of infringement.

The case holds implications for all jurisdictions in the EU in which the same or similar strict liability regime is adopted into national law.

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.

The so-called Bolar provision is generally understood as the rule allowing generic and biosimilar manufacturers to get prepared for launching a drug by the time the relevant patent expires, thereby offering broader options to patients as early as possible.