Life Sciences Report May 2021

We have the pleasure of presenting the latest issue of Setterwalls’ Life Sciences report. The report presents our view on selected current issues with respect to life sciences. 

We hope you will find the report of interest.

The Patent and Market Court of Appeal rejects the Image Rule of the Alcohol Act – a high-profile case about moderation and proportionality
Marketing of alcoholic beverages in Sweden is subject to specific restrictive regulations in the Swedish Alcohol Act (alkohollagen). As a general requirement under the Alcohol Act all business-to-consumer marketing of alcoholic beverages must observe particular moderation (the Moderation Rule). Continue reading.

New Swedish ruling shows that strict liability (still) applies for losses caused by a preliminary injunction
Setterwalls has successfully represented Orifarm Generics in a lawsuit against Novartis concerning losses caused by a preliminary injunction. A crucial issue in the case has been whether Swedish courts, following the European Court of Justice’s ruling in C-688/17 (“the Bayer Ruling”), still can apply strict liability for damages. Continue reading.

Marketing restrictions, age requirements and health warnings? – Proposed new regulations for tobacco-free nicotine products
Recently there has been rapid development of tobacco-free nicotine products for consumption. The marketing of these new products is extensive; we see them in ads, in sponsored posts on social media as well as in influencer collaborations. Continue reading.

Recent news in international trade in food
(This article is in part courtesy of Food Lawyers Network)

Regulation (EU) 2016/429 on transmissible animal diseases is amending and repealing certain acts in the area of animal health. The Regulation is complemented by Delegated Regulation (EU) 2020/692 and both entered into force on 21/4/2021. The importance of the law laid down in these animal health Regulations reaches far beyond the world of vets, pets and other animals. Its commencement date has been set to coincide with the coming into force of a whole series of rules on official controls on food, feed and agricultural and fishery products overall. Continue reading.

Access authorisation and a needs and risk analysis – a mandatory organisational security measure for health data processing in Sweden?
All companies and organisations working in life sciences and other health and wellness services will eventually need to process the more restricted special categories of personal data, such as health data, genetic data or biometric data. Continue reading.

Changed rules on the Swedish Keyhole label – Can ready meals be healthy?
From 1 March 2021, new rules apply regarding which food may be marketed with the Keyhole label (Nyckelhålet in Swedish). Following the change, more types of products will be allowed to be labelled with the Keyhole. Continue reading.

Medical Devices Regulation– the day is finally here
The Medical Devices Regulation, 2017/745, (MDR) and the In Vitro Diagnostics Regulation (IVDR) are now (finally) set to replace the current three EU-directives on medical devices. Continue reading.

Health claims for botanical products
As consumers become more aware of their health and well-being, many companies deploy marketing strategies to convey the message that their products provide health benefits. There are, however, limitations on the health claims companies can communicate to the market and requirements for how these claims must be scientifically substantiated to ensure a high level of consumer protection. Continue reading.