Life Sciences Report November 2022

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 EU’s proposed AI Act will constitute further significant regulation of innovative digital solutions. How can our experience of the GDPR help us adapt to new requirements in the life sciences sector?
New digitalisation opportunities offer significant benefits in the life sciences sector, both for patients and health care in general. However, the implementation of such advances must balance potential technical progress and other important interests, such as data protection and similar aspects of fundamental rights. Continue reading.

Enhanced requirements for disease awareness campaigns?
While the marketing of prescription pharmaceuticals to the general public is forbidden, disease awareness campaigns are becoming more and more common. Such campaigns are aimed at providing problem-oriented information, such as awareness of specific diseases, without promoting specific medicinal products or specific treatments. Continue reading.

European Health Data Space proposal: A step forward for patients, healthcare providers and the science community?
On 3 May 2022 the European Commission published a proposal for a regulation of the European Health Data Space to address several challenges related to electronic health data. Access to accurate and up-to-date health data is often key for individuals to receive appropriate care, and, in some cases, even vital. Continue reading.

Clarifications on the marketing of electronic cigarettes and refill containers
In a recent decision, Sweden’s Patent and Market Court of Appeal provided some clarifications regarding what is considered marketing of electronic cigarettes and refill containers. This article summarises the court’s conclusions.Continue reading.

Can you patent a drug/software combination?
The European Patent Office (“EPO”) Boards of Appeal concluded in a decision earlier this year that a drug and computer program combination is not patentable. The computer program that was subject to the EPO application was aimed at improving patient compliance with taking a known pharmaceutical formulation for the treatment of heart disease. Continue reading.

TLV reviews the price cap system
The Swedish Dental and Pharmaceutical Benefits Agency (Sw. Tandvårds- och läkemedelsförmånsverket; TLV) is beginning a review of the price cap system for the substitution of pharmaceuticals within the pharmaceutical benefit system. The review is being undertaken due to the increased costs in society in order to secure the supply of pharmaceuticals. Continue reading.

WTO allows limitation of patent rights to COVID-19 vaccines
This summer, the Ministerial Conference of the World Trade Organization made a decision that could limit the rights of patent holders in large parts of the world. The decision means that a developing country may allow the supply and distribution of COVID-19 vaccines without the consent of the owners of the patents for such vaccines. Continue reading.

Classification of products in the borderland between cosmetic and medicinal products
Where the line is drawn between a cosmetic and a medicinal product may seem intuitive. However, the preliminary ruling published by the Court of Justice of the European Union on 18 October 2022 in Case No. C-616/20 shows that it is not always entirely clear where the distinction should be made. Continue reading.

Update of Standard Contractual Clauses: the deadline is approaching
All relevant stakeholders must update their Standard Contractual Clauses (SCCs) before 27 December this year to comply with the GDPR. This deadline should be considered critical, as a breach of the GDPR can result in fines of up to EUR 20 million or 4 % of a company’s annual global turnover (whichever is higher). Continue reading.