Life Sciences Report May 2024

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.

Articles:

New regulation introduces stricter accessibility requirements – do your products and services meet the new requirements?

Providers of e-commerce platforms, apps, banking services and tech are among the economic operators that will be affected by the EU Accessibility Act. In Sweden, the corresponding legislation will enter into force on 28 June 2025, marking an important step towards a more inclusive internal market, where products and services are to be designed in a uniform way that makes them accessible for all citizens. Read more

Overview of recent developments regarding the distinction between marketing and non-commercial information in relation to medicinal products

Marketing of medicinal products in Sweden is strictly regulated, for example by the Swedish Medicinal Products Act (2015:315), the general rules on marketing in the Swedish Marketing Act (2008:486) and the Ethical Rules for the Pharmaceutical Industry in Sweden (LER). However, non-commercial information is protected by the constitutional rules on freedom of speech and therefore falls outside the rules on marketing of medicinal products. To pharmaceutical companies, the distinction between commercial and non-commercial information is therefore of significant importance. This article provides an overview of recent developments in this field, and offers insights into the key takeaways. Read more

The new Product Liability Directive and AI Liability Directive – implications for medical devices with AI functionalities

Back in September 2022, the European Commission published a proposed package of regulatory measures within the field of product liability. This will have significant implications for manufacturers and providers of medical devices featuring artificial intelligence (AI), including standalone software such as Software as a Medical Device (SaMD) and embedded software featuring AI functionalities. This package comprises: (i) the proposed revisions to the Product Liability Directive (PLD) and (ii) the proposed AI Liability Directive (AILD). Read more

Key takeaways for the environmental risk assessment (ERA) in the proposal for new EU pharmaceutical legislation

On 10 April 2024, the European Parliament adopted its position on a proposed revision of the EU pharmaceutical legislation covering medicinal products for human use. The proposed revision was put forward by the European Commission in April 2023 and includes a new directive and a new regulation that would replace inter alia Directive 2001/83/EC and Regulation (EC) No 726/2004. Read more

EMA’s new recommendations to strengthen supply chains of critical medicines – a short recap of what and why

On 19 April 2024 it was announced that EMA, through its Executive Steering Group on Shortages and Safety of Medicinal Products (MSSG), has developed a set of recommendations to strengthen supply chains of critical medicines. The following is a short recap of what the recommendations are and why they have been developed. Read more

Recent developments and an update on Geographical Indications (GIs)

This brief article intends to inform about recent developments in the legal framework, but also to provide an introduction to the most relevant types of GIs and their respective application, with a few illustrative examples from a Swedish perspective on what has been registered. Read more 

Switch and substitution of biological medicinal products in pharmacies

The Swedish Medical Products Agency (MPA) was tasked in 2023 with analysing the evidence for switch (substitution after renewal of a prescription) of biological medicinal products. Based on the outcome of the completed analysis, MPA was also to investigate the possibility of automatic substitution of biological medicinal products at pharmacy level. In September 2023, MPA published an interim report on switch, and now in April 2024 has published a final report on automatic substitution of biological medicinal products in pharmacies. The findings of the final report are summarized here. Read more

The Swedish Supreme Administrative Court seeks guidance from the CJEU on the interpretation of the provisions of EU law on the labelling of food for special medical purposes

The Swedish Supreme Administrative Court has recently decided to request a preliminary ruling from the Court of Justice of the European Union (CJEU) on the interpretation of the EU rules governing the labelling of food for special medical purposes. By way of requesting a preliminary ruling, the Supreme Administrative Court is seeking clarification as to whether information concerning energy value and nutrients on the front of the packaging constitutes prohibited repetitions or, on the contrary, if it constitutes necessary information on the properties and characteristics of the product. Read more

Labelling sausages “riktig korv” (eng. real sausage) was misleading

A Swedish food company launched a new product range of sausages and labelled them “riktig korv” (eng. real sausage). According to the company, the sausages were special as they were free from sugar and preservatives and contained Swedish meat of good quality. The Swedish Food Agency found the labelling to be misleading. Read more