Article | 24 November 2025
Setterwalls Life Sciences Report November 2025
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.
In this issue you can read about for example updates in the ethical rules, labelling of foods for special medical purposes and Sweden’s adaptations to the AI Act. We hope you will find the report of interest.
The report contains the following articles:
- Updates in the ethical rules – how are pharmaceutical companies affected?
- EU Court clarifies front‑of‑pack nutrition labelling for foods for special medical purposes: per‑portion figures included in such labelling constitute a prohibited repetition
- A closer look at MDCG 2025-4 guidance for medical software apps
- Do not call it probiotics
- Proposal for a new Swedish product liability act – what does that mean?
- A brief update on Sweden’s adaptations to the AI Act – SOU 2025:101
- Two Judgments on Sales of Alcoholic Beverages in Sweden on Producers’ Sites – Opening Hours Are Not Required to Match Those of Systembolaget
Content:
Updates in the ethical rules – how are pharmaceutical companies affected?
At the end of September this year, several updates to the Ethical Rules for the Pharmaceutical Industry in Sweden (LER) entered into force. The rules are binding on member companies of the Swedish Association of the Pharmaceutical Industry (Lif). While the rules have previously been updated at relatively frequent intervals, a longer period has now passed since the last amendments were made. In this article, Setterwalls summarises the changes and their impact on pharmaceutical companies.
EU Court clarifies front‑of‑pack nutrition labelling for foods for special medical purposes: per‑portion figures included in such labelling constitute a prohibited repetition
The European Court of Justice clarifies front‑of‑pack nutrition labelling requirements for foods for special medical purposes – here are the main takeaways.
A closer look at MDCG 2025-4 guidance for medical software apps
In June 2025, the Medical Device Coordination Group (MDCG) issued guidance document MDCG 2025-4, a pivotal development for digital health regulation in the European Union. This guidance responds to the growing prevalence of medical device software (MDSW) apps released through online platforms. The framework addresses patient safety, regulatory compliance and transparency obligations related to MDSW apps and their distribution channels.
Do not call it probiotics
Marketing products and services in the Life Sciences field is not a simple task. In addition to the general marketing law rules that apply to all goods and services, there is a rich array of special regulations to consider, for example regarding medicinal products and foods.
Proposal for a new Swedish product loability act – what does that mean?
The existing regulations on product liability for consumer protection were designed way before the current digital environment came into being. To align the regulations with the digital era, new rules are on their way. In this article, Setterwalls summarises some of the implications these changes may have on the Life Sciences sector.
A brief update on Sweden’s adaptations to the AI Act – SOU 2025:101
In October 2025, the Swedish inquiry (SOU 2025:101) (“SOU”) aiming to investigate the measures necessary to implement the Artificial Intelligence Act, Regulation (EU) 2024/1689 (“the AI Act” or “the Act”), delivered its report. The aim of the inquiry was, among other things, to clarify how responsibilities should be shared between national authorities, to submit proposals on what is needed to meet the requirements for sanctions in the event of violations of the Act and to analyse what is needed to establish regulatory sandboxes for AI.
Two Judgments on Sales of Alcoholic Beverages in Sweden on Producers’ Sites – Opening Hours Are Not Required to Match Those of Systembolaget
Following the June 2025 legalisation of on‑site sales of alcoholic beverages at producers’ premises in Sweden, judgments on the first cases under the new framework have now been issued. On 23 October 2025, the Administrative Court in Stockholm examined permissible sales hours in the light of local conditions, and granted permits for the sale of spirits also on non‑holiday Saturdays from 3.00 p.m. to 8.00 p.m. and on Sundays and public holidays from 10.00 a.m. to 8.00 p.m.
