Setterwalls Life Sciences Report May 2025

Affärskritiska rättsfall, nya EU-krav och ett skärpt juridiskt landskap. Setterwalls presenterar vårens viktigaste regulatoriska skiften inom life sciences.

Sverige har en stark och internationellt erkänd position inom life sciences, med betydande bidrag till forskning, innovation och export inom bland annat läkemedel, bioteknik och livsmedel. Den innovationsdrivna och expansiva branschen står inför snabba och föränderliga juridiska krav som påverkar bolagens affärsförutsättningar i grunden.

Sedan 2011 har Setterwalls Advokatbyrå, en av Sveriges största och äldsta affärsjuridiska byråer, presenterat sin Life Sciences Report. Två gånger per år släpps rapporten, som samlar aktuella insikter för aktörer som verkar inom området, och den har kommit att bli en viktig källa till kunskap för branschen. Setterwalls kartlägger i rapporten avgörande rättsliga förändringar och domar som påverkar bolag i branschen, och vårens upplaga bjuder på viktiga medskick till bolag inom medtech, läkemedel, livsmedel och kosmetika.

Bland annat analyseras en ny dom som resulterat i en betydande bot för långa betaltider i livsmedelskedjan, en intressekonflikt mellan en ny typ av patentrelaterade anpassningar av produktinformation och utbytbarheten för generiska läkemedel, samt nya krav på bland annat verifiering och dokumentation av miljöpåståenden i marknadsföring när Green Claims-direktivet träder i kraft.

Välkommen till Setterwalls. En av Sveriges ledande affärsjuridiska byråer.

Innehåll:

Important decision on the distinction between marketing and non-commercial information in relation to medicinal products

Setterwalls has previously written about the significance of the distinction between marketing and freedom of speech, for example here. This distinction is of material importance as it determines which rules apply to communications in relation to medicinal products. A recent decision gives us reason to revisit this topic. The decision highlights the importance of pharmaceutical companies reviewing and, if necessary, correcting statements made to journalists, as the company may be held responsible for what is stated in the article.
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When legal and important areas of interest collide – the impact of patent law on interchangeability

A company about to launch a prescription medicinal product must necessarily take several legal aspects into account. One such constantly relevant issue is which patent rights may affect the launch. Even if the relevant substance itself is not patent- protected by a third party, there may be patent rights in relation to, for example, a certain dosage regimen or a certain form of administration.

In some cases, patent-related issues may also spill over into other legal areas. The company launching the product may have ensured through various measures/limitations that the launch and sale of the product does not constitute any patent infringement, but as a result of these measures/limitations, it might face problems with the regulatory authorities.
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A walk-through of the latest CJEU case law on the SPC regulation

In 2024, the CJEU delivered two rulings on the interpretation of Regulation (EC) No. 469/2009 of the European Parliament and of the Council of 6 May 2009 concerning the supplementary protection certificate for medicinal products (the SPC regulation):

• Case C-181/24, relating to the designation of a marketing authorisation (MA) under Article 3(d), and
• Joined Cases C-119/22 and C-149/22, relating to the concept of “protected by a basic patent” in accordance with Article 3(a), as well as the relationship between Article 3(a) and (c).

This article summarizes the findings of the CJEU in its latest rulings
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Significant fine upheld for unfair trading practices in the agricultural and food sector: A landmark case on the Swedish implementation of the UTP Directive

Since 1 November 2021, the Act on the Prohibition of Unfair Trading Practices in the Purchase of Agricultural and Food Products (the “UTP Act”) has applied in Sweden. Initially, the Swedish Competition Authority (the “SCA”) focused on increasing awareness of the regulatory framework. In recent years, however, the SCA has also issued several decisions and opinions to provide guidance. In addition, Swedish case law has now begun to emerge regarding the interpretation and application of the ban on late payments, with a recent example being a ruling on 17 February 2025, by the Administrative Court of Appeal in the case at hand. This is the first ruling by the Administrative Court of Appeal based on the UTP Act.
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Strengthening EU’s medicine supply: The EU Commission’s Critical Medicines Act proposal

In recent years, shortages of medicines have become an increasingly urgent challenge within the EU. The pandemic, geopolitical tensions and a growing dependence on manufacturing outside the EU have exposed vulnerabilities in the supply chain for critical medicines. In response, on 11 March 2025, the European Commission presented a proposal for a new regulation—the Critical Medicines Act (CMA)—aimed at strengthening the EU’s resilience and ensuring access to essential medicines in the EU.
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Court ruling: Delivery of cosmetic products that do not comply with labelling requirements constitutes an unfair marketing practice

Swedish regulations applicable to cosmetic products require labelling in Swedish, including details of specific precautions. In a recent ruling (2025-03-12, Case no. PMT 12383-21), the Swedish Patent and Market Court of Appeal (Patent- och marknadsöverdomstolen) examined Sweden’s implementation of the EU E-commerce Directive and its interaction with Swedish marketing law and regulations concerning cosmetic products. This article delves into the Court’s findings, focusing on the implications for cosmetics businesses operating within the EU.
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EU introduces stricter rules on plastic food contact materials

On 21 February 2025, the European Commission introduced amendments to existing EU regulations concerning plastic materials and articles intended to come into contact with food. The new regulation aims to enhance safety, quality control and the use of recycled plastics in food contact materials. The changes took effect on 24 March 2025. In this article, Setterwalls provides a brief analysis of the key changes and their implications.

A key element of the regulation is the introduction of the concept and requirement of a “high degree of purity” for substances used in the manufacture of plastic materials and articles that may be present in the final plastic material, including those manufactured from waste. A substance is considered to have a high degree of purity if containing only minor amounts of non-intentionally added substances that meet specific conditions.
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Five steps to ensure Data Act compliance for IoT products and services within the MedTech sector

In December 2023, the new regulation on harmonized rules on fair access to and use of data (2023/2854; the “Data Act”) was published in the Official Journal of the European Union, with most of the new requirements becoming applicable later this summer, on 12 September 2025. The new regulation aims to foster a competitive data market by making data, especially industrial data, more accessible. It will have an impact on many businesses, not least those within the MedTech sector.

The Data Act imposes design and manufacturing obligations on IoT products and services to ensure users have access by default to relevant data. It specifies when, how and on what terms data must be shared with users and other businesses. Additionally, it includes transparency requirements by mandating the pre-contractual provision of information to users about the data generated by connected products or related services.
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The Green Claims Directive – New rules regarding environmental claims

The EU Commission adopted a proposal for a Directive on Green Claims in 2023, which is expected to be finally adopted in mid-2025. The proposal aims, among other things, to make green claims reliable, comparable and verifiable across the EU, and to protect consumers from greenwashing. The directive introduces stricter requirements as to how companies substantiate and communicate voluntary green claims to consumers. As many companies in the life science sector use environment and sustainability statements — such as claims about eco-friendly production of pharmaceuticals, “green” medical devices and biodegradable diagnostic tests — the new directive will impact the life sciences industry and its marketing. In this article, we summarise some of the key points of the proposed directive that companies in the life sciences sector should be aware of.
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