Article | 22 May 2026
Setterwalls Life Sciences Report May 2026
We have the pleasure of presenting the latest issue of Setterwalls’ Life Sciences Report.
This edition covers a broad range of current developments across the life sciences sector. Topics include new EU cosmetics regulations strengthening consumer protection, the progress of the landmark EU pharmaceutical package – the most comprehensive overhaul of EU medicines legislation in over twenty years – and the Swedish Food Agency’s efforts to reduce the regulatory burden for food businesses. The report also examines the Swedish Government’s proposed measures to combat fraud in the agri-food chain, recent patent case law on supplementary protection certificates and salt form coverage, the application of the EU’s International Public Procurement Instrument in Sweden, proposed new regulations from the Swedish Dental and Pharmaceutical Benefits Agency on subsidies and pricing of medicinal products, and the newly appointed Swedish pharmaceutical inquiry.
We hope you will find the report of interest.
The report contains the following articles:
- Regulatory changes in EU Cosmetics Law: Regulation (EU) 2026/78
- The Swedish Food Agency is reducing the regulatory burden for food businesses
- Has it become harder to obtain patent and specifically supplementary protection for pharmaceutical combination products?
- The EU pharma package: how close is it to becoming law?
- The Swedish Dental and Pharmaceutical Benefits Agency proposes new regulations on applications for subsidies and the pricing of medicinal products
- The Swedish Government is proposing new rules to enhance controls of fraud within the agri-food chain
- Further reading on the new pharmaceutical inquiry
- ADHD Drug Patent Held to Cover All Salt Forms
- Sweden’s application of the IPI measure in relation to Chinese medical devices: almost one year on
Content:
Regulatory changes in EU Cosmetics Law: Regulation (EU) 2026/78
The European Commission has adopted Regulation (EU) 2026/78, amending the EU’s Cosmetics Regulation regarding which substances should be classified as carcinogenic, mutagenic or reprotoxic (CMR). With these new rules, the Commission is taking a further step towards strengthening the EU’s legal framework for consumer protection in the field of cosmetics. The Regulation came into force on 1 May 2026.
Has it become harder to obtain patent and specifically supplementary protection for pharmaceutical combination products?
The extension of the protection term of a pharmaceutical patent through application for a Supplementary Protection Certificate (SPC) is a key opportunity or risk, depending on whether you are the patent holder or a competitor wishing to explore the patented technology. The issue concerns the very heart of the patent system: disclosure of an advance in technology in exchange for time-limited protection. The essence of SPCs is that, following their introduction as a response to the time-consuming process of patent prosecution and associated regulatory processes in the pharmaceutical field, they pose a challenge in relation to the time limitation and thus the focus of attention for stakeholders in the field. The Court of Justice of the European Union (CJEU) has introduced an ‘invention test’ for assessing whether applications for SPCs covering combination products (a pharmaceutical product containing more than one active ingredient) satisfy Article 3(a) of Regulation (EC) 469/2009. The Swedish Patent and Market Court of Appeal (PMCA) applied this test in an AstraZeneca case in mid-2025, a decision now digested and which may have significant implications for pharmaceutical patent strategy.
The Swedish Food Agency is reducing the regulatory burden for food businesses
Over the past two years, the Swedish Food Agency has been conducting a comprehensive simplification initiative that aims to reduce the regulatory burden and administrative costs for food businesses in Sweden. The overarching objective has been to draft regulations that take profitability, competitiveness and sustainable transition into account, and to ensure that businesses also are provided with service, clear information and the right support at the right time. This is an ambitious goal. In March 2026, the Swedish Food Agency published its final report, which sets out the results of more than 40 activities carried out. These include regulatory simplification, improved service and efforts to ensure more risk-based controls.
The EU pharma package: how close is it to becoming law?
The long-awaited EU pharma package will consolidate and substantially replace the existing body of EU medicine-related legislation – including the rules on marketing authorisations, centralised procedures, orphan medicines and paediatric medicines. This will be achieved by a new Directive and a new Regulation, marking the first comprehensive revision in over twenty years. The reform, proposed by the European Commission in April 2023, seeks to promote innovation, strengthen the availability and affordability of medicinal products, reduce regulatory burdens and modernise the framework governing how medicines are authorised and supervised across the single market. Companies operating in the life sciences sectors will need to closely monitor these developments, as the new framework will have significant implications for regulatory strategy, product lifecycle management and market access procedures and requirements across the EU.
The Swedish Dental and Pharmaceutical Benefits Agency proposes new regulations on applications for subsidies and the pricing of medicinal products
On 20 March, the Swedish Dental and Pharmaceutical Benefits Agency (TLV) issued a consultation document containing proposals for new regulations on applications for subsidies and the pricing of medicinal products (ref. no. 01020/2026), along with an accompanying impact assessment. The proposal means that the current regulations and general guidelines (TLVFS 2008:2) on applications and decisions regarding medicinal products will be repealed and replaced by a new regulatory framework. The new regulations also amend the Swedish Dental and Pharmaceutical Benefits Agency’s regulations (TLVFS 2003:2) on non-prescription medicinal products under the Act (2002:160) on Pharmaceutical Benefits, etc. The new regulations are proposed to enter into force on 1 July 2026.
The Swedish Government is proposing new rules to enhance controls of fraud within the agri-food chain
The Swedish Government has submitted a government bill, 2025/26:206, with the purpose of enhancing controls of fraud within the agri-food chain. The Government proposes the introduction of a mechanism allowing central government agencies to assume responsibility for official controls in certain categories of cases of violations perpetrated through fraudulent or deceptive conduct. To enhance the control authorities’ access to information and their ability to conduct effective supervision, the Government also proposes provisions on information-sharing obligations between control authorities within the agri-food chain.
Further reading on the new pharmaceutical inquiry
Setterwalls has previously reported that the Swedish Government has appointed a new commission of inquiry tasked with analysing and proposing how Swedish state responsibility for medicinal products and vaccines should be expanded, enhanced and organised. In this article, Setterwalls goes into further detail on the tasks of the inquiry and potential proposals. The special investigator appointed to lead the inquiry is to submit an interim report by 1 June 2027 and a final report by no later than 31 December 2027.
ADHD Drug Patent Held to Cover All Salt Forms
Does a patent whose claims specify two particular salt forms of a pharmaceutical compound prevent competitors from launching other salt forms? The Patent and Market Court of Appeal (PMÖD) recently answered in the affirmative, further holding that it was immaterial that the patent could only be granted after the holder had narrowed claims originally covering all pharmaceutically acceptable salts.
Sweden’s application of the IPI measure in relation to Chinese medical devices: almost one year on
In June 2025, we reported on the European Commission’s decision to restrict Chinese participation in EU public procurement for medical devices under the International Public Procurement Instrument (see here). The implementing regulation, Commission Implementing Regulation (EU) 2025/1197, entered into force on 30 June 2025, marking the first application of the IPI. Almost one year on, we summarise how the measure has been applied in Sweden and where questions remain.
