Life Sciences Report November 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. The enclosed report, together with earlier editions, is also available on our website. We hope you will find the report of interest.

Articles

An updated Swedish national strategy for life sciences

On 7 November 2024, the Swedish government launched an updated strategy for life sciences in Sweden. The strategy was first presented in December 2019 with the ambition of establishing Sweden as a leading life sciences nation. The strategy has now been updated with the aim of contributing to excellence, long-term competitiveness and enhanced patient benefit in Sweden. Read more.

How has Sweden’s new FDI regime affected investments in the life science sector?

It has now been almost a year since the Swedish Foreign Direct Investment Act (2023:560) (“the FDI Act”) entered into force on 1 December 2023. The FDI Act states inter alia that investments in companies engaged in “protection worthy activities” must be notified to and approved by the Swedish Inspectorate for Strategic Products (“ISP”). Activities conducted by entities in the life science sector to a great extent fall within the scope of the FDI Act. This means that the FDI Act has a major impact on investments and entities in the sector that are deemed to be engaged in protection worthy activities. Read more.

The interpretation of Personal data concerning health – key takeaways from recent decisions

In recent rulings, both the Court of Justice of the European Union, or the European Court of Justice (“ECJ”), and the Swedish Authority for Privacy Protection (Sw. Integritetsskyddsmyndigheten, “IMY”) have provided clarifications regarding the definition and interpretation of the use of sensitive personal data (i.e. “special categories of personal data”), specifically where such data concerns a data subject’s health. This brief article intends to provide a short background on the recent rulings, as well as some key takeaways for those processing sensitive personal data, for example, concerning health. Read more.

Updates in the ICC Advertising and Marketing Communications Code

On 19 September 2024, the ICC launched updated rules for advertising and marketing communications. From 1 January 2025, the revised rules will be applicable to the Swedish market. A summary of some of the updates follow in this article. Under the Swedish Marketing Act, all marketing should be in accordance with good marketing practice. Examples of good marketing practice in the use of marketing claims in Sweden include the ICC Advertising and Marketing Communications Code (the “ICC Code” in the following). The revised rules therefore have a direct impact on marketing in Sweden. Read more.

Injunction based on market exclusivity – comments on recent Swedish case law

It is not uncommon for actors in the pharmaceutical industry to simultaneously have to engage in legal battles on several fronts. For example, intellectual property rights and, in particular, patents have to be taken into account, while the demands from regulatory authorities also have to be faced. However, although the concept of launch at risk is well known in the field of patent law, it is unusual for the “risk” in question to be understood as referring to the regulatory concept of market exclusivity. Nevertheless, the latter scenario has been subject to discussion in a recent case between a generics company (“the Company”) and the Swedish Medicinal Products Agency (“the Agency”). The case also sheds light on injunction as a sanction in a regulatory context. Read more.

Fighting Antibiotic Resistance: Global and European legal strategies driving research and innovation

Antimicrobial resistance (AMR) is among the most critical health issues globally, emerging when bacteria evolve to resist the medicinal products that are meant to kill or inhibit them. The global consequences are profound. According to the World Health Organization (WHO), antibiotic resistance threatens to reverse decades of progress in modern medicine. If left unchecked, antibiotic-resistant infections could cause 10 million deaths annually by 2050, surpassing cancer as a leading cause of mortality. This urgent challenge calls for a coordinated global response. Read more.

The EU Health Technology Assessment Regulation will soon apply

The Regulation (EU) 2021/2282 on health technology assessment (the “HTA Regulation”) which governs joint clinical assessments, joint scientific consultations and identification of new health technologies at EU ‍level entered into force on 11 January 2022 and will apply from 12 January 2025. In this article we summarise some of the provisions and what Sweden is currently doing on implementation. Read more.

The European Court of Justice rules on the lawfulness of patent dispute settlement agreements under Article 101 TFEU

In June this year, the European Court of Justice (ECJ) issued its ruling in an ongoing case concerning ‘pay-for-delay’ agreements. The ruling largely upheld the European Commission’s 2014 decision to impose fines on the Servier pharmaceutical group and several generic pharmaceutical companies for entering into patent settlement agreements. In this article, Setterwalls analyses some of the key takeaways from the Court’s ruling on the assessment of the agreements under Article 101 TFEU. Read more.

Preliminary ruling from the European Court of Justice on plant-based “steak” and “sausage”

Legal actions were presented to a French court on the grounds of a French decree that banned the use of certain animal-related designations for plant-based products, such as “steak” or “sausage”. The applicants argued that the decree was contrary to EU Regulation No 1169/2011 on the provision of food information to consumers (the “Regulation”). The French court requested a preliminary ruling from the European Court of Justice (ECJ), which ruling now has been made in case C-438/23. In this article we will briefly summarise the findings of the ECJ. Read more.