Article | 06 Dec 2023
Life Sciences Report December 2023
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.
EU Artificial Intelligence act: potential implications for healthcare AI
Technological developments over the past decade have led to an unprecedented increase in data about various aspects of our lives, including healthcare. With the increasing availability of data, artificial intelligence (AI) is rapidly moving into healthcare, making remarkable advances in a range of applications, such as scan and image diagnostics, therapy development, patient triage and care planning. In April 2021, the European Commission (EC) presented a proposal for the regulation of AI in the European Union (EU).
Preparing for the NIS 2 Directive: Impacts on the health sector
By 17 October 2024, all European Union (EU) Member States must complete the process of implementing the EU’s Network and Information Security 2 Directive ( “NIS 2” or the “Directive”) into their respective national laws. NIS 2 introduces cybersecurity risk management measures and reporting requirements for an expanded list of highly critical sectors. NIS 2 will impact a wide spectrum of organisations, including the health sector.
Pharmaceutical companies fined €13.4 million by the European Commission for price fixing
Five pharmaceutical companies have been fined a total of €13.4 million by the European Commission for participating in a price-fixing cartel regarding an important active pharmaceutical ingredient. The cartel was revealed to the Commission by a sixth participating company, which escaped fines under the Commission’s leniency programme. This is the first time that the Commission has issued fines for cartel formation in the pharmaceutical sector and regarding an active pharmaceutical ingredient.
Proposal for new Directive and Regulation on medicinal products for human use
As previously reported, the European Commission published its proposal for the reform of the EU pharmaceutical legislation on the 26 April 2023. The long-anticipated framework outlines several significant proposals affecting stakeholders in the industry. In this article, Setterwalls’ Nicolas Pershaf and Johan Montan highlight the most-debated proposals in the framework, based on the consultative responses recently submitted by key stakeholders.
Pharmaceutical marketing compliance
Recently, a significant decision has provided guidance on the issue of the possibilities of going beyond the Summary of Product Characteristics (SmPC) in marketing of a medicinal product. The decision concerned Chapter 1, Section 1, Article 2 of the Ethical Rules for the Pharmaceutical Industry (LER). The article is of major significance in the field of pharmaceutical information, encompassing the stipulation that a medicine’s SmPC constitutes the factual basis for information about the medicinal product.
In order for a parallel imported product to be launched on the market of the Member State of destination, the package leaflet generally has to be changed to a leaflet in the domestic language. This, along with other rules that may apply in the specific case, means that the parallel importer must open the packaging. In some situations, the parallel importer might have to completely repackage the medicine. As this practice risks infringing upon the trademark rights of the original manufacturer, the Court of Justice of the European Union (CJEU) has established certain conditions under which a medicinal product may be repackaged.
First administrative fine based on the UTP Directive now imposed in Sweden
On 1 May 2021 the Directive (EU) 2019/633 on unfair trading practices in business-to-business relationships in the agricultural and food supply chain (“UTP”) was implemented in the Member States. The directive is intended to target the imbalances in bargaining power between suppliers and buyers in the agricultural and food supply chain, as they could inter alia potentially lead to unfair trading practices. On the basis of this legislation, the first administrative fine based on the UTP Directive as implemented in Sweden has now been imposed.
Switch of biological medicinal products
The Swedish government has tasked the Swedish Medical Products Agency (Sw. Läkemedelsverket, MPA) with investigating the use of single and multiple switches between biological medicinal products in Sweden, as well as the substitution of such products at pharmacies. On 15 September, the MPA published an interim report, while the final report is expected in April 2024. In this article, Setterwalls outlines the MPA’s conclusions in the interim report, as well as the current legal situation regarding substitutability of biological medicinal products.
The Medical Devices Regulation, 2017/745, (MDR) and the In Vitro Diagnostics Regulation (IVDR) have replaced the three former EU Directives on medical devices, which Setterwalls has previously reported on here and here. The new regulations have introduced EUDAMED, the European Database on Medical Devices, as a database comprising several electronic systems for medical devices. The systems will include information on actors, such as manufacturers, authorised representatives, importers and distributors, as well as device-identifier elements and certificates issued by notified bodies.
