Life Sciences & Healthcare newsletter, April 2025

Publication / 23 April 2025 / Lise-Lotte Lääne, Marika Grunte, Dovydas Gudžiūnas, Kärt Saar

In this newsletter, we discuss legal news which affects the pharmaceutical and pharmacy sector.

The Commission’s proposal on the Critical Medicines Act will hopefully provide tools for member states to avoid supply chain issues in relation to critical medicines. Interpretations by the Court of Justice of the European Union assist market players to navigate in the field of regulations and help member states to ensure the safe use of medicinal products.

Read about this and more in this issue of the newsletter.

Worth noting:

On 11 March 2025, the European Commission published the Critical Medicines Act proposal. The aim of the proposal is to address supply chain vulnerabilities with critical medicines and to reduce dependencies on third countries. The proposal envisages granting strategic project status to projects that create, increase or modernise manufacturing capacity for critical medicines or their ingredients. Strategic projects may benefit from funding and fast-tracked administrative, regulatory and scientific support. Additionally, the proposal sets new criteria for awarding public procurements, focusing on the resilience of supply chains. Read more here.

On 27 February 2025, the Court of Justice of the European Union clarified whether pharmacies’ campaigns consisting of price reductions and payments must be considered as advertising medicinal products within the meaning of Directive 2001/83/EC.The Court found that if pharmacies’ campaigns are solely related to unspecified prescription-only medicinal products, then these campaigns are outside the scope of the Directive, as the campaigns essentially advertise pharmacies, not medicinal products. However, if the advertising campaigns encourage the purchase of unspecified non-prescription medicinal products, then these campaigns are considered to be within the scope of the Directive.In addition, the Court emphasised that member states must prohibit the use of advertising material that encourages the irrational and excessive use of non-prescription medicinal products. For example, vouchers that allow the consumer to obtain, at a reduced price, products from the entire range of products of the pharmacy concerned encourage irrational and excessive use and, as such, should be prohibited. Read more here.

On 13 March 2025, the Court of Justice of the European Union found that substances which, by means of reversible binding to bacteria, prevent the bacteria from adhering to human cells exert “pharmacological action”. The Court affirmed that if there is doubt over whether the product should be classified as a medicinal product or another kind of product, then it should be considered to be a medicinal product. Therefore, products that exert “pharmacological action” have to be considered medicinal products, not medical devices. Read more here.

Estonia intends to establish a legal basis for the Health Insurance Fund in order to, in exceptional cases, finance authorised orphan medicines on the application of a patient or their representative. This amendment to the legislation would accelerate and improve access to authorised orphan medicines, since the patient would be partially reimbursed for authorised orphan medicine that is not subject to a price agreement between the Health Insurance Fund and the marketing authorisation holder.Price agreement negotiations for authorised orphan medicines are started at the initiative of the marketing authorisation holder or the Health Insurance Fund. Currently, the patient or their representative can apply for financing from the Health Insurance Fund only if the orphan medicine listed in the ministerial decree is necessary for out-patient treatment or if the orphan medicine is without authorisation. The possibility of applying for reimbursement of authorised orphan medicines is essential since the marketing authorisation holders may not be motivated to initiate price agreement negotiations with the Health Insurance Fund, or the negotiations may be too time-consuming considering the critical nature of the treatment. Read more here.

#sorainenlifesciences: our practice in action

Our partner, Lise-Lotte Lääne, as a member of the AmCham Healthcare Committee, has been visiting Estonian parliamentary fractions to introduce the committee’s new position paper. The position paper is available here.

Lise-Lotte is also one of the organising committee members of Central European Congress of Life Sciences EUROBIOTECH 2026. The event will take place next year in June in Krakow, Poland and will bring together specialists from diverse areas of life sciences, fostering new connections and interdisciplinary collaborations.

On 4 April, senior associate Dovydas Gudžiūnas represented the AmCham Healthcare, Medtech & Biotech Innovations Committee in a meeting with the Ministry of Health of the Republic of Lithuania.

On 26 March, our Latvian office held a business breakfast seminar for companies operating in the field of beauty and aesthetic medicine, such as aesthetic medicine clinics, dental practices, etc. Clinics, just like any other businesses, often face various legal challenges in their daily work, which can affect their operations. However, they are not always aware of all the complications of the law or able to weigh potential risks in their daily work. At the business breakfast, representatives of the Sorainen Life Sciences and Healthcare sector group provided practical insight into some of the problem areas that clinics may encounter on a daily basis. At the breakfast seminar, we talked about the following topics:

- Legal challenges in addressing unlicensed providers offering aesthetic medical services
- Lawful utilisation of patient data for marketing purposes
- Integration of artificial intelligence in medical practice
- Managing patient expectations and mitigating legal risks from unsatisfactory surgical outcomes
- Navigating the intersection of competition and labour law in order to safeguard your clinic’s investment in medical specialists.

The issue of the activities of unlicensed service providers in the field of beauty and aesthetic medicine, advertising and offering filler and botulinum injections, which often cause negative health consequences for people who have undergone such injections, is particularly relevant in Latvia. The existing regulatory framework is incomplete and so does not effectively combat such unregistered service providers. The capabilities of supervisory authorities to identify service providers of this kind and to apply sanctions are also limited.

We will continue to talk about these and other issues and to jointly seek solutions with market participants in the industry.

Our international Life Sciences & Healthcare team is at your disposal, should you need advice on any legal issues you are facing.

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