As cross-border innovation, investment and service provision continue to accelerate across the Baltic region, stakeholders are increasingly focused on how regulation shapes market entry and growth opportunities.
From clinical trials and health data systems to digitalisation, access to medicines and advertising rules, regulatory expectations in the Baltic life sciences and healthcare sector are evolving rapidly.
What are the key regulatory developments currently shaping the Baltic life sciences and healthcare sector?
- Estonia: authorities have published an overview of clinical trials and clinical trial inspections for 2025, and plans are underway to establish a national infertility treatment information system.
- Latvia: reforms aim to enhance transparency in the beauty services sector and improve access to medicines. In parallel, initiatives are being developed to strengthen the e-health system, mandate the use of electronic referrals, clarify reporting obligations for medical professionals, and simplify the registration and transfer of general practices.
- Lithuania: recent regulatory and court decisions point to a stricter approach to misleading or prohibited advertising in the health and wellness sector.
Taken together, these developments show that the Baltic region is actively modernising its regulatory frameworks, with a clear focus on enabling market activity and improving the quality of healthcare services.
Estonian legal updates: from clinical trials to the infertility treatment information system
Summary of clinical trials in 2025
The State Agency of Medicines (SAM) has published an overview of the volume, phases, and sectoral distribution of clinical trials in 2025.
- Twenty-seven initial applications for clinical trials were submitted to the SAM, of which 24 were phase 3, two were phase 2, and one was phase 1.
- The highest number of applications concerned oncology (8), followed by neurology (5) and infectious diseases (4).
- In total, 32 clinical trial authorisations were issued.
Summary of clinical trial inspections in 2025
The SAM also published an overview of clinical trial inspections. In 2025, the SAM conducted eight clinical trial inspections in Estonia and participated in three international inspections. The inspections in Estonia identified six critical, 10 major and 27 minor findings. Critical findings concerned deficiencies in informed consent, inclusion of non-eligible subjects, the absence of a clinical trial agreement, and the handling of investigational medicinal products. Major findings concerned shortcomings in task delegation, informed consent procedures, data documentation, monitoring, adverse event recording, and electronic data systems.
Plan to establish an infertility treatment information system
The Ministry of Social Affairs has published a plan to compile data on infertility treatment and gamete donation into a central national information system. This national information system has multiple benefits:
- The system will eliminate fragmented data and ensure donor use limits, donor-cell use tracking, legal clarity, and high treatment quality.
- The collected data will allow long-term analysis of the health and treatment outcomes of children born through assisted reproduction, and their parents and donors, as well as enabling comparison of different treatment methods.
The data could also possibly be used for research at the six infertility treatment clinics in Estonia that would benefit from the information system. The database is expected to be completed in 2027, with a transition period for clinics to join.
Latvian legal updates: beauty services transparency, access to medicines and e-health reforms
Enhanced transparency in the beauty services sector
The government has approved amendments that introduce greater transparency in the beauty industry by requiring providers, when commencing operations, to submit information on both the services offered and on staff qualifications.
Beauty and tattoo service providers will now have to submit detailed information regarding employee qualifications to the Health Inspectorate, including about cosmetologists, beauticians, manicurists, hairdressers, micropigmentation specialists, make-up artists, sauna masters, and others. A public list on the website will help clients verify specialists’ qualifications, differentiating professionals from course-trained staff. Amendments also require service providers to notify the Health Inspectorate about tooth-whitening services, in which up to 0.1% of hydrogen peroxide is included in the treatment, offered in beauty salons.
The reporting deadline for any changes regarding service providers’ information has been reduced from 14 to five working days, enabling more timely supervision.
Increased access to affordable medicines
From 1 July 2026, the state will cover the EUR 0.75 pharmacist fee for prescription medicines costing up to EUR 10. From 1 September, the fee will also be reimbursed for all prescription medicines for people with Group I disabilities. Currently, the pharmacist’s fee (one of the components of the price of medicines) is already fully covered by the state budget for prescriptions for children under 18 years of age, persons in need, and asylum seekers. At the same time, it has been determined that the fee of EUR 0.75 will remain for prescription medicines, 100% of the cost of which is reimbursed to the patient from the state budget.
The aim of the changes is to reduce patient co-payments for pharmacist services for low-cost prescription drugs and to improve access to medicines for socially vulnerable groups.
The ministry is continuing to work on the next steps: improving the pricing of the cheapest medicines, expanding pharmaceutical services at pharmacies, replacing paper prescriptions with electronic ones, and strengthening cooperation with other EU countries to implement joint procurement of medicines.
Broadened support for mother and child health
The government has approved amendments introducing 100% state compensation for all medicines necessary for pregnant women during childbirth and in the postpartum period. Currently, 75% of the cost of medications for complications and other pregnancy-related conditions are compensated. Under the new rules, the costs will be fully covered. The aim is to ensure timely treatment, reduction of complications, and additional support for maternal and child health throughout pregnancy, delivery and recovery.
Starting from 2026, Latvia will substantially enhance state-funded reproductive and maternal healthcare. Women undergoing government-funded IVF will be covered for three fertilisation attempts instead of two, and a new service – pre-implantation genetic testing for families with inherited monogenic diseases – will be introduced. All high-risk pregnant women, including those over 35 or with abnormal first-trimester results, will gain access to NIPT testing. For children, the state will begin funding advanced hearing screening and improve access to outpatient specialist services.
Draft amendments advancing Latvia’s health and life sciences regulatory framework
Multiple draft amendments across the health sector are currently under review in order to improve patient access to higher-quality services.
- transition to electronic referrals – mandates full use of e-referrals within the e-health system from 5 May 2026 (with limited exceptions), reducing the number of missed appointments, preventing duplicate bookings and cutting the administrative workload
- improvements to the e-health system – introduces procedures for submitting doctors’ council decisions and surgery descriptions to the e-health system and clarifies which data the National Health Service may process to support patients’ rights
- medical practitioners to report their professional activities abroad to the certification commission and confirm that no professional misconduct has occurred during their work outside Latvia
- requirements for general practice takeovers eased by granting up to two years to meet accessibility standards, helping maintain continuity of primary care and attract new specialists
- new framework for clinical guidelines, algorithms and patient pathways, introducing a unified system for evaluating, registering, implementing and updating clinical guidelines, clinical algorithms and patient pathways.
- update to the national regulations to incorporate updates to the WHO’s International Health Regulations (IHR), designate IHR authority in Latvia, and enhance the monitoring and coordination of public health threats in the country, improving institutional cooperation and the country’s readiness to manage international health risks.
Lithuanian legal updates: stricter enforcement against misleading health and wellness advertising
The Supreme Administrative Court of Lithuania (Court) upheld a EUR-20,309 fine imposed on a clinic for unlawful advertising of health care services. The court confirmed that the clinic had promoted services across various online platforms involving medical interventions using patients’ names, images and testimonials, breaching Article 15(1) of the Lithuanian Advertising Law. The court emphasised that such advertising directly affects consumer behaviour in a sensitive area involving health and must therefore strictly comply with the statutory prohibitions aimed at protecting public health and consumer interests. More information can be found here.
In a separate case, the State Food and Veterinary Service (the Service), together with the State Consumer Rights Protection Authority (the Authority), sanctioned a private company with a EUR-29,788 fine for repeatedly misleading consumers. The company promoted NMN – a substance intended solely for scientific research – as a food supplement with health claims relating to disease prevention, longevity and cognitive performance. More information can be found here.
Both cases signal a clear regulatory trend: Lithuanian authorities are increasingly proactive and coordinated in targeting misleading or prohibited health-related advertising, regardless of whether it concerns medical services or products presented as wellness solutions.
#sorainenlifesciences: our practice in action
- The Sorainen Life Sciences team is organising a lecture series for biotech companies in collaboration with LithuaniaBIO. The first lecture took place in Vilnius on 18 March, with partner Lise-Lotte Lääne delivering the first session of the series, “EU biotech playbook: core legal issues & regulatory hurdles”. The next lecture, “From discovery to deal: creating, protecting and licensing intellectual property”, will take place on 28 April via Teams. More information will be shared soon.
- In March, partner Lise-Lotte Lääne also gave lectures at TalTech, introducing students to the legal framework for health technology. Students on the master’s programme “Medical Technology and Physics” were introduced to the basics of the legal framework governing pharmaceuticals, medical devices, and healthcare more broadly.
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Contact our experts:
regional head of the Life Sciences & Healthcare sector group, partner (Estonia)
senior associate, head of the Life Sciences & Healthcare sector group in Latvia
senior associate, head of the Life Sciences & Healthcare sector group in Lithuania
