The world has changed dramatically since our last newsletter. Sorainen Life Sciences and Healthcare sector group is actively contributing to supporting Ukraine and providing assistance to clients affected by the situation, as are all our sector groups. At the same time, we need to continue providing legal advice on everyday matters and making our contribution to sustaining and supporting businesses that aim to make the world a better place.

Please find below our short highlights about important legal developments in the healthcare and life sciences sector in the Baltics.


The new patient insurance system

On 13 January, the Estonian Government approved the draft law of the new compulsory liability insurance act for healthcare providers and sent it to the parliament to discuss. The draft act passed the first reading in the parliament and is now pending in the second reading. According to the current plan, the patient insurance system will come into force on 1 July 2024.

In short, the act would establish a patient insurance system, which would mean mandatory liability insurance from healthcare providers. The aim of the new system is better protection of patients and greater ease of application for compensation. In the event of damage which could have been avoided, the circumstances of the claim will be assessed by the insurer. The sum insured is up to 100,000 euros per patient who has suffered damage, and up to 300,000 euros per insured event.

Among other things, it is planned to establish minimum requirements for the organisation of patient safety, including the establishment of an information analysis system, to prevent damage being caused. According to the draft act, healthcare professionals will be obliged to document all patient safety incidents and collect relevant information. The aim is to create a central national patient safety database.

Vaccination damage fund

The amendments to the Medicinal Products Act provide for compulsory insurance for vaccine damage (hereinafter vaccine insurance) as a type of compulsory insurance. Development of the vaccine insurance system was initiated due to the COVID-19 pandemic, although as is detailed in the explanatory note, many countries have been using similar funds for years. The purpose of this is to ensure compensation for damage caused as a result of vaccination to the entitled person if the patient has suffered serious health damage lasting at least four months or if the person has died as a result of vaccination.

The regulation creates the opportunity for people who suffered serious health damage after vaccination to demand compensation for damage at the rate established by law depending on the severity of the damage. Vaccine insurance establishes an insurance premium obligation for vaccine distributors, the amount of which depends on the number of doses marketed for use in Estonia and the rate of payment established by the government. The causal link between health damage and vaccination must be assessed by the State Agency of Medicines, but the Estonian Health Insurance Fund will be the responsible entity deciding on payments to the patients.

Vaccine insurance rules are scheduled to come into force from 1 May 2022. In 2022, injury cases caused by COVID-19 vaccines will be retroactively compensated. From 2023, the system will extend to other vaccines, including immunisation schedule vaccines, vaccines against influenza and tick-borne encephalitis, and so-called travel vaccines. The cost of vaccine damage compensation is estimated at 1 million euros in 2022, with system management and IT costs totalling 1.4 million euros.


Compensation procedure for damage caused by COVID-19 vaccines

The Cabinet of Ministers is working on regulations for compensation of damage to health caused by Covid-19 vaccines. Although the law provides that the state covers expenses for vaccination against Covid-19 and the treatment of side-effects caused by it, there is still no clear and effective mechanism to compensate the damage to health as such.

The draft regulations provide for the right to claim compensation for severe or moderate damage to health or life caused by the vaccine against Covid-19. Compensation will be available to persons who have received a vaccine against Covid-19 in Latvia and who have experienced damage to health or life directly related to the side-effects of the vaccine indicated in the vaccine description, resulting in a permanent or long-term condition that has prevented the patient from regaining self-care and functionality.

The draft regulations stipulate that the State Agency of Medicines will be the responsible institution to decide on granting compensation. According to the regulations, persons who wish to receive compensation are required to submit the application within two years of the date that the fact of damage is established, but no later than three years from the date of vaccination. In the event of a patient’s death, the patient’s heir will be able to file a claim for compensation.

Currently the draft regulation is in the process of development with the Ministry of Health. It is planned that the draft regulation will enter into force on 1 May 2022.


Compensation for damage caused by COVID-19 vaccines

On 13 January 2022 the draft amendment to Patient Rights and Health Compensation Act was published for public consultations. The draft law relates to compensation for damage to health caused by Covid-19 vaccines.

After discussions in the Parliament, which took place in January 2022, the draft law was returned to the Committee on Health Affairs for further improvement; however, based on information provided during the hearing, the right to claim compensation for damage should arise if:

  • the patient experiences damage due to a serious adverse reaction, i.e., a reaction which resulted in the death of a person, endangered their life, required them to be hospitalised or extended their inpatient treatment, or caused them to develop a long-term or significant disability, incapacity or birth defect. Other reactions shall be considered to be mild adverse reactions
  • the patient was vaccinated during a state-level emergency and/or quarantine throughout the territory of the Republic of Lithuania
  • the patient has been vaccinated with a vaccine listed in the Government Resolution on the declaration of a state-level emergency and/or quarantine throughout the territory of the Republic of Lithuania
  • the patient or other person entitled to compensation applies to the Commission for the Determination of Damage to Patients (Commission) in writing for compensation for the damage caused by vaccines not later than three years after he/she has become aware or should have become aware of the damage caused by vaccines
  • the provisions regarding vaccine manufacturer’s liability under the Civil Code shall not apply to compensation for damage caused by vaccines

The compensation shall be paid by the Ministry of Health from the state budget funds allocated to it.

It is important to note that the draft law foresees retrospective application, i.e., it shall allow compensation for damage caused before the draft law enters into force. In this case, the three-year term for applying to the Commission for compensation shall be calculated from the draft law’s effective date.

The draft law was expected to enter into force on 1 February 2022; however, having been returned to the Committee on Health Affairs for further improvement, the amended draft law has not yet been published for public consultations. Consequently, the expected date of adoption is not currently known.

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