Our Life Sciences & Healthcare team has prepared a summary of measures adopted up to April 14 2020 in Estonia specifically targeted at Life Sciences companies.
A draft law is currently pending in the Estonian parliament which foresees many changes to the law due to the Covid-19 crisis. Among others, the Medicinal Products Act is subject to changes. According to the draft law, the Estonian State Medicines Agency would be able to implement exceptions to the requirements for handling medicinal products, for marketing authorization of medicinal products, etc. This means that the authority could also change the conditions for import of medicines.
In March, the Estonian State Medicines Agency banned the export of 16 medicines. The Medicines Act allows the State Medicines Agency to prohibit the export of medicinal products as an extraordinary measure, where the continuous supply of a medicinal product is important from the point of view of human or animal health and where other medicinal products with the same active substance and strength are either not distributed or are distributed in insufficient quantity in Estonia.
On 26 March 2020, the Health Board imposed a total ban on provision of all planned specialist medical care in private medical institutions. However, the Ministry of Social Affairs later stated that online consulting and provision of necessary health services are still allowed.
On 1 April 2020, the State Medicines Agency published “Guidance on clinical trial management in the context of the COVID-19 pandemic”. The guidance is intended to provide regulatory clarification for all parties concerned (eg, sponsors and investigators) in clinical trials. The guidance can be found here.
On 4 April 2020, an amendment to the Minister of Social Affairs Regulation “Conditions and procedure for the wholesale of medicinal products” entered into force, adding further obligations to wholesalers during the state of emergency. In particular, wholesalers whose share of the pharmaceutical market is at least 10% of the market volume of human medicines according to the latest statistics published by the State Medicines Agency and who have stocks at the end of the working day are required to submit the following data to the State Medicines Agency each working day: the name of the medicinal product in stock, the packaging code and the number of packages. The State Medicines Agency will prepare a summary report on the basis of the data submitted within the next working day.