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Estonia · Law · SE

532

Act on Amendments to the Medicines Act (hospital exception)

avaldatud riigiteatajasEstonia· Riigikogu· ET

Introduced

4 November 2024

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AVALDATUD_RIIGITEATAJAS

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Source updated

16 April 2025

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Summary

The bill is presented to ensure better availability of medicines manufactured under hospital exemption. Hospital exemption refers to the exceptional preparation and use of a new drug, such as gene therapy, for the treatment of a specific patient, when a conventional licensed drug is not available or there is no suitable clinical trial. In 2022, the hospital exemption regulation was introduced, which sets strict restrictions, but in practice the need for their for relief. The bill seeks to change the conditions of the hospital exemption, allowing the manufacture of novel drugs for a wider range of patients and removing the limit on the number of manufacturers and patients. The administrative burden will also be reduced and the deadlines for issuing permits will be shortened. However, requirements for the quality, efficacy and safety of the drug remain in place, and patient protection remains a top priority. The hospital exemption favors patients with rare diseases treatment options and supports innovation and the development of high-tech treatment methods. The changes do not lead to additional costs, but they affect the activities of the Medicines Agency and the Health Fund, depending on the issued permits and possible funding in the list of health services.

Machine translation from Estonian. The official text remains authoritative.

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26 official files

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