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Estonia · Law · SE

413

The Act on Amendments to the Medicines Act and Amendments to Other Acts Related to It

avaldatud riigiteatajasEstonia· Riigikogu· ET

Introduced

14 June 2021

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Status

AVALDATUD_RIIGITEATAJAS

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Source updated

15 December 2021

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Summary

The bill brings the Medicines Act into line with the legislation of the European Union, which stipulates rules for clinical trials of drugs used in healthcare, clinical trials of veterinary drugs, and hospital exemption medicine. The bill provides for the possibility to prepare and use new medicines in the hospital in exceptional circumstances. Requirements are established to ensure the quality, safety and monitoring of treatment. Such novel drugs can be prepared and to be used only in Estonia on the basis of an individual order of a specialist doctor and under his professional responsibility for the treatment of a specific patient in a hospital. These are medicines designated as novel medicines in the EU, which are divided into gene therapy, somatic cell therapy and tissue engineering medicines, and which offer patients new treatments for certain types of diseases and malfunctions. Based on the data obtained from the use of the drug, hospital exemption will be possible later to start clinical trials with the drug and then reach the application for a marketing authorization. The hospital exemption regulation allows for planning specific development directions and cooperation opportunities between Estonian universities, biotechnology companies and hospitals. The draft will simplify the process of applying for authorization for clinical trials, especially if the applicant wants to conduct the trial in many EU member states. In this case, the applicant communicates with one throughout the process with the drug administration of the member state, who coordinates the entire process and information exchange between the applicant and other member states in the EU, and who also prepares the scientific evaluation report of the research application. In the future, applying for a clinical trial license will be done on the basis of a single application in all desired member states using a single license application file through the clinical trial portal and paperless. The sponsor will also pay when applying for a clinical trial in the future one-time fee in one Member State. Currently, the sponsor in Estonia pays three different fees: a fee to the Medicines Board, the ethics committee and a state fee. The clinical trial request is evaluated jointly by the member states and a joint final decision is drawn up. The final results of the clinical trial are in a common database and public, and therefore more information becomes public. The summary of the survey assessment, survey and inspection results will be made public. Requirements are also established to ensure the quality and safety of drugs administered to study participants during a clinical trial. Special attention is paid to the high-level protection of patient rights and safety. The law was scheduled to enter into force six months after the European Commission publishes a notice in the Official Journal of the European Union that the EU Clinical Trials Portal and the EU Database have reached full functionality, which is expected to happen in July 2021. With regard to clinical trials of veterinary drugs, the amendments to the law are scheduled to enter into force on January 28, 2022, and the provisions concerning the regulation of the hospital exemption will enter into force in a general manner.

Machine translation from Estonian. The official text remains authoritative.

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