Hungary has amended laws on clinical trials to adjust them to CTR requirements. In addition, new provisions have been adopted to regulate non-commercial trials, patient recruitment and patient cards.
Regulation (EU) No. 536/2014 of the European Parliament and Council of 16 April 2014 on clinical trials on medicinal products for human use (CTR), repealing Directive 2001/20/EC, is applicable as of 31 January 2022.
Given the applicability of CTR, several Hungarian laws have also been amended, in particular by deregulating the rules covered by the CTR and standardizing the legal definitions.
Most significantly, as part of the amendments, a new definition for non-commercial trial has been added to Act XCV of 2005 on Medicinal Products for Human Use and on the Amendment of Other Regulations Related to Medicinal Products (“Medicinal Products Act“):
Section 1 (8) Non-commercial trial: A clinical trial:
- Where the sponsor is a legal person independent of the pharmaceutical industry, in particular a university, a healthcare institution providing inpatient care, a non-profit organization, where the independence from the pharmaceutical industry is not precluded by providing the investigational medicinal product free of charge to the sponsor or by reimbursing the investigator for the certified costs of the trial
- Where the resulting data shall be owned by the sponsor and
- Where there is no legal relationship between the sponsor and a third party in connection with the marketing authorization of the results or making the results available for the purpose of obtaining a marketing authorization.
A significant difference compared to the previous definition of non-commercial investigation is that (i) the independence of the investigation is not precluded by the reimbursement of the certified costs of the trial to the investigator, and (ii) that there should be no legal relationship between the sponsor of the study and a third party where the third party would be entitled to use the result of the trial for marketing authorization.
A further amendment to the Medicinal Products Act is that the sponsor of the clinical trial or the person authorized in writing is entitled to obtain and deliver to the study site the investigational or auxiliary medicinal products set out in the study protocol without medicinal product wholesaler distribution authorization.
Furthermore, the administrative fees of authorization procedures for clinical trials have also been amended. The respective administrative fees set out in Annex No. 1 of the Medicinal Product Act have been supplemented by new categories of procedures introduced by the CTR. Examples of new categories include clinical trials conducted in several EU Member States with an administrative fee of HUF 750,000 (approximately EUR 2,050), or additional fees for clinical trials carried out in several EU Member States where Hungary acts as the reporting or safety-assessing Member State, with an additional administrative fee of HUF 500,000 (approximately EUR 1,370). The administrative fee for the authorization of a clinical trial conducted exclusively in Hungary HUF 580,000 (approximately EUR 1,585) and the administrative fee for amending such authorization HUF 110,000 (approximately EUR 300) remain unchanged.
The other significant amendment concerns Minister of Health Decree No. 35/2005 (VIII. 26) on the Clinical Trials of Investigational Substances for Human Use and the Good Clinical Practice:
- Before the start of a clinical trial — except for phase IV trials and bioequivalence trials — the investigator will issue for the subject of the trial a patient card with the statutory content in case the subject requires emergency care during the trial.
- The rules on recruitment are changing regarding several points. The mention of the manufacturer or marketing authorization holder in the recruitment notice is not considered to be advertising. The recruitment notice can be published in printed press and on other websites, including social media platforms.
- In light of the amendment, the information will no longer be separate from the informed consent form; therefore, the uniform informed consent form has also to include the elements that were previously explicitly linked to the information. The informed consent must cover, in particular, the patient card, the possibility of payment for damages, restitution and information on access to judicial remedy procedures and — if any — reimbursement of expenses.
Another amendment concerns the labeling of investigational medicinal products. Based on the amendment of the Minister of Health Decree No. 30/2005. (VIII. 2.) on labeling and package leaflets of medicines for human use, the information set out by Annex No. VI of CTR has to be displayed on the label of an investigational medicinal product without marketing authorization. However, in the case of an investigational medicinal product that has a marketing authorization, it is possible to choose between the provisions of Minister of Health Decree No. 30/2005. (VIII. 2.) and those of Annex No. VI of the CTR.
The amendment of Minister of Health Decree No. 57/2009. (XII. 30.) on the administration and registration of administrative service fees payable in connection with certain authorization procedures for medicinal products for human use establishes two exceptions when the administrative service fee for clinical trials does not have to be paid at the time the application is submitted:
- If an additional fee is necessary because Hungary is the reporting Member State, this additional fee must be paid by the 25th day following the submission of the application.
- The fee for the Member State cooperative assessment procedure under Article 44 of the CTR must be paid at the same time as the suspected unexpected serious adverse reaction is reported by the sponsor or the submission of an annual report if Hungary is the safety-assessing Member State.
Furthermore, within the amendments, Annex No. 1 of the Minister of Health Decree No. 44/2005 (X. 19.) on personal and material conditions for the manufacture of medicinal products for human use, which contains the actual personal and material condition for manufacture, has also been changed. The content of the new annex harmonizes the Hungarian legislation with the requirements of the Commission Delegated Regulation (EU) 2017/1569.
The Hungarian legislative changes entered into force on 31 January 2022.
The Commission of the European Union, the European Medicines Agency and the OGYÉI have published notices, information and educational materials on the CTR and the related Hungarian legislative changes, respectively, which can be accessed on the website of the OGYÉI.