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Eurecnet - National Information: Bulgaria

National Information: Bulgaria

    Short description of RECs system:

      Research ethics committee system in Bulgaria includes:
    • Ethics Committee for Multi-Centre Trials (Drug Law, Article 103);
    • Central Ethics Committee (Drug Law, Article 107);
    • Ethics committees established in the treatment establishments (e.g. regional hospitals) (Drug Law, Article 103) and in other institutions (e.g. universities, scientific organizations) where biomedical research is conducted (Health Act, Article 203).

    According to the Bulgarian Drug Law (Article 103), Ethics Committee for Multi-Centre Trials (Комисията по етика за многоцентрови изпитвания (КЕМИ)) is established under the Minister of Health. The composition of the Committee is determined by the order of the Minister of Health. Following the mentioned law (Articles 103, 114), when the clinical trial with medicinal products is to take place in more than one centre on the territory of the Republic of Bulgaria, an application shall be filed with the Ethics Committee on Multi-Centre Trials, when the trial is to take place in only one centre on the territory of the Republic of Bulgaria, an application may be filed with the respective ethics committee (either Ethics Committee on Multi-Centre Trials or ethics committees established in the treatment establishments) at the choice of the applicant. The Bulgarian Drug Agency shall keep and maintain a register of the ethics committees that should be posted on the Bulgarian Drugs Agency website. The approval of the Bulgarian Drug Agency is also required for clinical trials with medicinal products (Article 109). Where the opinion of the respective ethics committee is negative, the sponsor may appeal its decision before the Central Ethics Committee which is set up with the Council of Ministers. The opinion of the Central Ethics Committee is final and binding on the respective ethics committee (Article 115). The Central Ethics Committee may also draft an opinion on deontological and ethical issues in the area of clinical trials when it has been approached by the respective ethics committee, by the Bulgarian Drug Agency or by the sponsor. The Central Ethics Committee provides methodological guidance to the ethics committees as well. The composition of this Committee is stipulated by the decision of the Council of Ministers at the proposal of the Minister of Health.

    Bulgarian Health Act (Article 203) covering all biomedical research projects states that biomedical research should be conducted after receiving a positive opinion from the ethics committee established in the health care facility, scientific organization or in other institution where biomedical research is going to be conducted. The composition of ethics committees is determined by the order of the manager of the respective institution where ethics committee is established. Ethics committees, which issued the positive opinion, supervises whether biomedical research project is properly conducted.

    Networking between RECs:

    Networking mainly focuses on formal training activities for the members of RECs: basic training for the members of the Ethics Committee for multicenter trials on the legal instruments (the Drug law, Chapter IV Clinical trials; the Law on Medical Devices; Regulations on the Good Clinical Practice; the Hesinki Declaration; the EU Directives 2001/20/EC and 2005/28/EC on the Good Clinical Practice; the leading principles of the European Community on Drugs) and continious training - annual training courses, organized by BDA for the members of RECs.
    Seminars and local meetings are organized on relevant subjects and practical issues.

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