ABSTRACT

The Statute of Ethics Committees governs the recruitment of committee members. Members are proposed by the Ministry of Welfare and appointed by the Cabinet of Ministers. The committee was set up by the Republic of Latvia's Cabinet of Ministers on 25 March 1998. Its legal basis is a Statute of the Cabinet of Ministers of Latvia. The procedures concerning the clinical trials of drugs and pharmaceutical products are set out by the Cabinet of Ministers of the Republic of Latvia through the 1997 Pharmaceutical Law. The Minister of Welfare confirms the Statutes of the ethics committees for the clinical trials of drugs, and coordinates the personnel on the above-mentioned committees. The Ethics Committee on Clinical Trials of Drugs consists of 14 members including physicians, a pharmacist, a journalist, a lawyer and a computer specialist. The Independent Ethics Committee for the Investigation of Drugs and Pharmaceutical Products consists of 12 members including physicians, economists, pharmacologists, lawyers, a psychologist and laypersons.