Eurecnet - National Information: Latvia

National Information: Latvia

Short description of RECs system:

CMEC (Central Medical Ethics committee of Latvia) is governed by specifically designed law – Cabinet Regulation No. 9 “Statutes of Central Medical Ethics Committee”, issued in 1998 and amended in 2003 and 2009 to introduce the changes in its membership. CMEC is seen as the central and the most important element of the whole system. It consists of 12 people: a chairperson and 11 members. The functions assigned to CMEC are following: to evaluate the compliance of new medical technologies, biomedical research involving human subjects with the norms of medical ethics; to evaluate the compliance with principles of ethics in genetic research,creation of genome data base and the activities of the chief processor; to consult governmental, municipal, medical and other institutions about the compliance of regulations issued by those institutions to the norms of medical ethics; facilitate the inclusion of medical ethics in the study programs of social medicine, psychology and communication; develop draft laws and other regulations regarding the ethics of biomedical progress (both Latvian and foreign); initiate the revocation of medical certificates in case of breach of ethical norms; to consult and advise the interested institutions about the ethical issues of biomedical progress; to review any application from either physical or legal person and to issue resolutions on the ethics of biomedical pogress requested by ethics committees of professional organizations of medical specialists; issue resolutions regarding research and biotechnologies of both national importance and international scale; educate the population, advise on the ethical issues of biomedical progress, and consult ethics committees reviewing biomedical research. CMEC is organised conferences, meetings, workshops. Any new information was sent by e-mail to any EC in Latvia. A newly amended version of statutes has added another very important function: (Art 4.9) “to coordinate and methodically supervise the operation of ethics committees reviewing biomedical research…”.

Other Latvian RECs can be divided into two large groups according to the field of their activity. The first group consists of those RECs that review clinical trials of drugs and pharmaceutical products. They are regulated by Law on Pharmacy (1997), which states that clinical trials of medicinal products, involving humans as subjects of the investigation, may not occur if the permission of a clinical medicinal product investigation ethics committee has not been received.The same requirement is expressed in CabinetRegulation No. 289 (Adopted 23 March 2010) „Regulations Regarding the Procedures for Conduct of Clinical Trials and Non-interventional Trials of Medicinal Products, Labelling of Investigational Medicinal Products and the Procedures for Assessment of Conformity of Clinical Trial of Medicinal Products with the Requirements of Good Clinical Practice”. There are 4 Clinical Drug Trial committees in Latvia. Prior to its issuance after receiving the opinion from CDTs RECs, research protocols had to be submitted also to the State Agency of Medicines to receive the final approval.According to the regulation, the sponsor may submit the application simultaneously to the Ethics Committee and the State Agency of Medicines(hereinafter SAM), and the trial can start only after the first gives a favorable opinion and the second has issued the authorisation. Decisions of clinical drug trial REC’s (as well as their activities in general) are not overseen by SAM, but these committees are obliged to report to it every case of negative assessment of research protocols. Also, according to the Model bylaw, they are obliged to annually submit to the SAM the list of all reviewed applications for drug clinical trials and drug administration surveillance trials.

The second group of RECs, reviewing all other kinds of research appears to be regulated by Cabinet Model Regulation No. 1 (issued in 1998 and still in force), which is issued according to the Law on Medical Treatment. According to the law, these are RECs functioning within medical treatment institutions as „advisory bodies established for resolving problems of medical ethics“ (Section 13). They are not specifically defined as research ethics committees but as „medical ethics committees” that shall examine ethical matters related to the activities of medical practitioners and new medical technologies (Section 14). Other regulations are their own statutes and international guidelines. Latvian RECs contain 7 – 13 members, and again differences in size are determinedby what kind of trials they review. Model by-law requires that CDTs RECs must consist of at least 9 members; According to the law, among them should be at least 2 professionals without medical educational.

RECs dealing with other kinds of research are required by Cabinet Model Regulation No. 1 to include at least 6 members. In practice, they consist of 7 – 9 members. Besides medical professionals, these committees also include representatives of religion, engineers, parliament members,and diplomats. There are 5 RECs in Latvia.

Last year in Latvia took place about 240 drug clinical trials and was allowed 70 new studies. Mostly studies was in oncology, endocrinology, pulmonolgy, neurology and rheumatology.

The last two years has increased the number of clinical trials involving children and adolescents. Medicines registered for use in adults, children are to be used in other doses or other dose regimes, therefore, require special studies to clarify the effective drug dose in children and support their safe use. Last year in Latvia was allowed to do 10 clinical studies in pediatric medicine pulmonology, neurology, intra-abdominal surgery.

Overall, the studies occurred in 85 study centers. Popular research centers last year was Paul Stradins Clinical University Hospital, Riga Eastern Clinical University Hospital, Daugavpils Regional Hospital, Vidzeme Hospital, Children's Clinical Hospital, "Health Center 4", Liepaja Regional Hospital, VSIA „Seaside Hospital“. EC in Latvia.

In 2011 State Agency of Medicines created expenditure 'Good Clinical Practice'. Edition combines the International Conference on Harmonisation (ICH/CPMP/135/35) developed guidelines for good clinical practice, and includes the World Medical Association Declaration of Helsinki. Good clinical practice is an internationally recognized ethical and quality standards to be followed when planning and conducting clinical drug studies involving a man.
The edition „Good Clinical Practice“ will guide the physician – a clinical drug research performer, as well as all the professionals associated with clinical drug trials.

Existing or planned networking activities
• CMEC plans to organize a seminar meeting of Latvian RECs to discuss currtent situation and plan for future.
• Facilitation of public communication by means of modern technologies.
• Revision of normative documents and establishment of a register of acting RECs.

Contact: eurec@eurecnet.org