Estonia - RECs and Medical Research

History

The University of Tartu founded a multifunctional ethics commission in 1990 and a similar committee was established in 1993 at the Institute of Experimental & Clinical Medicine in Tallinn. These were renamed in 1999 as Human Research Ethics Committees in Tartu and Medical Research Ethics committee in Tallinn.

In 1998 the Ministry of Social Affairs set up the Estonian Council on Bioethics as a national co-ordinating centre. It acts in an advisory capacity to health authorities and government. This Ministry is also responsible for the requirements for membership, and the remit of, ethics committees.

The State Agency of Medicine, established in 1991, is the body responsible for final authorisation of clinical trials.

There is a separate committee, established in 2001, that deals solely with the Estonian Genome Project

The new Medicinal Products Act entered into force on 1 March 2005. The previous Act from 1996, amended on several times has been repealed together with several lower implementing Acts in full.

The new Act regulates RECs under Chapter 5, Articles 87 to 99. The new Act implements a number of European directives –including Directive 2001/20 and provides comprehensive regulation of the manufacture, handling, distribution, marketing, prescribing, advertising and authorising of medicinal products (both human and veterinary) and provides the rules for supervision and liability.

A decree by the Ministry of Social affairs is expected to fully implement these provisions.

Summary of Estonian RECs

Type of REC	Human Research Ethics Committee	Medical Research Ethics Committee
Where situated?	University of Tartu	National Institute for Health Development, Tallinn
Who applies to them?	Researchers conducting Clinical Trials Doctoral research Master level study projects Bachelor level study projects	Researchers conducting· Clinical Trials Doctoral research Master level study projects
Formal/Informal	Formal - legal requirement for clinical trials	Formal - legal requirement for clinical trials
National/Regional	National	National
Laws Involved	Medicinal Products Act 2005 Decree No.77 (2001) of the Ministry of Social Affairs	Medicinal Products Act 2005 Decree No.77 (2001) of the Ministry of Social Affairs
Guidance Involved	Declaration of Helsinki Nuremberg Code Oviedo Convention on Human Rights & Biomedicine	Declaration of Helsinki Nuremberg Code Oviedo Convention on Human Rights & Biomedicine
Membership requirements	At least 7 members appointed by Rector of University multidisciplinary consisting of scientists and representatives of different disciplines 1 member must be appointed whose main activity is not scientific research At least one member appointed must be independent of the research centre	At least 7 members appointed by Director of the Institute multidisciplinary consisting of scientists and representatives of different disciplines 1 member must be appointed whose main activity is not scientific research At least one member appointed must be independent of the research centre
Responsible/accountable to whom?
Approval or Advisory powers	Approval	Approval

Not submitting research or failing to follow review

Approval by an ethics committee is mandatory for clinical trials according to the Medicinal Products Act

Which body, if not the REC itself takes this action, and how do they proceed?

The State Agency of Medicines is the extra-judicial body which conducts proceedings in the case of misdemeanours in clinical trials. Relevant laws they may utilise are the Medicinal Products Act and the Code of Misdemeanour Procedure. They can suspend trials and impose fines.

Impact of Directive 2001/20 EC

There will be a time limit of 60 days for an REC to give an opinion.

Legal action that can be taken against RECs

There would appear to be no legal action that can be taken against RECs.

Links section

Ministry of Social Affairs (in Estonian, Russian & English)
Medicinal Products Act (in Estonian & English)
State Agency of Medicines (in Estonian & English)
Ethics Committee of the Estonian Genome Project (in Estonian, Russian & English)
Estonian Genome Foundation

Articles

Tikk, Arvo, Parve, Valdar 'Ethics Committees in Estonia' In Ethics Committees in Central and Eastern Europe. J. Glasa. Strasbourg, Council of Europe (2000).

See the REC bibliography section for more links and papers, and the Data Protection Page