E. GefenasGlobal Forum 8, June, 2007, Vilnius Regional Perspective to Keynote Challenges - Europe

E. GefenasGlobal Forum 8, June, 2007, Vilnius What are the specific European features? Almost all challenges listed in the sessions 1 and 2! Generalizations very difficult: e.g., CEE vs Western/Northern countries Concentrate on two aspects: –CEE (transition society) perspective –Implementation of international European instruments

E. GefenasGlobal Forum 8, June, 2007, Vilnius clinicaltrials.com/index.html Patients in Eastern European countries and Russia are very motivated to participate in clinical trials because participation provides them with access to the best physicians and novel efficacious drugs. Study subjects benefit from close supervision by the doctors during the course of the trial. Clinicians are motivated to participate in clinical trials because access to cutting-edge research serves as means of furthering their professional qualifications and prestige among colleagues.

E. GefenasGlobal Forum 8, June, 2007, Vilnius European international instruments: The Convention on Human Rights and Biomedicine, Oviedo Convention, 1997 –and its Additional Protocol on Biomedical Research, 2004 (AP-CHRB-BR) - deals with all the biomedical research including pharmaceutical trials Directive 2001/20/EC on Clinical trials on medicinal products for human use

E. GefenasGlobal Forum 8, June, 2007, Vilnius The European Union – 27 countries Initially established to deal with trade and economy, now it also deals with human rights issues Its directives are mandatory to the member states –Old Member States (MS) - 15 –Enlargement - May 1, 2004, when 10 states joined, and the most recent on January 1, 2007, when Bulgaria and Romania joined.May 12004January BulgariaRomania Directive on CT deals with clinical trials on medicinal products for human

E. GefenasGlobal Forum 8, June, 2007, Vilnius European Union (before the enlargement)

E. GefenasGlobal Forum 8, June, 2007, Vilnius Directive 2001/20/EC on Clinical trials on medicinal products for human use Art. 9 Commencement of clinical trial The sponsor may start a clinical trial: –Favorable opinion by an the ethics committee (is mandatory - based on a review of design, brochure, protocol, ) –Competent authority: has not informed the sponsor of any grounds of non-acceptance

E. GefenasGlobal Forum 8, June, 2007, Vilnius What are the most problematic points? Division of responsibilities between RECs and Competent authorities (usually drug state agencies) –not clearly defined –Differs from one country to another –Sometimes RECs and Competent bodies/authorities duplicate its functions –RECs are not directly involved in the EU structures dealing with regulatory/scientific aspects of clinical trials (EMEA)

E. GefenasGlobal Forum 8, June, 2007, Vilnius The Council of Europe 47 member states A state may become a member of the Council of Europe if it is deemed able and willing to respect human rights and fundamental freedoms Its Conventions are legally binding after the Member States ratify them (and additional protocols)

E. GefenasGlobal Forum 8, June, 2007, Vilnius Europe

E. GefenasGlobal Forum 8, June, 2007, Vilnius Ratification of the Oviedo convention Test case for a common European approach By November of 2002 the Convention was ratified by 15 out of 43 member states of the Council of Europe. By July 2006 it was ratified by 19 out of 46 MS 11 of the 19 ratifications - countries of Central and Eastern Europe

E. GefenasGlobal Forum 8, June, 2007, Vilnius Diversity of opinions on bioethical/research ethics issues in Europe Ratifications (red) and Signatures (yellow) of the Convention on Human Rights and Biomedicine updated 13/10/2006

E. GefenasGlobal Forum 8, June, 2007, Vilnius

E. GefenasGlobal Forum 8, June, 2007, Vilnius Why CEE countries are more active in ratification? Is this an expression of a political will to integrate with Western Europe? Could the reason be that some Western European countries are more sensitive to the discrepancies between the provisions of the Convention and socio-cultural attitudes prevalent in their countries? Despite the willingness to accept international European standards their implementation is not a simple process …

E. GefenasGlobal Forum 8, June, 2007, Vilnius The main objective To built an infrastructure for responsible conduct of research that helps to prevent exploitation of vulnerable research populations –Adequate ethical review of research protocols (should integrate training) –Efficient system to cope with the conflicts of interest GF8 creates a unique platform for this: –Sharing experience by experts from all the continents –Representation of most important international organizations in the field