REGIONAL WORKSHOP ON THE MEDICRIME CONVENTION SINGLE POINTS OF CONTACT

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10 June 2016 REGIONAL WORKSHOP ON THE MEDICRIME CONVENTION SINGLE POINTS OF CONTACT With the participation of representatives from: Armenia, Azerbaijan, Bulgaria, Czech Republic, Georgia, Greece, Hungary, Israel, Republic of Moldova, Morocco, Poland, Romania, Russian Federation, Slovak Republic, Turkey, Ukraine PROGRAMME 15-16 June 2016 Tbilisi Georgia www.coe.int/medicrime

Background and objectives The Council of Europe Convention on the counterfeiting of medical products and similar crimes involving threats to public health (the MEDICRIME Convention) constitutes the first international treaty in the criminal law field dealing with the counterfeiting of medical products and similar crimes involving threats to public health. Safeguarding public health through penal measures targeting criminal behaviour, protecting victims, promoting co-operation at national and international levels, and providing preventive measures are the principal aims of this Convention. The core values of the Council of Europe are the protection of human rights and essential freedoms, the promotion of the rule of law and democracy. The organisation aims to identify solutions to the challenges faced by today s society. The counterfeiting of medical products and similar crimes threatens the right to life enshrined in the European Convention on Human Rights and Fundamental Freedoms (ECHR). Incidences of counterfeit medical products and similar crimes undermine public trust in healthcare systems and the authorities surveillance thereof. The counterfeiting of medical products and similar crimes has spread worldwide, no country has been spared. The Council of Europe has long been concerned about the absence of harmonised international legislation, the existence of non-deterrent sanctions in proportion to the harm caused to patients and the involvement of criminal organisations which operate across borders. Thanks to its pan-european membership and co-operation with States and regions beyond Europe, the Council of Europe has been able to develop an international criminal law treaty focusing on public health and with a truly global impact. The MEDICRIME Convention was opened for signature in Moscow (Russian Federation) on 28 October 2011 and entered force on 1 January 2016 after the ratification of five signatories (Republic of Guinea, Hungary, Republic of Moldova, Spain and Ukraine). Armenia and Albania ratified the Convention on 5 February and 6 June 2016 respectively, becoming the sixth and seventh States party to the Convention. Aim of the workshop The objectives of this Regional Workshop are: 1. to consolidate the single points of contact (SPOCs) structure foreseen in the MEDICRIME Convention; 2. to align the working methodology of judicial and law-enforcement authorities and link it with the one already developed by health authorities; 3. to share experiences in combating threats to public health. 1

Target audience Given the multidisciplinary nature of the action against pharmaceutical crime, the target audience of this workshop includes representatives of judicial, law enforcement and customs authorities from 14 Council of Europe Member States invited to this event as well as from 2 countries participating in the EU-Council of Europe Joint Programme "Strengthening democratic reform in the southern Neighbourhood". Speakers Details of the speakers are listed in the appendix to this programme. Organisation Venue Old Tbilisi Hotel, Tbilisi, Georgia Registration 8:45-9:30 am, 15 June 2016 Coffee break Lunch / Dinner Plenary session Break-out sessions Workshop venue Workshop venue Main room Information to be given Group photo 10:15 2

Wednesday, 15 June 2016 Plenary session 8:45-9:30 Arrival and registration of participants OPENING SESSION Chair: Mr Oscar ALARCÓN JIMÉNEZ Co-Secretary of the European Committee on Crime Problems (CDPC), Council of Europe 9:30 Mr Alexandre BARAMIDZE, first Deputy Minister of Justice, Georgia Mr Giorgi GOGADZE, Deputy Chief Prosecutor, Georgia Ms Ana ZEC, Deputy Head, Council of Europe Office in Georgia 10:15 Group photo - SESSION I - THE MEDICRIME CONVENTON: STATE OF PLAY Chair: Ms Irina BERIDZE Advisor, Unit of European Integration and Cooperation with International Organizations, Chief Prosecutor Office, Georgia 10:30 The MEDICRIME Convention: purposes, objectives and the importance of ratifying it. Mr Mkrtich SHAKARYAN, Head of GMP/GDP inspection department, The Scientific Centre of Drug and Medical Technology Expertise, Ministry of Health, Armenia 10:50 Problems, risks and trends in the counterfeiting of medicines and similar crimes Ms Lynda SCAMMELL, Medicines & Healthcare products Regulatory Agency (MHRA), United Kingdom 11:10 The experience in tackling the counterfeiting of medical products: a case study (The Pillendienst Case) Mr Alexander ROTH, Public Prosecutor at the Staatsanwaltschaft Potsdam, Germany 11:30-11:45 Coffee break 11:45 Detection techniques and mechanisms: detection of falsified medical products in the legal supply chain Mr José María ESTEBAN FERNÁNDEZ, Member of the Spanish National Health Pharmaceutical Squad 12:20 How to overcome obstacles in the ratification process: Armenian case Mr Hamlet GASOYAN, Standing Committee on Healthcare, Maternity and Childhood Issues, National Assembly of the Republic of Armenia 12.30-14:00 Lunch break 3

Break-out sessions - SESSION II - THE ROLE OF THE SPOCs Note: During this Session, judicial, law enforcement and customs authorities will attend separate seminars. Judicial authorities (J) Law enforcement authorities (LEA) Customs authorities (C) J LEA C 14:00 Tasks and role of the SPOCs 14:30 Cooperation with Customs authorities 15:00 Cooperation with Law Enforcement authorities 15:30 Cooperation within Judicial authorities Cooperation with Judicial authorities Tasks and role of the SPOCs Cooperation with Customs authorities Cooperation within Law Enforcement authorities Cooperation with Law Enforcement authorities Cooperation with Judicial authorities Tasks and role of the SPOCs Cooperation within Customs authorities 15:50-16:10 Coffee break Lecturers: Tasks and role of the SPOCs Ms Verica TRBIC, Directorate for Cooperation of Police Bodies, Bosnia and Herzegovina, Rapporteur of the Committee of Experts on minimising the public health risks posed by counterfeiting of medical products and related crimes (CD-P-PH/CMED) for the CMED Training Strategy Cooperation with Judicial authorities Mr Alexander ROTH, Public Prosecutor, Staatsanwaltschaft, Potsdam, Germany Cooperation with Law Enforcement authorities Mr Jan VAN DEN BOEYNANTS, Judicial Commissioner, Federal Judicial Police, Serious and organised crime Directorate, Belgium Cooperation with Customs authorities Mr José María ESTEBAN FERNÁNDEZ, Member of the Spanish National Health Pharmaceutical Squad Mr Francisco Javier MOLINERA DE DIEGO, Police Chief Inspector of the Consumer, Environment and Doping Section, Spain 4

Plenary session - SESSION III - CURRENT TRENDS Chair: Ms Verica TRBIC 16:10 Online threats: actions taken in illegal online sales and suppliers Ms Lynda SCAMMELL, Medicines & Healthcare products Regulatory Agency (MHRA), United Kingdom 16:40 The fight against falsified medical products: current situation and investigative techniques Mr Francisco Javier MOLINERA DE DIEGO, Police Chief Inspector of the Consumer, Environment and Doping Section, Spain 17.00 End of Day 1 19:00-20:00 Dinner Thursday, 16 June 2016 Break-out sessions - SESSION IV - TOUR DE TABLE Note: During this Session, judicial, law enforcement and customs authorities will be split again into 3 groups and expand on the questions and views raised during the debates of Day 1. The break-out session will be moderated and assisted by a Chair, who will act as a Rapporteur at a later stage. 9:30 Reflections on the break-out sessions Participants are expected to share opinions and ideas with regard to the setting up of the SPOCs network and to share experiences on their role as judicial, law enforcement or customs authorities. Judicial authorities (J) Mr Alexander ROTH Law enforcement authorities (LEA) Mr Jan VAN DEN BOEYNANTS Customs authorities (C) Ms Alicja CEGLARZ 10:45 Country coordination meetings Representatives of the different authorities of each country will gather (per country) and discuss their national approach to the SPOCs network. Participants should also determine if they foresee any issue that may hamper the correct implementation of the SPOCs in their countries. 10:30-11:00 Coffee break 5

Plenary session 11:30 Debate - SESSION V WAY FORWARD Chair: Ms Lynda SCAMMELL Ms Alicja CEGLARZ Mr Jan VAN DEN BOEYNANTS Ms Verica TRBIC Mr Francisco Javier MOLINERA DE DIEGO Mr Alexander ROTH Rapporteurs of the judicial, law enforcement and customs authorities will present their conclusions in view of a proper implementation of the SPOCs network. 12:30 Final remarks - Session VI - CLOSING Mr Alexandre BARAMIDZE, first Deputy Minister of Justice, Georgia Mr Zurab SANIKIDZE, Director, Analytical Department, Ministry of Justice, Georgia Mr Oscar ALARCÓN JIMÉNEZ, Co-Secretary of the European Committee on Crime Problems (CDPC), Council of Europe 13:00 End of the Regional Workshop 13.00-14:00 Lunch break 15:00 Social event 6

Criminal Law Division Action against Crime Department Council of Europe