4 TH REGIONAL CONFERENCE ON THE MEDICRIME CONVENTION

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6 November 2015 4 TH REGIONAL CONFERENCE ON THE MEDICRIME CONVENTION With the participation of representatives from: Algeria, Belarus, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Iceland, Israel, Latvia, Lithuania, Morocco, Norway, Slovak Republic, Sweden and Tunisia DRAFT PROGRAMME 10-11 November 2015 Larnaca Cyprus www.coe.int/medicrime

Background and objectives The Council of Europe has drafted a convention which constitutes, for the first time, an international treaty in the criminal law field dealing with the counterfeiting of medical products and similar crimes involving threats to public health (the MEDICRIME Convention). 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 and the promotion of the rule of law and democracy. Our organisation aims to identify solutions to the challenges faced by today s society. The counterfeiting of medical products and similar crimes threaten 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: mandated by the Committee of Ministers of the Council of Europe and supported by intersecretariat co-operation between the Directorate General of Human Rights and Rule of Law through its Criminal Law Division and the Directorate General of Democracy through its European Directorate for the Quality of Medicines & HealthCare (EDQM). The Convention was opened for signature in Moscow (Russian Federation) on 28 October 2011 and will enter into force on 1 January 2016 after the ratification of five signatories (Ukraine, Spain, Hungary, Moldova and Guinea). Aim of the conference The aim of this conference is make significant advances in the fight against counterfeit medical products and similar crimes in Europe and worldwide through seeking political support for the practical implementation of the MEDICRIME Convention. The objectives are the following: 1. to encourage states to sign and ratify the Convention; 2. to raise awareness among members of parliament, law enforcement agencies, NGOs, the media and professionals working in the field; 3. to discuss the benefits and challenges in ratifying the Convention; 4. to exchange experiences, know-how and make contacts. 1

Target audience The target audience of the conference includes officials responsible for policy-making, representatives of judicial, health and enforcement authorities as well as State Prosecutors, Heads of Police and Customs Agencies, Heads of Medicines Agencies and members of relevant international and European institutions and organisations. Speakers Details of the speakers are listed in the appendix to this programme. Organisation Venue Palm Beach Hotel, Larnaca, Cyprus Registration 9.00-9.30 Coffee break Conference venue Lunch Conference venue Dinner Offered by the Republic of Cyprus Interpretation Simultaneous interpretation (English/Arabic) for all sessions Group photo 10.00 Press point 10.15 Social event TBC 2

Tuesday, 10 November 2015 EN/AR 9.00-9.30 Arrival and registration of participants 9.30 OPENING SESSION Mr Ionas Nicolaou, Minister of Justice and Public Order, Cyprus Mr Ivan Koedjikov, Head of Action against Crime Department, Council of Europe Ms Popi Kanari, Director, State General Laboratory, Ministry of Health, Cyprus 10.00 Group photo 10.15 Press point SESSION 1 OBJECTIVES AND BENEFITS OF THE MEDICRIME CONVENTION Chair: Ms Lynda Scammell Medicines & Healthcare products Regulatory Agency (MHRA), United Kingdom 10.30 Origin, purpose and objectives of the MEDICRIME Convention Mr Hugo Bonar, Enforcement Manager, Health Products Regulatory Authority, Ireland 10.45 The work of the PACE in the MEDICRIME Convention Ms Stella Kyriakides, Sub-Committee on Public Health, Parliamentary Assembly of the Council of Europe 11.00 Cyprus added value to the MEDICRIME Convention Ms Popi Kanari, Director, State General Laboratory of Cyprus, Ministry of Health 11.15 Cyprus Strategy against Counterfeiting of Medical Products Ms Anna Paphitou, Pharmaceutical Services, Head of Good manufacturing and distribution practice (GMDP), Ministry of Health, Cyprus 11.30-12.00 Coffee break 12.00 Combating falsified counterfeiting of medical products through criminal law Ms Elena Kleopa, Attorney of the Republic, Law Office of the Republic of Cyprus 12.15 Discussion SESSION 2 PROTECTING THE VICTIMS OF COUNTERFEITING MEDICAL PRODUCTS Chair: Mr Asier Urruela Mora Professor of Criminal Law, University of Zaragoza, Spain 12.30 A break-through for victims protection - the MEDICRIME Convention Ms Lynda Scammell, MHRA, United Kingdom 12.45 Victims protection from counterfeiting medical products: European legislation Mr Hugo Bonar, Enforcement Manager, Health Products Regulatory Authority, Ireland 13.00-14.30 Lunch break 14.30 A customs approach to combat trafficking in counterfeiting of medicines Mr Genti Çani, Professional Associate, World Customs Organization 14.45 Discussion 3

SESSION 3 TOUR DE TABLE Chair: Mr Oscar Alarcón Jiménez Co-Secretary of Council of Europe s Committee of Crime Problems (CDPC) 15.00 State of play of the signature/ratification of the MEDICRIME Convention The following delegations will take the floor: Algeria, Belarus, Cyprus, Czech Republic, Denmark, Estonia, Finland, Greece, Iceland, Israel, Latvia, Lithuania, Morocco, Norway, Slovak Republic, Sweden and Tunisia. These delegations are requested to make a statement indicating the state of play of the signature/ratification of the MEDICRIME Convention in their country 16.15 16.30 Coffee break SESSION 4 TACKLING A TRANSBORDER CRIME Chair: Mr Hugo Bonar Enforcement Manager, Health Products Regulatory Authority, Ireland 16.30 Operation PANGEA: how to combat counterfeit and illicit medicines? Ms Cecilia Fant, Specialized officer, Medical product counterfeiting and Pharmaceutical Crime Sub-Directorate, INTERPOL 16.45 The experience in tackling the counterfeiting of medical products: a case study The Pillendienst Case Mr Alexander Roth, Prosecutor, Germany 17.00 The role of customs authorities in fighting against counterfeiting of medical products Mr George Constantinou, Customs Officer, Customs & Excise, Cyprus 17.15 Discussion End of Day 1 Social Event 4

Wednesday, 11 November 2015 EN/AR SESSION 5 COMBATING FALSIFIED MEDICINES THROUGH CRIMINAL LAW: THE CRIMINAL OFFENCE AND PROSECUTION OF THE PERPETRATORS Chair: Mr Ivan Koedjikov Head of Action against Crime Department, Council of Europe 09.30 The prosecution of the perpetrators: international experience Mr Francisco Jiménez-Villarejo, EUROJUST 09.45 The added value of the MEDICRIME Convention from the criminal law perspective Mr Asier Urruela Mora, Professor of Criminal Law, University of Zaragoza, Spain 10.00 Combating falsified medicines through criminal law: the criminal offence and prosecution of the perpetrators Mr Marios Aristidou, Police Officer, Cyprus Police 10.15 Criminal offences through Internet: the case of the MEDICRIME Convention Country experience: United Kingdom, Ms Lynda Scammell, MHRA, United Kingdom 10.30 Discussion 11.00-11.30 Coffee break SESSION 6 REINFORCING INTERNATIONAL COOPERATION Chair: Ms Popi Kanari Director, State General Laboratory of Cyprus, Ministry of Health 11.30 Multisectorial cooperation through SPOCs and the Committee of Experts on Minimising the Public Health Risks posed by Counterfeiting of Medical Products and Related Crimes (CD-P-PH/CMED) Ms Monika Macisowicz, Chief Specialist for International Cooperation, Main Pharmaceutical Inspectorate, Poland 11.45 The example of the Official Medicines Control Laboratories (OMCL) Network Ms Dora Partassides, Senior Chemist for Section B, State General Laboratory, Ministry of Health 12.00 Discussion CLOSING SESSION 12.30 Mr Ivan Koedjikov, Head of Action against Crime Department, Council of Europe Ms Popi Kanari, Director, State General Laboratory of Cyprus, Ministry of Health 13.00 End of the conference 5