Tackling pharmaceutical crime: initiatives within the European Union

1. THE COUNCIL OF EUROPE CONVENTION ON COUNTERFEITING OF MEDICAL PRODUCTS AND SIMILAR CRIMES INVOLVING THREATS TO PUBLIC HEALTH (MEDICRIME CONVENTION) COUNTERING THE SPREAD OF COUNTERFEIT MEDICAL PRODUCTS International High-LevelConference Moscow, 26-28 October 2011 Tacklingpharmaceutical crime: initiatives within the European Union Lutte contre la Criminalité Pharmaceutique: initiatives au sein de l’Union Européenne Christian TOURNIE -SNE European CommissionHome Affairs

2. European Union A unique economic and political partnership between 27 democratic European countries

3. 498 million citizens Frontier-free travel and trade, the euro (the single European currency), safer food and a greener environment, better living standards in poorer regions, joint action on crime and terror, cheaper phone calls, millions of opportunities to study abroad … and much more besides. The European Union has contributed to prosperity over the years by creating a single market and single currency, and by removing other obstacles to trade and mobility. Freedom, security and justice To tackle cross-border crime and terrorism, EU countries have taken steps to ensure full cooperation between their police and customs officers, immigration services and law courts. One practical step has been to introduce a European arrest warrant, to make it easier to transfer suspected criminals from the country where they have been arrested to the country where they are wanted for questioning or to stand trial. EU countries are also coordinating asylum policies and tightening controls at the EU’s external frontiers. Since EU citizens are free to live in any member country, they must have equal access to justice everywhere in the EU. . Member governments have to ensure that they all apply EU laws in the same way, and that court rulings in one country can be enforced in another. The EU has done a lot to make it easier to solve cross-border legal problems.

4. European Union Main EU bodies to run the EU and adopt its legislation: the European Parliament (representing the people of Europe) the Council of the European Union (representing national governments) the European Commission (representing the common EU interest)

5. The Council of the European Union— formerly known as the Council of Ministers — is the EU’s principal decision-taking body. It shares with Parliament the responsibility for passing EU laws. It is also in charge of the EU’s foreign, security and defence policies, and is responsible for key decisions on justice and freedom issues. . Every six months, a different member state assumes the so-called Presidency of the EU, meaning that it chairs these meetings and sets the overall political agenda. The European Parliamentis elected every five years by the people of Europe to represent their interests. The main job of Parliament is to pass European laws on the basis of proposals presented by the European Commission.

6. The European Commission is the EU’s executive organ. It represents and upholds the interests of Europe as a whole. It drafts proposals for new European laws, which it presents to the European Parliament and the Council. It manages the day-to-day business of implementing EU policies and spending EU funds. The Commission also makes sure that everyone abides by the European treaties and laws. Commission consists of 27 men and women — one from each EU country. They are assisted by about 24 000 civil servants, most of whom work in Brussels. The president of the Commission is chosen by EU governments and endorsed by the European Parliament. The other commissioners are nominated by their national governments in consultation with the incoming president, and must be approved by the European Parliament. They do not represent the governments of their home countries. Instead, each of them has responsibility for a particular EU policy area. The president and members of the Commission are appointed for a period of five years, coinciding with the period for which the European Parliament is elected.

7. NOTICE This presentation does not represent an official position of the European Commission

8. Measures to fightagainst the pharmaceuticalcounterfeiting Counterfeiting is a growing and increasingly dangerous phenomenon in the EU. The statistics of seizures confirm an existing trend. Counterfeit threats the health and safety of EU citizens, but as well their jobs, Community competitiveness, trade, and investment in research and innovation.

9. Conference on Counterfeiting 2010.Two days of discussions allowed experts from various fields (justice, police, economics, the Bar, associations, etc.) to examine the extent of the criminal phenomenon of counterfeiting in several sectors, including medicinal products, cigarettes and the Internet. The various presentations confirmed and again highlighted the threat that counterfeiting poses to public safety. In this regard, the transnational character of the counterfeiting phenomenon, its links with organised crime and the low-risk, high-return ratio were highlighted by some participants. Conference PHARMACRIME 2010 on: « Counterfeit medicines and organised crime: Identification of effective investigations practices in Europe »

10. Modern-day counterfeiting offers an ideal opportunity to criminal organisations: • lack of public awareness of this form of criminality • reduced risk of a prison sentence • difficulty of establishing proof • virtual impossibility of assessing damages • potentially unlimited global markets • prospect of significant profits

11. Counterfeiting provides an additional way for criminals to launder their ill-gotten gains while increasing profits • need to intensify the fight against this phenomenon is of essence, both within the EU and in third countries. • - effective measures must be taken at national, European and international levels. • - a number of European legal instruments have been adopted and other specific initiatives are already in place.

12. European Union initiatives: • 1) Member States provisions and national strategies • (MS have generalydomestic provisions to combat counterfeit • medicalproducts) • 2) Legal instruments, EU strategies and agenciesat the EU level • (joint action at the europeancommunitylevel) • Law Enforcement (Polices, Customs, Justice…) • Civil and administrative frameworks, • Europol, Eurojust, Olaf… Joint Investigation Team… EU network… • Customs Action Plan (2009/2012)

13. Certain EU cooperation mechanisms are laid down for counterfeiting : • Council Decision on the establishment of a European Police Office (Europol); • Council Decision setting up Eurojust (college of EU magistrats); • European arrest warrant; • Council Framework Decision on the execution in the European Union of orders freezing property or evidence; • Council Framework Decision on the application of the principle of mutual recognition to financial penalties.

14. the fourth European Union Organised Crime Threat Assessment (2009 OCTA). The OCTA is a core product of the intelligence-led law enforcement concept and its drafting is one of Europol’s top priorities. The OCTA is an assessment of current and expected new trends in organised crime (OC) impacting on the EU and its citizens. It is drawn up in order to enable decision-makers to take the appropriate action to counter the anticipated threat. … The 2009 OCTA assesses the threat of OC in the EU through the analysis of the organised crime groups (OCGs), of the criminal markets, and of their interaction within and without territorial entities denominated as criminal hubs. … Rob Wainwright Director of Europol Through this 3-D perspective we assess that the most significant criminal sectors are drug trafficking, trafficking in human beings (THB), illegal immigration, fraud, counterfeiting and money laundering. 19

15. The industrial sectors mostly affected by counterfeiting are: • music, software, • tobacco, • products, automotive parts, • Pharmaceutical, • chemical products, • clothing. Pharmaceutical products, mainly those from abroad represent the most alarming dimensions of this phenomenon. To maximise profits, OC groups produce medicines without regard to ingredients – including the active principle – composition and production methods.

16. the recommendations of the seminar focusing on combating counterfeit medicines, held in Budapest on 3 and 4 March 2011; DECLARING since falsified and/or counterfeit medicines cannot be combated successfully with isolated measures, an integrated and multifaceted approach is necessary; there is a need for Member States to ensure cooperation between the various authorities involved, such as public health authorities and medicines agencies, as well as customs and police authorities, and including the private sector;

18. one of the political priorities for the period 2010-2014 is to strengthen Europe’s security, and that special attention should be paid to the application and development of existing tools as well as to enhancing the fight against types of criminal offences with cross-border implications that can affect the daily life of European citizens; falsified and/or counterfeit medicines may pose a serious threat to public health…; the ongoing European Union efforts to combat falsified medicines, such as amending Directive 2001/83/EC on the prevention of the entry into the legal supply chain of falsified medicinal products, and the work of the European Commission, the European Medicines Agency and the Member States in implementing this Directive; the EU Customs Action Plan to combat counterfeit for 2009 to 2012 which provides for extensive activities to combat the illicit trade;

19. … a coherent, integrated approach throughout the investigation and prosecution process should be developed in order to make the fight against organised and serious international crime more integrated, efficient, transparent and accountable as part of a policy of deterrence, while guaranteeing the fundamental rights and ensuring that the promotion of cooperation and the exchange of experience between the Member States by all possible means could contribute to this objective;

20. INVITES THE MEMBER STATES: to use Internet-monitoring Units within their respective authorities active in the field of falsified and/or counterfeit medicines, if available and as appropriate, to identify websites with potentially illegal offers of medicines, including websites in the Member States that do not meet the safety requirements laid down in the Directive that concern the sale of medicinal products at a distance to the public; to ensure adequate training for the personnel of competent law enforcement authorities who are active in the field of combating falsified and/or counterfeit medicines and to involve experts from the relevant stakeholders, thus covering the private and public sector; to encourage specific awareness-raising programmes and campaigns pointing out the health threat posed by falsified and/or counterfeit medicines;

21. to encourage cooperation, including exchange of intelligence and – in accordance with national and international legislation – operational information, between all authorities involved, such as health authorities and agencies, customs authorities and police authorities, and to establish partnerships with private takeholders, notably marketing authorisation holders and right holders, and, as regards online-sales of medicines, e-commerce operators and online payment providers; to consider the possibility of submitting project proposals (for example, as regards studies, training courses, joint operational teams) with a view to obtaining EU supportive funding (notably under the ISEC programme) for the purpose of combating falsified and/or counterfeit medicines;

22. INVITES THE COMMISSION: to consider the possibility of carrying out a study on the scope and nature of falsified and/or counterfeit medicines (organised crime investment) and their impact within the EU; INVITES CEPOL to consider the possibility of developing training modules and exchange programmes for senior police officers in the field of combating falsified and/or counterfeit medicines, and to examine the possibility of expanding such training to other competent law enforcement authorities."

23. THE COUNCIL OF EUROPE CONVENTION ON COUNTERFEITING OF MEDICAL PRODUCTS AND SIMILAR CRIMES INVOLVING THREATS TO PUBLIC HEALTH (MEDICRIME CONVENTION) COUNTERING THE SPREAD OF COUNTERFEIT MEDICAL PRODUCTS International High-LevelConference Moscow, 26-28 October 2011 European Union initiatives concerningfakemedicineswithinlegal and criminaltrades Initiatives de l’Union Européenne concernant les faux médicaments dans les filières commerciales légales ou criminelles Mr Christian TOURNIE -SNE European CommissionHome Affairs

24. Thank you