P R E S S K I T

Falsified medicine – A challenge for the European Union

Tuesday Decembre 7, 2010

Medicines tested for quality control © fondation Chirac

Table of Contents

PRESS RELEASE P. 4

I. COMMITMENT OF THE FONDATION CHIRAC AGAINST THE TRAFFIC OF FALSIFIED MEDICATION P. 5

International mobilisation p. 5

Acting on the supply p. 5

Acting on the demand p. 5

II. FALSIFIED MEDICINE - A CHALLENGE FOR THE EUROPEAN UNION P. 6

1. Fake drugs, at the crossroads between several problems p. 6

2. Making this scourge into a health priority and contributing to structural improvements and governance reforms p. 6

3. A conference to seek European responses to a public health development problem p. 7

Program p. 7

4. The European Development Days p. 8

Participation and involvement p. 8

Policy-making “laboratory” p. 8

The key role of the European Union p. 9

III. THE TRAFFIC OF FALSIFIED MEDICATION - A HEALTH CATASTROPHE P. 10

1. What is falsified medication? p. 10

2. An expanding traffic p. 10

3. Factors encouraging the rise of this illegal trade p. 11

Examples p. 12

4. Health issues stemming from the traffic of falsified medication p. 13

a. Therapeutic failure p. 13

b. Resistance p. 13

IV. THE WORK OF THE FONDATION CHIRAC IN THE FIELD OF ACCESS TO QUALITY MEDICINES AND HEALTHCARE P. 14

1. The expansion of Benin's National pharmaceutical quality control laboratory p. 14

2. Advocacy p. 15

a. The Cotonou Declaration against fake medicines p. 15

b. The ratification of an International Convention against the traffic of falsified medication at the United States p. 17

Addressing the lack of information in order to encourage awareness p. 17

Training technicians for quality control laboratories p. 17

Elaborating a repressive tool to regulate the distribution of medication and reinforce patients' rights to access quality controlled medication p. 19

V. PARTNERS P. 18

VI. CONTACTS P. 20

Fondation Chirac p. 20

Press Contact p. 20

APPENDIX - JED'S PROGRAM P. 21

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I. Commitment of the Fondation Chirac against the traffic of falsified medication

INTERNATIONAL MOBILISATION The production and trafficking of fake pharmaceutical products does not spare any continent or any country, but countries with limited resources are affected to a greater extent by this plague: their pharmaceutical authorities, in charge of controlling and legislating the distribution of medicinal products, are overwhelmed by the globalisation of the pharmaceutical circuit, and are unable to ensure the security of drug inflows at borders, or of circuits organising sales of drugs to patients. Faced with this health emergency, the action of the international community must be clearly focused on public health. This is the reason why the Chirac Foundation has preferred talking about fake, rather than counterfeit, drugs as the latter word implies a business rationale. To work efficiently against the growing traffic of fake medicines, the Fondation Chirac is leading an international awareness campaign. This initiative implies the political mobilization of Heads of State, international organizations, regional organizations (such as the European Commission, and the Commission of the African Union) committed alongside the Foundation1 to put into practice the Cotonou Declaration. This advocacy fits into a global framework, targeting offer as well as demand. ACTING ON THE SUPPLY For efforts to achieve concrete results, they must:

• Promote the enforcement of legislation of suitably repressive regulations leading to the end of the manufacturing and distribution of non-standard pharmaceutical products.

• Ensure the safety of manufacturing and distributions chain in order to offer drugs that respond to qualitative norms.

However, these first measures will not be efficient in the long term if we do not commit sufficient national and international funding to keep in line with sanitary and economic stakes.

ACTING ON THE DEMAND

Awareness and information must appropriately target not only consumers and dispensary pharmacists but also officials working in the field, who witness illegal practices. Promoting, for the general public, the use of quality medication and changing certain buying habits (encouraging for example the use of high quality generic medication).

• Informing dispensary pharmacists about product origins and the dangers of falsified medication.

• Training inspection officials (judges, health authorities, police services, customs officials) about the circuits used by this parallel economy in order to ensure adequate product tracking.

• Guarantee the proper functioning of laboratories for drug safety by training field technicians.

1 Signatories of the Cotonou Declaration, see page 16

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II. Falsified medicine – A challenge for the European Union

1. Fake drugs, at the crossroads between several

problems The problem of fake drugs encompasses prevention and repression policies, as well as structural policies that allow the security of the pharmaceutical circuit to be ensured and the cost of drugs to be lowered, in countries where health expenditure accounts for a family’s second-largest budget item.

Policies striving to enhance the structure and security of the pharmaceutical circuit cannot be dissociated from the efforts of the international community, and of the European Union, to improve the access to lawful and safe generic drugs.

Several organisations are working at both a diplomatic and an operational level on stamping out this trafficking and building up capacity in the worst affected countries.

• The European Parliament voted on 7 September 2006 a resolution on the counterfeiting of medicinal products, upon an initiative of its Development Commission (P6_TA-PROV(2006)0351).

• The Cotonou Declaration against fake medicines is launched in October, the 12th, 2009. This declaration has to date benn signed by forty Heads of Sates and international leaders.

• The World Health Organisation has been working on this issue since 2006, and pledged in May 2010 to give governments a significant role in its studies.

• The Council of Europe is drafting a Convention called Medicrime, which criminalises the “counterfeiting of medical products”.The World Customs Organization, just like Interpol does, dedicates a significant share of its activities to consolidating the means of intervention of member countries’ authorities. The operation " Pangéa III " led by Interpol last October, allowed the seizure of more than a million false medicines in 45 countries.

• The Heads of State and Government of the Organisation Internationale de la Francophonie (OIF), who met at Montreux for the XIIIe summit of the Francophonie October 23 – 24, 2010, adopted a resolution for the “reinforcement of the cooperation among states in the fight against fake medicines and falsified medical products.”

2. Making this scourge into a health priority and

contributing to structural improvements and governance reforms

The complexity of the issue of fake drugs entails working to establish specific governance for medicinal products in affected countries. One of the proposals of the Chirac Foundation consists in setting up multi-disciplinary committees in charge of fighting fake drugs, able to exert influence on governments’ decisions. Structural progress would enable countries to give themselves a legal basis adapted to the new challenges they face, with regard to standards regulating the way in which drugs are put on to the market, as well as codes for customs. A sub-regional approach that would transcend the merely national dimension is indispensable, in order to pool funding and means of action to control the pharmaceutical circuit in countries with limited resources.

Drafting a binding legal framework with an international scope, seeking to prevent the production and trafficking of fraudulent drugs, has to be the repressive counterpart of prevention policies and initiatives aimed at providing access to healthcare: mutual health plans, incentives to manufacture drugs locally, laboratories in charge of controlling the quality of drugs, and so forth.

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3. A conference to seek European responses to a public health development problem

« Access to counterfeit drugs is a moral issue, an ethical problem that undermines the credibility and effectiveness of health systems. It should challenge the conscience of political leaders around the world. What is fascinating about the European Development Days is this common consciousness that unites all those who work daily to promote a fairer and better world. » Louis Michel

The conference proposed by the Chirac Foundation and Mr Louis Michel is aimed at promoting the political advocacy of this issue among decision-makers, and more particularly European decision-makers. By making the conference on the traffic of falsified medicines one of six plenary sessions of the European Development Days, the organizers are showing the importance of the issue. In three round tables, decision-makers, technicians, experts and players in the field will assess the structural, legal and political needs of the most vulnerable countries. They will also work on the initial cooperation-based approaches to be implemented in order to build the capacity of authorities and improve the healthcare organisations that help provide access to high-quality healthcare and drugs. The proposals stemming from the conference might be set out in a White Book, as a tool to help promote the project among European decision-makers and elected representatives.

By bringing together international organizations, governments, NGOs, foundations and associations representing the pharmaceutical industry, wholesalers, groups of health professionals, and civil society, the Fondation Chirac wants to unite all of these efforts to bring forth concrete propositions of best practices to secure the whole distribution chain, to inform the public, and to help lift political “blockages” that slow down the whole system.

PROGRAM Gold Hall 10:00 – 10:45 Conference Opening Louis MICHEL, Minister of State, European Deputy, co-President of the ACP–EU Joint Parliamentary Assembly, former European Commissioner for Development and Humanitarian Aid. Thomas BONI YAYI, President of the Republic of Benin Blaise COMPAORÉ, President of the Republic of Burkina Faso Mo Ibrahim, President of the Mo Ibrahim Foundation

10:45 – 12:15 Opening session on the current state of governance in health and access to quality medicines.

MODERATOR: Jean-Michel SEVERINO, President of the French Water Partnership

Erastus MWENCHA, Vice-President of the Commission of the African Union Isabelle DURANT, Vice-President of the European Parliament Georges SERRE, Deputy Director General Branch of Globalization, Development and Partnerships, French Ministry of Foreign Affairs Mohamed IBN CHAMBAS, Secretary General of the ACP GROUP OF STATES, former Executive Secretary of the ECOWAS Hilde JOHNSON, Deputy Executive Director of UNICEF Didier MERCIER, Deputy Director General of the Agence française de Développement Auditorium 400 1:30 – 3:00 Round Table: Needs analysis and priority field efforts.

MODERATOR: Professor Marc GENTILINI, Managing Director for the Fondation Chirac's program "Access to quality medicines and healthcare"

Thijs BERMAN, MEP, Member of the European Parliament's Committee on Development Pierre CHIRAC, adviser to Doctors Without Borders

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Professor Philippe GUÉRIN, Executive Director of Worldwide Antimalarial Resistance Network Boniface OKOUYA, President of the Inter-African Association of Pharmacists Bernard PÉCOUL, Director of the Drugs for Neglected Diseases Initiative (DNDI), former executive director of Doctors Without Borders Celestin TAWAMBA, President of CINPHARM, manufacturer of essentiel drugs in Douala, Cameroon Maryse DUGUÉ, Health and social protection Division Technical Department, Agence française de Développement

3:00 – 4:30 Round Table: What legal and structural developments are needed to prevent the production and trafficking of counterfeit drugs?

MODERATOR: Claude DEBRULLE, Honorary Director General of the Belgian Ministry of Justice

Kristian BARTHOLIN, Administrator, Division of Criminal Law, Council of Europe Thierry CORNILLET, former MEP, Standing Rapporteur for Humanitarian Aid in the European Parliament Margareth Ndomondo-SIGONDA, Pharmaceutical Coordinator of NEPAD Aline PLANÇON, HEAD of Interpol's Medical Products Counterfeiting and Pharmaceutical Crime Unit Christophe ZIMMERMANN, Coordinator, Fight against Counterfeiting and Piracy, World Customs Organization Christian TOURNIE, Expert in the “fight against organized crime” unit, European Commission Vincent AHONKHAI, Senior Regulatory Officer, Global Health Delivery at Bill & Melinda Gates Foundation (subject to change) Gold Hall

4:30 P.M. JACQUES CHIRAC WILL ADDRESS ALL PARTICIPANTS AT THE CLOSE OF THE EUROPEAN DEVELOPMENT

DAYS

4. The European Development Days

This year, the 5th edition of the European Development Days (EDD) will take place in Brussels on 6 and 7 December. Organised by the European Commission and the Belgian Presidency of the Council of the European Union, EDD is the leading European forum where the questions and issues about international development cooperation are debated.

The scope and scale of EDD are growing every year, as links with new networks and new partners are made, and new platforms are created. The first four EDD events have established some important characteristics:

PARTICIPATION AND INVOLVEMENT At every level, participants, hosts, moderators, debaters, exhibitors, whether they’re from the North or the South, can all take part, put forward their ideas, examine creative solutions and question responsibilities. Male and female politicians, parliamentarians, representatives of international institutions, local authorities, NGOs, business leaders, researchers, journalists, artists and students… all share their knowledge and their experiences. The debates are in plenary sessions or in bilateral meetings, in workshops or in the framework of parallel events, in quiet lounges or before the press. The European Development Days represent an opportunity to make good use of the diversity of viewpoints and models operating in the world. The forum’s agenda is the result of collaboration, in which every stakeholder can propose events, network meetings or exhibitions.

POLICY-MAKING “LABORATORY” The European Development Days are a policy forum which highlights recent developments and important initiatives “to be continued” in the key areas of development cooperation. Under the leadership of President José Manuel Barroso, will deliver a keynote speech at the opening of this major

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political discussion forum, and Commissioner for Development, Andris Piebalgs, the 2010 edition of EDD will feature 15 High Level Panels, two keynote speeches and 30 seminars on subjects as sensitive as :

- the place of development in the institutional setup prescribed by the Lisbon Treaty, - governance, reflection on the future of development cooperation, - access to energy, - the “Global Health Policy”, - the management of natural resources, - support to the private sector, - the effectiveness of aid, - human rights, - etc.

THE KEY ROLE OF THE EUROPEAN UNION The European Development Days offer the European Union and its Member States the chance to take stock regularly of some of its founding values, such as solidarity, respect between peoples, elimination of poverty, commitment to international law and to the principles of the Charter of the United Nations. The previous four editions of EDD have all confirmed the role of Europe, not only as the leading donor of development aid but also as the leader of international thinking about development cooperation. They have strengthened public awareness of development issues and helped to improve European cohesion with a view to increasing the effectiveness of aid. The EDD will be accompanied by numerous side-events, and launch of Prizes and reports. A highlight among these will be the award ceremony of this year's Lorenzo Natali Journalism Prize in the Town Hall of Brussels and the award ceremony of the winners of the Music Against Poverty contest1.

« Access to counterfeit drugs is a moral issue, an ethical problem that undermines the credibility and effectiveness of health systems. It should challenge the conscience of political leaders around the world. What is fascinating about the European Development Days is this common consciousness that unites all those who work daily to promote a fairer and better world. » Louis Michel

1 JED program see in appendix page 21

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III. The trafic of falsified medication – a health catastrophe

Many countries in Africa and parts of Asia and Latin America have areas where more than 30% of the medicines on sale can be couterfeit1. This ever-growing traffic kills more people than drugs in southern countries. But this plague touches the entire planet, especially Africa and Asia; even Europe and the United States, are not unaffected.

1. What is Falsified Medication?

The term « falsified medication » refers to medicinal products as well as vaccinations that have been forged or badly designed, that contains no active ingredients, insufficient active ingredients, or those in falsified packaging (either deliberately or fraudulently mislabeled). They are sold in the street and in markets, and consumers buy them in good faith. Their ingredients and active principles are badly dosed, sometimes toxic, and their consumption results in devastating consequences: renal or bone marrow complications, drug resistance, and so forth. They can even lead to the death of patients: In 2006, the WHO estimates that the number of victims of fake anti-malaria drugs totals 200,000.

2. An expanding traffic The illegal nature of the falsified drug trade and weak commitments on behalf of Nations to eradicate it make collecting data difficult. Nevertheless, health officials and field experts all describe an alarming situation. In countries with no social security, the second highest household expense is the purchase of medication. Drug quality therefore represents considerable economic stakes for the general population. The falsified drug trade has replicated the methods of the illegal drug traffic and is becoming even more profitable. Whereas a drug user is conscious of consuming illicit products, a sick patient is unaware that the medicine he is taking is dangerous. Today, with the exception of several all too rare countries that have started to organize official responses, authorities have not taken the necessary measures to control and prevent this serious threat to public health. By not reacting as forcefully as with the illegal drug traffic, the international community and international institutions are rendering the manufacture, traffic, and sale of falsified medications and vaccines more attractive for international crime rings. Criminals realised that the developing use of vaccines and medication created a lucrative market that was until now, safe and easy to exploit. Groups of transnational dealers have taken over this profitable trade and the earnings garnered have been reconverted into other delinquent activities. Laundered, this money will never be reinserted into national economies. More often than not is placed in fiscal paradises. “Our countries are the primary target for the informal trade of medicines: our borders are porous, the States are not ready for globalization, health insurance is virtually non-existent, and two people out of three live under the poverty line. The mold is in place for the proliferation of this shameful trade!” Idrissou Abdoulaye, Director of the National University Hospital Centre of Cotonou. Furthermore, Internet sales of pharmaceutical products also multiplies the risk of buying non-standard medication and the difficulty to control the quality of the products bought by patients. The Internet drug trade for example can involve manufacturers in Ukraine, packagers in Germany, hosts in the Canary Islands, storage in Vanuatu, and off-shore accounts in Cypress…. Such opaqueness encourages falsification. According to experts, According to experts, more than 50% of the time, medication bought from websites that do not show their physical address, are fake2.

1 Counterfeit drugs kill ! – OMS, groupe IMPACT, 2008 2 WHO, January 2010

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3. Factors encouraging the rise of this illegal trade Many factors1 are directly or indirectly responsible for the falsified drug trade and its emancipation:

• Corruption. Bad leadership, weak institutions favouring corruption, and conflict of interests that can damage the efficiency of authorities of pharmaceutical regulations and those in charge of enforcing the law. Corruption allows dealers to avoid arrest, prosecution, and conviction

• Reticence on behalf of governments to recognise the gravity of the problem. Countries need appropriate legislation to fight this traffic.

• An insufficient legal framework, weak sanctions and administrative measures. When legislation is not fully enforced and does not fully cover the manufacturing and distribution of medication, illegal trade escapes judicial pursuits.

• Weakness, absence, or clemency of penal sanctions that are not adapted to the risks to public health. Not punishing violations of pharmaceutical legislation encourages the traffic of falsified medication.

• Ineffectual process inspections from manufacturing to distribution. In countries where regulatory authorities are weak, falsified medication surpasses 10%. Insufficient, weak, or ineffectual regulatory controls encourage the non-monitored importation, manufacturing, and distribution of medication, which in turn leads to the proliferation of non-standard medicine and stimulates the birth of new illicit markets.

• The lack of collaboration between different actors implicated in trade regulation, quality control, investigations, and judicial pursuits can be observed both nationally and internationally.

• Non-regulated, parallel imports occur when a distributor does not belong to a pharmaceutical group's distribution network. Such distributors are free to buy medicines in a State with lower prices and sell them in another state where prices are higher.

• The improvement of clandestine manufacturing. With the appearance of improved manufacturing and packaging material, detecting falsified medication is that much more difficult. Dealers can produce goods that are almost identical to their original counterparts.

• Higher or differential prices for certain medications encourage the supply of cheaper falsified medication. The general population is not sufficiently aware that high quality generic products are available for 10 times less than brand name counterparts.

• Inadequate access to health services for populations and insufficiently trustworthy pharmaceutical supply routes.

• Poverty and illiteracy. According to UNESCO2, there are approximately 774 million people today who do not know how to read or write. This is about one out of every five adults in the world. This situation concerns mainly sub-Saharan Africa, southern and western Asia, and the countries in the Pacific.

• Multiplying middlemen. This complex process, from product manufacturing to marketing, distribution and finally retail sales implies a large number of actors. It also facilitates the commerce of falsified drug dealers.

1 According to the Guide for the creation of measures aimed at eliminating counterfeit medicines – WHO 2000 2 International Literacy Statistics : A Review of Concepts, Methodology and Current Data – UNESCO Institute for Statistics, Montreal, 2008

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From their conception to their consumption, we can diagram the medication circuit thusly:

Production chain from conception to distribution and the different inspections

EXAMPLES “In 1998, European customs intercepted 18 million counterfeit products. In 2009, 117 million products were seized, of which 18 million were products that were health hazards.” Christophe Zimmermann, Coordinator Fight against Counterfeiting and Piracy, World Customs Organization

• In July 2009, Bangladesh authorities seized chemically toxic, contaminated acetaminophen syrup that had killed 24 children, all between 1 and 5 years old. In 1992, falsified medication had killed 300 children in Bangladesh1.

• The parallel market for fake medicines in Europe represents 10,5 billion Euros per year 2.

• 77 million individuals will consume medication that was obtained illegally3.

• In December 2009, 34 million fake tablets were seized in Europe during customs checks carried out on all EU member states4.

1 Agence France Presse (AFP) 2 Cracking Counterfeit Europe, étude réalisée par Pfizer, février 2010 3 Cracking Counterfeit Europe, étude réalisée par Pfizer, février 2010 4 Statement by Günter Verheugen, European Commissioner for Industry, in Die Welt, December 2009

Health and Safety Inspections

Safety and Judicial Inspections

Tests of conformity, quality, and modes of

distribution

Tests of conformity, quality, and modes of

distribution

Tests for efficacy and tolerance

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4. Health issues stemming from the traffic of falsified medication

The majority of victims of this thriving traffic are once again, those living in the poorest countries. If we consider the right to health a fundamental human right, it is only logical that vaccines and medication must be accessible to all. However, we must also ensure their quality, that they contain active ingredients that prevent or heal affections. Both vaccines and medication are some of the most important elements in illness prevention and healthcare. No country is safe. It is not rare to discover important quantities of non-standard products in Europe and North America, but developing countries are the hardest hit. All types of products are targeted: expensive or affordable treatments, brand-name drugs or their generic counterparts. They can be found in community pharmacies and hospitals. In developing countries, medication is frequently sold in the street, which makes regulating and controlling that much more difficult.

Illnesses associated with geographical zones are seen as lucrative opportunities for dealers. One hundred and eight countries are faced with malaria1. In 2008, the WHO recorded 247 million cases, causing nearly a million deaths, particularly among children living in Africa.This scourge has triggered a high demand for anti-malarial drugs in West Africa. The majority of falsified anti-malarial treatments are therefore sold in the member countries of the Economic Community of West African States (ECOWAS).

“In Haiti, even though nothing is rebuilt and that the administrative structures are totally disorganized, and incapable of protecting the population, the traffickers are there.” Hélène Degui, Executive Director of the Centrale humanitaire médico-pharmaceutique.

a. THERAPEUTIC FAILURE An individual’s or a population’s chances of improving their state of health is often challenged when treatment is sought on the illegal market, when the origin and quality of the product is highly uncertain. Therapeutic failure is therefore likely and can lead to a worse state of health. The consequences for public health can be quite important.

b. RESISTANCE

This traffic is particularly alarming in countries with weak regulatory control mechanisms. It is often these same countries who have the highest rates of illnesses, the poorest populations, and the greatest need for trustworthy medication. Non-standard medications are poisons. They do not treat patients; they endanger their lives, and contribute to the rise in the resistance of certain illnesses (drug resistance) that are sometimes lethal. When antimicrobial medication is used inadequately, the chances that the micro-organisms adapt and multiply instead of disappearing are very high. Drug resistance occurs when antibiotic or antiparasitic doses are insufficient or administered over too short a time span. As falsified medication is so common in market stalls, illegal traffic represents one of the main obstacles to conquering serious illnesses such as malaria or tuberculosis. In the WHOs report on the efficiency of antimalarial drugs and resistance to treatments, they found that in South-East Asia, fake and sub-standard medication are the major cause of a new resistance to artemisinin, a common component in antimalarials2.

1 WHO, World Malaria Report, 2009 2 Global report on antimalarial efficacy and drug résistance, 2000 – 2010 - OMS

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IV. The work of the Fondation Chirac in the field of access to quality medicines and healthcare

1. The extension of the National Laboratory of Quality Control of Medicines in Cotonou

The Fondation Chirac started by concentrating its efforts on projects that allowed the Less Developed Countries to gain in independence in the pharmaceutical management and quality control. With this in mind, the Fondation Chirac financed the expansion of Benin's National pharmaceutical quality control laboratory Conceived in partnership with Benin's Health Ministry and the Pierre Fabre foundation, this extension will allow the laboratory:

• To fulfil all the necessary criteria to obtain the World Health Organisation's certification,

• To develop Control and Training projects at the national and regional level,

• To acquire a regional dimension and to consolidate political access to quality medication in West Africa - public health and security stakes that hold true on a global scale.

Benin authorities consider this project to be a top priority and have made the strengthening of the capacities of the national laboratory of quality control of medicines one of its major recommendations in the Etats généraux de la santé, held in Cotonou in November 2007. The new laboratory will be inaugurated on December 20th, 2010, it will dispose of an additional 300 m2 with five laboratories.

National Laboratory of Quality Control of Médicines in Cotonou © Fondation Pierre Fabre

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2. Advocacy

a. THE COTONOU DECLARATION AGAINST FAKE MEDICINES

Cornerstone of the rallying efforts the Cotonou Declaration, launched October 12, 2010 aimed to raise the alarm about the health, economic, and social consequences that the scourge of falsified medication engenders. The highest political authorities of all the world's countries, without exception, must act. To do so, we must create and implement appropriate legislative measures with strict enforcement, an efficient and adequate administrative and judicial organisation, specific training for health and repression officials, but also an awareness program aimed at the general public and more specifically at the patients themselves, whose rights are being violated. This declaration has to date benn signed by forty Heads of Sates and international leaders.

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The signatories are classified by date of signature

OCTOBER 12, 2009, THE COTONOU DECLARATION Jacques Chirac, Former President of the French Republic, President of the Fondation Chirac / Thomas Boni Yayi, President of Republic of Benin / Blaise Compaoré, President of Burkina Faso / Denis Sassou N'Guesso, President of Republic of Congo / Mamadou Tandja, President of Republic of Niger / Abdoulaye Wade, President of Republic of Senegal / Faure Gnassingbé, President of Togolese Republic / François Bozizé, President of the Central African Republic / Ely Ould Mohamed Vall, Former President of Islamic Republic of Mauritania from 2005 to 2007 / Jean-Louis Borloo, former French Minister for Ecology, Energy, Sustainable Development and Town and Country Planning / David Mwakyusa, Minister of Health, United Republic of Tanzania / Ponmek Dalaloy, Minister of Health, Laos PDR / Louis Michel, Member of European Parliament, co-president of the EU/ACP parliamentary assembly / Babatunde Osotimehin, Minister of Health, Republic of Nigeria / Oumar Ibrahim Touré, Minister of Health, Republic of Mali / Sebastian Pavlovic, On behalf of Michelle Bachelet, Republic of Chile / Clavenda Bright Parker, Responsible of the fight against falsified medicines on behalf of Ellen Johnson-Sirleaf, President of Republic of Liberia / Amidou Diarra, Ambassador of Republic of Côte d'Ivoire / Robert Fillon, Ambassador - Principality of Monaco / Adv. Bience Gawanas, Commissioner in charge of Social Affairs - the African Union Commission

JANUARY 2010 Amadou Toumani Touré, President of Republic of Mali

FEBRUARY 2010 Boutros Boutros-Ghali, Former United Nations Secretary-General

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MARCH 2010 Ronald K. Noble, General Secretary of Interpol / Abdelaziz Bouteflika, President of the Republic of Algeria Zine El Alibine Ben Ali, President of Tunisia / HSH Albert II of Monaco, Sovereign Prince of Monaco / Danilo Türk, President of the Republic of Slovenia / Abdou Diouf, Secretary general of the Organisation Internationale de la Francophonie / Ismail Serageldin, Director of the Bibliotheca Alexandrina

APRIL 2010 Vaira Vike Freiberga, former President of the Republic of Latvia / Andrés Pastrana Arango, former President of the Republic of Colombia / Karolos Papoulias, President of the Hellenic Republic / Idriss Déby Itno, President of Chad

MAY 2010 Michel Sleiman, President of the Libanese Republic / Demetris Christfias, President of the Republic of Cyprus / Ali Bongo Ondimba, President of the Gabonese Republic / Jose Manuel Durao Barroso, President of the European Commission

JUNE 2010 Georgi Parvanov, Président of the Republic of Bulgaria / Ivan Gašparovič, President of the Republic of Slovakia / Kunio Mikuriya, Secretary General of the World Customs Organization

b. THE RATIFICATION OF AN INTERNATIONAL CONVENTION

AGAINST THE TRAFFIC OF FALSIFIED MEDICATION AT THE

UNITED NATIONS

It aims to tackle the three main problems linked to the traffic:

ADDRESSING THE LACK OF INFORMATION IN ORDER TO ENCOURAGE AWARENESS

• Purchasing habits must change. In order to facilitate access to adequate health care, even for the poorest populations, it is vital to inform them about quality generic medication, available for ten times less than in public or private circuits.

• It is imperative to systematically inform dispensary pharmacists who in turn must warn their patients against the dangers of falsified medication.

TRAINING TECHNICIANS FOR QUALITY CONTROL LABORATORIES

• If laboratories are to function properly and sustainably, it is essential to train people on the field and supply the necessary resources.

• To optimise this measure, it will mean creating teams of technicians to ensure the maintenance and training of different laboratories.

ELABORATING A REPRESSIVE TOOL TO REGULATE THE DISTRIBUTION OF MEDICATION AND

REINFORCE PATIENTS' RIGHTS TO ACCESS QUALITY CONTROLLED MEDICATION

• Because the traffic of falsified medication is a public health problem, it is our duty to establish an internationally recognised law to put an end to this scourge. The World Health Organisation (WHO) and France both have existing legislation that could be used as models.

The implementation of this legislation must federate health professionals (dispensary pharmacists, pharmaceutical councils, laboratories...) and inspection services (police and customs officials) to ensure the safety of the pharmaceutical distribution chain. They must be adequately informed about the circuits employed by this parallel economy.

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V. Partners

European Development Days was launched in 2006 as a vehicle for aid effectiveness and an opportunity to strengthen the European Consensus on development cooperation. The four previous editions have featured 31 Heads of State, 44 Heads of Government or ministers and 6 Nobel Prize winners. The last edition in 2009 in Stockholm attracted a total of 6000 participants.

The French Ministry of Foreign and European Affaires (MAEE) is responsible for:

• The summary of information on the evolution of the international situation as well as research for French foreign policy decisions,

• The design of French foreign policy,

• The coordination of French international relations,

• The protection of French interests abroad and assistance to French nationals outside of French territory.

Created in 2009, during the reorganization of the MAEE, the branch for globalization, development and partnerships (DGM), allows the French diplomacy to better predict, identify, and respond to the challenges of globalization.

Confronted with major global issues that have a direct impact on the lives of our fellow citizens, as well as the emergence of new actors, the MAEE works with the DGM to put emphasis on the necessary solutions to these global issues. The MAEE is convinced that each of the major economic, cultural and social questions call for collective action with increased cooperation and partnerships, anticipation, inter-ministerial coordination, responsiveness, and an interdisciplinary and resolutely European approach.

The Centrale Humanitaire Medico-Pharmaceutique (CHMP) France is an association that was created in 1992 and its satellite office in Kenya was created in 1993.

Present in over 90 countries, it helps develop pharmaceutical systems that meet the needs of populations in countries with limited resources.

Its medical quality control laboratory is pre-certified by the WHO, and garanties the quality of pharmaceutical products that are distributed by the CHMP. The laboratory also tests medications for partners who want to confirm the quality of medicines that they are distributing to patients.

CHMP pharmacists perform audits on producers of generic medicines wishing to have their products approved by a structure recognized for its knowledge in the domain.

Lastly, in the area of health projects, a team of professionals participates with international organizations, foundations, and health ministries, with the support of local actors, to improve access to quality healthcare for local populations.

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AFD stands for the Agence Française de Développement. AFD is a public development finance institution that has worked to fight poverty and support economic growth in developing countries and the French Overseas Communities for almost 70 years. AFD executes the French government’s development aid policies.

Through offices in more than fifty countries and nine French Overseas Communities, AFD provides financing and support for projects that improve people’s living conditions, promote economic growth and protect the planet: schooling, maternal healthcare, help for farmers and small business, water supply, preservation of tropical forests, and fighting climate change, among other concerns.

In 2009, AFD committed more than €6.2 billion to financing aid activities in developing and emerging countries and the French Overseas Communities. The funds will help vaccinate 1.8 million children, improve drinking water access for 7.3 million people and support 900,000 private sector jobs, while energy efficiency projects save nearly 5 million tons of carbon dioxide emissions per year. www.afd.fr

The CFAO is a leader in specialized distribution in its core sectors of automobiles and pharmaceuticals, in Africa and in French Overseas Collectivities. The group is equally present in certain industrial and technological activities in Africa. The CFAO is present in 34 countries and employs 9400 people. In partnership with the biggest international groups in their domain, CFAO's 2009 consolidated turnover stood at 2,582 million Euros.

Sanofi-aventis is a diversified global healthcare company, focused on patient needs. Leading pharmaceutical company in emerging markets, the group employs approximately 105,000 collaborators in 110 countries and enjoys a broad and balanced presence. As a world health leader, Sanofi-aventis reached total sales of 29,3 billion Euros in 2009.

Sanofi-aventis has core strengths in the health field with six platforms for growth: emerging markets, human vaccines, consumer healthcare, the management of diabetes, innovative products and animal health.

Challenging biology, improving health

With extensive experience in industrial microbiology, Institut Mérieux contributes to serving medicine and public health across the globe. For the fight against infectious diseases and cancer, it imagines and develops new approaches in the fields of diagnostics, immunotherapy, and food safety and nutrition.

With its three business activities— bioMérieux, Transgene and Mérieux NutriSciences—Institut Mérieux has the potential to provide answers to the new challenges of public health globally.

Present in 150 countries, Institut Mérieux employs nearly 10,000 people in the service of public health worldwide and generates net sales of over 1.3 billion Euros. www.institut-merieux.com

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VI. Contacts

FONDATION CHIRAC 14 rue d’Anjou 75008 Paris Tél : + 33 (0) 1 47 42 87 60 Fax : + 33 (0) 1 47 42 87 78 www.fondationchirac.eu

PRESS CONTACT

FONDATION CHIRAC : Seth Goldschlager  seth.goldschlager @fondationchirac.eu Tél : + 33 (0) 1 57 32 86 25

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Appendix

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