FIGHTING COUNTERFEIT MEDICINES

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1 FIGHTING COUNTERFEIT MEDICINES G4 indicators: G4-DMA, G4-PR3 I. BACKGROUND 1. A public health challenge Fighting counterfeit drugs represents a substantial public health challenge. The figures most commonly cited by international organizations indicate that counterfeiting involves, on average, 10% of the global pharmaceutical market, although this figure may be higher in certain emerging regions, where the pharmaceutical control system is less regulated. Counterfeiting is most rampant in areas where regulatory and enforcement systems for medicines are weakest. According to the World Health Organization (WHO), approximately 50% of drugs sold on illegal websites that conceal their physical address have been found to be counterfeit, and trafficking in counterfeit medicines is estimated to generate a total of several hundred million euros in sales each year. Counterfeit medicines give rise to multiple risks because they: endanger patients health (according to the WHO, counterfeit medicines may be responsible for a large number of deaths worldwide); and feed a parallel and freeloading economy, which is contrary to sustainable development and may present risks to safety, hygiene, environment, ethics, human rights, etc. 2. A global mobilization The fight against counterfeit drugs mobilizes an increasing number of stakeholders, governments and healthcare authorities as well as police organizations and customs officials. II. MORE STRINGENT LEGISLATION 1. The European Union Directive 2011/62/EU introduced tougher rules to protect public health with new harmonized measures to prevent the entry of falsified medicines in the legal supply chain with provisions ensuring easier identification of falsified medicines as well as improved verifications and controls including: a tamperproof system on the outer packaging as well as safety features for identification by serialization/aggregation; a common eu-wide logo to identify legal online pharmacies so that it will be easier to distinguish between legal and illegal online pharmacies throughout the eu; tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and more stringent record-keeping requirements for wholesale distributors. 2. The Council of Europe 1 Medicrime is the Council of Europe s Convention on the counterfeiting of medical products and similar crimes involving threats to public health. It constitutes, for the first time, an international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health. Adopted in December 2010, the Medicrime Convention has been signed by 26 countries (Albania, Armenia, Austria, Belgium, Bosnia and Herzegovina, Croatia, Cyprus, Denmark, Finland, France, Germany, Guinea, Hungary, Iceland, Israel, Italy, Liechtenstein, Luxembourg, Moldova, Morocco, Portugal, Russia, Spain, Switzerland, Turkey and Ukraine) and ratified by Ukraine and Spain, Hungary, Moldova and Guinea. The fifth ratification by Guinea in 2015 paved the way for the entry into force of the Convention as of January 1, III. POLICY 1. Fighting counterfeit medicines and promoting access to safe medicines Counterfeit drugs are a major concern for Sanofi. The Group coordinates international efforts to fight against the counterfeiting of its medicines in cooperation with many different health and enforcement authorities, and has developed a number of programs to promote access to safe medicines. 1 The Council of Europe is an international organization comprising 47 member states in Europe whose aim is to promote democracy and protect human rights in Europe. For more information about Madicrime: published in May 2016 Page 1 of 6

2 The Group actively supports public authorities efforts to maintain the highest standards of drug quality and safety and fight counterfeit drugs through the following actions: 2. Quality of our medicines: using innovative technology working closely with local authorities and professional organizations to deliver information and educational programs to create awareness and fight against counterfeiting drugs and their potential damage to patients health; reinforcing cooperation with official bodies (international agencies, customs, police, etc.) To support their work in the fight against counterfeiting; centralizing all sanofi suspect counterfeit drugs and samples from markets in our specialized laboratory (lcac) based in tours (france); securing the supply chain and proactively implementing innovative solutions for its products to better protect them from falsification and counterfeiting; and fostering a dedicated and structured organization involving experts from security, legal, industrial affairs, quality, cybercrime, communication, medical and regulatory departments to coordinate at global, regional and local level all activities regarding the fight against counterfeit medicines. Counterfeiters increasingly use sophisticated means to produce fake medicines. Consequently, the pharmaceutical industry must continuously update innovative technological solutions to ensure the protection and traceability of products, to identify fake products and to secure the supply and distribution chain. To reduce risks of falsification and rapidly authenticate our products, Sanofi has developed a specific label known as the Sanofi Security Label (SASL). It contains the means for visible verification (by distributors and patients) as well as invisible verification (which are known by Sanofi only). In 2015 Sanofi continued the development of these technologies for all new drugs and is addressing new worldwide regulations, in terms of identification and serialization to protect products and secure the supply chain. Moreover, Sanofi is working on the use of tamper-evident packaging to reduce risks of violation of the integrity of the original manufacturer s packaging. For more information please see our Position Paper in the download center. IV. ACTIONS Sanofi organizes a wide range of initiatives in support of a single, critical goal: contributing to the fight against counterfeit drugs and, whenever possible, preventing the phenomenon. Our approach simultaneously pursues a large number of different objectives: protecting the patient, preserving trust in the supply chain, cooperating with national and international organizations, using cutting-edge technology to ensure product quality and operating our own dedicated Anti-Counterfeit Laboratory. 1. An essential tool: the Central Anti- Counterfeit Laboratory The Sanofi LCAC, which opened in 2008, is located at the Group s pharmaceutical site in Tours, France. The Laboratory is an integral part of the program set up by the Group to combat counterfeit drugs. 3. Implementation of a Data Matrix for increased traceability Since January 1, 2011, in compliance with French legislation, all products marketed by Sanofi in France have been equipped with a Data Matrix identification system, a two-dimensional barcode printed on each box that contains traceability information: product code (CIP code), batch number and expiration date. Data Matrix codes are read when drugs are dispensed, improving traceability and enabling the automatic detection of falsified or expired products. They also facilitate batch recalls. Sanofi actively works on the implementation of the requirements of the EU Directive 2011/62/EU to create a harmonized codification and verification system for medicines based on the use of Data Matrix, mass serialization and systematic controls at the time of dispensing by pharmacies and hospitals. The implementation of serialization operation on packaging lines follows regulatory updates. The same procress has been deployed for our Contract Manufacturing Organizations. With a dedicated team of specialists and state-of-the-art technologies, the Sanofi Central Anti-Counterfeit Laboratory pursues a three-fold mission: perform direct technical examination of suspected samples with the most sophisticated analyses techiques; design new analytical methods, in part with the aim of sharing them globally, to allow each industrial site worldwide to apply the same criteria when examining and performing analyses on all suspected products that correspond to products manufactured by sanofi; and centralize so-called identity cards containing information about counterfeit products in a single, centralized database the only database that enables wide-scale group crossreferencing of identified products counterfeiting the group s drugs. published in May 2016 Page 2 of 6

3 4. Global medicines protection strategy A layered approach toward pack protection These collaborative ties have made it possible for Sanofi to: sign charters supported by the French Ministry of Industry to facilitate prevention and contribute to the fight against counterfeit drugs sold on the Internet. These charters were signed with key players of e-commerce (2009) and classified ads and postal operators (2012). For more information, please refer to the following document available in the download center: Charte de lutte contre la contrefaçon; contribute to World Customs Operations; and support the Pangea Operation (see below) to dismantle counterfeiting networks on the Internet. Combating networks responsible for illicit sales of medicines online: the Pangea Operation 2 Pangea VIII took place in June 2015: In the frame of patient s safety and company responsability, Sanofi has put in place a new End-to-End product security program. Lead by Corporate security in close collaboration with supply chain, quality and Insurance, it aims at: participation of 115 countries; seizure of 20.7 million of fake and illicit potentially, worth approximately US$81 million; identifiying threats and vulnerabilities from R&D, manufacturing, distribution to destruction and establish a cross risk assessment; defining procedures, monitoring and auditing the third parties to mitigate malicious acts all along the supply chain and avoid products attempts; and ensuring a secure delivery to our products to patients everywhere, particularly in emerging and sensitive areas. 5. Cooperation with national and international organizations Convinced that public/private cooperation is essential to effectively fight counterfeit drugs, Sanofi participates actively in international and local organizations. Internationally, the Group collaborates with: organizations such as the World Customs Organization (WCO), the International Criminal Police Organization (Interpol), Europol; national and international health agencies; and professional federations, such as the International Federation of Pharmaceutical Manufacturers & Associations (IFPMA), the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Pharmaceutical Security Institute (PSI). At the local level, the Group cooperates with: the national anti-counterfeit committee (cnac) and union des fabricants (unifab), an french organization of manufacturers aiming at protecting intellectual property and fighting against counterfeit; the pharmaceutical research and manufacturers of america (phrma) in the united states; and national federations such as leem (the french pharmaceutical companies association). more than 2,410 websites being shut down; 156 people under arrest; and 550 adverts for illicit pharmaceuticals removed from the Internet. This global initiative, which also relies on support from Internet service providers, postal services and financial intermediaries, is aimed at educating Internet users about the dangers of buying medicines online. The Pangea Operation clearly demonstrates the importance of cooperation between public authorities and private companies to identify and dismantle these networks. Each year, experts from Sanofi Corporate Security collect and analyze information on some illicit networks and send to Interpol dedicated cases that are ready to be handed over for action. Sources as of February 1, 2016: 6. Developing awareness and education programs In 2015 Sanofi continued its training program, including employees, public health agents, customs officials and police officers from around the world: around 15,000 people were trained. Focus has been made on internal awareness to sales forces, quality and supply chain representatives to better detect 2 published in May 2016 Page 3 of 6

4 malicious acts on products (theft, counterfeit, diversion) and put in place mitigation measures in the frame of End-to-End product security program. Raising awareness among the employees of Sanofi, healthcare professionals and the health authorities is an important part of anti-counterfeit actions leaded by Sanofi. The Group pursues a policy to actively promote information and education across the globe, based on: developing e-learning programs for in-house training; creating a press kit about fighting counterfeit drugs; organizing regular information meetings and conferences at the tours site (france) and throughout the world. during this year, the tours lcac has been visited by 112 people; providing training specifically for customs officials and police officers; promoting the the third sanofi global anti-counterfeit day: it was held in june involving more than 60 sanofi sites/affiliates; and in december 2013, we launched a website dedicated to counterfeit medicines. it was created to meet information needs, to provide advice, and to highlight the engagement of sanofi on this public health issue. the website is available at: At the same time, we launched a mobile application called Travel Tips, delivering advice and information to travelers. As a member of the International Federation of Pharmaceutical Manufacturers and Associations, Sanofi supports the Fight the Fake campaign. Launched in November 2013, this campaign gathers together several health organizations in a worldwide campaign to protect patients from fake medicines. The campaign gives a voice to those who have been personally impacted and shares the stories of those working to put a stop to this threat to public health. More on the Fight the Fake campaign at: V. INDICATORS Indicator Improvement of sampling, analysis and data collection of counterfeit Sanofi products. The Central Anti-Counterfeit Laboratory recorded more than 5,000 entries in order to detect counterfeit products. In 2014, due to a better targeting and good collaboration with authorities around the world, the percentage of suspect products received from seizures (police, customs ) grew from 6% in 2013 to 16% in The product range analyzed in 2014 is much larger including veterinary products and vaccines. Since the LCAC was opened in 2008, around 30,000 entries were recorded by the Central Anti- Counterfeit Laboratory in order to analyze potential counterfeit products. Since the LCAC was opened in 2008, more than 30,000 entries were recorded by the Central Anti- Counterfeit Laboratory in order to analyze potential counterfeit products. published in May 2016 Page 4 of 6

5 Indicator Improvement of the visibility of commitment of Sanofi against counterfeit medicines worldwide. Development of partnerships to better collaborate with enforcement authorities (police, customs, etc.). In 2013, Sanofi trained more than 17,000 people, including around 9,000 employees and around 8,000 external persons. The second Sanofi Global Anti-counterfeit Day was held in June involving more than 50 Sanofi sites/affiliates. During this year, 188 people visited the Tours LCAC. On December 20, a new website dedicated to counterfeit medicines was launched. It was created to meet information needs, to provide advice, and to highlight the engagement of Sanofi on this public health issue. At the same time, a mobile application called Travel Tips was launched, delivering advice and information to travelers. More than 6,300 public agents (e.g. Ministry of Health [MOH], customs, police, judges) were trained on Sanofi product recognition and/or mobilized on the danger related to pharmaceutical counterfeiting worldwide. Contribution of Sanofi to several major operations: In 2014 Sanofi trained around 20,000 people including employees and external persons. For the third Global Anti-counterfeit Day, 50 sites/affiliates participated to the event. The website and travel application are now in place. More than 7,300 public agents (MOH, customs, police, judges) were trained on Sanofi product recognition and/or mobilized on the danger related to pharmaceutical counterfeiting worldwide. Sanofi trained around 15,000 people including employees and external persons. For the third Global Anti-counterfeit Day, more than 60 sites/affiliates participated to the event. Focus has been made on internal awareness to sales forces, quality and supply chain representatives to better detect malicious acts on products (theft, counterfeit, diversion) and put in place mitigation measures in the frame of End-to-End product security program. Contribution and involvement in international operations. Pangea 6: participation of 99 countries; the seizure of 10.1 million potentially harmful medicines, worth approximately US$36 million; more than 13,700 websites being shut down; and 213 individuals under investigation or under arrest. Major seizure in Europe by French customs: in May 2013 customs seized in Le Havre (France) 1,218,000 sachets of a counterfeited Sanofi product. Sanofi participated through OMD in two operations in Africa: Operation Biyela in April 2013; and Operation Giboia in October They were conducted in several African countries, resulting in the seizure of illicit medicines. No Sanofi products were seized. In Latin America, Sanofi participated in Operation Tiger 3 (November 2013). Contribution of Sanofi to major operations: Pangea 7: participation of 113 countries; the seizure of 9.6 million potentially harmful medicines, worth approximately US$32 million; 11,800 websites being shut down; and 434 individuals under investigation or under arrest. Sanofi participated through OMD to Operation Biyela II April 2014: 14 customs administrations; 10 days; 290 containers inspected; and 118 million of fake/illicit products intercepted among them 113 pharma. The operation was conducted in several African countries, resulting in seizure of illicit medicines. No Sanofi products were seized. Contribution of Sanofi to major operations: Pangea 8: participation of 115 countries; seizure of 20.7 million of fake and illicit potentially, worth approximately US$81 million; more than 2,410 websites being shut down; 156 people under arrest; and 550 adverts for illicit pharmaceuticals removed from the Internet. published in May 2016 Page 5 of 6

6 Indicator Protecting the patient, ensuring product quality and preserving trust in the supply chain. In 2013, in line with the different worldwide regulations on product identification, Sanofi has continued to work on serialization/aggregation programs. In 2013, all products identified at risk such as new launches of core products were protected with our Security Labels in order to authenticate them and to make it more difficult to copy them. All our plant are gradually equiped with serialization technologies 8 total in 2014 (among 48). In addition, work is also done with external manufacurers and we are following regulatory calendar for implementation. In the frame of patient s safety and company responsability, Sanofi has put in place a new End-to-End product security program. Lead by Corporate security in close collaboration with supply chain, quality and Insurance, it aims at: identifiying threats and vulnerabilities from R&D, manufacturing, distribution to destruction and establish a cross risk assessment; defining procedures, monitoring and auditing the third parties to mitigate malicious acts all along the supply chain and avoid products attempts; and ensuring a secure delivery to our products to patients everywhere, particularly in emerging and sensitive areas. published in May 2016 Page 6 of 6

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