The global market value for counterfeit pharmaceuticals reached $4.4 billion in 20161. Why this explosion? The penetration of the legal distribution chain by criminal organizations, and the explosive growth of online sales, which are reaching more and more victims. Diving into the heart of one of the most active black markets on the planet.
A fake rabies vaccine in the Philippines, fake leukemia treatment tablets seized in Switzerland, a counterfeit antibiotic distributed in Haiti, fake face masks… In 2018, seizures of fake medicines by law enforcement authorities increased by 63% over the previous year, according to the Pharmaceutical Security Institute.
ALL MEDICATIONS ARE AFFECTED
The first observation is that all categories of medicines are affected, from the most common such as painkillers to the most sophisticated, such as anti-cancer medicines, including vaccines, diabetes medicines and sedatives. The second observation is that the fake medicines look real. Visually, they are often an exact replica. They may even contain a small amount of the active ingredient of the real medicine to create perfect copies that are significantly underdosed. According to the OECD, India and China are the largest identified producers of counterfeit pharmaceuticals. However, a patient has no way of distinguishing a real from a fake medicine, especially if it is sold individually.
AFRICA, MAIN VICTIM OF COUNTERFEITING
While all countries are affected by counterfeit medicines, low and middle-income countries pay the highest price. Africa, with its often inadequate network of pharmacies and health facilities, its customary informal distribution systems and the low incomes of its inhabitants, is the preferred terrain for traffickers. Hundreds of thousands of people die each year because of a “medical product of insufficient quality or falsified”, according to the WHO. Fake treatments for tuberculosis or malaria claim a great many victims, due to lack of care. In some cases, fake medicines are even directly toxic. In 2015, in the Democratic Republic of Congo (DRC), a false sedative caused eleven deaths and more than 1000 hospitalizations for meningitis-related symptoms. The tablets actually contained doses of antipsychotic medication 20 times higher than the norm.
THE WEB AS A DISTRIBUTION NETWORK
The best protection against traffickers of fake medicines is still a country’s health system and its health coverage. But with highly organized criminal networks, no country is immune from counterfeit medicines. The United States, for example, is beset by a serious opiate trade, with counterfeit tablets circulating on the black market, sold over the counter or online. With their fatal doses, they cost hundreds of lives every year. Most of this traffic takes place online. The figures speak for themselves: 96% of online pharmacies are illegal. Fake online pharmacies lure patients with the ease of mail order shopping, or the possibility of obtaining prescription medicines without a prescription. It has also been noted that social networks have become a key vehicle for buying fake medicines online. Hundreds of different websites, in different languages and countries, can be operated by the same criminal network. The trafficking of fake medicines is a global scourge that requires concerted action at the international level. Operation Pangea, which is coordinated by Interpol, brings together more than 100 countries, making it possible to seize millions of counterfeit medicines and dismantling criminal networks every year.
A MAJOR PLAYER IN THE FIGHT AGAINST FAKE MEDICINES
The Servier Group, as a member of the Anti-Counterfeiting Group of the European Federation of Pharmaceutical Industries and Associations (EFPIA), has established a rigorous organization to help fight counterfeit medicines. The first part of the action is prevention operations, in partnership with authorities. Training and traceability of medicines, boosted by the Matrix serialization system, are the other two major aspects of the Group’s action.
ESTABLISHING A PARTNERSHIP OF TRUST WITH THE AUTHORITIES
This is one of the pillars of the Group’s action. Detailed information on the supply and distribution chain, the provenance and packaging of Servier medicines distributed in a country help improve the detection of suspicious flows. In order to provide these elements, the Anti-Counterfeiting Department works closely with the entire Group, including subsidiaries and the Regulatory Affairs Department. The success of future customs and police interventions depends on the reliability of the information given. One of Servier’s strengths within this partnership is to respond effectively to requests, both upstream, in the context of ad hoc exchanges with the authorities, and when a suspicious flow is identified. Practical guides, such as how to photograph a medication to request verification, help expedite the processing of requests. The quality of the information provided and the responsiveness of Servier’s employees encourage the public authorities’ confidence in the Group
RESPONDING TO PUBLIC AUTHORITY TRAINING REQUESTS
Being fully engaged in the fight against counterfeiting, Servier participates in an increasing number of training courses each year. Thus, 1,729 people were trained in 2018-2019. This involvement is made possible by a rigorous internal organization and crossfunctional communication between departments. More specifically, in 2019, Servier contributed to the training of 452 law enforcement officers (301 customs officers, 74 police officers, 77 health agencies members) around the world. These training courses–which are conducted at the request of international organizations or national governments–are an opportunity for Servier to support the authorities, by providing essential knowledge so that law enforcement officers are confident in their checks and have all the elements to identify counterfeits. In charge of a range of nearly 400 missions, customs officers are not medicine specialists. Servier’s training courses provide them with accurate tools to identify risk indicators.
ENSURE MEDICINES’ TRACEABILITY AND AUTHENTICITY
Since 2015, the Matrix (Mark Aggregate Track & Report for International Exchanges) program has established the individual traceability of medicine boxes, with a view to preparing the Group for the implementation of serialization in Europe in February 2019. Matrix assigns a unique identifier (product code + serial number) that is no longer per batch but per box, introducing a tamper-proof system to allow pharmacies to verify the compliance of the product dispensed to the patient. In addition to equipping the packaging lines, Matrix also had to make it possible to set up complex data exchange systems. After being deployed throughout the European Union, serialization will be implemented in Russia in the summer of 2020. Servier has also developed innovative tools to secure its products, such as Securistamp, a coded digital authenticator printed on products in the most at-risk countries. In addition, Servier has a laboratory for analyzing counterfeit medicinal products in Orléans (France).
 OECD/EUIPO 2020 Report