A more effective war when waged together
The war against fake drug traffickers is a race against time.
To be effective, stakeholders must adopt a coherent, well organized strategy and find ways to remain one step ahead of the criminals who are continually evolving in order to bypass the law. Like trafficking itself, the response to these criminal activities should be without borders. And in this respect, the determinant factor is the quality of cooperation between the public and private players on the international scene. Many forms of partnerships between states, major international organizations, representative bodies and pharmaceutical companies exist, allowing the sharing of expertise, bilateral agreements, information exchange and coordinated, concerted actions.
The preventive or punitive actions presented in this document are emblematic of the many global initiatives aimed at improving international cooperation in the fight against the illicit trade of fake drugs.
Although it is not always easy to assess the direct impact on trafficking, each initiative contributes reducing the isolation of each actor, breaking down counter-productive barriers and delivering the means to act with greater efficiency.
Created by the World Health Organization in 2006, the IMPACT group is a partnership of stakeholders engaged in the fight against counterfeit drugs, including representatives of the following organizations: Interpol, the Organization for Economic Cooperation and Development (OECD), the World Customs Organization (WCO), the World Intellectual Property Organization (WIPO), the World Trade Organization (WTO), the International Federation of Pharmaceutical Manufacturers (IFPMA), the International Generic Pharmaceutical Alliance (IGPA), the World Self-Medication Industry (WSMI), the Latin American Association of Pharmaceutical Industries (ALIFAR), the World Bank, the European Commission, the Council of Europe, the Commonwealth Secretariat, the Secretariat of the Association of Southeast Asian Nations (ASEAN), the European Association of Pharmaceutical Wholesalers (GIRP), the International Pharmaceutical Federation (FIP), the International Council of Nurses, the World Medical Association, and Pharmacists without Borders.
IMPACT is organised into 5 groups, with each one focusing on one particular aspect of the fight against fake drugs:
-Legal and regulatory infrastructure
-Application of the law
-Implementation of the regulation
IMPACT members work closely together in international criminal investigations, helping countries to strengthen their own systems of detection and punishment. They also work with industrialists on technological developments such as high-tech security devices for drug packaging.
Interpol’s Medical Products Counterfeiting and Pharmaceutical Crime (MPCPC) unit was founded in January 2010. Its mission is to:
-Coordinate field operations to dismantle transnational criminal networks;
-Provide skills and knowledge training to all the actors involved in the fight against pharmaceutical crime.
-Build partnerships across a variety of sectors.
The ” Public-Members Interface ” (IPM) of the World Customs Organization (WCO):
The IPM’s mission is to improve the real-time flow of information between laboratories and customs authorities across the globe.
Customs are the front line troops in the battle against counterfeit products. They account for about 90% of counterfeit goods confiscation in Europe, and 70% in the world.
The WCO proposes to improve the exchange of information between the private sector and customs authorities in order to facilitate their work in the identification of counterfeit medicines.
Since 2010, the IPM has worked with pharmaceutical manufacturers to create a centralized database containing detailed information about their products.
Customs officers in the field dispose of online access to this product information which is translated, made secure and updated in real time. Another tool help keep a record of seizures.
The “Pharmaceutical Security Institute” (PSI)
A resource centre for all health professionals.
The Pharmaceutical Security Institute is a non-profit organization whose purpose is to protect public health, to share information on drug counterfeiting and diversion and to promote pertinent legal actions by competent authorities. The PSI currently groups security managers from 21 major pharmaceutical manufacturers based in several countries.
Each year it publishes a comprehensive report on trends in drug counterfeiting around the world (based on information provided by its members), and places the following tools at the disposal of health professionals:
-“SafeMeds Alert System”: a free email service that transmits the alerts issued by the U.S. FDA concerning counterfeit medicines.
-“Safedrug Checklist”: an 8 step guide on drug safety and on the steps to be taken in the case of suspected counterfeit drugs.
-“Safe Savings”: a particularly useful guide to understanding programs sponsored by Governments and the industry to provide safe, quality drugs at reduced price.
-“VIPPS Pharmacies”: direct access to legitimate online pharmacies approved by the FDA.
The Pharmaceutical Research and Manufacturers of America Association(PhRMA)
The Pharmaceutical Research and Manufacturers of America Association (PhRMA) represents the major American companies engaged in research and biotechnology development for medicines. Its mission is to foster public policies in support of the discovery of new drugs.
PhRMA’s action in the fight against counterfeit drugs essentially consists of warning patients and the U.S. Government about the risks associated with the proliferation of fake medicines.
PhRMA advocates for an increase of prison sentences for counterfeiters and traffickers of fake medicines. The association would like to extend current sentences of 3 years on average in the US to 20 years.
Cambodia and the Japan Pharmaceutical Manufacturers Association (JPMA)
An international program based on the transfer of know-how. As in many countries of Southeast Asia, Cambodia suffers from a high rate of counterfeit drugs. In 2007, the French-Cambodian Chamber of Commerce estimated that 30 to 40% of the drugs sold in the country were fake. To stem this scourge, the Cambodian Ministry of Health appealed to the Japan Pharmaceutical Manufacturers Association (JPMA) comprised of 68 pharmaceutical research laboratories. Since 2006, the two entities have been collaborating in a program to reduce the number of counterfeit drugs. The JPMA has graciously provided drug analysis equipment and also offers expert advice to health authorities in the field. The project has not only allowed to improve counterfeit drug detection. It has also raised the local actors’ awareness on issues related to the quality of pharmaceutical products and has contributed to resolving problems encountered by the national drug registration system. The JPMA has proposed a certain number of reforms to the Cambodian Ministry of Health that are bearing fruit. Since the program was started, the number of non-registered drugs and illegal pharmacies has been in decline.
Laboratories, the French federation of medicine companies (the Leem) and the French customs authorities
Better targeting of repressive actions through shared expertise. The Leem is a professional organization representing some 270 member companies. These companies are responsible for more than 98% of total sales of medicinal products in France.
The Leem collaborates closely with French customs, and the two organisations regularly reinforce their arsenal of cooperative tools.
As an example, a drug observatory has been created within the National Customs Investigations and Intelligence Directorate (DNRED). Its mission is to locate production and storage sites, identify supply lines and criminal networks and to provide pertinent information to the field teams responsible for intercepting infringing drugs.
This cooperation has also led to the creation of “Médifraude” – a network composed of 50 specialised Customs agents strategically positioned within the national territory and abroad.
Improved tools to detect orders placed on the Internet and to control the contents of shipping containers have also been developed.
Indeed, the major laboratories have cooperated to provide product identification notices concerning major counterfeit drugs. These information sheets are of practical and reliable assistance in the detection of orders via the Internet and are directly accessible online to 18 000 customs agents via the Customs intranet.
National and international cooperation has broadened, associating law enforcement bodies (military and civil police services), the European supervisory authorities, pharmaceutical industries and the banking sector.
Finally, the national judicial customs service (SNDJ) now benefits from the expertise of pharmacy inspectors within their services, and as a result, its capacity for investigation and intervention is enhanced.
The Medicines Transparency Alliance (MeTA) and pilot countries.
Improving access to medicines and the coordination between the players in national health systems.
META is a coalition of partners working to increase transparency and accountability in the healthcare market. It is part of the worldwide effort to improve access to medicines.
Launched in 2008 with the support of the UK Department for International Development (DFID), the WHO and the World Bank, this multi-stakeholder cooperation aims to study all aspects of drug marketing in seven pilot countries: Ghana, Jordan, Kyrgyzstan, Peru, Philippines, Uganda, and Zambia.
The participating countries are committed to progressively disclosing data concerning the quality, availability, price and use of medicinal products. The committment’s success relies on the efforts of all the players (civil society, companies, the public sector…) who must work together to collect, share and debate the data, and to take appropriate actions.
The “FSP Mekong” project – (for priority solidarity fund) – supports the fight against high-risk counterfeiting activities threatening human health or safety in three Mekong countries: Viet Nam, Cambodia and Laos. This project began in June 2010 for a three-year, renewable term. It is funded by the French Ministry of Foreign and European Affairs (MAEE), One of the components of the project is the “Observatory of illicit trafficking” hosted by the Research Institute on Contemporary Southeast Asia (IRASEC) in Bangkok – itself a part of the MAEE network.
The Observatory has 3 missions:
-Communication / awareness-raising.
Thanks to this initiative and to the support that it has received from Cambodian authorities, 13 tons of counterfeit products seized over a period of 5 months, including 7 tons of fake medicines and fake cosmetics, were destroyed on December 6, 2010.
International Federation of Pharmaceutical Manufacturers & Associations (IFPMA or FIIM)
Founded in 1968, the IFPMA is a non-governmental organization with its headquarters in Geneva. It represents industrial actors in pharmaceutical research including the biotechnology and vaccine sectors. It comprises 26 internationally renowned companies and 45 national and regional associations.
Its main role is to represent the views of its members in the dialogue with global intergovernmental organizations, diplomatic missions of national governments and specialized non-governmental organizations.
It promotes and supports principles of good conduct and ethical practices, and encourages the discovery of and access to drugs that can improve the lives of patients around the world.
The IFPMA supports the definition of drug counterfeiting proposed by the WHO’s IMPACT group (see “Definitions”) and is engaged in the fight against fake drugs. Its members work closely with the authorities to help in their investigative work.
The IFPMA has also joined with various partners to support actions of awareness and education on the risks associated with counterfeit medicines.
European Federation of Pharmaceutical Industries and Associations (EFPIA)
The European Federation of Pharmaceutical Industries and Associations (EFPIA) represents some 31 national associations and 38 large pharmaceutical companies. That’s a total of approximately 2000 companies engaged in the research, development and marketing of new drugs.
One of the missions of EFPIA is to obtain favourable regulatory, economic and political support for the pharmaceutical industry.
Particularly active in the fight against counterfeit medicines, EFPIA advocates for the standardized identification of European pharmaceutical products.
Cooperation between the leading actors engaged in this battle is an essential key to overcoming the threat.
In complement to the daily actions led by these large organizations in the fight against the manufacturing and trafficking of fake drugs, many other cooperative actions are carried out around the world on an ad hoc basis.
For enforcement actions to be successful in dismantling networks of traffickers and stopping the falsification of health products, it is essential to have strong and reliable cooperation between services and between public agencies and private companies (see “Punishment”).