“Taking action against counterfeit medicines means protecting a fundamental right: the right to life”
, the customs office, LEEM[4]and the French Ambassador responsible for transnational criminal threats) attended the event[5]. Their work resulted in an overview of the current situation in terms of the counterfeiting of medicines and identified the legal, administrative and financial obstacles hindering the implementation of preventative and repressive actions.
On 20 June 2016, IRACM
[1]organized a conference-debate on the counterfeiting of medicines at the French Senate, in partnership with CNAC
[2]. The event, held at the Palais de Luxembourg in Paris, gathered together around one hundred people from the private and public sectors and NGOs.
Experts from international
organizations such as the
WCO
,
Interpol,
Council of Europe, Fondation Chirac and IRACM as well as from national organizations (National Chamber of Pharmacists and OCLAESP
. Their work resulted in an overview of the current situation in terms of the counterfeiting of medicines and identified the legal, administrative and financial obstacles hindering the implementation of preventative and repressive actions.
“The link between terrorism and counterfeiting is now a given, with trafficking representing the main source of income for terrorist networks! Why risk the threat of spending 10 years in prison by robbing a bank when the risks involved in the trafficking of counterfeit medicines are virtually nil?” Senator Richard Yung declared at the opening of the conference. As this problem poses not only a threat on a health, social and economic level, but also in terms of terrorism, there is a pressing need to establish the legislative and legal means to fight against it. “Nothing is worse or more immoral than counterfeit medicines”, announced Jean-David Levitte, Ambassador of France. “Indeed, and unlike drug trafficking or other forms of counterfeiting, when you purchase a counterfeit medicine, you are always a victim, you are never aware of the risks and never an accomplice of the criminals”.
Already far beyond danger levels
Beyond the ethical issues, Jean-David Levitte outlined three alarming realities: “According to WHO, 30% of medicines sold in Africa are counterfeit. For the European Commission, counterfeit medicines have been the number one product intercepted in postal traffic by European customs over the last five years. According to INTERPOL, counterfeit medicines kill more people than terrorism.” In view of this situation there is a need to act within a comprehensive strategy that includes raising the awareness of governments and the general public, strengthening national laws, training stakeholders on the ground (police, customs officers, public prosecutors, judges, etc.) and carrying out coordinated law enforcement actions. Thus, operation Pangea IX, carried out from 30 May to 7 June 2016 in 103 countries, resulted in the arrest of 393 traffickers and the seizure of counterfeit medicines with a market value equivalent to 53 million dollars.
Round Table 1: Counterfeit medicines in France: myth or reality?
“Even though France remains relatively protected, it would be unwise to not feel concerned”, declared Marc Gentilini, Professor emeritus in infectious and tropical diseases.
“If we remain indifferent, we will rapidly become exposed and turn into victims”. “This problem is already present in Europe and most of our neighbouring countries are already affected; however, counterfeit medicines have not yet entered into the legal pharmaceutical channels in France”, Isabelle Adenot, the Chair of the National Chamber of Pharmacists, confirmed.
Factors ensuring a relative protection
France benefits from a high-level of social security cover and this, added to the moderate price of medicines, is another factor that protects us. “Moreover, in France, from the manufacturer to the chemist and even including the distributor, the entire chain of a medicine is overseen by graduate pharmacists”, Isabelle Adenot indicated. However, recent legalisation allowing the sale of medicines without a prescription over the Internet has changed the situation. For the around 300 legal sites, there are thousands of fraudulent on-line retail sites distributing counterfeit medicines. To make matters worse, these illegal e-pharmacies sometimes use the former URL addresses of authorised websites, which are returned automatically to the public domain, without anyone being able to challenge them.
A traffic that is intensifying and diversifying
“Traffic has risen sharply since 2010″, Nicolas Monnier, the head of the French customs and excise office, explained. “Counterfeit medicines now represent around half of the counterfeit goods seized by customs”. At the beginning, we saw a flood of erectile products and anabolic steroids, but the traffic has now diversified into other categories: antidepressants, antibiotics, anti-diabetics, etc. “In view of this intensification of traffic over the Internet, the customs office now has a department specialising in cybercrime”. Training officers on the ground is also an issue. “It is extremely difficult to distinguish real medicines from counterfeit ones” indicated Wilfrid Rogé, Director of Training at IRACM, which trains many officers, particularly in Africa. “A partnership between law enforcement and pharmacists would allow us to further refine our checks”. This professionalism would be a real bonus at a time when the trend in trafficking now see dispatches being split up, with packages increasingly seized on the couriers themselves.
Round Table 2: Counterfeit medicines in Europe: is the legislation adequate?
The necessary legislative harmonisation between European countries is slowly taking place. In several States, legislation is less effective than in France and the range of penalties varies considerably. According to Jean-Christophe Galloux, Professor at the University of Panthéon-Assas, “
Medicrime is allowing us to spread, little by little, a culture sympathetic to our cause.By adopting the draft bill for the ratification of the Convention in May 2016, France has issued a strong signal in this direction.” States need to make an effort to harmonise the penalties and their enforcement, added Carlo Chiaromonte, from the Council of Europe, who spoke about the right to life. “National laws are not enough. If on top of this there is not political cooperation between States and mutual trust between judges, we will not make adequate progress in this fight”.
Totalitarian Mafia practices
“Organized crime sees the world like an astronaut does, i.e. without borders. Organized crime takes a globalisation standpoint while more often than not judges see the borders as walls that protect them”, added Bernard Leroy, Director of the IRACM, which is also calling for greater international cooperation. We need to fight against new criminal practices such as, for instance, ‘purchasing the road’ meaning that the traffickers bribe police and customs officers and magistrates/judges to cover an entire route over a given period, thereby ensuring total impunity. However, unfortunately, to confront these changes to mafia-like practices, political commitment is not always up to the task. “In France, in terms of the fight against drugs, it unfortunately took the first death by overdose in 1970 for people to become aware of the danger. And we fear it will be the same in our country regarding counterfeit medicines”, Bernard Leroy lamented.
Greater traceability
Yet there are real reasons for hope. “Barely a few years ago, intellectual property rights were the only way for manufacturers to fight against traffickers. However, we are now no longer talking about an infringement of intellectual property rights but a threat to public health”, explained Christelle Marshal from LEEM. Moreover, and from 2019 onwards, the European “Falsified Medicines” Directive will impose upon countries of the Union full traceability of medicines, box-by-box, which will help to significantly secure drug distribution channels.
Round Table 3: Counterfeit medicines worldwide: is it a global war?
“Counterfeiting is the second highest source of income for criminals after drug trafficking and causes two to three times more victims than the first type of trafficking,” said Michèle Ramis, the ambassador responsible for the fight against organized crime, at the start of the discussions. The trafficking of falsified medicines is ten times more profitable than drug trafficking, and the penalties are often derisory. And it is for this reason that it attracts gangs and crooks of all sorts.
Health as a driver to take action
Based on the quantities of confiscated fraudulent goods, the traffic is soaring with 75% of counterfeit medicines seized by customs officers worldwide coming from the major countries in Southeast Asia. Africa is the continent that is paying the highest price for this traffic. The lack of medical infrastructure and legal dispensaries has allowed ‘street medicines’ to become deeply entrenched everywhere. According to several studies, up to 60% of medicines consumed in the most affected countries of the continent are counterfeit.
Global strategy for the future?
So, how do we need to confront this problem? “We need to carry out fewer but better checks”, said Philippe Vorreux of the World Customs Organization. “Faced with millions of containers that flow through the ports, risk analysis techniques will allow customs officers to focus on suspicious containers based on their origin and appearance. Unfortunately, the creation of free-trade zones complicates our work. Customs checks are reduced in these zones, which is also a boon to the trafficking of illicit goods”. “We need to train investigators, police and customs officers, and judges on a worldwide level”, confirmed Christian Tournié, from OCLAESP, which is calling for a global strategy for widespread coordinated action. “Corruption is the primary obstacle in the way. When you think that customs revenues represent up to 40% of the financial resources of a country, you need to have very good reasons for stopping a container”.
“Representing one of the most serious problems of globalisation, trafficking in counterfeit medicines poses a triple threat: against human health, against the rule of law and the economic resources of a country”, concluded Michèle Ramis. “In this fight against organized-crime networks, all initiatives are important. Representing more than just a symbolic action, the ratification of Medicrime by all French-speaking countries would be an example of a key stage”.
[1] International Institute of Research Against Counterfeit Medicines
[2] Comité National Anti-Contrefaçon [National Anti-Counterfeiting Committee]
[3] World Customs Organization
[4] (Office Central de Lutte Contre les Atteintes à l’Environnement et à la Santé Publique – Central Office on the Fight against Threats to Environmental and Public Health
[5] French association of pharmaceutical companies