With fears growing about the impact of fake medical products on European health care sytems, the Council of Europe will open for signature a new ‘Medicrime’ treaty next month.
The convention criminalises the production and distribution of counterfeit medical products and imposes stiffer penalties on the criminals making rich profits from the illegal trade.
In this interview, the author and journalist Isabel Stilwell interviews the Council of Europe’s Sabine Walser on the importance of tackling drug counterfeiting, a commerce more lucrative than heroin trafficking.
Note : Medicrime is the abbreviation of the convention
Q: What is the Medicrime convention
It is the first binding international instrument in the criminal law field on counterfeiting of medical products and similar crimes involving threats to public health.
It is the result of the Council of Europe long held concern about the absence of harmonised international legislation, non-deterrent sanctions that were not proportionate to the harm caused to patients, and the involvement of criminal organisations which operate across borders.
Q: What will it proscribe?
There is an urgent need to take decisive repressive and preventive measures against counterfeiting of medical products and similar crimes in order to protect the lives of individual patients/consumers and public health in general.
Though counterfeiting and the unauthorised manufacturing and supplying of medicinal products as well as the placing on the market of medical devices that are not in compliance with conformity requirements have already been outlawed at national level in many states, the absence of a dedicated international legal instrument establishing these activities as criminal offences carrying effective, proportionate and dissuasive penal sanctions and providing the basis for efficient international co-operation to combat them has facilitated the cross- border operation of criminals in this field.
Amongst its primary goals the Medicrime convention lists ‘prevention’ of suchcrimes, also providing a legal frame work supporting health authorities. The purpose of this Convention is to address these shortcomings.
The treaty aims to safeguard public health through penal measures against criminal manufacture and distribution of counterfeit medical products.
The Convention lays down a framework for national and international co- operation between the various public administration sectors, measures for co- ordination at the national level, preventive measures for use by the public and private sectors and protection of victims and witnesses. Furthermore, it provides for the establishment of a committee to monitor the implementation of the Convention by the signatory States.
Q: Who can sign it?
The Council of Europe sees it as a common responsibility for the global community to eradicate the manufacture and distribution of counterfeit medical products and hence accession to the Medicrime Convention, which will be formally adopted later this year, will be open for all states interested in working with Council of Europe on this important goal.
Q: How significant is medicrime
A: Counterfeiting of medical products and similar crimes comprise the manufacturing, the distribution of counterfeit medical products (i.e. medicinal products, medical devices, ingredients and compounds used for medical devices),; It includes also the falsification of documents, and the unauthorized manufacturing and supplying of such products with criminal intent.
A counterfeit medical product is a product whose identity and/or source are misrepresented with criminal intent on the label. Counterfeiting and similar crimes target all kinds of medical products, such as those protected under IPR and not (so called generic medicines), medicinal products for human and veterinary use, active substances and excipients and materials designated to be used with medical devices.
Medicrime – the counterfeiting of medical products and similar crimes – thus violate the right to life, enshrined in the ECHR and compromises member states’ obligation to provide for the protection of human life.
Medicrime is now a global concern and an increasing worry in Europe and other regions of the world because counterfeit medicines and similar crimes can kill or harm severely patients. Ineffective and counterfeit veterinary medicines can promote the spreading of animal diseases to humans. (Avian flu!)
Research from the World Health Organisation (WHO) indicates that many developing countries have areas where more that 30% of the medicines on sale are counterfeit.
Europe must protect public health of its citizen, demonstrate solidarity with other regions of the world affected seriously by this sourge. It shows leadership and offers cooperation to the world on this basic human rights issue by opening the treaty for accession of states in the world.
The Council of Europe is behind the first treaty which will criminalise the production and distribution of medical products that are counterfeit or have been manipulated by similar crimes, protects victims and witnesses, provides a framework for international cooperation between health and enforcement authorities at national and international levels.
Q: How do you estimate the numbers?
A: We do know that patients have died as a result of taking fake medical products (It is reported in the United States of America that some 80 deaths resulted from the use of counterfeit heparin). We also know that the health of European patients has suffered as a result of their exposure to counterfeit medicines.
Medicinal products intended to treat prostate cancer, high cholesterol levels and to protect against future heart attack or stroke and treat the symptoms of psychotic conditions such as schizophrenia and other mental disorders have been discovered counterfeit in the legal distribution chain in Europe.
During the time of the avian flu (Bird Flu), Tamiflu, the main treatment for this viral disease was a counterfeit target, due to the high demand and short in supply.
The fact that counterfeit medical products have become increasingly difficult to detect without carrying out costly laboratory test means that there is today an omnipresent risk that counterfeit medical products may enter into the legal supply chains for medical products, in the process getting mixed up with legitimate products with potentially disastrous results for the public health.
According to WHO, counterfeit medical products account for less than 1% of market value in developed countries, where there are efficient regulatory control mechanisms, but up to more than 50% from Internet sites that conceal their identity.
Q: Have you had complaints of real consequences or do the medicines only act as placebos and have no side effects?
Medicines that are counterfeit or were manipulated through similar crimes, can be very dangerous and effectively deny available treatment to patients: by the ineffective treatment provided by these products, the patient suffers harm or dies from the underlying disease if acknowledged treatment is no longer of value. In some cases, the counterfeit medicines contain also toxic substances not present in the genuine product.
Due to this facts, the identification of harm is difficult. It also undermines the trust the public can have in healthcare systems, medical treatment and the authorities supervisory control.
Q: More profitable that conventional drug traffic? Is it an organised crime?
The reason for the strong growth of this type of crime is clearly the relatively low risk of detection and prosecution compared with the potential high financial gains. Using the internet to advertise and supply their inherently dangerous products directly to patients and consumers around the world has proven to be a safe and easy modus operandi for the criminals involved and has given them a global reach. The result is a serious threat to public health of truly global proportions.
Expert evidence indicates that the production and distribution of counterfeit medical products is approximately 15 times more lucrative than heroin trafficking. Criminal organizations are actively involved with all stages of production and distribution of fake medical products.
Q: Which countries are most affected?
The evidence shows that counterfeit medicines have greatest impact in countries where the regulatory system is weak and market control is less effective.
Europe does have an effective regulatory system and market control which has been able to prevent the incidences of counterfeit medicines from causing serious public health problems.
Yet, evidence from the United Kingdom and elsewhere in the Council of Europe gives no reason for complacency: That is why the effective implementation of the Council of Europe’s treaty is so important: it must be prevented by all means that what is today a rare incident manageable by the authorities becomes frequent reality.
Q: Are counterfeit drugs a side effect of the internet? Are medicines by post the only ones that can be counterfeit?
The internet is an enormous opportunity for the marketing of counterfeit or illegal medicines. The Internet supply route can be deliberately counfused by the criminals so as to hide source and production and distribution paths.
The Council of Europe Medicrime convention approach is to focus on the criminal activity and not on the internet. In some countries mail order trade in medicines via the Internet has become legal.
The internet has created a global market place offering access to medicines often without a doctor’s prescription.
For many customers, the Internet means low prices, discounts, and confidentiality, and provides easy access for people living in remote locations or wanting to access novel medical products first.
However, The Internet is used to make countless illegal offers of medicines, many of which are counterfeit or illegal. The World Health Organization (WHO) has found that over 50% of medicines purchased on Internet sites that conceal their real address are counterfeit.
The public should follow certain precautionary rules when purchasing medicines from the net. The trend of self-diagnosing and self prescribing is potentially dangerous, but unless a website has a physical address clearly displayed and a certification of a recognized authority or association, the likelihood of obtaining a counterfeit product is greatly increased.
Q: Is it possible to be fooled by these drugs in a hospital or a pharmacy?
In countries where regulatory systems, market surveillance and law enforcement are well organized and operational, the risk of encountering counterfeit or illegal medicines in the legal chain is very small.
Reports from law enforcement agencies indicate that counterfeiters seeing the scale of the profits involved in their enterprise, have every incentive to produce convincing products. That is why we stress vigilance.
The Council of Europe’s treaty is the cornerstone of a comprehensive attack plan against medicrime with its potentially and real devastating effects on health care systems.
Q: What are the “favourite” counterfeit drugs?
Criminals active in the European market are known to have produced products counterfeiting antibiotics, anti-asthma medicines, hormones, medicines to increase the number of red blood cells, to treat high cholesterol, high blood pressure, and to control weight gain with the intention of introducing them into the legal and illegal chains.
Of course, treatment for erectile dysfunction is much sought after, particularly on the internet.
Q: Do they come in boxes and with instructions just like normal medicines?
Yes. The large-scale, international counterfeiters want their products to be convincing.
Q: Does medicrime include alternative drugs like diet pills?
The scope of the medicrime convention encompasses medical products claiming an effect in the therapy, prevention or diagnosis of diseases. This includes weight loss medication. Counterfeit medicines to control weight gain have been found in Europe.