Counterfeit medicines are part of the broader phenomenon of substandard pharmaceuticals – medicines manufactured below established standards of quality and therefore dangerous to patients’ health and ineffective for the treatment of diseases. The difference is that counterfeits are deliberately and fraudulently mislabeled with respect to identity or source. Counterfeiting occurs both with branded and generic products and counterfeit medicines may include products with the correct ingredients but fake packaging, with the wrong ingredients, without active ingredients or with insufficient active ingredients.
Counterfeit medicines represent an enormous public health challenge. Anyone, anywhere in the world, can come across medicines seemingly packaged in the right way, in the form of tablets or capsules that look right, but which do not contain the correct ingredients and, in the worst case scenario, may be filled with highly toxic substances. In some countries, this is a rare occurrence, in others, it is an everyday reality.
Counterfeit medicines range from random mixtures of harmful toxic substances to inactive, useless preparations. Occasionally, there can be “high quality” fakes that do contain the declared active ingredient. In all cases, contents of counterfeits are unreliable because their source is unknown or vague and always illegal. Fake drugs can cause harm to patients and sometimes lead to death.
Any kind of product can be and has been counterfeited: expensive lifestyle and anti-cancer medicines, antibiotics, medicines for hypertension and cholesterol lowering drugs, hormones, steroids and inexpensive generic versions of simple pain killers and antihistamines. In developing countries the most disturbing issue is the common availability of counterfeited medicines for the treatment of life-threatening conditions such as malaria, tuberculosis and HIV/AIDS.
The regular use of substandard or counterfeit medicines can lead to therapeutic failure or drug resistance. In some cases, it can lead to death.
Veronica Diaz was a healthy 22 year old woman, living in Viedma, Argentina, who had mild anaemia caused by insufficient iron in her blood and required her to receive iron injections. In December of 2004, she became very sick and died of liver failure after receiving the 7th of a 10 injection treatment. The medicines authority of Argentina, ANMAT, determined that she had been given a highly toxic counterfeit. Authorities were unable to determine the source of the counterfeit product due to falsified paper work. While most of the counterfeit production throughout Argentina was recovered and four persons were prosecuted, the highly fragmented distribution system prevented the recall from being 100% successful. In May of 2005 another woman died and a 22 year old pregnant woman was injected with the same counterfeit. She survived but gave birth to a 26 week premature baby. To date, Argentinean law does not consider counterfeiting medicines a crime.
Some other examples are below.
The US based Centre for Medicines in the Public Interest predicts that counterfeit drug sales will reach US$ 75 billion globally in 2010, an increase of more than 90% from 2005.
Although precise and detailed data on counterfeit medicines is difficult to obtain, estimates range from around 1% of sales in developed countries to over 10% in developing countries, depending on the geographical area. That range takes into consideration both regional disparities in the presence of counterfeits, and specific global market value shares. Apart from the huge differences between regions, variations can also be dramatic within countries, i.e. city versus rural areas, city versus city.
Currently, the sources of information available include reports from non-governmental organizations, pharmaceutical companies, national drug regulatory and enforcement authorities, ad hoc studies conducted on specific geographical areas, and occasional surveys.
Counterfeiting is greatest in those regions where the regulatory and legal oversight is weakest.
In industrialized countries and to some extent in poorer countries, Internet-based sales of pharmaceuticals are a major source of counterfeit medicines, threatening those who seek cheaper, stigmatized or unauthorized treatments. Some Internet pharmacies are completely legal operations, set up to offer clients convenience and savings. They require patient prescriptions and deliver medications from government licensed facilities. Illegal Internet pharmacies sell medications without prescriptions and use unapproved or counterfeit products. In some cases, Internet pharmacies are operated internationally and sell products that have an unknown or vague origin.
Trade in fake medicines is more prevalent in countries with weak drug regulation and enforcement, scarcity or erratic supply of basic medicines, unregulated markets and unaffordable prices. But as counterfeiting becomes more sophisticated, these products are increasingly present even in better controlled markets.
Because of inadequate regulation and enforcement, the quality, safety and efficacy of both imported and locally manufactured medicines in many developing countries cannot be guaranteed. Smuggling and illegal importation of drugs are rife. Counterfeit drugs are not only sold in countries with ineffective drug regulation but they are also exported or re-exported.
Counterfeiters and their allies aggressively seek to avoid detection. They engage in elaborate conspiracies to disguise their activities. They establish fictitious businesses and front companies. They exploit weaknesses in border control whenever governments try to promote world commerce by reducing border inspections. They use false documents to obtain essential active pharmaceutical ingredients, as well as manufacturing equipment to replicate genuine products.
Some policy-makers have argued that drug regulation represents an unnecessary barrier to trade and should be reduced to a minimum. Pharmaceuticals, however, are not a standard commodity, since consumers and prescribers are unable independently to assess their quality, safety and efficacy and the consequences of ineffective regulatory oversight can be deadly to patients.
The production of counterfeit drugs need not occur in large infrastructures or facilities. The majority of the counterfeiters apprehended so far carried out their activities in ordinary households, small cottage industries, or in backyards.
Counterfeiting of medicines is a hugely lucrative business due to the continued high demand for medicines and low production costs. The absence of deterrent legislation in many countries also encourages counterfeiters since there is no fear of being apprehended and prosecuted.
When prices of medicines are high and price differentials between identical products exist there is a greater incentive for the consumer to seek medicines outside the normal supply system. In many countries the official supply chain fails to reach many communities, especially in rural areas. Poverty, and the lack of an official supply chain, are major factors in creating markets for counterfeit products.
In order to mobilize awareness and action in the fight against fake drugs, in February 2006, WHO created the first global partnership known as the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT). IMPACT is comprised of all 193 WHO Member States on a voluntary basis and includes international organizations, enforcement agencies, national drug regulatory authorities, customs and police organizations, non-governmental organizations, associations representing pharmaceutical manufacturers and wholesalers, health professionals and patients’ groups. These groups have joined to improve coordination and harmonization across and between countries so that eventually the production, trading and selling of fake medicines will cease. To accomplish this mandate, IMPACT will focus on the following five key areas:
Legal systems are often not equipped to deal with the extremely serious consequences of counterfeit medicines and penalties for counterfeiters are too light to act as deterrents. Stronger legislation will help empower those who have to deal with counterfeits and counterfeiters in the course of their work; namely, the police, customs officials and the judiciary. IMPACT will look at existing laws in countries; present effective models countries can replicate and adapt to meet their own needs. IMPACT will focus on developing a set of principles for the establishment of appropriate legislation and penal sanctions including a clear legal definition of counterfeit medicines.
IMPACT will identify the means by which regulators may take action and implement legislative measures taken on counterfeit medicines, including revised approaches to ensure that standards for quality, safety and efficacy are implemented and distribution chains effectively controlled. In many countries regulatory oversight of pharmaceuticals is ineffective, especially of distribution channels. Coordinated action at the local level is essential between health authorities, police, customs, and judiciary institutions to ensure proper regulation, control, investigation and prosecution. IMPACT will help countries with weak regulatory systems to strengthen them by improving collaboration and drawing from the experience, capacity and resources of all IMAPCT stakeholders.
IMPACT will help to identify and coordinate action between customs, police and the judiciary of different countries to monitor borders, track counterfeit goods and apprehend counterfeiters. By working with the World Customs Agency, INTERPOL, and informal networks of enforcement officers, IMPACT will facilitate communication between enforcement and health authorities, improve international collaboration and develop appropriate mechanisms that will enable importing countries, especially in the developing world, to trigger investigation and identification of the actual source of counterfeit medicines plaguing their markets.
By utilizing the broad partnership from health agencies to pharmaceutical manufacturers and distributors, IMPACT aims to help develop innovative solutions. Given disparities between the level of technological access in industrialized and developing countries, IMPACT will help facilitate the transfer of technology across both developed and developing countries. Technology can contribute creative tools and in some cases leapfrog lengthy legal and administrative processes to provide faster solutions. For under-resourced countries, means to technology transfer and adapt it to the local situation should be explored.
IMPACT will identify and create the most coordinated and effective mechanisms required to both respond and alert key audiences, stakeholders and the general public about counterfeits in communities and across countries. International information networks will be created or strengthened to monitor the traffic of goods, exchange information, issue alerts from country to country and region to region. Increased public information is essential for patients, dispensers, and doctors who have a right to know if there are suspect goods on the market but must also contribute to detecting counterfeits by reporting and helping to investigate suspicious cases. Special initiatives will be launched to make internet users aware of the risks they run when purchasing medicines from unknown sources and to address consumers in extremely poor and rural areas where patients may be unable to make informed choices and may not be aware of their rights.