Essential medicines and health products

Counterfeit medicines


Around the world: reports of counterfeit medicines

  • In Peru the sale of counterfeit drugs has risen from an estimated US$ 40 million in 2002 to a current US$ 66 million, according to Peru’s Association of Pharmaceutical Laboratories (ALAFARPE). These figures include medicines that entered the country as contraband, expired, counterfeit, adulterated, with altered or missing labels and those stolen from the warehouses of the Ministry of Health, the armed forces, and the police. In Lima alone the number of illegal pharmacies devoted to counterfeit medicines has increased from an estimated 200 in 2002 to a current number of 1,800 stores. The General Directorate of Medicines, Supplies and Drugs (DIGEMID) of the Department of Health (MINSA) seized around 460,000 adulterated and expired medicines in 2005 alone.
  • In 2006, Russia’s Federal Service for Health Sphere Supervision (FSHSS) reported that 10% of all drugs on the Russian market were counterfeit. However, other sources estimate that the real figure could be much higher.

In 2005

  • The Dominican Republic’s Public Health Department reported that 50% of the countries pharmacies operated illegally and 10% of the medicines that arrived in the country were fake. For example, some of the medicines found had expired over 10 years before.
  • El Salvador’s Association of Pharmaceutical Companies (INQUIFAR) reports that there is a widespread availability of counterfeit drugs on the domestic market. According to the local manufacturer Gamma Laboratorios, the commercialization of counterfeit medicines generated economic losses of around $40 million to the country's pharmaceutical industry that year.
  • Indonesia’s International Pharmaceutical Manufacturers Group (IPMG) estimated that pirated drugs constituted 25% of Indonesia’s $2 billion pharmaceutical market. According to IPMG, the fake drugs hit foreign pharmaceutical companies’ bottom lines and posed a potential serious public health threat.
  • In Kenya, a random survey by the National Quality Control Laboratories (NQCL) and the Pharmacy and Poisons Board found that almost 30% of the drugs in Kenya were counterfeit. Some of the drugs were no more than just chalk or water marketed as legitimate pharmaceutical products. According to figures from the Kenyan Association of Pharmaceutical Industry, counterfeit pharmaceutical products account for approximately $130 million annually in sales in the country.

In 2004

  • In Angola, according to the National Department of Intellectual Copyright Crime of the Economic Police, approximately 70% of medicines used by the Angolan population were forgeries.
  • In Colombia, the Association of Colombian Pharmaceutical Industries (ASINFAR) estimated that US$ 60 million or 5% of the total annual market of medicines sold were contraband, counterfeit or adulterated.
  • Lebanon’s National Health Commission (NHC) reported in 2004 that 35% of pharmaceuticals available in the Lebanese market were counterfeit.
  • In Mexico, federal agents seized approximately 60 tons of stolen, expired and counterfeit pharmaceuticals in Sahuayo, Michoacán, and Guadalajara, Jalisco. Reports indicated that in Mexico alone, illegal products represented about 10% of the pharmaceutical market.
  • In Nigeria, the Ebonyi State Task Force on Counterfeit and Fake Drugs reported that approximately 48% of goods and drugs imported into the country were substandard or counterfeit.

In 2003

  • The Philippine’s Bureau of Food and Drug (BFAD) reported that 30% of drug store outlets visited by food and drug deregulation officers carry and sell counterfeit drugs.

In 2002

  • In Cambodia, a Health Ministry survey conducted in 2002 revealed that 13% of drugs on the domestic market were counterfeit or substandard, including anti-malaria drugs and antibiotics.
  • China’s Research and Development-based Pharmaceutical Association estimated that about 8% of over-the-counter drugs sold in China are counterfeit.
  • India’s pharmaceutical companies suggested that in India’s major cities, one in five medicines sold was a fake. They claimed a loss in revenue of between 4% and 5% annually. The industry also estimated that illegal drugs had grown from 10% to 20% of the total market.
  • Nigerian health officials estimated that 70% of drugs in circulation in the country are either fake or adulterated.

Key challenges to halting counterfeit medicines

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.

Counterfeiting medicines is a lucrative business

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.

WHO leads the global effort to combat counterfeit medicines

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:

Legislative and regulatory infrastructure

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.

Regulatory implementation

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.

Enforcement

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 both 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.

Technology

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.

Risk Communication

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.


For more information contact:

Daniela Bagozzi, WHO media communications, tel. +41 22 791 45 44;
mobile +41 79 475 54 90; bagozzid@who.int

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