Tackling fake drugs needs technology and collaboration

Counterfeit drugs can undermine confidence in life-saving medications including antibiotics Copyright: Flickr/ Quinn_anya

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Developing countries must be given all the scientific, technical and legal help they need to counter the growing trade in fake medicines.

One of the most important ways in which modern science actively contributes to the reduction of poverty and the promotion of well-being in the developing world is through the development of drugs against disease.

Yet such drugs will only be bought and used if those who purchase them are confident they will work. And this confidence risks being undermined by the rising menace of counterfeit medicines — defined by the World Health Organization as "medicines that are deliberately and fraudulently mislabelled with respect to identity and/or source".

The problem exists in both developed and developing countries. In the former, where regulatory and law enforcement systems tend to be strong, the incidence of counterfeit medicines is relatively low — most estimates put it at less than 1 per cent of the total market.

But many parts of the developing world — particularly in rural areas of Africa, but also in much of Asia and Latin America — have weaker infrastructure for regulation. Here the problem is much larger: one estimate suggests that in some regions at least a third of the drugs supplied to patients are counterfeit.

And by using new technologies, counterfeiters are getting better at replicating genuine drugs, mass-producing them and expanding their market via the Internet.

The result is massive fraud with potentially lethal consequences. Counterfeit drugs can harm patients either directly or by increasing resistance to treatment for serious diseases such as malaria.

Detecting and identifying counterfeit drugs has become a major scientific and technical challenge for developing countries, and its urgency is becoming ever more widely recognised.

Rising to the challenge

This week, we explore in a series of articles how new technologies and regulations are helping to combat counterfeit drugs.

A background article by Priya Shetty summarises the challenges facing the public health community in fighting the trade. At a basic level, the target is far from clear: counterfeit medicines can be confused with substandard ones that have little medicinal value but are produced lawfully.

Things get more complicated when anti-counterfeiting laws are so broad that they encompass generic drugs. The article outlines technologies designed to outsmart the increasingly sophisticated techniques used by counterfeiters, and describes international initiatives to chase down fake drugs and stop them reaching patients.

In the accompanying feature, science journalist Yojana Sharma describes how mobile phones, mini labs and simple kits can all help to detect counterfeits quickly and cheaply. Patients and pharmacists can use these technologies to make sure that the medicines they buy are genuine. These tools can pick out the worst offenders — but to make the drug supply safe, there’s no substitute for regulation.

Three opinion articles give different perspectives on the major challenges and successes of preventing the trade in counterfeit drugs.

Leena Menghaney, project manager for Médecins Sans Frontières’ Campaign for Access to Essential Medicines in New Delhi, India, argues that initiatives set up to fight counterfeit drugs are on the wrong track and should refocus on poor-quality medicines. She says the legal definition of ‘counterfeits’ is a threat to the legitimate trade in generic medicines that happen to resemble trademarked ones, and diverts attention from substandard drugs.

But Aline Plançon of Interpol, based in Paris, France, who heads an anti-counterfeiting unit that works closely with the WHO, describes how law enforcement operations have successfully intercepted large volumes of counterfeit drugs. Criminals are adept at exploiting loopholes in health systems, she says, so cooperation between countries and stakeholders is essential.

Charles Delacollette, coordinator of the Mekong Malaria Programme in Bangkok, Thailand, says that both counterfeit and substandard drugs are fuelling the emergence of resistance to antimalarial drugs in the Mekong region. He describes efforts to gather evidence about the problem and strengthen capacity for detection and surveillance. But developing countries need more support to build on current efforts to tackle the trade and document good results.

Effective partnerships

This collection of articles makes clear that there are no quick fixes or easy solutions. Thwarting the trade in counterfeit drugs will take a mix of measures to help developing countries mount a lasting response.

New technologies are helping. But counterfeiters waste no time in finding ways around new protection procedures.

A large group of organisations have enlisted in the fight against counterfeits, from law enforcement agencies to health and medical organisations and nongovernmental organisations.

Also involved are pharmaceutical companies, for which counterfeit medicines can mean not only a loss of income, but also a loss of reputation if the counterfeits cause substantial damage.

But drug manufacturers are coming under fire, accused of pushing anti-counterfeiting initiatives that also threaten the supply of generic drugs in the developing world. To counter these claims, they must join forces with other groups to refine the definition of counterfeits and improve technologies to target the right drugs.

Collaboration is the name of the game here. As these articles show, a significant amount is already taking place. But more needs to be done.

Effective partnerships between national and international organisations will allow developing countries to build robust capacities for good manufacturing, regulation of the drug supply, and detection of counterfeits.

This can reduce their reliance on global agencies and help tackle the trade in medicines of poor quality, whether they are fake or substandard.

David Dickson, Director
Anita Makri, Commissioning editor

This article is part of a Spotlight on Detecting counterfeit drugs.