International plan to protect against counterfeit medicines

Nov 15 2006

The World Health Organization (WHO) and more than 20 international partners are today launching a comprehensive package of measures to help national authorities safeguard their populations from the dangers of counterfeit medicines.

At the opening of the first official meeting of IMPACT (the International Medical Products Anti-Counterfeiting Taskforce) in Bonn, WHO and its partners are unveiling a programme covering legislation, law enforcement, regulation, technology and communication. IMPACT is also issuing a warning against buying medicines from rogue web sites as well as cautioning governments that existing laws against medical counterfeiters are inadequate and do not act as deterrents.

Counterfeit medicines range from products containing no active ingredients to those containing highly toxic substances. They can harm patients by failing to treat serious conditions, can provoke drug resistance and in some cases kill.

The latest estimates jointly elaborated by WHO, the OECD, and the Pharmaceutical Security Institute show that more than 30% of medicines in some areas of Latin America, South East Asia and Sub-Saharan Africa are counterfeit. In emerging economies, the proportion is estimated at 10% but in many of the former Soviet republics it can be as high as 20%. In wealthy countries, with strong regulatory mechanisms, counterfeits account for less than 1% of the market value, but 50% of illegal Internet sales are counterfeit.

“The impact on people's lives behind these figures is devastating,” said Dr Howard Zucker, WHO Assistant Director-General for Health Technology and Pharmaceuticals. “Whether rich or poor, many patients trustingly taking medicines may end up sicker or die. In addition, precious resources spent on these medicines go to waste.”

The legal systems of most countries do not consider the counterfeiting of medicines a more serious crime than counterfeiting luxury items such as handbags or watches. Their laws are designed mainly to protect trademarks than people’s health. In some industrialized countries, counterfeiting t-shirts receives a harsher punishment than counterfeiting medicines.

WHO and its IMPACT partners will present guiding principles for model legislation to help countries adapt their laws to the gravity of the crime. "A major objective is for countries to agree that counterfeiting is a crime against human security and incorporate that principle into their laws," added Dr Zucker.

Legislation, regulation and enforcement also provide the basis for dealing with the sale of counterfeit medicines on the Internet, which is already rife in industrialized countries and is growing in a number of emerging economies in Latin America and Asia.

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. Other Internet pharmacies operate illegally, selling medications without prescriptions and using unapproved or counterfeit products. These rogue Internet pharmacies are operated internationally, they have no registered business address and sell products that have an unknown or unclear origin.

"This area needs more work," said Dr Valerio Reggi, WHO Coordinator of IMPACT. "But the message for now is: do not take the risk of buying your medicines from unknown sources, such as the Internet. If you must buy from the Internet, ensure that the website is that of a pharmacy you know and trust."

In the technology area, WHO has launched a challenge to technology providers to come up with new technologies or adapt existing ones to prevent counterfeiting and detect and track counterfeits on markets and on web sites.

WHO is currently looking at proposals from three mobile telephone companies to apply their technologies to check the authenticity of medical products. DNA-based technologies, nanotechnology and other approaches will be assessed by IMPACT in the first quarter of 2007.

To improve communication, a small group has been created to continuously update global data on medical counterfeiting and share the information with IMPACT partners. In addition, advocacy campaigns including public service announcements, short descriptive films and other awareness raising materials have begun targeting different professional sectors likely to come across the problem of counterfeits. Organizations representing health professionals and consumers are supporting these initiatives.

Three countries with a high proportion of counterfeits have already started tackling the problem with IMPACT’s support. Indonesia and Mali have begun wide communication campaigns to educate the general public on the dangers of counterfeits and to dissuade people seeking treatment from buying on the black market. Vietnam is establishing mechanisms to coordinate more effectively between regulatory, police, customs and provincial authorities in order to improve detection of counterfeit medicines and counterfeiters.

“It is clear that action in a single sphere, like legislation or technology is not enough to deal effectively with the problem,” said Dr Reggi. “This is why we need to act on five axes – legal, enforcement, regulatory, technology and communication. It’s also why we need to coordinate action at a global level. But the fact that individual countries are already taking this on bodes well for the future.”

By the end of 2007 IMPACT aims to have all 193 WHO Member States formally collaborating to stem global and national counterfeiting of medical products.

For more information contact:

Daniela Bagozz
WHO Media Communications
Telephone: +41 22 791 4544
Mobile phone: +41 79 475 5490
E-mail: [email protected]