Expert Consultation on the Surveillance and AlertSystem for Counterfeit Medicines

Dr Shin Young-soo, WHO Regional Director for the Western Pacific

8 February 2010

DISTINGUISHED COLLEAGUES,

LADIES AND GENTLEMEN,

Good morning and welcome to this Expert Consultation on the Surveillance and Alert System for Counterfeit Medicines. This is a very important meeting and your participation is greatly appreciated.

As we all know, counterfeit medicines pose a serious threat to public health, especially in areas such as the Mekong subregion. We also know that counterfeiting involves not only readily available medicines, but also medicines such as antimalarials and antibiotics which are prescribed for the treatment of serious diseases. There is no doubt: counterfeiting is a serious criminal activity that can kill its unsuspecting victims.

Anyone, anywhere can inadvertently buy medicine that seems to be packaged correctly in tablet, capsule or liquid form. These counterfeits might appear legitimate, but they do not contain the proper ingredients to treat disease. In worse-case scenarios, they are tainted with highly toxic substances. Unfortunately, it is often the poor who are attracted to the less costly but fake medicines, which often can be found in unlicensed outlets.

Over the years, WHO has been working with Member States and our partners in combating the production, distribution and sale of counterfeit medicines. We have held intercountry workshops and training, advocacy activities for health care providers and consumers, and national training for inspectors. We have conducted surveys of counterfeit medicines and have devised a Rapid Alert System. We have also worked with INTERPOL and other law enforcement agencies.

But the problem continues to persist, endangering public safety in many countries and communities.

We know that the production, distribution and sale of counterfeit medicines involve transnational criminal organizations capable of moving the fake medicinal products across national borders. Combating these criminals requires efficient collaboration among countries, including the exchange of relevant information and tighter border controls, particularly as they relate to the movement of medicines. In addition, we need greater enforcement of existing regulations and better collaboration among medicinal regulatory authorities, customs agencies and law enforcement.

In most of the developing countries in the Western Pacific Region, the medicinal regulatory authorities do not have police powers. Therefore, effective collaboration between regulatory authorities and law enforcement agencies is of the utmost importance to bring perpetrators to justice and to stop this dangerous, criminal activity.

Deadly catastrophes have resulted from the distribution and sale of medicinal products tainted with toxic ingredients. A common example is diethylene glycol poisoning which recurs in different countries with high mortality among children. The most recent case occurred four years ago in China and Panama. Experience shows that our existing surveillance systems too often fail to detect trouble at an early stage. To counter this, we need a far more proactive approach to surveillance.

During your consultation, I hope you will discuss in detail and recommend answers to the following questions:


Ø What barriers are we encountering in combating counterfeit medicines and what further measures can we take?

Ø How can we improve surveillance of counterfeit and substandard products?

Ø How can we improve the Rapid Alert System for counterfeit medicines?

Progress in answering these questions will be a significant next step in tackling this troublesome and often life-threatening problem.

Thank you very much and I wish you a pleasant stay in Manila.