[Ip-health] Margaret Chan's opening remarks at SSFFC: Turn off the tap of unsafe medicines

Thiru Balasubramaniam thiru at keionline.org
Tue Mar 1 01:01:20 PST 2011


Turn off the tap of unsafe medicines Dr Margaret Chan
Director-General of the World Health Organization
Opening remarks at the Working Group of Member States on Substandard/ 
Spurious/ Falsely-labelled/Falsified/Counterfeit Medical Products
Geneva, Switzerland
28 February 2011

Mr Chairman, distinguished delegates, ladies and gentlemen,

I will be brief and to the point.

An area of work that affects the capacity of medicines to protect  
public health has become clouded with confusion and controversy. We  
need to clear the air.

Let me put some of the issues, as I understand them, on the table.

The first priority for public health, and this is the priority for  
WHO, is to protect populations from the harm caused by poor-quality,  
unsafe medicines.

The objective is to keep these harmful products off the market  
everywhere, but especially in the developing world.

Approaches, initiatives, and definitions should support this public  
health priority, and not undermine it or divert the response to serve  
other purposes.

Substandard/spurious/falsely-labelled/falsified/counterfeit medical  
products are products whose quality, safety, or efficacy has been  
compromised. This can happen for a variety of reasons, and these  
reasons can be unintended as well as deliberate.

Factors that compromise quality, safety, and efficacy include  
substandard active and inactive ingredients, poor manufacturing  
practices, improper packaging, transport, and storage, and product  

Products and their labels can be deliberately falsified. A true  
counterfeit violates a trademark and is deliberately deceptive.

While many factors can compromise the quality, safety, and efficacy of  
medical products, what allows these products to get on the market and  
into the hands of consumers has a straightforward root cause: the  
inadequate capacity of national drug regulatory authorities.

Building this capacity is the best solution to the problem, and this  
is the approach long followed by WHO.

The WHO approach to address the problem in developing countries is the  
same as that used successfully by wealthy nations to protect their  
populations. That is: strict regulatory control of medicines on the  
market, strict enforcement of quality standards, and diligent  
pharmacovigilance. Nothing suggests the need for a double-standard.

Here is the bottom line. Any medicine, whether good, worthless, or  
harmful, can be sold in a country that lacks appropriate laws and  
regulations, administrative procedures for registering medicines,  
quality control laboratories, and enforcement capacity.

Strengthening drug regulatory capacities is the best way to turn off  
the tap of bad medicines.

Ladies and gentlemen,

WHO is not interested in expanding IP enforcement or introducing  
stricter rules for doing so. And we certainly do not favour any  
initiative that reduces competition from generic products.

WHO not only supports generic products. We aggressively promote them,  
whether through guidelines for conducting bioequivalence studies or  
through the prequalification programme.

Generic products serve public health in multiple ways. In terms of  
improving access to medicines, price and quality go hand in hand.

Generic products are considerably less expensive than originator  
products, and competition among generic manufacturers reduces prices  
even further.

Generics serve the logic of the pocket. An affordable price encourages  
good patient compliance, which improves treatment outcome and also  
protects against the emergence of drug resistance.

Ladies and gentlemen,

Let me summarize.

WHO wants the responsibility for protecting populations from useless  
or harmful medical products to remain in its proper domain. That is:  
with national drug regulatory authorities.

WHO promotes generic medicines and opposes barriers to the production  
and international trade of generic products that meet WHO standards.

I understand some reasons for the confusion and controversy. You will  
be considering the role of WHO and our relationship with the  
International Medical Products Anti-Counterfeiting Taskforce.

WHO stands ready to be guided by your deliberations and advice.

I look forward to this guidance, and wish you a most productive meeting.

Thank you.


Thiru Balasubramaniam
Geneva Representative
Knowledge Ecology International (KEI)
thiru at keionline.org

Tel: +41 22 791 6727
Mobile: +41 76 508 0997

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