Keeping harmful medicines off the market

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 deterioration.

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.

Source: WHO Release News