STATEMENT BY DR. FELICITAS R. ZAWAIRA
WHO REPRESENTATIVE DURING THE COMMISSIONING OF THE NATIONAL PHARMACEUTICAL QUALITY CONTROL LABORATORY
28TH JUNE 2007
Your Excellency the President, Dr. Ahmad Tejan Kabbah
Honourable Minister of Health and Sanitation, Mrs. Abator Thomas,
Colleagues,
Ladies and Gentlemen.
It is my honour and pleasure to take part in this ceremony where I have been asked to make a statement as you Mr. President Commission this state-of the art quality control laboratory.
One might ask, “Why do we need facilities such as these?”
Given the fact that 25-50% of medicines consumed in the developing countries are believed to be counterfeit, my answer to you would be that we are facing a global public health crisis.
Counterfeit medicines are sub-standard pharmaceuticals manufactured below the standards of safety, quality and efficacy, some with fake packaging, wrong ingredients, without the active ingredients or insufficient active ingredients. We have seen counterfeit medicines for life-threatening conditions such as malaria, avian Flu TB and HIV/AIDS. Trade in these products is more prevalent in countries with weak drug regulation, control and enforcement, where supply of drugs is erratic, markets are unregulated and where prices of drugs are unaffordable.
Drug regulatory authorities need to remain vigilant as counterfeit methods become more sophisticated
Effective drug regulation promote and protects public health by ensuring that:
Ø Medicines are of the required quality, safety and efficacy;
Ø Medicines are appropriately manufactured, stored, distributed and dispensed;
Ø Illegal manufacturing and trade are detected and adequately sanctioned;
Ø Health professionals and patients have the necessary information to enable them to use medicines rationally;
Ø Promotion and advertising is fair, balanced and aimed at rational drug use;
National government are responsible for establishing strong national drug regulatory authorities with a clear mission: solid legal basis, realistic objectives, appropriate organizational structure, adequate number of qualified staff, sustainable financing, access to technical literature, equipment and information as well as capacity to exert effective market control. What we are witnessing today is the culmination of various efforts from Government and partners such as ADB, EU, Global Fund and WHO, among others, to fulfill the requirement of appropriate equipment to ensure quality control.
The role of WHO has been multifaceted. One aspect relates to the development of internationally recognized norms, standards and guidelines. The second aspect relates to providing guidance, technical assistance, and training in order to enable countries to adapt global guidelines to meet their specific drug regulatory environment and needs. Specifically we help assessing national regulatory systems, providing practical manuals for Drug Regulatory Authorities (DRAs) to follow, mounting training courses, providing a model web site for drug regulatory authorities to exchange information including a Model system for computer-assisted drug registration..
WHO provides support to countries to strengthen pharmaceutical legislation, good manufacturing practices , national drug regulatory capacity and performance as well as strengthening drug procurement and ensuring that quality assurance is built into the drug supply chain? We have also provided “mini labs” – simple inexpensive ways for analyzing the authenticity of drugs such as at the ports of entry into countries.
Sierra Leone has a long and porous border that allows the country to be not only a destination but also a conduit for all sorts of products, fake drugs included, I wish to congratulate the Pharmacy Board for their tireless efforts as they work across the length and breadth of this country checking on the quality of drugs that are being dispensed and destroying those that are of poor quality. This is not a job for the fain-hearted as it hits the pockets of importers and dispensers of these fake drugs. Mr. President may I humbly request that you, and through you the government, ensure that the Board is well armed with enough staff and finances to do their work as well as appropriate legislation and law enforcement to back them up. Without that they are incapacitated and the health of the nation is at risk!
We as WHO will continue to the best of our ability, to support your government as you endeavor to provide good quality and affordable medicines for your people. Without this, the Millennium Development goals will not be reached
I thank you.
