17 May 2000
COTTAGE INDUSTRY OR ORGANIZED CRIME?
"Every day people die because of counterfeit drugs", said Dr Idrissou Abdoulaye, senior official at the Ministry of Health of Benin, at today's session of the World Health Assembly in Geneva. "How many? We'll never know. But they keep buying these drugs because they're cheaper."
"Fighting this global problem puts an additional burden on health systems that are often already over-stretched", commented Dr Yasuhiro Suzuki, WHO Executive Director in charge of Health Technology and Pharmaceuticals. "No country is immune from the threat of counterfeit drugs but those with weakly regulated pharmaceutical markets suffer most." It is a multi-faceted problem that was reflected in the presence of senior health officials, non-governmental organizations, pharmaceutical industry, as well as representatives of Interpol.
"The most common way of describing counterfeit drugs in customs forms is to declare "harmless pharmaceutical substances of no commercial value"", explained Mr Guy Woods of the Lacuna Research Ltd, "Nothing could be further from the truth." The audience was told that it took an expert to detect fake labelling and packaging. The criminals are running highly sophisticated operations taking advantage of cross-border loopholes. Supplies, production, shipping, re-labelling, financing, distribution are all handled in different countries. The sad part is that those who play by the rules are having much greater problems as opposed to smugglers bribing corrupt customs officials."
Some WHO Member States are faring better than others. In 1996, a special law on counterfeit drugs came into force in the Philippines. It is not only about random sampling and monitoring of drug quality in pharmacies and hospitals. It is also about heavy penalties for offenders: from six months to life imprisonment along with a hefty US$ 25 000 fine. "We need cooperation with WHO", said Mrs Nazarita Lanuza, Head of the Food and Drug Bureau in the Philippines. "This fight is a cooperative undertaking. We cannot do it alone."
To start with, there is no common definition. In some countries production of counterfeit drugs is described as fraud while in others the term is "production of counterfeit substances". As a result, even Interpol would not have a unified database. There is an urgent need for closer cooperation between law-enforcing agencies, legislative bodies and pharmaceutical industry.
"It is all about deliberate fraud", said Margriet den Boer of Médecins sans Frontières, the Netherlands. "Poor legislation and lack of quality control impact on safety and efficacy of both generics and brand names. But there are countries with a proven track record of manufacturing reliable generics like Brazil, China, India and Thailand. Only by ensuring minimal quality standards can we increase access to g ood quality essential drugs for all."
It includes inspection and control of sources of chemical supplies and use of good manufacturing practices. It is not unheard of for the raw materials to come from unidentified sources resulting in toxicity, chemical instability, reduced efficacy and antibiotic resistance.
"A deadly combination of demand for cheap drugs and fat profit margins makes counterfeit drugs irresistibly attractive to greedy criminals", commented Dr Suzuki. "Clearly, there is an urgent need for action if unnecessary human suffering is to be stopped."
To further support efforts by countries to combat this problem, a working group has been established with World Health Organization, International Federation of Pharmaceutical Manufacturers Associations, International Generic Pharmaceuticals Alliance, World Self-Medication Industry, and CHMP/Pharmaciens sans Frontières.
For further information, please contact Mr Valery Abramov, Office of the Spokesperson, WHO, Geneva. Telephone (+41 22) 791 25 43. Fax (+41 22) 791 4858. Email : firstname.lastname@example.org.
All WHO Press Releases, Fact Sheets and Features can be obtained on Internet on the WHO home page http://www.who.int