Over the last 10 years there has been a considerable increase in the number of reports of counterfeit drugs, i.e., drugs whose identity and/or source have been deliberately and fraudulently mislabelled. The scale of the problem is impossible to gauge accurately; however, the Counterfeit Intelligence Bureau estimates that 5% of total world trade in 1991 was in counterfeit goods; for pharmaceuticals that are in high demand and are easily transported this proportion is likely to be higher. Counterfeiting of drugs occurs worldwide and changes in international trading conditions could lead to a further rapid increase in this activity.
A pharmaceutical product that is made with the same care that is assured within the legitimate manufacturing facility may not present a hazard to public health. Counterfeit products, in contrast, escape all modalities of control, and no assurance can be given about their quality. Such products may contain the labelled active ingredients in an acceptably bioavailable form that meets the relevant characteristics or contain too little of the therapeutically active substance. This may result in patients not receiving the right amount of active compound, and consequently, in their disease remaining untreated. Worst of all, the products may have been accidently adulterated or deliberately formulated using toxic industrial chemicals that have no place in pharmaceutical manufacture.
In 1988 the World Health Assembly adopted resolution WHA 41.16 in which governments and pharmaceutical manufacturers were requested to cooperate in the detection and prevention of the increasing incidence of the export or smuggling of falsely labelled, counterfeit or substandard pharmaceutical preparations. Against this background, WHO and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA) convened a joint workshop on 1-3 April 1992 in Geneva to discuss the problem. The workshop was attended by representatives from the International Chamber of Commerce, Interpol, the Customs Cooperation Council, the International Narcotics Control Board, the International Organization of Consumers Unions, the European Association of Industries of Branded Products, and GATT.
Below are summarized the recommendations made by the participants for action at various levels.
* There is a need for a greater international awareness and acknowledgement of the hazards to health presented by counterfeit medicines. Political will is needed to mobilize resources for the implication of effective countermeasures. * A sound legal framework to deal with the problem is provided by the proposed anti-counterfeiting provisions in the draft GATT-TRIPS agreement, which is based on effective international trademark protection and supported by enforceable sanctions and penalties, including imprisonment. * Governments should implement appropriate legislation that identifies as a customs offence the import, national transit and export of counterfeit goods into, across, and out of their customs territories and should confer upon their customs services legal powers to seize the goods with a view to forfeiture if they prove to be counterfeit. * A mechanism should be established through which organizations can exchange information about the nature and extent of counterfeiting, the movement of counterfeit products, and the results of investigations into counterfeit operations. * A databank of cases should be established.
* A legal and administrative framework needs to be in place to define and control the legitimate drug market and drug distribution system. A drug regulatory agency with a regisnation procedure is a prerequisite for this, and the workshop endorsed the WHO Guidelines for Small Drug Regulatory Authorities. Full use should also be made of the WHO Certification Scheme for Pharmaceutical Products moving in International Commerce. …