Counterfeit Drugs. Guidelines for the development of measures to combat counterfeit drugs
(1999; 61 pages) [French] [Spanish] View the PDF document
Table of Contents
View the documentExecutive Summary
Close this folder1. Introduction
View the document1.1 Background
View the document1.2 DMP-DAP joint project on counterfeit drugs
View the document1.3 Structure of the guidelines
View the document2. Overview of the problem
View the document3. Impact on public health
View the document4. Factors facilitating counterfeiting
Open this folder and view contents5. Developing national strategies
Open this folder and view contents6. Specific measures
Open this folder and view contents7. Assessment of the problem at the national level
Open this folder and view contents8. Inspection when pharmaceutical products are suspected to be counterfeit, spurious or substandard
Open this folder and view contents9. Test methods
Open this folder and view contents10. Developing training programmes: inspection and examination of counterfeit pharmaceuticals
View the document11. Conclusion
View the documentReferences
View the documentSelected further reading
View the documentAcknowledgements
View the documentGlossary

1.1 Background

Concern about the quality of drugs is as old as drugs themselves. Writings from as early as the fourth century BC warn of the dangers of adulterated drugs and, in the first century AD, the Greek physician Dioscorides identified such products and advised on their detection. Despite all the advances made over the years, this concern has not disappeared. In the recent past, the unregulated proliferation of pharmaceutical industries and products has brought with it many diverse problems of varying magnitude. Counterfeiting is just one example.

Concern regarding the quality of drugs in international commerce took on a global dimension following the establishment of WHO in 1948. In 1951, WHO Executive Board adopted resolution EB7.R79, which requested the Director-General to consider the advantages of more uniform methods for the control of drugs in countries in the interest of health and international commerce (1).

The problem of counterfeit medicines was first addressed at the international level in 1985 at the Conference of Experts on the Rational Use of Drugs in Nairobi. The meeting recommended that WHO, together with other international and nongovernmental organizations, should study the feasibility of setting up a clearing house to collect data and to inform governments about the nature and extent of counterfeiting (2).

In 1988, the World Health Assembly adopted resolution WHA41.16 which requested the Director-General of WHO to initiate programmes for the prevention and detection of the export, import and smuggling of falsely labelled, counterfeited or substandard pharmaceutical preparations. The resolution also requested the Director-General to cooperate with the Secretary General of the United Nations in cases when the provisions of the international drug treaties are violated (3).

The first international meeting on counterfeit drugs, a workshop organized jointly by WHO and the International Federation of Pharmaceutical Manufacturers Associations (IFPMA), was held from 1 to 3 April 1992 in Geneva in response to this resolution (4). The participants agreed on the following definition:

A counterfeit medicine is one which is deliberately and fraudulently mislabelled with respect to identity and/or source. Counterfeiting can apply to both branded and generic products and counterfeit products may include products with the correct ingredients or with the wrong ingredients, without active ingredients, with insufficient active ingredient or with fake packaging.

The workshop also adopted comprehensive recommendations which urged the commitment of all parties involved in drug manufacture, distribution and use, including pharmacists and consumers, in solving the problem of counterfeit drugs.

Given the rapid spread of counterfeit drugs in many national drug distribution channels, the World Health Assembly in 1994 adopted resolution WHA47.13. This requested the Director-General of WHO to assist Member States in their efforts to ensure that available drugs are of good quality, and in combating the use of counterfeit drugs (5).

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