|Counterfeit drugs (WHO/EDM, 1999, 61 p.)|
In 1988, the World Health Assembly adopted resolution WHA 41.16, which requested the Director-General of WHO to initiate programmes for the prevention and detection of the export, import and smuggling of, inter alia, counterfeit pharmaceutical products. This resolution was reinforced by another WHA resolution in 1994, WHA 47.13, which asked the Director-General to assist Member States in their efforts to ensure that available drugs are good quality, and in combating the use of counterfeit drugs.
These guidelines respond to the WHA requests: They are aimed to provide guidance to Member States in developing their own national measures to combat counterfeiting of drugs.
The guidelines provide an overview of the problem and factors contributing to the counterfeiting of drugs. They outline also the steps to be followed in developing national strategies as well the specific measures to be considered in combating counterfeit drugs. Issues such as, approaches to country studies, inspection of suspected counterfeit drugs, screening of potentially counterfeit products and training of human resources are also dealt with in the guidelines.
Information on the scale of the problem is inadequate and there are no global studies conducted. However, it is known to affect both developed and developing countries. The problem is more pronounced in countries where the manufacture, importation, distribution, supply and sale of drugs are less regulated and enforcement is weak.
So far, the counterfeit drugs that have been discovered have rarely been efficacious and, in many cases have been positively dangerous and detrimental to public health.
The factors facilitating the occurrence of counterfeit drugs vary from country to country. However, the most common factors are considered to be: lack of legislation prohibiting counterfeiting of drugs; weak penal sanctions; weak or absent national drug regulatory authorities; weak enforcement of drug laws; shortage/erratic supply of drugs; lack of control of drugs for export; trade involving several intermediaries and free trade zones; and corruption and conflict of interest.
There is no simple or standard solution that is applicable to all countries to eliminate the problem. Each country has to develop a strategy based on its own situation taking into account the available infrastructure and human and other resources. This should be part of the overall national drug quality assurance system.
In developing a national strategy, assessment of the current situation should be the starting point. All concerned parties: government agencies, pharmaceutical industries, drug suppliers, health care providers and professionals, consumers, nongovernmental and international organisations should be involved in the process of development and implementation of the plan. The plan should have clear and realistic goals that are attainable. The role of each party must be clearly defined to ensure accountability. Progress on implementations of the plan of action should be monitored and evaluated from time to time to identify successes or failures and take timely corrective actions.
At national level, political will and strong commitment of the government are critical if there is to be a concerted effort to improve drug control and decrease the prevalence of counterfeit drugs. Governments have to enact comprehensive drug legislation, including provisions prohibiting the manufacture, import and sale of counterfeit drugs.
Establishing drug regulatory authorities
Governments have to establish adequately resourced drug regulatory authorities (DRA) with the appropriate powers. Governments should provide the necessary support to ensure the enforcement of the drug laws and regulations.
Drug regulatory authorities need to ensure that the manufacture, importation, distribution, supply and sale of drugs are carried out under specific licences/authorisation in licensed/approved premises under the supervision of qualified persons. They should conduct regular monitoring and surveillance of premises to ensure that practices employed in the manufacture, import, distribution and sale of drugs comply with the specified requirements and standards. They should ensure that all drugs in the national drug distribution channels have been authorised/licensed. The ports of entry and drug establishments, including drug-manufacturing industries, wholesalers and retail pharmacies must be regularly inspected and samples collected and tested.
DRA inspectors play a crucial role in the identification and investigation of counterfeit drugs and in the prosecution of counterfeiters. There should be sufficient and adequately trained drug inspectors with authorisation to enter premises and seize any drugs suspected of being counterfeit. Countries that do not have full-fledged drug quality control laboratories should look for simpler and less resource demanding testing/screening methods for the identification of counterfeit drugs. Thin-layer chromatography, test-tube colour reactions, melting point determination could be considered to serve the purpose. However, such simple tests or screening methods must not be considered as a replacement of pharmacopoeal, compendial or legally accepted test methods. Products considered to be potentially counterfeit have to be subjected to further testing according to the pharmacopoeal, compendial or legally accepted reference method(s).
A shared responsibility
Combating counterfeiting of pharmaceutical products at national level is a shared responsibility involving, relevant government agencies, pharmaceutical manufacturers, distributors, health professionals, consumers and the general public. Governments have to create the appropriate environment for the participation of all concerned partners. Similarly, cooperation and collaboration between the various government agencies such as the DRA, customs, police, is also essential for any success in this field.
Counterfeiting of pharmaceuticals is of international dimension. There is therefore, a need to foster intercountry, subregional and regional cooperation in the fight against the counterfeiting of drugs.