Essential medicines and health products

General information on counterfeit medicines

Measures to combat counterfeit medicines

At а national level, each country should develop appropriate medicines policy options, legislation, and enforcement strategies in view of its own situation and availability of institutional framework, professional and financial resources. The policies should aim at involving the Government, its agencies, the pharmaceutical industry, drug importers and distributors, the pharmaceutical profession, governmental organizations, public interest groups and consumer groups, etc in efforts to prevent the supply of counterfeit medicines. Measures are often effective when carried out by all concerned working together.

More specifically, governments of each country should show political will/commitment for evolving and implementing programs for combating counterfeit medicines. Political will and commitment should be demonstrated by:

  • enacting new drug laws or updating existing drug laws for prohibiting counterfeit medicines;
  • establishing institutions for the regulation of medicines and clearly setting out in the drug laws, the power, duties and responsibilities of the institution(s);
  • training of personnel, including enforcement officers, for national drug control;
  • making available necessary financial and other resources;
  • ensuring that the drug laws are enforced; and
  • fostering international cooperation in the control of pharmaceuticals and entering into bilateral and multilateral agreements with other governments and with international organizations such as WHO, Interpol and the World Customs Organization (WCO).

Judicial procedures and policies should reflect the seriousness of the problem and the offence. Courts should speedily dispose of cases involving counterfeit medicines and impose appropriately severe penalties on convicted offenders. 1n addition, courts should order the confiscation/forfeiture and destruction of counterfeit medicines.

Combating counterfeiting of medicines is а shared responsibility to which all interested parties have to contribute. Non-governmental organizations or community based organizations such as consumer associations should be informed about the problem of counterfeiting and the possible presence of counterfeit drugs in the national distribution chain. They should be provided with information and methods for detection so that they are able to report cases to the national drug regulatory agencies.

The general public should be encouraged to become involved in the fight against drug counterfeiting. Education and information campaigns directed at the general public should be established and the public should be advised to buy medicines from legitimate sources rather than from peddlers and hawkers or from market places and streets. Consumers should also be encouraged and advised to report to their prescribers or physicians any lack of improvement in their health status in spite of the treatment or any adverse reactions experienced.

More privatization and liberalization of the world economy, more extensive opening of borders to trade and increased promotion and sale of drugs through the internet are going to lead to increased circulation of counterfeit drugs in national and international markets. This means greater cooperation between countries at subregional, regional and international levels will be needed to combat counterfeit drugs in the future. Cooperation should include developing common strategies, timely exchange of information and harmonization of measures to prevent the spread of counterfeit drugs. Cooperation would improve if all countries adopt а common definition of counterfeit drugs.

At а global level, а more effective response to the threat of counterfeit drugs could be the development of an international convention to control trade in counterfeit and substandard drugs.