Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) View the PDF document
Table of Contents
Open this folder and view contentsOpening Ceremony
Open this folder and view contentsGood regulatory practice
Open this folder and view contentsGood certification practice
Close this folderCounterfeit drugs: challenges and solutions
View the documentIllicit pharmaceutical markets
View the documentThe situation of counterfeit drugs
View the documentRecommendations
Open this folder and view contentsCurrent issues in regulation and quality
Open this folder and view contentsInternational Conference on Harmonization: implementation and implications
Open this folder and view contentsDrug utilization studies
Open this folder and view contentsInternational Conference on Harmonization and the common technical document
Open this folder and view contentsKeynote address
Open this folder and view contentsGlobal and national efforts to reduce tobacco use
Open this folder and view contentsElectronic communication in the regulatory process
Open this folder and view contentsTransparency in monitoring the safety of medicines
Open this folder and view contentsPharmaceutical products for use in special groups
Open this folder and view contentsNeed for Bioequivalence
Open this folder and view contentsAntimicrobial resistance: battling the bugs
Open this folder and view contentsSafety issues of plasma-derived medicinal products
Open this folder and view contentsHerbal medicines
Open this folder and view contentsRegulation and access to essential drugs
View the documentParticipants
View the documentBack cover
 

Recommendations

1. Political will to combat counterfeiting at national and international levels should be encouraged.

2. The WHO definition of counterfeit pharmaceutical products should be considered for adoption by all countries.

3. Member States should make every effort to collect and verify more accurate data on counterfeiting within their countries and submit these data to WHO or Interpol, as appropriate, to facilitate international collaboration.

4. Liaison officers of the WHO anti-counterfeit drugs network should be utilized for information exchange and investigation of counterfeit drugs. The draft WHO guidelines for the development of measures to combat counterfeit drugs are useful instruments and will be made available on the WHO website.

5. A national legislative framework should be in place with appropriate penalties and enforcement. National regulatory authorities should be strengthened to implement appropriate measures. In addition, customs services and the police should become integral partners in implementation. Fraudulent activities by members of the responsible authorities should not be tolerated.

6. At national level there is a need to encourage more reporting of counterfeit drugs. The introduction of innovative national approaches to this problem should be considered such as the Brazilian initiative to introduce toll free telephone lines for anonymous reporting of counterfeit drug trafficking.

7. At national and international level, industry should be more closely engaged with the regulatory authority by assisting in the identification of possible counterfeit medicines and in finding ways to address the counterfeiting problem. Action should be focused on the domestic, export and import markets and should cover raw materials and the final product.

8. International cooperation should be strengthened and involve international agencies such as WHO, UNICEF and Interpol. WHO and Interpol should develop initiatives to improve the exchange of information. International agencies should give specific consideration to the conflict between the need for regulatory authorities to know of the circulation of counterfeit products and the need for confidentiality when criminal investigations are under way.

9. Specific recommendations made by Interpol.


• Manufacturers should be legally required to report to regulatory authorities any information brought to their attention concerning a product which has been or may be counterfeited.

• Regulatory authorities should be informed of offers of drugs at prices substantially below the official price.

• Extradition treaties should be expanded to include the crime of drug counterfeiting.


10. The high cost of medicines in developing countries makes them unaffordable to large sectors of the population and increases the risk of counterfeiting. This should be addressed by the manufacturing companies who may need to consider lowering the price of drugs in poor countries most at risk of counterfeiting.

 

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Last updated: April 24, 2012