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PDF - Counterfeit medicines - Survey report (2006)
Counterfeit medicines pose an ever-greater threat to public health in Europe today. In an effort to adequately measure the scope of the phenomenon and reduce the inherent risks, the Council of Europe has commissioned a survey on issues related to this particularly disquieting form of fraud.This report covers, among others, the current and estimated market and trade matters; the status of pharmaceutical regulation; national and international co-operation between authorities, the industry and wholesalers; detection systems and procedures; the adequacy of legal, judicial and administrative systems and professional training in the matter. It also sets out to define counterfeit medicine and pharmaceutical crime.
Executive summary
1. Introduction
2. Known current and estimated future market for counterfeit medicines
3. Trade issues concerning counterfeit medicines
4. Pharmaceutical regulation status with respect to manufacture, distribution, storage and import/export/transit of active pharmaceutical ingredients, bulk products and finished products
5. Analytical testing procedures for suspected counterfeit medicines
6. National regulatory authority co-operation
7. International regulatory authority co-operation
8. Regulatory authority, industry and wholesaler co-operation
9. Authorities, systems and procedures for detection of counterfeit medicines
10. Legal provisions, enforcement, sanctions, and judicial, and intellectual property procedures concerning unlicensed and counterfeit medicines
11. Adequacy of legal/judicial/administrative systems for dealing with counterfeit medicines - The authority perspective
12. Adequacy of existing countermeasures to prevent medicines counterfeiting and public health damage due to counterfeit medicines - The industry and wholesaler perspective
13. Counterfeit medicine and pharmaceutical crime definitions
14. Adequacy of authority/wholesaler/manufacturer personnel training concerning detection and control of counterfeit medicines
15. Conclusions and recommendations made by Council of Europe survey respondents
16. Discussion and final conclusions
17. Recommendations for the implementation of legislative and administrative measures against medicines counterfeiting
References
Acronyms
List of tables and charts
Appendices
Counterfeit medicines pose an ever-greater threat to public health in Europe today. In an effort to adequately measure the scope of the phenomenon and reduce the inherent risks, the Council of Europe has commissioned a survey on issues related to this particularly disquieting form of fraud.This report covers, among others, the current and estimated market and trade matters; the status of pharmaceutical regulation; national and international co-operation between authorities, the industry and wholesalers; detection systems and procedures; the adequacy of legal, judicial and administrative systems and professional training in the matter. It also sets out to define counterfeit medicine and pharmaceutical crime.