Proceedings of the Ninth International Conference of Drug Regulatory Authorities (ICDRA) - Berlin, Germany 25-29 April 1999
(1999; 102 pages) Voir le document au format PDF
Table des matières
Ouvrir ce répertoire et afficher son contenuOpening Ceremony
Ouvrir ce répertoire et afficher son contenuGood regulatory practice
Ouvrir ce répertoire et afficher son contenuGood certification practice
Fermer ce répertoireCounterfeit drugs: challenges and solutions
Afficher le documentIllicit pharmaceutical markets
Afficher le documentThe situation of counterfeit drugs
Afficher le documentRecommendations
Ouvrir ce répertoire et afficher son contenuCurrent issues in regulation and quality
Ouvrir ce répertoire et afficher son contenuInternational Conference on Harmonization: implementation and implications
Ouvrir ce répertoire et afficher son contenuDrug utilization studies
Ouvrir ce répertoire et afficher son contenuInternational Conference on Harmonization and the common technical document
Ouvrir ce répertoire et afficher son contenuKeynote address
Ouvrir ce répertoire et afficher son contenuGlobal and national efforts to reduce tobacco use
Ouvrir ce répertoire et afficher son contenuElectronic communication in the regulatory process
Ouvrir ce répertoire et afficher son contenuTransparency in monitoring the safety of medicines
Ouvrir ce répertoire et afficher son contenuPharmaceutical products for use in special groups
Ouvrir ce répertoire et afficher son contenuNeed for Bioequivalence
Ouvrir ce répertoire et afficher son contenuAntimicrobial resistance: battling the bugs
Ouvrir ce répertoire et afficher son contenuSafety issues of plasma-derived medicinal products
Ouvrir ce répertoire et afficher son contenuHerbal medicines
Ouvrir ce répertoire et afficher son contenuRegulation and access to essential drugs
Afficher le documentParticipants
Afficher le 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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Dernière mise à jour: le 3 mai 2013