Europe is today where FDA was two years ago. But we’re standing still while the WHO is moving forward. It’s time for some trans-Atlantic harmonization.
CONCLUSIONS AND RECOMMENDATIONS OF THE
WHO INTERNATIONAL CONFERENCE ON COMBATING COUNTERFEIT MEDICINES
DECLARATION OF ROME
18 FEB 2006
The participants of the WHO International Conference
‘Combating Counterfeit Drugs: Building Effective International Collaboration’,
gathered in Rome on 18 February 2006
1. Counterfeiting medicines, including the entire range of activities from manufacturing to providing them to patients, is a vile and serious criminal offence that puts human lives at risk and undermines the credibility of health systems.
2. Because of its direct impact on health, counterfeiting medicines should be combated and punished accordingly.
3. Combating counterfeit medicines requires the coordinated effort of all the different public and private stakeholders that are affected and are competent for addressing the different aspects of the problem.
4. Counterfeiting medicines is widespread and has escalated to such an extent that effective coordination and cooperation at the international level are necessary for regional and national strategies to be more effective.
5. National, regional and international strategies aimed at combating counterfeit medicines should be based on:
a) Political will, adequate legal framework, and implementation commensurate to the impact of this type of counterfeiting on public health and providing the necessary tools for a coordinated and effective law enforcement,
b) Inter-sectoral coordination based on written procedures, clearly defined roles, adequate resources, and effective administrative and operational tools,
c) Creating an awareness about the severity of the problem among all stakeholders and providing information to all levels of the health system and the public,
d) Development of technical competence and skills in all required areas,
e) Appropriate mechanisms for ensuring vigilance and input from healthcare professionals and the public.
6. The WHO should lead the establishment of an International Medical Products Anti-Counterfeiting Taskforce (IMPACT) of governmental, non-governmental and international institutions aimed at:
a) Raising awareness among international organizations and other stakeholders at the international level in order to improve cooperation in combating counterfeit medicines, taking into account its global dimensions
b) Raising awareness among national authorities and decision-makers and calling for effective legislative measures in order to combat counterfeit medicines
c) Establishing effective exchange of information and providing assistance on specific issues that concern combating counterfeit medicines
d) Developing technical and administrative tools to support the establishment or strengthening of international, regional and national strategies
e) Encouraging coordination among different anti-counterfeiting initiatives.
The IMPACT shall function on the basis of existing structures/institutions and will in the long term explore further mechanisms, including an international convention, for strengthening international action against counterfeit medicines.