The role of international medical products anti-counterfeiting taskforce has been discussed in this work.
Keywords: World Health Organization, IMPACT, counterfeit medicines, public health
The problem of counterfeit medicines is global and acute, so the fight with this problem is a burning issue on the international conferences, seminars and round tables at all levels.
The main actors during this discussions and activities are the four specialized agencies of the United Nations Organisation (UNO): the World Health Organization (WHO), the World Trade Organisation (WTO), the World Customs Organisation (WCO), the World Intellectual Property Organisation (WIPO), etc. The WHO was established as the main organisation for providing leadership on global health problems. International Medical Products Anti-Counterfeiting Taskforce (IMPACT) is the taskforce administered by the WHO. IMPACT was created in 2006 to promote and strengthen international collaboration to combat counterfeit medical products. The participants of IMPACT are international organizations, enforcement agencies, non-governmental organizations, pharmaceutical manufacturers associations and drug and regulatory authorities. The WHO recognises that combating the counterfeiting of medical products cannot be successfully achieved by the health sector alone. IMPACT’s primary focus is the protection of public health.
In 2011 Report the WHO Working Group recognised that IMPACT has delivered important results to many countries, but in future it should concentrate on: information exchange and awareness raising about counterfeit medicines, in developing/updating/promoting norms and standards of medicines quality/ safety/efficacy/stability, and providing technical support to countries to build and further strengthen national regulatory infrastructures and capacity.
As per its Terms of Reference, IMPACT may establish Working Groups to address and advise IMPACT participants on specific issues relating to its goal and objectives, including the coordination of country focused initiatives. Working Groups will be lead by a Chairperson, selected by the General Meeting. The Chairperson must be a participant. Nowadays there are 5 Working Groups:
- Communications Working Group
- Legislative and Regulatory Infrastructure Working Group
- Regulatory Implementation Working Group
- Enforcement Working Group
- Technology Working Group
Working Groups provide the appropriate expertise and ensure representation of the different stakeholders. The Planning Group and the IMPACT Secretariat will have to ensure that these principles are met.
Each Working Group will develop proposed work plans, report and submit proposals to the General Meeting through the Planning Group.
IMPACT is an international multi-stakeholder initiative for coordinating efforts in order to protect public health against counterfeit medical products. It is essential opportunity to discuss all matters and formulate proposals and recommendations to be adopted through a consensus-based approach. Such proposals and recommendations and working plans constitute a reference for guidelines, official policy or other action under the responsibility, and according to the prerogative, mandate and internal rules and procedures of each such participating governments, organisations, institutions, agencies and associations.
The WHO has developed and published Guidelines for the development of measures to combat counterfeit medicines:
- Guidelines for the development of measures to combat counterfeit medicines
- Rapid Alert System for counterfeit medicines
Trade of counterfeit medicines is widespread and affects both developed and developing countries. IMPACT activities concentrate only on international discussion, collaboration and prevention in combating counterfeit drugs.
The crisis of the UNO, the decline of its reputation in nowadays problems decision, the WHO’s reform: couldn’t help to address the complex challenges of the public health in the 21st century.
IMPACT partners' cooperation should include the timely and appropriate exchange of information and the harmonization of measures to prevent the spread of counterfeit medicines.
Guidelines of the WHO provide advice and encourage on measures that should be taken by the various stakeholders to combat counterfeiting of medicines - they are not obliged.
Nowadays it could be useful to think not only about the greater interaction among the major anticounterfeiting players but about new forms of such interaction in the medicines’ anti-counterfeiting struggle.