World-wide system will help to bring about uniformity in identifying them
The World Health Organisation (WHO) has put in place a mechanism to define counterfeit medical products.
The set of definitions of sub-standard, spurious, falsely labelled, falsified and counterfeit products will be globally accepted and help to bring about uniformity in identifying such drugs, without interrupting worldwide supplies.
The decision to establish a member state mechanism was taken at the World Health Assembly, the WHO's policymaking body, at a meeting held recently.
The meeting also limited the WHO's role to public health issues, taking it off Intellectual Property Rights matters in the context of defining counterfeit drugs.
India was backed in this effort by Brazil, Thailand, Russia, China and South Africa, besides the South East Asia Region Organisations nations.
An earlier working group of member states had recommended that a storm enforcement network be set up as an informal group led by Interpol in collaboration with the WHO's Western Pacific Regional Office to strengthen collaboration among relevant agencies in combating counterfeit medical products and other pharmaceutical crimes in Asia Pacific. But there was no consensus on defining what these products were.
In the past, countries making generic drugs, especially India and China, have run into serious problems in pushing consignments across the European borders for want of uniform quality standards. At present, there is no uniformity on what constitutes a sub-standard, spurious, falsely labelled, falsified and counterfeit drug. Every country has its own quality standards, which differ vastly from the developed and developing countries.
“The member state mechanism is expected to clean up the WHO's work on medicines with compromised quality, safety and efficacy. This particular aspect of the WHO's program is directly under the control of pharmaceutical multinational companies (MNC) and the developed countries, and they use this program to pursue Intellectual Property Rights enforcement standards, instead of addressing issues relevant to tackling the circulation of medicines with compromised quality such as high prices,” said K.M. Gopa Kumar of The World Network, a global health agency.
“India should play an active role, along with the like-minded countries, to ensure that the WHO should not be a forum for pharmaceutical MNCs' IP enforcement agenda, in the name of protecting quality, safety and efficacy of medicines,” he said.
Sources in the Ministry of Health and Family Welfare told The Hindu that some developed nations often brought up Intellectual Property Rights issues to stall the supply of generic drugs to the less developed nations by questioning their quality.
The setting up of this mechanism was also important from the public health perspective, the sources said, as it took the WHO away from issues revolving round the trade and intellectual property considerations of medical products that hampered the supply of generic medicines to poor countries from India and China, which turned out a bulk of the world's generic medicines being used by millions of people.
According to the resolution adopted at the World Health Assembly, the mechanism will identify major needs and challenges; make policy recommendations; and develop tools for prevention, detection and control of sub-standard, spurious, falsely labelled, falsified and counterfeit drugs.
The mechanism will strengthen national and regional capacities to maintain the supply chain and facilitate exchange of experiences, best practices and information on the ongoing activities at the national, regional and global levels. It will also identify activities and behaviours that result in such drugs and make recommendations for improving the quality, safety and efficacy of products.
Importantly, the mechanism will help to promote international cooperation in and collaboration on surveillance and monitoring of such products.
Making an intervention on the resolution, India said the WHO's basic mandate was public health, and it should not involve itself in issues of Intellectual Property Rights enforcement. It strongly opposed the involvement of the WHO's Western Pacific Regional Organisation in enforcement activities to combat counterfeit products.