New Delhi : The World Health Organization (WHO) in a significant move has dropped “Counterfeit” while retaining the term falsified to describe faulty or inferior quality medicines. The decision was taken by a technical team of WHO on draft working definitions of substandard/spurious /falsely-labelled/falsified/counterfeit (SSFFC) medical products in a meeting on Wednesday, reports The Hindu.
The decision will enable the organisation to distance itself from many intellectual property disputes arising in relation to medicines and products.
The World Health Organization statement said, “The adopted definition drops the word counterfeit and uses the term falsified which is much more in line with public health concerns regarding medicines, which make false claims about what they contain or where they are from, that represent a genuine problem.”
The development would prove benefitial in settling long-standing battle between India and European countries, about labeling of generic drugs which are made in India claiming them as counterfeit.
Substandard, spurious, falsely labeled, falsified and counterfeit (SSFFC) were the terms that were used interchangeably by European countries under European Union Free Trade Agreement (EU FTA), to confiscate Indian generic drugs made utilizing even the right methods.
“Between the year 2008 and 2009, around 20 shipments of generic drugs were confiscated in European countries including basic antibiotics and anti-retrovirals. This led to derailment of free trade agreement negotiations, reported The Hindu.”
Leena Menghaney, South Asia head of humanitarian aid organisation Médecins Sans Frontières (MSF), stated, “This decision by the WHO settles a long-standing battle about labelling of drugs. For far too long, genuine generic medicines have been labelled as counterfeit. The confusion had taken away the much needed attention from the substandard medicines — which is a bigger public health problem for developing countries.
Also big pharmaceutical companies were using the term ‘counterfeit’ to describe generic medicines and disrupting trade of generic medicines.” She added.
The international law described the counterfeit drugs as illegal and not considerable weighing both counterfeit and falsified in one category. However, more genuinely falsified drugs would be more suitable for non-consideration as they do not contain the right compounds and formulations and can lead to problems for the patient.
“In reality, campaigns and legislation against counterfeit drugs often have nothing to do with concerns about drug quality. Major U.S. and European pharmaceutical companies have a vested interest in limiting competition from generic drugs, and are using increased enforcement of intellectual property laws as a tool to clamp down on the legitimate trade in high-quality generic medicines between developing countries,” said K.M. Gopakumar, Legal Advisor with the Third World Network (TWN), a transnational policy think tank.
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