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WHO drops the word 'counterfeit' to use the term 'falsified' on addressing quality of medicines

Ramesh Shankar, Mumbai
Tuesday, November 29, 2016, 08:00 Hrs  [IST]

The World Health Organisation (WHO) has finally distanced its work on addressing the quality of medicines from an IP enforcement agenda. The WHO's SSFFC working group dropped the word counterfeit and uses the term falsified. Definition of ‘falsified’ further states that any consideration related to intellectual property rights does not fall within this definition. It also clarifies that medical products should not be considered as falsified solely on the grounds that they are unauthorized for marketing in any given country.

In fact, India has been fiercely pushing to get the term counterfeit dropped. Dr. V G Somani, Joint Drugs Controller of India, CDSCO, New Delhi represented India in the negotiations.
 
According to sources, the WHO's Member State Mechanism on substandard/spurious/falsely labelled/falsified/counterfeit (SSFFC) medical products adopted the report of the informal working group on the definition. 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.

Numerous policy initiatives claim to promote patient safety by taking action against 'counterfeit' medicines. But most, if not all, of these initiatives are on the wrong track. In reality, campaigns and legislation against counterfeit drugs often have nothing to do with concerns about drug quality.

According to health groups, major US 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. Confusion around the term 'counterfeit' is feeding into this, diverting resources from the real problem of drug quality.

People use the term to describe substandard or falsified medicines. But under international law — the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) — the definition of counterfeit is clearly targeted at one particular area: wilful infringement of trademark on a commercial scale.

Anti-counterfeit initiatives with this misplaced focus are growing fast. The dangers of this approach are clear. As a result of European customs regulations put in place in 2003 (EC Council Regulation no. 1383/2003), which cover infringements of intellectual property, almost 20 shipments of generic drugs, including basic antibiotics and anti-retrovirals, were detained while in transit from India to several developing countries via Europe in 2008 and 2009.

The European Union first claimed it was fighting trade in counterfeit medicines. But an official response by the Dutch government to a Freedom of Information Act request, filed by Health Action International, revealed that these shipments contained generic medicines detained on allegations of infringing intellectual property. Under international law, goods cannot be detained in transit on the grounds of trademark or patent infringement — trademarks and patents are specific to a particular territory.

Even the WHO's attempts to address the issue have been controversial. The discussion on terminology and the confusion it creates has been taken up by the Intergovernmental Working Group on substandard/spurious/falsely labelled/falsified/counterfeit medical products, a body set up by WHO member states.

 

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