The World Health Organisation (WHO) has dropped the term ‘counterfeit’ and retained ‘falsified’ to describe medicines of inferior quality.
This decision was taken by a WHO’s technical working group on draft working definitions of substandard/spurious /falsely-labelled/falsified/counterfeit (SSFFC) medical products.
It settles longstanding India, EU medicine dispute and battle about labelling of drugs. It is considered as a significant victory for the global access to medicines campaign.
What is the issue?
- The above mentioned terms were used interchangeably to confiscate Indian made cheap generic drugs exported to other countries by showing that they were in violation of Intellectual Property Rights (IPR).
- It was also alleged that big pharmaceutical companies were using term ‘counterfeit’ to describe generic medicines and disrupting trade of generic medicines especially from India.
- Even the European Union Free Trade Agreement (EU FTA) was derailed after affordable, safe-to-use generic drugs made in India were confiscated as ‘illegal’ and ‘counterfeit.’
- Between 2008 and 2009, nearly 20 shipments of generic drugs were detained while in transit from India to several developing countries via Europe.
What were the concerns?
- Under the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) — the definition of counterfeit was clearly targeted at one particular area.
- It clearly mentioned that it is wilful infringement of trademark on a commercial scale.
- However in reality, campaigns and legislation against counterfeit drugs often have nothing to do with concerns about drug quality.
- The major European and US pharmaceutical companies used these rules for vested interest by limiting competition from generic drugs.
- They were using increased enforcement of IP laws as a tool to clamp down on the legitimate trade in high-quality generic medicines between developing countries
Significance of WHO decision
- The adopted definition will use falsified and drops the word counterfeit. The term falsified is much more in line with public health concerns regarding medicines.
- It makes false claims about what they contain or where they are from, that represent a genuine problem.
- It clarifies that the term ‘counterfeit’ will now be used by member States with respect to protection of IPR.
- Settles a long-standing battle about labelling of drugs as for far too long, genuine generic medicines have been labelled as counterfeit.
- Removes confusion on the much needed attention from the substandard medicines — which is a bigger public health problem for developing countries.
WHO is a specialized agency of the United Nations that is concerned with international public health. It was established on 7 April 1948. It is headquartered in Geneva, Switzerland.