Generic Drugs Current Affairs

WHO settles India, EU medicine dispute issue

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.

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Delink drug prices from R&D costs: UN

The United Nations High-Level Panel on Access to Medicines has called for delinking drug prices from research and development (R&D) costs.

The report submitted by panel calls for human rights to be placed over intellectual property laws of pharmaceutical companies and incoherence between them should be narrowed.

Key Recommendations

  • All countries must freely be able to use flexibilities granted under TRIPS (Trade-Related Aspects of Intellectual Property Rights) to access affordable medicines.
  • Countries that retaliate and threaten against generic drugs makers in different countries under the TRIPS Agreement must be forced to face significant sanctions.
  • Public health assessments must be done with every free trade negotiation to assess the possible impact on public health and creation of public health patentability criteria.
  • Governments engaged in bilateral and regional trade and investment treaties should ensure that these agreements do not include provisions that interfere with their obligations to fulfil the right to health.
  • Research institutions and universities that receive public funding must prioritize public health objectives over financial returns in their patenting and licensing practices.
  • Governments should increase their current levels of investments to in heath technology innovation to address unmet needs.

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