Counterfeiting medicines are serious health hazard and they should be strictly regulated world over. At the same time there should be a clear definition and regulatory framework to identify, locate and seize counterfeiting medicines and those manufacturing and dealing with the same. While doing so care must be taken to differentiate between counterfeiting medicines and generic drugs and medicines.
United Nations Office on Drugs and Crime (UNODC) has been dealing with counterfeiting drugs and fraudulent medicines for long. UNODC has been working in the direction of curbing trafficking in fraudulent medicines (PDF) and the resolution 20-6 of UNODC on countering fraudulent medicines and their trafficking (PDF) shows the commitment of UNODC in this regard. UNODC’s technical meeting of experts on the trafficking in fraudulent medicine (PDF) has already been convened in this regard.
In 2012, the WHO Resolution on Substandard, Spurious, Falsely-Labelled, Falsified-Counterfeit Medical Products on 130th Session 2012 (PDF) was passed. The resolution decided to establish a new Member State mechanism for international collaboration among Member States, from a public health perspective, excluding trade and intellectual property considerations, regarding “substandard/spurious/falsely-labelled/falsified/counterfeit medical products”.
The WHO resolution was the result of confiscation of Indian off-patent generic drug consignments by some European countries customs authorities for violation of intellectual property rights (IPRs). Reacting to confiscation, India and Brazil filed a case against the EU in the World Trade Organisation (WTO) protesting the action.
India and EU also decided to sign a Letter of Understanding and as per the understanding, none of the customs authorities in the 27-nation EU bloc would confiscate any drug dispatch meant for third country destinations like Latin America or Africa. In exchange India assured that it would not file any WTO dispute in this regard at WTO. In addition, EU also agreed to India’s request for adoption of guidelines which would confirm the principles agreed to in the Understanding with a view to give greater and immediate legal certainty for producers and traders. EU also agreed to reflect the principles contained in the Understanding in its proposal for a new Regulation to replace Regulation 1383/2003.
However, the latest development at UNODC resulting in involving IPRs issues in the fraudulent medicines has complicated the scenario further. India led BRICS has strongly opposed this move of UNODC. Let us see how the matter would be resolved at the international level.