Even after the Centre proclaimed victory in the drug seizure row and made clear its plans to withdraw complaint against the European Union from the World Trade Organisation, industry stakeholders in the domestic market are not relieved and remain sceptical about EU?s intentions.
A cross section of representatives from the domestic pharma industry admitted to FE that the government?s unexpected announcement on Thursday about withdrawing the case from WTO took them by surprise.
The reason behind it is the content of the latest draft of the Anti-Counterfeiting Trade Agreement (ACTA) released in Tokyo on Wednesday, a day before India made its decision to withdraw the case public.
The domestic pharma companies feel that the laws envisaged in the latest draft of the Anti-Counterfeiting Trade Agreement, released in Tokyo on Wednesday, leave ample scope for such drug seizure incidents to recur. Many of them, however, believe that after the EU countries communicated to India their decision to amend the notification evoked to confiscate the in-transit generic drugs, the Indian government was left with little choice legally.
?We cannot be complacent on the issue. The provisions incorporated in ACTA appear more stringent than what is part of EU regulations in many cases, especially on trademark violations. So, it is possible that what EU appears to be giving away through the amendment is much less than what seems to be the case. We have to closely follow the ACTA to see what awaits the fate of generic drugs in future. Also, this gesture could be an EU strategy to push for the EU-India FTA, negotiations for which are currently going on,? said DG Shah, secretary general, Indian Pharma Alliance.
ACTA aims to establish a new legal framework globally that countries can join on a voluntary basis and would create its own governing body outside existing international institutions such as the World Trade Organization (WTO), the World Intellectual Property Organization or the United Nations. The US, Canada, EU are among many other countries that form party to the negotiation which till recently has been criticised by many quarters for the secrecy surrounding it.
?The Indian government should refrain from committing or announcing anything on the drug seizures issue. Let EU give it in writing under the aegis of WTO that it would not confiscate generic drugs in transit under one pretext or the other, be it the domestic laws or global laws that they adopt. On the ACTA, we should carefully watch out for Obama?s declaration,? said Daara Patel, secretary general. Indian Drug Manufacturers? Association.
For one, while discussing intellectual property rights protection at the borders, ACTA gives each country the discretion to follow its own rules, even though patents have been excluded from the ACTA draft?s chapter on border measures. This means the patent-holder of a drug under patent in the EU but not India should not have the rights to petition Dutch customs authorities to seize generic versions en route from India to Brazil.
However, global patent analysts warn that this doesn?t guarantee complete immunity to generic drug shipments under ACTA. Border measures still apply to trademarks.
According to international reports, there have been instances last year when EU member states (including German customs officials) seized generic drugs enroute on suspicion of trademark violation. The government officials also maintain that India would be keenly watching the developments following the EU amendments to decide on their future course.