The Centre has assured that it will hold consultations with all the stakeholders before finalising the clauses, especially on the chapter on intellectual property rights, in the proposed bilateral trade agreement between India and European Union.

However, the government has admitted that the issues flagged by the European Union for discussion in the draft chapter on IPRs in the Bilateral Trade and Investment Agreement (BTIA) include proposals for patent linkage, patent term extension and access to medicine. "The chapter on IPRs in the BTIA is at a draft stage which gives the preliminary position of each of the parties and is only a consultative draft which will be subject to stakeholder consultations," sources said.

Though general and public consultations are unlikely at this stage by the commerce ministry, the health ministry is learnt to be planning to hold discussions with the concerned stakeholders on the clauses related to IPR and its fall-out on drugs, before sending its observations to the administrative ministry.

The public interest groups in the country and outside had expressed concerns on the possible impact of the FTA can have on the access to medicines because of the clauses on the IPR and had been calling for public consultations before finalising the deal which is under negotiation now. They had cautioned the government that the FTAs being negotiated with EU and Japan would drastically reduce the access to newer medicines, especially those for HIV and cancer.

Even the Department of Pharmaceuticals had reportedly opposed the proposal to include IPR clauses in the FTA. The Commerce ministry had sought the views of the DoP in this regard and the latter had declined the proposal to link patent status of a medicine to the drug approval process and provide exclusivity to the clinical trial data generated by the innovator company.

India and EU are going ahead with the negotiations for the agreement which is likely to be signed by the end of this year during the India-EU summit of 2010. After initiating the process in 2007, eight rounds of talks have been completed between the two sides and the authorities have claimed considerable progress on several issues.