While the Indian pharmaceutical industry, related Government departments and Ministries, NGOs, various stakeholders and committees are still divided on the issue of data exclusivity despite debating for over two and a half years, there is a move to reach consensus among the various government departments to allow protection against disclosure and a fixed-term data exclusivity for three years, it is learnt.
Informed sources said that the government departments, which opposed data exclusivity, are now showing signs of supporting the move. This could be influenced by the visits of the US President, US Trade Representative, Pfizer Chief, etc and active lobbying by multinational backed interest groups, they say.
The noticeable volt face came from none other than the Prime Minister's Office. India has no obligation under TRIPS to have provisions for data exclusivity in the country as it is not binding on WTO member countries, news reports said in May 2003 quoting a spokesperson of the PMO's office. Ironically, it is the same PMO's office reconsidered its decision and formed an inter-ministerial committee to decide whether data exclusivity is necessary for India or not, sources cite.
It may be noted that the two possible options put forward by the chemical ministry are (a) protection against disclosure without any data exclusivity and (b) protection against disclosure and fixed-term data exclusivity for three years with sufficient safeguards.
Sources say many of the related ministries and key official departments have changed their stand in the recent past. An example is the stand taken by the Department of Scientific and Industrial Research (DSIR). DSIR earlier had said the provisions applicable under common law of India and existing IPR laws are adequate /sufficient to address the issues or concerns related to data protection. In the last meeting of the inter-ministerial committee on data protection, held on May 22, 2006, Dr Mashelkar, who heads CSIR, said "there is a change in the stand of DSIR and now they are recommending three years data exclusivity along with non reliance by regulator for both in pharmaceutical and agricultural sector". India has become innovative and is not copying innovation of others. There is a substantial increase in R&D activities in the last two years. Therefore, there is a need to respect innovations and any possible data protection model should support innovations by Indian companies as well as multinationals. This model should satisfy everybody and also help in promoting R&D, he reasoned.
Two other key departments, the Ministry of Health and the Department of Industrial Policy & Promotion (DIPP), which spoke against data exclusivity, were asked to 're-examine their stand' by the Inter-ministerial Committee on data protection.
The Department of Health maintained it supports protection against disclosure without any data exclusivity. "However, the Government should guard against any provision, which is either TRIPS Plus or Article 39.3 plus. While giving market approvals to drugs and pharmaceutical products the competent Regulator (DCGI) relies on bio-equivalence and bioavailability data. Such reliance cannot be termed as unfair commercial use in the context of Article 39.3," the ministry had informed the data protection committee its stand.
Sources who attended the last week workshop organized by Health Ministry and WHO to debate data protection say that the health ministry is also likely to change its stand on the issue.
The data protection committee also had concluded that 'there is a shift among the pharmaceutical industry towards fixed term data protection along with non reliance and therefore further discussion are necessary to achieve a consensus'.
Sources cite that the Department of Commerce had clearly argued against data exclusivity and had said "the compliance with Article 39.4 not necessary to provide data exclusivity as this would tantamount to TRIPS Plus. If concerned administrative Ministries feel any necessity for granting, they may do so independently, without linking it to the requirements of TRIPS."
The Department of Industrial Policy and Promotion maintained that "there is adequate clarity about the level of protection and exclusivity of data is not a comfortable proposition and is not as per the spirit of Article 39.3. Besides this, the views expressed by Department of Commerce are also applicable to Department of IPP as conveyed by Minister, Commerce & Industry," IPP officials had informed the committee.
It may be noted that the Department of Commerce had asked Dr Gopalakrishnan of Centre for Intellectual Property Rights Studies, Cochin to undertake a study to suggest suitable changes in the Indian laws to make them TRIPS complaint. He suggested that there is no need to provide data exclusivity and only certain amendments are required in the Drugs and Cosmetics Act and Insecticides Act to strengthen data protection.
The Department of Biotechnology also had opposed data exclusivity. "The present regulatory procedures are already TRIPS compliant. Another period of data exclusivity over the twenty years under product patent would lead to further greening of the patent for a product and this would hamper the progress of biogenerics for which India has a great strength. Hence there is no need for data exclusivity," the department had maintained.