A. Data exclusivity for the agro-chemical industry – A brief history
(i) The Inter-Ministerial Committee on Data Protection & Article 39.3 of TRIPS: This committee, which is also known as the Satwant Reddy Committee, was constituted in February, 2004 by the Ministry of Chemicals and Fertilizers to examine the requirements of Article 39.3 of TRIPs. Since the question of data protection/data exclusivity had a wide ranging impact on several stakeholders, the Government had setup this inter-ministerial committee with representatives from the Ministry of Chemicals and Fertilizers, the Ministry of Commerce, Ministry of Agriculture, Ministry of Health etc.
In its final report which was released in the year 2007, after much debate within the Committee, it was recommended to the Government that a data exclusivity regime be setup for the agro-chemical industry. The reasoning behind this recommendation was that in order to rigorously establish the safety and efficacy of agro-chemicals in the unique climate and geography of the Indian sub-continent, the innovator company would have to necessarily carry out extensive trials in India itself, since test results from other countries would be unreliable in this respect. The only way to ensure that innovator companies would actually invest in trials that establish the safety and efficacy of agro-chemicals being used by Indian farmers, was to ensure that these innovator companies receive a limited term of data exclusivity for test data generated by them.
(ii) The Pesticides Management Bill, 2008: This Bill which was aimed at replacing the Insecticide Act, 1968, was introduced in Rajya Sabha in September, 2008 by Union Agriculture Minister – Mr. Sharad Pawar. The relevant provision of this Bill, which mandates data exclusivity is reproduced below:
Section 12: (6) The data submitted for the purpose of registration in respect of a pesticide under this section which has not been previously registered shall not be relied upon for grant of registration of the same pesticide in respect of any other person for a period of three years.
(7) Subject to sub-section (6), where a pesticide has been granted a patent, the period of non-reliance on data shall be limited to the period of the patent.
Explanation.. The words “not been previously registered” in respect of a pesticide shall include its name or label expansion through “new uses”:
Provided that the provisions of non-reliance on data submitted for registration of a pesticide by the first registrant shall be available for the period with effect from the date of the first marketing approval granted anywhere in the world and this shall not apply to the data relating to bio-efficacy and shelf-life part of pesticides where data is to be generated for use under Indian conditions.
(8) Subject to the provisions of sub-section (6), the Central Government may relax or exempt the provision of non-reliance of data submitted for registration of a pesticide by the first registrant in the following circumstances, namely:.
(i) (a)national exigency; or
(b) in cases of urgency; or
(c) public interest; or
(ii) for use by the Government for academic and research purposes.
(iii) Report of the Parliamentary Standing Committee on Agriculture: Keeping with the normal Parliamentary practice the Bill was referred to a Standing Committee of Parliament after it has been laid before Parliament. The Standing Committee which was headed by Samajwadi Party MP, Mr. Mohan Singh conducted atleast three public hearings last year and then submitted its report to Parliament on the 17th of February, 2009.
This Committee acknowledges the recommendations made by the Satwant Reddy Committee Report for ‘data protection’ in para 14 of its Report. It however then recommends that the period of data protection should be increased to five years. The only reasoning given by the Committee for this increase from the three year period specified by the Satwant Reddy Committee is that a five year period would help in encouraging the introduction of newer pesticide molecules in the country. There is absolutely no other reasoning given by the Parliamentary Standing Committee for increasing the term of exclusivity from 3 to 5 years!!! So much for maintaining brevity when they are least required to do so!
(iv) ‘Data Exclusivity’ as enforced through notifications of the Central Government: The delay in passing the Bill however will not affect the innovator companies in any way since the Government of India has passed two notifications already implementing a data exclusivity regime under the Insecticides Act, 1968. These two notifications are as follows:
(i)No.17-2/2006-PP.I dated 30th October, 2007
(ii)F.No.17-2/2006-PP.I dated 18th February, 2008;
The text of these notifications can be found in this judgment by Justice Bhat where Syngenta had attempted to enforce these data exclusivity provisions against a domestic company. We had blogged about this case over here. It is pertinent to mention over here that Justice Bhat questions the legality of these notifications since in his opinion “There is no statutory guidance, either in the substantive portion of the enactment, or under the Rules, enabling even the rule making authority to prescribe a period of limitation for “data exclusivity”.”
B. The political opposition to the data exclusivity provision of the Bill: The ET in its report has mentioned that the Bharatiya Janata Party (BJP) is opposed to the Bill “on the ground that that certain clauses had been inserted in it under pressure from the West and were inimical to the country’s interests.” The main bone of contention appears to be the data exclusivity provision which in the opinion of BJP leaders, will have ‘dangerous consequences’ for the entire country. It is surprising that the comrades from the Left Parties, who are the traditional defenders of farmer rights, have not yet made any public statements on this Bill, especially the data exclusivity provisions.
C. Conclusion: I’m guessing that this Bill will come before Parliament only in the monsoon session. Given that data-exclusivity, even for the agro-chemical industry, is coming into sharp political focus; it would bode well for the Union Government to throw open for public discussion the issue of data exclusivity that is being negotiated as a part of the Indo-E.U. FTA. We’ll hopefully keep you updated on this topic.