Agri-biotechnology Agriculture Policy

Your Guidelines on Licensing of GM Traits are Arbitrary, Naive and Regressive, FSII Tells Agriculture Ministry

The Federation of Seed Industry of India (FSII), has asked the agriculture ministry to ‘review and rescind’ the guidelines on licensing of genetically-modified traits like insect resistance that were notified on May 18 but were converted into a draft for consultation five days later.

Calling the guidelines ‘arbitrary,’ ‘naive’ and ‘regressive,’ it says they were not warranted because competition among 49 licensees and their sub-licensees has ensured that Bt cottonseed is available on demand. Farmers have also not flagged off trait price as an issue because its share is ‘less than five percent of revenue from cotton.’

FSII is the breakaway group from the National Seed Association of India. The founder members are Bayer Cropsciences, Dupont Pioneer, Syngenta India, Dow Agro Sciences India, Monsanto Holdings, Maharashtra Hybrid Seeds Company (Mahyco), Shriram Bioseed Genetics, Rasi Seeds, Namadhari Seeds and Metahelix Life Sciences. The formation of the group was announced at a press conference in Delhi on 26 August.

The cottonseed price control order of December 2015 and the GM trait licensing guidelines of May 18 will negatively impact the seed industry, which has been driven by Bt  cottonseed for the past decade and a half.  In FSII’s estimate, Bt cottonseed has created a cumulative value of Rs 5 lakh crore since it was approved for cultivation in 2002.  Of this, Rs 4 lakh cr has been shared by more than 75 lakh cotton farmer families.  The market for cottonseed has grown from Rs 450 cr a year in 2002 to Rs 4,000 cr in 2015, owing to insecticidal Bt gene.

The group faults the May 18 guidelines on various counts. The life of a trait depends on its efficacy and willingness of farmers to use it.  To prescribe a span of 15 years is ‘arbitrary’ in its view.

Not all traits are equal. To say that royalty cannot exceed 10 percent of the maximum retail price for the first five years, and prescribe a 10 percent reduction every year thereafter is ‘without justification,’ because there are traits which are readily accepted, and those that take time. Some are for niche segments and others for broader markets.

The provision for deemed license if a technology developer does not grant it to a seed seller within 30 days does not discriminate between good companies, which have a long-term view and invest in farmer education, and those interested only in quick profits

Several technologies like herbicide tolerance, nitrogen-use efficiency and salinity tolerance are in the research and regulatory pipeline. These will be available in crops like rice, wheat and maize, impacting a larger number of farming families. Restrictive policies like price control and compulsory licensing will deter research in these technologies and access to them.

When prices are affected by global trends, Indian farmers will have to improve productivity, which is below the global average in most crops.  Biotech seeds can influence yields enormously. A free market environment will allow multiple technology developers to flourish for the same trait from both the public and private sectors. Seed companies will have a greater choice of franchisers.

The restrictions on pricing and licensing go against this government’s commitment to make businesses easy to operate and markets to function without fetters.

Crop biotech research takes a lot of time, money and effort. Product development takes seven to 12 years. Then there is add-on time and effort for obtaining regulatory clearance.  If earnings become uncertain no private investor would be interested in doing research here or deploying their proprietary technologies.

FSII says there is an attempt to obfuscate the protection available under Indian laws to biotech innovations when there is no conflict in the concept, scope and provisions of the Indian Patent Act, 1970 and those of the Protection of Plant Varieties and Farmers’ Rights Act, 2001.  The latter gives exclusive rights for the production and commercialization of new plant varieties. They are granted to breeders. To be eligible, a plant variety must be new, distinct, uniform and stable.

PVP rights protect a new variety as a whole but not any specific trait. These are protected by patents. A plant which is characterized by a particular gene, as opposed to its whole genome, is not included in the definition of a plant variety and is therefore patentable. In most jurisdictions transgenic traits are patentable if they are not restricted to a specific plant variety and can be used across plant groups.

FSII acknowledges that the 2002 amendment of the Indian Patent Act stipulates that any plant, animal (whole or part), including seeds, varieties and species which have been processed using biotech means cannot be patented. There is an exception to micro-organisms which have been created using biological processes. They are patentable. By the amendment of 2005, recombinant DNA and protein sequences, say for insect control or herbicide tolerance, were made patentable, thereby providing protection for plant biotech material.

FSII says the pricing of technology is an industry issue to be agitated between technology provider and licensees. It is not an issue for farmers as the cost of technology is a small part of the total cost of cultivation. Not does it call for government intervention. In its view, ‘giving weight to such extraneous considerations is not a desirable precedent.’

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