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Under new norms, pharma firms may get away with lower benefit-sharing obligation

Experts are critical of the guidelines, which have proposed a “minimal” benefit sharing obligation for drugmakers for extracting biological material and mitigating environmental pollution caused in the process

india Updated: May 26, 2019 08:09 IST
Jayashree Nandi
Jayashree Nandi
Hindustan Times, New Delhi
Pharma,India news,National Biodiversity Authority
Pharma companies that use plants, animal extracts or microorganisms in manufacturing their products may need to share minimal benefits.(BLOOMBERG FILE PHOTO FOR REPRESENTATION)

Pharma companies that use plants, animal extracts or microorganisms in manufacturing their products may need to share minimal benefits with the local community from which they source such natural ingredients if new guidelines proposed by the environment ministry are implemented in their current form.

Experts are critical of the guidelines, which have proposed a “minimal” benefit sharing obligation for drugmakers for extracting biological material and mitigating environmental pollution caused in the process. Such a clause wasn’t in the “Guidelines on Access to Biological Resources and Associated Knowledge and Benefits Sharing Regulations, 2014,” which the ministry wants to replace with the new ones.

The guidelines are meant to lay down rules on how the access and benefit sharing clauses in the Biological Diversity Act 2002 are to be implemented. But after receiving comments and suggestions from various national and international companies and research organisations in the past five years, the National Biodiversity Authority (NBA) drafted a new set of guidelines which were put up for public feedback on April 24.

Legal experts are seeing several loopholes. For example Shalini Bhutani,a legal researcher on intellectual property rights (IPR), pointed out that the guidelines expand the definition of biological resources to include traditional knowledge associated with them.

“The definition is subsuming associated knowledge in along with biological resources. It’s a contentious issue,” she said, adding that it has major implications for intellectual property rights like patents and trademarks.

The Biological Diversity Act’s definition of biological resource does not include associated knowledge. “Therefore, the regulations stand in direct contravention on the parent Act and Rules. Any amendment to the definition requires at the very least a discussion in the Parliament of India,” Bhutani and Kanchi Kohli , a legal researcher with the Centre for Policy Research (CPR), wrote in their comments to the NBA.

On the clause proposing minimal benefit sharing for pharma companies dealing with diseases, Bhutani and Kohli pointed to a case in the Uttarakhand high court where an ayurvedic company was directed to share profits with local communities. The company had earlier declined to share profits, arguing that it was an Indian company and had no obligation to do so.

“This is ironic as one of the key challenges even in the Uttarakhand HC case judgment was by a company using biological resources to produce health and medicinal products and would seek to gain from this provision,” their comments said.

The guidelines also state that the NBA or the State Biodiversity Boards (SBB) “may consult” the biodiversity management committee which mainly constitutes of local people on extraction of biological resources. Consultation with the BMC is however mandatory as per the Biological Diversity Act.

“The role of state biodiversity boards and biodiversity management committees is somewhat ignored. This is against the spirit of the Act. The guidelines are about benefit sharing with no clause on sharing but it’s all about securing benefits. This is questionable,” said Balakrishna Pisupati, former NBA chairman.

The guidelines also propose that entering into a benefit sharing agreement with an applicant shall be deemed as a grant of approval for access. But the draft seems to overlook the fact that the question of benefit sharing arises only if access does not go against conservation and sustainable use of biological resources.

A senior officials at Chennai-based NBA said: “We are still receiving comments. Obviously all comments will be vetted before finalising the draft. We have translated the guidelines into many languages so that companies or institutions abroad can also see {them}. The new guidelines were drafted based on the suggestions we received in the past few years.”

Kohli said the NBA had missed out on making the benefit-sharing regime compliant with the Nagoya Protocol (international protocol on access to genetic resources, fair and equitable sharing of benefits) which upholds the requirement for free, prior, informed consent by local communities for companies to tap their biological resources.

“India’s Biological Diversity Act still talks about consultation, which too is being made optional in these draft guidelines,” Kohli said.

First Published: May 26, 2019 07:18 IST