Why Regulation Is Needed

The power to manipulate living organisms cannot simply keep expanding without regulation. Some ethical standards are needed to judge whether a given activity helps or harms living things, and beyond the moral question there is a hard biological one too.

The biological concern is unpredictability. Genetic modification of an organism can have unpredictable results once that organism is released into an ecosystem — effects that were never intended and cannot easily be reversed. This is why oversight is treated as essential rather than optional.

GEAC and the Role of Oversight

To provide that oversight in India, the government set up bodies such as the GEAC — the Genetic Engineering Approval Committee. Its job is to weigh two things carefully before green-lighting anything.

First, it judges the validity of GM research — whether a proposed line of genetic-modification work is sound. Second, it assesses the safety of introducing GM organisms for public services, such as their use as sources of food and medicine. In effect, GEAC acts as the gatekeeper between the laboratory and the public.

Patents and the Basmati Case

Using living organisms for public services has thrown up a second problem: patents. There is growing anger that some companies obtain patents on products and technologies built from genetic materials and traditional knowledge that farmers and indigenous people have developed and used for generations.

Basmati rice is the textbook example. India alone has an estimated 200,000 varieties of rice, and 27 documented varieties of Basmati are grown here, with references going back to ancient texts. Yet in 1997 an American company obtained a patent on Basmati rice through the US Patent and Trademark Office. The 'new' variety had actually been derived from Indian farmers' varieties crossed with semi-dwarf varieties, then claimed as a novelty. Similar attempts were made to patent uses of turmeric and neem.

Biopiracy and Fighting Back

These cases have a name. Biopiracy is the use of bio-resources by multinational companies and other organisations without proper authorisation from the countries and people concerned, and without compensatory payment.

The imbalance driving it is stark. Industrialised nations are rich financially but poor in biodiversity and traditional knowledge, while the developing world is rich in biodiversity and traditional knowledge about its bio-resources. As awareness of this injustice has grown, nations have begun writing laws to protect what is theirs. Toward this end the Indian Parliament cleared the second amendment of the Indian Patents Bill, taking such issues into account — including patent terms, emergency provisions and research and developmental initiatives.

Quick Recap

  • Manipulation of living organisms needs regulation; GM organisms can have unpredictable results in an ecosystem.
  • India set up GEAC (Genetic Engineering Approval Committee) to judge the validity of GM research and the safety of introducing GM organisms for public services.
  • Patents on products using farmers' and indigenous peoples' genetic materials and traditional knowledge are a major concern.
  • Basmati: India has ~200,000 rice varieties and 27 documented Basmati varieties; in 1997 an American company patented Basmati rice, a 'new' variety actually derived from Indian varieties crossed with semi-dwarf ones. Similar attempts targeted turmeric and neem.
  • Biopiracy = use of bio-resources without proper authorisation and without compensatory payment.
  • Industrialised nations are financially rich but biodiversity-poor; developing nations are biodiversity-rich. The Indian Parliament cleared the second amendment of the Indian Patents Bill.

Solved Examples — Section 11

Q1. Why is regulation of genetic modification considered necessary?

Answer: Because genetic modification of an organism can have unpredictable results when it is introduced into an ecosystem, and ethical standards are needed to judge whether activities help or harm living organisms.

Q2. What is the full form of GEAC and what does it decide?

Answer: Genetic Engineering Approval Committee; it decides on the validity of GM research and the safety of introducing GM organisms for public services.

Q3. How many documented varieties of Basmati are grown in India?

Answer: 27 documented varieties (India has an estimated 200,000 rice varieties in all).

Q4. What happened with Basmati rice in 1997?

Answer: An American company obtained a patent on Basmati rice through the US Patent and Trademark Office, for a 'new' variety actually derived from Indian farmers' varieties crossed with semi-dwarf varieties.

Q5. Define biopiracy.

Answer: The use of bio-resources by multinational companies and other organisations without proper authorisation from the countries and people concerned and without compensatory payment.

Q6. Which legislation did the Indian Parliament clear to address these issues?

Answer: The second amendment of the Indian Patents Bill.