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Who Can Profit From Digitised Genetic Data?

Who Can Profit From Digitised Genetic Data?

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  • Officials are set to discuss whether access- and benefit-sharing (ABS) requirements should apply to digital sequence information (DSI).
  • ABS is based on the principle that countries that are rich in genetic resources should be able to benefit from them, while distributing the gains among all stakeholders.
  • The DSI-ABS discussion is an important part of the agenda at a set of meetings about the Post-2020 Global Biodiversity Framework, to be held from March 14 in Geneva.

Digitising information and data has enabled scientists to overcome many limitations of time, space and use. This also opened many possibilities for scientists to work together, share and innovate. For example, sharing genomic data of viruses during the COVID-19 pandemic helped scientists decode the virus’s genetic information faster, and accelerated the development of diagnostics and vaccines. It also helped scientists interpret epidemiological data better.

Information and data from genetic resources are digitised and made available in data banks and digital depositories around the world. In discussions, such data is called ‘digital sequence information’ (DSI).

DSI has been in the spotlight of late because some of the restrictions that apply to actual genetic material – like a microorganism, a biological specimen or a plant – don’t apply to DSI. And experts are divided over whether it should be.

There is no agreed definition on DSI or what it covers. But one useful version is: “DSI as the constituent parts or part of an organism and understand DSI to be information on the sequence of components found in linear, polymeric molecules”. This information is stored in data repositories, most of which are in developed countries.

On the other hand, many economically ‘developing’ and ‘least developed’ countries lack the capacity to digitise and store DSI. They have also not been able to make the most out of accessing and using DSI. Thus, there is a Global North-South split on matters related to DSI.

DSI and access- and benefit-sharing (ABS) are emerging as key issues in negotiations regarding access to and use of digitised genetic resources around the world. Many organisations are addressing this in different ways.

In 1992, after protracted negotiations, many countries agreed to what came to be called the Convention on Biological Diversity. This is a landmark convention ratified by most countries in the world. It recognises the sovereign rights of countries over genetic resources that lie within their borders. Under the convention, states have the right to regulate access to these resources, including DSI. ABS is an important part of the Convention, and is often a mandatory condition for access.

In 2010, the Nagoya Protocol of the Convention further strengthened ABS in principle and practice. Many countries, including India, have mandated ABS conditions for people and companies to access and share genetic resources. (Note that human genetic resources are not covered by the condition.)

ABS is based on the principle that countries that are rich in genetic resources should be able to benefit from them, while distributing the gains among all stakeholders. Otherwise, free access without reciprocal benefits would benefit only the accessor, and not those who have spent time and energy protecting those resources. ABS addresses this by linking ‘access’ with ‘benefit sharing’.

Those who want to access genetic resources from a country should use the ABS regime of that country. There is no global ABS regime that is applicable to all countries – nor is there a grand repository of global genetic resources, digitised or otherwise. So an accessor must negotiate with multiple parties and sign multiple agreements before they can use the resources.

For example, when a company wishes to obtain the genetic information of a specific plant that grows in a specific area of India, it will need to negotiate with Indian officials. Once it has extracted that resource and commercialised it, say in the form of a drug, it should share the benefits (including profits) with the local people and authorities who have protected the plant and kept it from getting destroyed in the wild.

Generally, sharing genetic resources requires a binding ‘material transfer agreement’ (MTA). MTA specifies conditions for using and for further sharing or transfer. However, an MTA is not necessary for sharing DSI. In fact, DSI can on occasion be shared and used without ABS norms also.

This is where things get complicated: when DSI is used as a substitute for the actual genetic resources. That is, should ABS norms be applied to DSI when it is shared?

This is a hot topic that experts are currently debating around the world, under the terms of the Convention on Biological Diversity. It is also an important part of the agenda at a set of meetings about the Post-2020 Global Biodiversity Framework, to be held from March 14 to 29 in Geneva, Switzerland.

After scientists first shared the C15 strain of the Ebola virus, an American company named Regeneron Pharmaceuticals accessed the DSI of this strain without any condition or an MTA. It didn’t admit any ABS norms either. It subsequently developed a new drug for Ebola using that DSI. The country that was the source of this information – Guinea – gained nothing from this.

When digital information or DSI is shared this way, it defeats the purpose of ABS.

However, some experts are of the opinion that ABS norms should not be mandatory to access digital information. One line of argument is that genetic resources under the Convention only include physical or material resources and not digital information.

But many countries, including India, which are party to the Convention, disagree with this interpretation. Instead, they have maintained that digital information should also include ABS restrictions.

In the debate on ABS and DSI, there are many viewpoints and positions. One extreme is that DSI should be fully delinked from ABS. At the other extreme is the idea that ABS norms should apply fully to DSI, including the terms of the Nagoya Protocol. When government officials negotiate with each other over the terms of the Convention, they discuss the extent to which ABS should apply in terms of six categories. That is, they decide which category is mutually most acceptable.

Some have also recommended that DSI should be ‘open access’, without forcing it into the existing ABS framework, which could make the DSI even harder to access. The argument here is that doing so will benefit science and hasten innovation that is based on DSI. In fact, scientists have often voiced concerns about ABS regimes becoming barriers to access and that then slowing potentially life-saving research.

Open science and access are attractive ideals, to be sure, but they don’t have anything to say about benefit-sharing, which is important. The entity accessing a resource needs to make a commitment that they will share the benefits, and existing open-access systems don’t provide for this.

So the challenge lies in finding a golden middle ground that allows better access to DSI in return for a meaningful, equitable benefit-sharing protocol. For some purposes, such as pure research, access to DSI can be provided with minimal or even no benefit-sharing commitment. But when commercial entities are involved, benefits will have to be shared.

Given the number of possibilities and arguments, officials’ negotiations at the March 14-29 meetings are likely to be protracted. But the sooner an amicable solution is found, the better it will be. DSI is becoming increasingly important for research and innovation. It is sure to play an even more important role in fighting future pandemics.

Krishna Ravi Srinivas is a senior fellow and consultant, and managing editor, Asian Biotechnology & Development Review, RIS, New Delhi. The views expressed here are the author’s own.

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