Regulations on Genetic Data Could Threaten Genomics Innovation

As genetic research relies more and more on digital technology, international regulations are straining to catch up and some fear they threaten to stifle innovation. Is it possible to develop a regulatory framework for genetic data that is fair for everyone?

In just a couple decades, the digital revolution has taken over all sorts of industries. When it comes to genetics, the lightning-fast pace of progress in scientific research is leaving regulations far behind. 

Currently, the regulation of genetic resources worldwide follows an international binding treaty known as the Convention of Biological Diversity. One of its key goals is “the fair and equitable sharing of the benefits arising from the use of genetic resources.” 

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Though the goal seems reasonable, its implementation is not as straightforward as it may seem, especially when the science crosses borders. This obstacle led to the creation of a legal framework that was condensed under the Nagoya Protocol. In a nutshell, this legal framework sets out the steps to follow if collaborators want to commercially exploit a genetic resource that is native from a specific country or region, and the benefits that each of the key players would receive as a result of such exploitation. 

A positive example of international regulation in action was seen in the collaboration between the UK big pharma AstraZeneca and Griffith University in Queensland, Australia, back in 1993. Their aim was to discover new potential drugs from the flora and fauna of Queensland’s rainforest and the Great Barrier Reef. As a result of the partnership, AstraZeneca found new leads for therapeutic molecules while its partners benefited from royalties as well as boosts to scientific and technological capacity and the conservation of local biodiversity. 

The dilemma of digital sequencing information 

In recent times, the enforcement of the Nagoya Protocol is starting to clash with the digitalization of genetic data. When the Nagoya Protocol was established in 2010, the term ‘genetic resource’ referred just to the physical resource and not to any digital data associated with it. As DNA and protein sequencing technologies evolved and costs dropped, it became easier to read and obtain such information. In other words, the technology evolved faster than the regulations. 

This evolution led to the coining of the term ‘digital sequencing information’. The term broadly refers to any sequence of nucleotides or amino acids obtained from a certain organism and contained in a database. Though it seems innocuous enough, this digital information represents a threat to the enforcement of the Nagoya Protocol. Essentially, it creates a loophole where one could just access a genetic database, such as Genbank, remotely download any DNA sequence, reconstruct genes or entire genomes, and exploit them commercially as if extracted directly from a physical organism, thus avoiding benefit-sharing obligations. 

So, does or should digital sequencing information fall under the Nagoya Protocol? This is a debate that is still ongoing at meetings of the Convention of Biological Diversity. Some countries, including the European Union members, state that digital information downloaded from public databases is not covered by the Nagoya Protocol, while other countries say that it should be, or even that it is already covered.  

The main concern is that if digital sequencing information falls under the Nagoya Protocol, it could lead to a level of bureaucratic complexity that could make research and innovation stagnate. As of today, access to genetic and protein sequences remains open and free of charge. If this was to be regulated under the Nagoya Protocol, the open access status would certainly change, but it is uncertain to what extent. 

Regulating genetic data in the digital era

The problem becomes more pressing as digital data becomes essential for developing any biotechnological innovation. Nowadays, advances in synthetic biology and protein engineering mean that new molecules that do not exist in nature can be created, in some cases without accessing any physical sample. This also means that a startup could produce a protein or a DNA molecule with a structure that shares certain similarity with a sequence that is native to another country. How could this be fairly regulated under the current legislation? How would intellectual property be addressed? The genetic code is universal and similar sequences can be found across species, regardless of their location. Genetics knows no political boundaries.  

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The League of European Research Universities puts forward the argument that “open and free access to digital sequencing information allows scientists, irrespective of finance, status or location to be able to do genetics research.” Thus, it advocates for a clear definition of digital sequencing information and for it to be regulated separately, not as part of the Nagoya Protocol. 

In addition, easy and timely sharing of digital sequencing information can be a strong force for the public good, especially when applied to disease surveillance. According to Maria Mercedes Roca, a member of the Honduras delegation for the Convention of Biological Diversity raised the example of the worldwide Covid-19 pandemic, stating that stopping the information flow due to bureaucracy could bring more harm than benefits. Under her point of view, the regulation of digital sequencing information would be “a big misunderstanding on how the science behind works”

Robert Friedman, Vice President for Policy and University Relationships of the J. Craig Venter Institute in the US, expressed the need for scientists “to be more engaged and pay attention; to help to think constructively and to take the time to understand what is going on” in these international discussions. He also stressed his concern about the current legal ambiguity on how digital sequencing information would work under intellectual property scenarios. 

At the moment, there are some initiatives that seek to pave the way towards a consensus while avoiding the feared bureaucracy. One of them is the digital single market strategy of the European Union. 

In 2018, 13 European countries signed a declaration for allowing cross-border access to their genomic data, with the goal of preventing, diagnosing and treating disease, particularly cancer and rare diseases. Although this declaration deals with human health-related information, it serves as precedent of international cooperation and sharing of relevant digital data, as well as bringing together infrastructure and expertise. 

In a globalized world, the flow of information is crucial for problem solving. In the specific case of genetic data, there seems to be a growing consensus that easing the benefits of sharing information outweighs any possible harm.  A lot of roads remain to be examined, but it should not be forgotten that the open flow of genetic information is a form of benefit sharing itself. Regardless, it is paramount that the science behind digital sequencing information is fully understood at the decision making level when the Convention on Biological Diversity meets again in October this year. 

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Luis Francisco García is a biotechnology engineer based in Guadalajara, Mexico, who specializes in synthetic biology.

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