Open access under attack – how international regulation collides with the open use of genetic sequence data
Written by Fabian Rohden
Current discussions on international level, namely the Nagoya Protocol, circle around regulating the access to genetic sequence data. Although the issue is primarily about commercial use, this regulation may have severe impacts on all research using digital sequence data. The scientific community should increase its participation inside the negotiations to avoid collateral damage from new regulation.
The topic of Digital Sequence Information (DSI) became one of most controversial issues at the UN Biodiversity Conference 2016 in Mexico (see PLOS article from 2016). The next Biodiversity Conference was held in Egypt two years later on November 13 – 29Th. After two intensive weeks of negotiation, which sometimes took all night, disagreements between nations were not solved. For science, the most important issue is not about what is written in the final document, but what is not: the word “open” did not make it in front of “access to DSI”. At the moment the access to DSI is free and open, but this might not necessarily be the case in the future. Many countries see open access to DSI as a potential loophole for biopiracy. Their concern is legitimate and should not be ignored by the scientific community. At the same time open access is a crucial concept to spread scientific knowledge, especially towards poorer funded universities, institutions and countries. Developing countries, which feel left behind by economic and technological developments, should also beware of committing suicide from fear of death.
Benefit Sharing of Genetic Resources
In 1993, the Convention on Biological Diversity came into force, having as its third objective “the fair and equitable sharing of the benefits arising out of the utilization of genetic resources”. A genetic resource in general describes a species, but can also be a single gene or genetic element. Biodiversity is the amount of genetic resources. If a country loses biodiversity it loses resources and should be motivated by economic reasons to work against that loss. The principal idea behind the third objective is to use part of the capital generated by the use of nature to help conserving it. For example, if a company develops a product by using a plant from a specific country, the company should pay a profit-based royalty to the country of origin. The money is then used to help conserving that plant, especially via helping the local population. This shall help people in rural areas to overcome poverty not via destroying the biodiversity surrounding them, like burning forests to create farmland, but via using it in a sustainable manner. This idea is similar to and goes along with the concept of ecotourism. In praxis, benefit sharing is a very complex matter as the case of the Hoodia Cactus in South Africa shows.
In this context, the term biopiracy became established. Although not perfectly defined, it generally describes the practice of using genetic resources without sharing the benefits. Throughout the 90s and 2000s there were several famous cases considered biopiracy, involving the Neem tree, the already mentioned Hoodia Cactus, Basmati rice and the Enola bean. Those cases mostly circled around industrial patents which had severe effects on the economic situation of farmers. So it was more about damage reduction than actual situation improvement and the limitations of the convention already became obvious. A concrete legal framework was missing as well as an information system. How can local communities or countries know when their genetic resources are being used to create products in other countries? And how can companies know if they contacted all relevant stakeholders around a certain genetic resource they want to use?
The Nagoya Protocol and Digital Sequence Information
In order to overcome these problems, the Nagoya Protocol on Access and Benefit Sharing came into force in 2014. Access and Benefit Sharing (ABS) links the access to genetic resources, a need for both science and industry, with benefit sharing, which is crucial for biodiverse countries and indigenous communities. It also into account the plain fact that there needs to be access in order to generate benefits. To access a genetic resource legally, a user must obtain Prior Informed Consent (PIC) from the country of origin and the utilization has to be under Mutually Agreed Terms (MAT). PIC and MAT guarantee provider countries the sovereignty, since genetic resources are not accessed without informing them and they can define the terms of use.
The whole process is based on principle that genetic resources are physical and need to be accessed inside the country of origin. Digital Sequence Information, the term used inside the Nagoya Protocol to paraphrase genetic sequence data, puts this principle into question. In public databases such as Genbank, genetic information can be obtained via a mouse click. Even though this has been the case for decades, technological advancements circumstance have rendered this convenience particularly problematic. Via biotechnological methods, digital information can be used to artificially produce natural compounds, circumventing the access to the physical genetic resource behind that digital information. Therefore, many countries fear that the ongoing developments, especially in the field of synthetic biology, may render the physical access and thus the Nagoya Protocol irrelevant.
The principles of PIC and MAT on one side and open access on the other are diametrically opposed, a plain but sad fact that needs to be acknowledged. Nobody wants to limit or impede non-commercial research. Since humanity as a whole profits from research, as long as its results are freely available, scientific research falls under nonmonetary benefit sharing within the Nagoya Protocol. But open access also means that commercial research and product generation has free access to genetic information, without giving provider countries the chance to influence this access. Whatever ruling is anticipated, it also needs to take into account the scientific reality of methods like consensus sequences and codon usage bias. DSI, as the name implies, is information and not a resource. It is more than the sum of its parts and therefore assigning concrete value to specific sequences will be difficult if not impossible.
The way forward
The issue at hand is very complex and includes technical, judicial, economic and political aspects. There are possible solutions, like a multinational sharing mechanism and product-based regulations, which can preserve the principle of open access. But the scientific community should be more aware of the Nagoya Protocol and increase the participation inside its negotiations. Participation should not be limited to preaching about the importance of open access from the ivory tower, but rather acknowledging the complexity of the problem and making constructive contributions to find a balanced solution.
Fabian Rohden is part of the steering committee of the German Association for Synthetic Biology and responsible for political and ethical aspects. He is currently a graduate student in technical biology at the Technical University of Darmstadt.
Mail: Fabian.rohden@ga-sb.de
Twitter: @gasb_synbio
Facebook: German Association for Synthetic Biology