TWN Info Service on Biodiversity and Traditional Knowledge (Feb24/01)
29 February 2024
Third World Network

WHO: Developed countries dilute effectiveness and accountability in PABS proposal

Geneva, 27 February (Nithin Ramakrishnan) – During the first week of the 8^th meeting of the Intergovernmental Negotiating Body (INB8), developed countries sought to dilute the proposals of developing countries for an effective and accountable Pathogen Access and Benefit Sharing (PABS) System under the pandemic instrument.

This is contrary to their existing international commitments with respect to access and benefits arising from their use of genetic resources, under the Convention on Biological Diversity and its Nagoya Protocol.

INB8 is taking place at the WHO headquarters in Geneva from 19 February to 2 March in a hybrid mode.

The PABS System is a proposed access and benefit sharing mechanism which WHO Member States are trying to build in the new pandemic instrument under negotiation. This would enable fair and equal access to pathogens and their genetic sequence data (GSD) to all researchers, scientists and industries from all countries, and also sharing of benefits arising out of the use of these shared resources (such as diagnostics, vaccines, and medicines) through the WHO.

During the first week of INB8 (19 – 23 February) two dedicated discussions were held (21 and 23 February) on Article 12 on PABS. Apart from these two formal sessions in the subgroup format there were at least 2 informal sessions which were convened by the INB vice-chair.

Nearly 70 countries from two groups, the Africa Group and Group for Equity, have proposed comprehensive text proposals for the PABS system that provides legal certainty, effectiveness and accountability both in sharing access to pathogens and GSD, as well as fair and equitable sharing of benefits arising from their use. The proposals include calls for a WHO-coordinated laboratory network, PABS database, and certain legal devices like Standard Material Transfer Agreements, and Data Use/Access Agreements which not only obligate users to ensure benefit sharing, but also guarantee access to pathogens and their GSD in an accountable and transparent manner.

In order for the PABS system to be effective and accountable, it is important that the users enter into contractual obligations, while accessing pathogens and their GSD, to share benefits equitably and fairly. Thus, it is important that intermediaries such as laboratories and databases need to ensure that users enter into such agreements as developed by the Member States at the WHO or PABS system. They must also be willing to share information about the users and their access, as or when required by WHO or its Member States and be amenable to the governance of States participating in the PABS system. This ensures that users who have developed benefits share them fairly and equitably as stipulated in their contractual agreements.

Several of these proposals are already diluted by the intervention of the WHO Secretariat which helped to identify and draft design elements of the PABS system under the subgroup discussing Article 12.

During INB8, developed countries including Japan, the United Kingdom, Germany and the European Union apparently further sought to avoid provisions in the pandemic instrument that are intended to ensure effectiveness of benefit sharing provisions as well as accountability of laboratories, databases and the industries accessing pandemic-potential pathogens and their GSD through systems mediated by PABS. These countries ignored their commitments in various international legally binding instruments such as the Convention on Biological Diversity (CBD) and its Nagoya Protocol on access and benefit sharing and in various decisions and recommendations adopted by consensus.

In this regard, during the PABS System discussions in INB8, developed countries put forward the following three main positions.

Sequencing and GSD sharing itself as benefit

On 21 February during the INB subgroup meeting on Article 12 the United States argued that generation and free sharing of GSD themselves constitute benefit sharing and so GSD should be shared freely without any conditions. However, this would allow users to free ride by taking GSD from databases like the International Nucleotide Sequence Database Collaboration (INSDC) without any obligation to share benefits arising from their use.

The U.S. further stated that increased capacity to do genetic sequencing and sharing is already a benefit and accused developing countries in the INB of trying to stop existing sharing by coming up with additional benefits. However, the Africa Group and Brazil contested the U.S. position.  They clarified that the PABS System seeks an effective and accountable system to ensure access to pathogens and GSD as well as to benefits generated out of such use.

Earlier, Malaysia had clarified that the benefits in the context of PABS must be obligatory and should be the outcome arising from the use of pathogens and GSD.

While pushing the above argument the U.S. ignored the fact that sharing sequencing technology is not a benefit sharing, but an attempt to ease the transfer of genetic resources from developing countries to developed countries using digital tools and infrastructure, bypassing the benefit sharing commitments usually signed while transferring genetic resources physically.

Philanthropic foundations from the U.S. fund bioprospecting and bio-exploration in developing countries, and they often transfer the samples and GSD from these countries to the repositories or databases located in the U.S. which is a non-party to the CBD.

Further, the U.S. argued that surveillance and the pandemic instrument is itself a benefit, ignoring the fact that mere surveillance cannot prevent or cure diseases. The reality is that the U.S. is echoing industries that do not want to undertake any benefit sharing obligations.

Some other developed countries also tried to argue along the same lines as the U.S., asserting that the entire new pandemic instrument is a benefit.

Notably, on the other hand, there is not a single legally binding provision of assistance to developing countries in the current version of the draft pandemic instrument, either in terms of finance, technology or access to health products.

Other developed countries, who are Parties to CBD, in aligning with the U.S., are ignoring their obligation under Article 19(2) of the CBD, which mandates that the benefits arising out of the use of biotechnology shall be shared fairly and equitably with the providers of the genetic resources.

A delegate from the Africa Group told Third World Network that “It [benefit sharing] cannot be every other charity global north provides us. If we use the pathogens and GSD, we will also share benefits with WHO. It is a false assumption that it will always be the developed country who will invent the health products to counter a pandemic. Sometimes it will be the traditional knowledge of our indigenous communities that might fill a crucial gap in the knowledge for developing health products”.

Promoting anonymity in the GSD databases

Several databases that currently share GSD do not require users to register themselves with a valid account in the database in order to download GSD. This is in sharp contrast to the requirement of registration or identification for uploading GSD. Thus, the users of GSD can download the GSD from these databases without disclosing their identity, and can escape from obligations of benefit sharing. They can also subject the GSD to illegal experiments or research involving biosecurity risks without any monitoring or responsibility. In short, these databases promote bio-piracy and operate in a manner unaccountable to the international access and benefit sharing regime.

Germany, a major funder of certain unaccountable databases, and the scientist-industry lobby working to decouple access and benefit sharing, stated that it wants to continue with the existing systems which perpetuates “anonymous” usage. Germany asserted that the WHO “have to keep the system that is now in place”.

The U.K. supported Germany by stating that the WHO needs to obtain assurances from the big databases that they are willing to be covered by the WHO PABS system. This argument comes after their disagreement with the Africa Group’s call for establishing an open access WHO Database for the purposes of the PABS system.

This is an attempt to provide a favourable legal atmosphere for INSDC to continue its practice of anonymous access to GSD, facilitating data extraction from developing countries to developed countries without any obligation to share benefits. INSDC is the single largest database collaboration on GSD, managed by the U.S., Japan and 21 European Countries.

47 Member States of the Africa Group, Malaysia, Bangladesh, Brazil, Indonesia and India opposed these moves to continue with an unaccountable system. The INB Vice-Chair convening the subgroup also questioned the E.U. on how they argue on one hand for good governance, and on the other hand, for anonymity which is antithetical to accountability and transparency.

Developing countries questioned if GSD access continues to be anonymous, how will good governance be exercised over data sharing and data use. They reminded the developed countries that the latter’s support for anonymous databases runs contrary to the unanimously adopted UNESCO Recommendation on Open Science.

The UNESCO recommendation recognizes the principles of “responsibility, respect and accountability”. It states: “… with greater openness comes greater responsibility for all open science actors, which, together with public accountability, sensitivity to conflicts of interest, vigilance as to possible social and ecological consequences of research activities, intellectual integrity and respect for ethical principles and implications pertaining to research, should form the basis for good governance of open science”.

Developing countries argued that anonymous usage cannot serve the purposes of public accountability and vigilance. They said that in order to share more GSD, countries need to be confident that the PABS system also caters to the needs of the providers of GSD and avoids data being misappropriated for research that involves biosecurity risks, without any monitoring. This confidence can be built only when the database sharing GSD under the PABS system is amenable to governance by Parties to the pandemic instrument.

The E.U,, however, stated that it will be impossible to establish and maintain a data sharing system where there will never be free riding, and made it as the basis of their support for the current system. Germany which backed the E.U. arguments ignores that fact that it funds a private trust to run a database, i.e. GISAID, which is not a database that adopts an anonymous mode of usage, and is instead recognized as a “protected” open access database by the German ministry concerned.

It must be noted that though GISAID does not allow anonymous users and actually subjects users to data use or access agreements, the problems associated with its non-transparent governance has received severe criticism recently. The terms and conditions of GISAID also do not obligate users to share benefits in such a manner conducive to global public health.

In this regard, Decision 15/29 on Biodiversity and Health adopted unanimously at the 15^th Meeting of the Conference of Parties to the CBD  calls for strengthening compliance with national and international access and benefit sharing regimes, in particular those dealing with health sectors.

Further, it must be noted that almost all of these databases use data sharing that replicate and store GSD of pathogens outside the territorial jurisdiction of the provider State, compromising the sovereign rights of the State over such data. For instance, GISAID subjects uploaders of GSD to an irrevocable license that permits GISAID to store GSD permanently.

According to Part IV of the UNESCO Recommendation, Member States are recommended to take concurrent action in “ensuring that open science incorporates the values and principles as outlined in this Recommendation to ensure that the benefits of open science are shared and reciprocal, and do not involve unfair and/or inequitable extraction of data and knowledge”.

A developing country delegate well versed in data science told Third World Network last week that, “Unfortunately, some of the developed country delegations think it is between developed and developing countries. But it is increasingly about balancing private powers and public regulatory authorities. Even the general public from developed countries benefit from a better governed system and accountable way of sharing pathogens and GSD”.

Attempts to frustrate process

Japan objected to the consideration of GSD within the definition of “PABS Material”, saying that the discussions in the CBD have not resolved the question on whether GSD is a genetic resource or not within the context of the CBD.  The CBD decision does not stop WHO from considering GSD within the definition of PABS materials or resources; however Japan does not want the language used in the pandemic instrument to prejudice its position at the CBD.

Switzerland, the E.U. and the WHO Secretariat expressed that they understand Japan’s position.

According to a developing country delegate, this is a tactic to frustrate the process because what Japan was arguing against is what has been already agreed upon by States through various international instruments and practices.

In this regard, Japan is overlooking its own position taken in the WHO and other international fora. The CBD and its Nagoya Protocol already include sharing of benefits arising from the use of GSD and the 15^th Meeting of the CBD Conference of Parties has decided to develop solutions for sharing benefits arising from use of GSD (the term used in CBD is DSI instead of GSD). In fact, Japan has also agreed to the WHO Pandemic Influenza Preparedness (PIP) Framework which subjects the use of GSD to monetary benefit sharing. The PIP Framework has been in place for more than 10 years.

Similarly, Japan in 2022 also agreed to Decision 15/29 under the CBD, in which Parties to CBD are encouraged to strengthen compliance of national and multilateral access and benefit sharing mechanisms including for GSD in health sectors.

A delegate who is knowledgeable about CBD negotiations said that Japan’s arguments are baseless and without any legal impact: “It is disingenuous and immature that Japan wants to hold on to its position that GSD is not a genetic resource, because it has already agreed to share benefits arising from its use. Japan is simply employing a strict legal interpretation to one of the provisions in the CBD, and ignoring several other provisions in the CBD and its Nagoya Protocol, to create a loophole in the law which could perpetuate free riding of the use of GSD, unaccountability and non-transparency”.+