Governing knowledge in relation to Marine Genetic Resources and COVID-19 vaccines
This contribution is part of a MARIPOLDATA blog series on current developments and discussions about the negotiations towards an international legally binding instrument under the United Nations Convention on the Law of the Sea on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction (BBNJ). In this series, the team publishes updates on the four package items under the BBNJ Agreement which will be concluded in 2021 (Marine Genetic Resources (MGRs), Area Based Management Tools (ABMTs) including Marine Protected Areas (MPAs), Environmental Impact Assessments (EIAs), and Capacity Building and Technology Transfer (CBTT) from the intersessional online discussions taking place on MS Teams since September 2020, the virtual High Seas Dialogues taking place under Chatham House rules on Webex, and the MARIPOLDATA Ocean Seminar Series in which scholars and practitioners present and discuss current issues of ocean governance.
By Paul Dunshirn and Arne Langlet
Widely used in medicine production: deep-sea sponges
How fair and efficient are governance systems based on proprietary rights and global commons?
Marine genetic resources (MGRs)[1] are one of the key issues in the ongoing negotiations towards an intergovernmental legally binding instrument on the conservation and sustainable use of marine biological diversity of areas beyond national jurisdiction (BBNJ). In this blog post, we discuss MGRs from a ‘knowledge governance perspective’, focusing on how intellectual property rights (IPRs) and existing access and benefit-sharing (ABS) mechanisms shape ownership and usages of MGRs for the global community of stakeholders. The post sketches out some of the broader implications of this governance setting by drawing parallels to current controversies about the global distribution of COVID-19 vaccines. Throughout both cases, we show how combined attention to both fairness and efficiency of knowledge governance frameworks is necessary for the successful design of international treaties and associated institutions.
Our discussion is largely informed by the recently published MARIPOLDATA publication “Who owns marine biodiversity? Contesting the world order through the ‘common heritage of humankind’ principle” (Vadrot et al., 2021) and the MARIPOLDATA Ocean Seminar webinar from January 27, 2021, with Dr. Konrad Marciniak (Director of the Legal and Treaty Department, Ministry of Foreign Affairs of the Republic of Poland).
Key Arguments
| MGRs and IPRs are key issues in the BBNJ negotiations, which raises a variety of questions about the global governance of knowledge resources. |
| When approaching the governance of knowledge resources, countries should measure the possible avenues against the two factors: fairness and efficiency. |
| The application of IPRs to medical research is neither fair nor efficient. |
| Leaving MGRs to the applicable IPRs system is not fair, as it increases inequality concerning the access to and use of MGRs. |
| Current approaches to govern knowledge on MGRs through ABS systems do not seem efficient because they increase the administrative burdens on scientific research. |
| The BBNJ treaty could usefully differentiate between public and private research in governing knowledge resources. |
Knowledge Governance in BBNJ
The high seas and their organisms remain to a large extent unexplored and unknown. From what is known, however, genetic materials of high and deep-sea organisms can play a fundamental role in fighting diseases and conducting economically valuable pharmaceutical research (World Resource Institute; The Maritime Executive). For instance, COVID-19 rapid tests have been developed using materials from deep-sea bacteria. The drug Remdesivir, an antiviral approved as a treatment for Covid-19 by the U.S. Food and Drug Administration, draws substantially on genetic information extracted from sea sponges (The Maritime Executive).
The current negotiations towards a new BBNJ treaty aim to set rules and strengthen cooperation in researching the High Seas and conserving and sustainably using its biological resources, including MGRs. Introducing such rules and forms of cooperation has become an increasingly important agenda, as the current lack thereof led to conflicts amongst states and other stakeholders in the past (Vadrot et al., 2021). Within the BBNJ, this topic is addressed in the package on MGRs and in discussions about ABS related to these resources.
Most of the value to be gained from MGRs does not lie in the physical samples or the organic materials themselves, but in the scientific knowledge about marine organisms and their genetic makeup. Hence, international governance and cooperation in the context of MGRs is very much a matter of fair and efficient use of knowledge about the oceans – a matter of ‘knowledge governance’ in this sense.
Fairness and Equality in MGR Research
Knowledge about MGRs is politically salient because of its potential economic value and incredibly unequal global distribution (Blasiak et al., 2018). Research into MGRs is costly and requires a high level of investment and scientific capacity – something that only a few countries in the world can afford. It is no secret that “to date, mostly high-income countries have had the financial and other relevant capacities required to conduct marine genetic research and commercial activity associated with the ocean genome” (World Resource Institute). However, the “exploration and sampling of the ocean genome are often conducted in low- or middle-income countries’ ocean territories”, or in ABNJ under no country’s jurisdiction (World Resource Institute). Most countries “lack the resources to undertake the research themselves or to access and use the rapidly growing databases of genetic sequence data” (World Resource Institute). This lack of resources and infrastructures for exploring marine biodiversity has caused a global gap in research (Tolochko & Vadrot, 2021) and the issuing of patents covering MGRs (Blasiak et al., 2018). Exemplifying this, research has demonstrated that 47% of globally registered patents on marine genetic sequences are held by one German company alone (BASF), and 98% of all patent sequences belong to actors in 10 countries, with 165 countries holding none (Blasiak et al., 2018).
Some academics assess the practice of patenting MGRs as contributing to a trend towards more and more exclusive property rights to valuable ocean resources (e.g. Schlüter et al., 2020). Unsurprisingly, countries that cannot participate in this process are highly critical of how these knowledge resources (which may reasonably be considered as global common goods) are made artificially scarce and exclusive through this current lack of a clear governance regime. Thus, demands for more global equality have taken a central role in debates related to the MGR chapter in the BBNJ negotiations (Vadrot et al., 2021). Developing countries have proposed to declare MGRs as Common Heritage of Humankind, which has caused heated arguments throughout the negotiation rounds without any hint to compromise. In his MARIPOLDATA Ocean Seminar presentation, Dr. Konrad Marciniak pointed out that the legal interpretation regarding the opposition between the Common Heritage of Humankind Principle and the Freedom of the High Seas Principle currently remains unclear (Marciniak, 2017, 2020)[2]. Developing countries have argued that the absence of a clear legal interpretation contributes to existing disparities between the global North and South, to the extent that the successful negotiation of the BBNJ agreement hinges on the question of MGRs. In this context, some countries loudly question the global economic order and its fairness (Vadrot et al., 2021).
Efficiency and a Strong Access and Benefit Sharing System
Highly complex ABS systems that are internationally enforced may, however, run the risk of being inefficient. MARIPOLDATA’s observations of the BBNJ negotiations about MGRs show that developing countries favour a strict and enforceable ABS system for MGRs from ABNJ. For instance, the group of Latin American countries (CLAM) proposes a strict tracing of digital sequences through a unique identifier. CLAM sees this as the only way to ensure an effective governance system. To institutionalize this, they propose a mandatory, open, and self-declaratory electronic system in the Clearing-House Mechanism (CHM). This would mean that the CHM includes information on every sample of MGRs taken from ABNJ, filing a unique identifier per sample (and of genetic variants).
An ABS system can only be efficient if it is accepted and used by the scientific community. Representatives of scientific organizations have publicly voiced concerns over a potential ‘over-bureaucratization’ of research that the establishment of new “super” databases and the monetization of access to samples would entail. If all MGRs samples collected from ABNJ need to be registered and identified by the CHM, this may introduce considerable administrative burdens (Rabone et al., 2019). The Nagoya Protocol, which established a rather rigid ABS system, is often cited as a negative example, as it has complicated the access to genetic samples (from land and national waters). In this regard, many researchers stress the substantial difference and intensity of work that lies between biodiversity sampling and the creation of patentable biotechnologies. This ‘gap’ “may have been overlooked during the negotiations and subsequent implementation of the Nagoya Protocol, resulting in an ABS system that often comes at the expense of research for knowledge and conservation” (Arnaud-Haond, 2020, p. 29). Such a system could increase fairness but at the expense of making research inefficient and more complicated.
The argument for IPRs, in particular patents, is that they encourage innovation and safeguard investment in research and development (Posner & Landes, 2003) while being an efficient – market-driven governance tool. The IPR approach is assumed to be efficient because researchers look for property right protection on their own initiative, which in turn assures them the protection of their scientific advancements and secures necessary funding. Hence, IPRs are argued to incentivize scientific research. This has been voiced by many states in the BBNJ negotiations (USA, EU, Japan) that highlight that the conduct and freedom of marine scientific research are paramount to the new agreement.
The efficiency argument for IPRs, however, has become increasingly criticized in recent years. A variety of studies (Baker, Jayadev, & Stiglitz, 2017; Benkler, 2004; Stiglitz, 2006) have shown that an IPRs approach does not necessarily increase innovation but may actually slow it down and increase research costs by forcing researchers to negotiate licensing fees with holders of related patents. Patents are indicated to be responsible for higher prices and monopolies (Benkler, 2004; Heller & Eisenberg, 1998).
Fairness and Efficiency in the context of COVID-19 vaccines
The trend towards more and more exclusive or privatized IPR regimes in the governance of knowledge resources not only takes place in the context of MGRs, but also shapes current controversies about the global distribution of COVID-19 vaccines. In this section, we discuss some of these parallels to clarify the importance of critically evaluating knowledge governance regimes in terms of their efficiency and fairness.
Is the Proprietary Approach to Vaccine Development fair?
The COVID-19 pandemic has cost millions of lives, crippled the economy across the globe, and caused the delay of the BBNJ negotiations, as the fourth and final Intergovernmental Conference (IGC) had to be postponed. Currently, the roll-out of COVID-19 vaccines is a reason for hope (also for the next BBNJ IGC scheduled for August in New York), but also bears potential for conflict. Once again, global inequalities in access to vaccines are widely discussed in many intergovernmental institutions (The Economist; Fortune; UN). Tendencies for countries to prioritize their own access has led to what the new head of the World Trade Organization (WTO), Dr. Ngozi Okonjo-Iweala, has called – ‘vaccine nationalism’ (BBC; Gostin, 2020). Sources estimate that some African countries may receive doses of COVID-19 vaccines only by 2023 (The Economist). Some observers have linked this disparity in access to vaccines to how developed countries have successfully enforced patent protection on vaccines (New York Times). The chief of the World Health Organization (WHO), Tedros Adhanom Ghebreyesus, has stated that “even as vaccines bring hope to some, they become another brick in the wall of inequality between the world’s haves and have-nots” (UN). This observation has not only been heavily discussed within the WHO, but also in many big news outlets (The Economist; Fortune; New York Times), as well as amongst state representatives, health professionals (The Lancet), and NGOs (Médecins Sans Frontières).
This fear is largely triggered by the observed mismatch between demand and supply from the companies licensed to produce the vaccine. There is almost universal demand, but the supply currently does not suffice to even quickly vaccinate substantial parts of the population in wealthy developed countries. It appears that this mismatch is caused by the fact that vaccines against COVID-19 are subject to patents, which means that the vaccine cannot be freely reproduced (Hensher et al., 2020). The companies holding the patents (and knowledge over the Standard Operating Procedures (SOP) that are necessary to produce the serum) have the exclusive right to produce and sell the vaccine. This situation is causing increased criticism of the current practice of licensing and patenting under which the pharmaceutical companies holding the patents (and knowledge over the SOP) occupy a powerful monopolist position. Critics accuse pharmaceutical companies of abusing their monopolist position – of “choosing profits over human lives” (Zeit).
The fact that a small number of private companies hold patents over these vaccines is questionable, particularly because large amounts of public funding have flown into their research and development. The US has poured an estimated 10.5 billion $ into the research of COVID-19 vaccines (Scientific American). The Moderna vaccine emerged out of a cooperation between the company and the National Institutes of Health in the US (NIH). The EU and its Member States invested 9.8 € billion, out of which 1.4 € billion came directly from the European Commission. The Pfizer-BioNTech vaccine received substantial funding in its development phase from the EU and German public sources (European Investment Bank). AstraZeneca also holds exclusive licenses with no commitment to public access for publicly funded vaccines developed by Oxford University’s Jenner Institute (Hensher et al., 2020). The BBC estimates that public funding substantially supported the research that produced current COVID-19 vaccines. Without heavy public funding, the vaccines would likely not have been developed by now. However, these public investments have not precluded companies from adopting exclusive patenting practices.
This proprietary approach to vaccine development (i.e. an approach that focuses on establishing exclusive patents on pharmaceutical processes and products) has come under fire from different sides. A group of socialist EU lawmakers sent a letter to the European Commission urging the EU executive to explore ways of suspending patents for COVID-19 vaccines, calling it a “moral imperative”. Greece had proposed to the EU member states to jointly buy the patent rights for the COVID-19 vaccine – hence to communalize the patents (Reuters).
Is the Proprietary Approach to Vaccine Development efficient?
Some commentators argue that this proprietary approach has, in fact, slowed down research and development. The behaviour of the Wuhan Institute of Virology at the start of the pandemic is a good case in point. While being located in the epicentre of the pandemic, this institute issued a patent application (in February 2020) on a drug called Remdesivir, even before scientists investigated its effectiveness against COVID-19 (Bonadio & Baldini, 2020). The institute’s first instinct was, instead of sharing crucial data on the virus and giving other research institutes a heads up, to patent a possible treatment. Because of such informational gatekeeping practices, companies and research institutes competing to develop COVID-19 vaccines likely have to replicate basic elements of already existing research, hence, replicating fixed costs, which leads to a higher price of the product (Hensher et al. 2020). This can hamper, or at least slow down the global roll-out of vaccines, increasing the likelihood that the virus will evolve new vaccine-resistant strains (Hensher et al.; 2020).
Observers are also sceptical about how necessary IPRs are for encouraging research and development related to vaccines. For instance, the VFA (Verband Forschender Arzneimittelhersteller), one of Germany’s biggest research-focused drugmakers, argues that IPR protection for COVID-19 vaccines is not necessary for companies to ensure profitable returns on their investments into vaccine development (Bloomberg). This is due to the sheer size of the market: possibly more than 8 billion people need the product. In light of these economic perspectives, companies would be highly incentivized to develop the necessary knowledge and technologies, even if IPRs were not ensured due to the urgent necessity for these products on a global level.
Ways forward – what BBNJ can learn from the COVID-19 crisis
As we have shown in this post, international debates about MGRs and COVID-19 vaccine development revolve around a multitude of similar political and economic issues. We have argued that the global COVID-19 pandemic while being catastrophic in its own right, provides an opportunity for evaluating and possibly improving existing governance regimes. We have discussed the two dimensions of fairness and efficiency as important points of consideration for any possible institutional adjustments. In closing, we point out a few concrete avenues for policy makers to follow in addressing existing deficiencies and designing future-oriented knowledge governance frameworks.
Compulsory licensing
In the context of COVID-19 vaccines, countries such as South Africa and India are pushing for an alternative approach to intellectual property under WTO rules, known as “compulsory licensing” (CNBC). A compulsory license suspends the monopoly effect of a patent holder to produce and supply the product. While controversial, compulsory licenses allow eligible drug-makers to legally manufacture and sell copycat versions of patented drugs during national emergencies, public health crises, or in other instances of extreme need. “As a form of compensation for the original patent holder, the competent authority […] would require manufacturers to pay a fair market price” for the drug (Bonadio, 2020, p.391). When it comes to developing countries that do not have access to COVID-19 vaccines, the EU is willing to discuss several patent options in the framework of the WTO (Euractiv). Under WTO rules, the granting of compulsory licences without the patent owner’s consent can be fast-tracked in emergencies such as the current pandemic.
While compulsory licensing has some potential to enhance fairness and efficiency in the development and distribution of vaccines for the global population, it should probably not be considered an all-in solution for a number of reasons. Granted cases of compulsory licensing seem to be largely based on voluntary commitments from the industry and to emerge as ad-hoc legal solutions to these structural problems. In the long run, we may need a system that fosters knowledge sharing not only in such extreme cases as a global pandemic but also in normal situations. Additionally, we may ask why no compulsory licences on COVID-19 vaccines have been granted to any country so far. Indeed, developed countries within the WTO are currently blocking these proposals to protect their pharmaceutical industries (New York Times), which is indicative of the political dynamics within the WTO.
Open knowledge commons approaches
Other voices have called for substantial reform of global health law to guarantee more equal access to scientific progress (Gostin, Karim, & Mason Meier, 2020), for instance by formulating access to vaccines as a universal human right (Gostin et al., 2020). Related to this idea are various other discourses in the context of MGRs, framing them as ‘open knowledge commons’, ‘global public goods’, or as ‘common heritage’ (Gostin et al., 2020; UN[3]). As described throughout this post, particularly Southern countries advocate ideas of open knowledge commons, while countries of the Global North tend to oppose them.
Knowledge sharing: scientific vs. economic
Another possible consideration for the design of knowledge governance frameworks is the possibility to differentiate between public and private research. In the context of the BBNJ negotiations, public research could potentially be excluded from any access or benefit-sharing regulation as long as the data would be freely available. To facilitate more equal access to research and its outcomes, intensive capacity building needs to be undertaken to allow developing countries to reduce the research gap. At the same time, scientists’ preferences should be reflected in the Treaty draft text. In relation to the CHM, scientists prefer a sort of meta-database that streamlines “processes by providing documentation, guidance, and links to existing platforms and databases relevant to MGR” (Rabone et al., 2019; p.17). They also advocate voluntary commitments to a set of common principles, such as FAIR data and open access (Rabone et al., 2019; p.17).
While these principles and the policy of open data sharing are well established in most scientific contexts, this is not the case for the economic sector and research undertaken therein. The difference between scientific and economic research practices may be well exemplified in the COVID-19 case: “While genomic information on SARS-CoV-2 has been extensively shared amongst a worldwide network of researchers (Nature), current efforts to develop more than 150 candidate vaccines for COVID-19 are highly fragmented (Lancet)”. It is indeed likely that salaried scientists are motivated to work for the public good and tend to see data sharing and open knowledge as incentivizing to improve their research, while private research is much more profit-oriented (Hensher et al., 2020). International policymaking could benefit from recognizing this difference when designing treaties, for example by encouraging forms of peer-to-peer (P2P) generated and publicly funded research and development with an orientation towards the benefit of humankind.
Entering the digital age, the questions presented in this blog will only engrave, which means that fair and effective knowledge-sharing solutions are urgently required. As we discussed in this blog, ongoing information gatekeeping practices in the production and distribution of the COVID-19 vaccine are already driving conflicts between states and world regions. For the BBNJ negotiations, the case of the vaccines may serve as an important call for seriously considering the dimensions of fairness and efficiency in the governance of MGRs. If successful, the BBNJ treaty can become a role model for subsequent knowledge and information-sharing frameworks at the international level, reaching far beyond the immediate issues of ocean governance. More so, it can become an example of global solidarity and serve to counteract some of the existing global inequalities in relation to knowledge resources.
[1] The Convention on Biological Diversity (CBD) defines genetic resources as genetic materials of plants, animals, or microorganisms of (potential) value for future generations of humanity (CBD workshop, Ottawa 2009).
[2] All views expressed by Dr. Konrad Marciniak are personal only and do not necessarily represent the official position of the Government of Poland.
[3] United Nations, Committee on Economic, Social and Cultural Rights, General comment No. 25 (2020) on science and economic, social and cultural rights (article 15 (1) (b), (2), (3) and (4) of the International Covenant on Economic, Social and Cultural Rights), Geneva: United Nations; 2020, U.N. Doc. E/C.12/GC/25.
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