- The Convention on Biological Diversity and its subsequent Nagoya Protocol regulates access and utilisation of biological resources and the associated Traditional Knowledge.
- Subject to national legislations, they mandate fair and equitable sharing of commercial benefits with the country of origin, when commercial products such as vaccines or medicines, result from research on genetic resources such as clinical samples, microbial cultures or DNA sequences.
- Open access to genetic resources, where biological materials could be freely accessed and shared, is inevitable to address the multifaceted crisis faced by the planet earth, argue Prathapan K. Divakaran and Priyadarsanan Dharma Rajan in this commentary.
No virus respects national boundaries or sovereign rights of nation states. Yet, citing issues of equity in Virus Sharing Mechanism, Indonesia decided to withhold the virus samples of avian influenza from the World Health Organisation (WHO), after the outbreak of the extremely dangerous flu (mortality of 81%) in that country in July 2005. The revised International Health Regulations (IHR), adopted in 2005 by the WHO (IHR 2005), mandates that “during the spread of a Public Health Emergency of International Concern (PHEIC), the State Parties provide WHO with samples for surveillance purposes without preconditions or expectations of benefits in return.” However, the stand-off continued through most of 2007, till an agreement was reached at the World Health Assembly emphasising “transparent, fair and equitable sharing of the benefits arising from the generation of information, diagnostics, medicines, vaccines and other technologies”. Indonesia’s claims of sovereignty, particularly at a moment of crisis, delayed surveillance and mitigation for almost a year, threatening global public health, thanks to the contentious provision of Access and Benefit Sharing (ABS), among the three objectives of the Convention on Biological Diversity (CBD) adopted by the nations of the world at Rio de Janeiro, in 1992.
Global pandemic and the CBD
The CBD and its subsequent Nagoya Protocol (NP) regulates access and utilisation of biological resources and the associated Traditional Knowledge (TK) globally. Subject to national legislations, the NP mandates fair and equitable sharing of commercial benefits with the country of origin, when commercial products such as vaccines or medicines, result from research on genetic resources such as clinical samples, microbial cultures or DNA sequences. Thus, any plant, fungus or microbe with therapeutic value, or a pathogen or knowledge associated with it, is a source of monetary benefits for the country or the community where it has originated.
Due to the high expectations on the commercial value of the native biological resources, the megadiverse countries of the world have imposed stringent legal measures for sharing biological resources and the associated knowledge across borders. These restrictions have largely stifled research in agriculture, public health and biodiversity conservation.
Indonesia’s refusal to share the samples of avian influenza virus with the WHO, invoking the CBD, and the resultant crisis in the global public health surveillance and mitigation, is only an indication of the fallouts of CBD, which established sovereign right of the nation state over biological diversity. As the Global South successfully negotiated for and included Access and Benefit Sharing (ABS) as one of the three objectives of the CBD, they are entitled to take legislative, administrative and policy measures to regulate the access and share benefits arising from the commercial utilisation of biological resources through appropriate mechanisms.
The timeline of the current global pandemic COVID-19, which has already resulted in more than a million deaths, infected 39.9 million (as of 19 October 2020) and is continuing its spread, follows a different trajectory. China informed the WHO about the mysterious pneumonia on 31 December 2019. The virus was identified on 7 January 2020 and the Chinese authorities shared the genetic sequence of the novel coronavirus on 11 January 2020. On 13 January 2020, the U.S. National Institute of Health (NIH) and Moderna finalised the sequence for mRNA – 1273, the candidate vaccine against the virus. On 7 February 2020, the first clinical batch of the vaccine was completed, on the 28th day of virus sharing. On 16 March 2020, the NIH announced that the first participant in the Phase 1 study for the vaccine was dosed, a total of 65 days from the sharing of the virus sequence by the Chinese authorities to the first human dosing of the experimental vaccine.
The COVID-19 pandemic, as against the avian influenza outbreak, witnessed the free exchange of information and technology across the globe, which has been greatly contributing towards its management. Most countries have openly shared the virus sequences and information in the global fight against the pandemic. This is promoting research across continents to develop vaccines and drugs to combat the pandemic, which is likely to result in the development of several vaccines and drugs. This will increase the treatment options available to the world and effectively curtail the monopoly of any one company or country.
Biodiversity Access and Benefit Sharing
The existence of genetic resources beyond the domain of national authority facilitated free exchange and utilisation across national boundaries, which was crucial in mitigating disease and hunger throughout the developing world. Yet, it is a historical anomaly that the developing world pushed for the nationalisation of genetic resources (GR) in the CBD.
Biodiversity Access and Benefit Sharing (ABS), initially conceived as a means of realising a share of the profit gained by the multinational companies of the wealthy, biodiversity deficient but technologically advanced countries, has clearly failed in both theory and practice. ABS models such as the Jeevani (Indian ginseng) of the Kani tribe in India, Merck-INBio deal in Costa Rica and the San-Hoodia in Africa have vividly demonstrated that the expectation of financial gains through ABS is unrealistic. Nearly all biodiscovery stories and examples of ABS partnerships from all over the world relate to marginal arrangements, of very little financial significance, for the use of biological material.
The high expectations of commercial benefits from biodiversity management through the ABS regime are gradually fading after 25 years of CBD, while the CBD itself has turned out to be a hurdle in the scientific study, conservation and utilisation of biodiversity for improving the livelihood of people across the globe.
Intellectual Property Rights and Traditional Knowledge
Ambiguity and disputes over ownership of biodiversity and the associated traditional knowledge (TK) make benefit-sharing complex and imprudent. Claims for Intellectual Property Rights (IPR) on Traditional Knowledge (TK) follow the same logic as for IP protection of new inventions through patenting. The system of patents endows the patentee with exclusive rights for a tenure of only 20 years, while the same seeks perpetual rights on TK which itself is lacking in both inventiveness and novelty. TK is a common pool of knowledge as its origin and ownership are uncertain and prone to dispute. Infinite IPR on common knowledge would drastically curtail research and innovation.
Quinine is the first known plant-derived medicine used in the treatment of an infectious disease. This anti-malarial drug, the forerunner of Hydroxychloroquine (HCQ), now being revived as a candidate drug against viral diseases, including COVID-19, has an interesting history. The original range of distribution of cinchona includes countries such as Bolivia, Ecuador, Peru, Colombia and Venezuela. There is no certainty about the native Indians who shared the indigenous knowledge regarding the therapeutic value of cinchona bark. It is said that natives of Peru shared this with the Spanish. However, Cinchona ledgerianum, which is used for the commercial production of quinine, is originally native to northern Bolivia. In case IP Rights have to be realised for the TK on the therapeutic value of cinchona bark and its derivatives, there could be multiple countries and indigenous groups associated with TK, as the origin is ambiguous. Similarly, the IP Rights could be easily extended to the synthetic derivatives of quinine such as chloroquine and hydroxychloroquine, since the therapeutic use of these synthetic chemicals too, is based on the TK of the medicinal property of the cinchona bark. The history of quinine, its therapeutic use and further development of derivatives, all point to the need for treating TK as common knowledge that would benefit humans across national boundaries. In this case, the TK on cinchona has alleviated the sufferings of generations of humans, especially from the Global South.
Open access to Genetic Resources
Intrinsically, biological resource is a public resource – non-rivalrous and non-exclusive – much similar to knowledge resources. This very fact mandates that GR be retained as a common heritage. The spread and development of human civilisation are intricately associated with the sharing of GR. Humans, as a biological species, depend more or less on the same genetic resources for survival, irrespective of national boundaries, and have hence taken along their pool of plants and animals all through their migrations and invasions. Thus, open access to genetic resources, where biological materials could be freely accessed and shared, is inevitable to address the multifaceted crisis faced by the planet earth, our only home. Hence it is imperative that GR is brought back to the common heritage of humankind.
Establishment of sovereign rights over genetic resources undermines its transnational sharing and distribution. Evidently, for any society, the benefits of unbridled access to genetic resources far outweigh that of restricted access and benefit-sharing. National legislations governing access to biodiversity often tend to be excessively restrictive, and thus even undermine the objectives of the CBD. The COVID-19 pandemic has not only exposed the limitations of CBD and NP, but also underscores the necessity of open sharing and access of genetic material and information.
Priyadarsanan Dharma Rajan is a senior fellow at the Ashoka Trust for Research in Ecology and the Environment (ATREE) and K. Divakaran Prathapan is a faculty member at the Kerala Agricultural University (KAU).
Banner image: Tribal life depicted in murals. Photo by Md Khurshid.