the art of covid

We learn to share. Yet we share things, many things without paying attention. We share our life with "our" microbiome without which we would have a difficult time to digest food.

We share food and food itself shares its bounty, to the point of "self-sacrifice", even if it does not know it. Life is about sharing and humans have to come to term with the management of sharing: open sharing, restricted sharing, patents, secrets, illusions, knowledge, food, shelter, etc. In the following article, the sharing of knowledge — without political acceptance nor denial of various level — is important. For whatever reasons, from altruism to profit for pharmaceutical industries, we try to increase our individual longevity. This can lead to decrease of our quality of life in our frailer years, as our brain isn't what it used to be — providing an opportunity for the "care" industry. Meanwhile, we are always under attack from various other genomic creatures who want to share a piece of us. This in turn will make us sick and degraded. We have thus developed systems of interventions to limit the damage, from vaccines to drugs — some on the border of lethality. 

Sometimes our own body "eats itself" when our immunity becomes hostile to ourself.  But sharing is still important. This comes in:

Policy opportunities to enhance sharing for pandemic research

The coronavirus disease 2019 (COVID-19) pandemic has demonstrated the critical importance and persistent challenges of rapidly sharing public health and scientific information, biological samples, and genetic sequence data (GSD). Sharing these resources is crucial to characterizing the causative agent, understanding its spread, and developing diagnostics, antiviral treatments, and vaccines. But even though these resources are critical for the global health community, there is currently no legal obligation for countries to share physical pathogen samples or associated GSD. To date, researchers have often shared such resources in a spirit of scientific openness. Yet ongoing scientific cooperation has been insufficient (1) despite the scale of the pandemic threat. The lack of a clear legal obligation to share pathogens or associated GSD during a health emergency represents a blind spot in international law and governance, impeding pandemic response and scientific progress. We examine the sharing of public health information, biological samples, and GSD in the still early days of the COVID-19 pandemic, identify barriers to sharing under the current international legal system, and propose legal and policy reforms needed to enhance international scientific cooperation.

On 10 January, scientists in China publicly uploaded the first genetic sequence of severe acute respiratory syndrome–coronavirus 2 (SARS-CoV-2) (2). Two days later, China officially shared the viral GSD with the World Health Organization (WHO) (3). The WHO praised China for sharing GSD less than 2 weeks after the first case cluster was reported on 31 December 2019 (3). The early availability of GSD enabled laboratories around the world to rapidly begin developing diagnostic test kits and launching research into antiviral medications and vaccines.

Since that time, thousands of SARS-CoV-2 sequences from around the globe have been uploaded to online databases such as GenBank and the Global Initiative on the Sharing of All Influenza Data (GISAID). These genetic sequences have helped to track the spread of SARS-CoV-2, determine which containment strategies have been successful, and monitor the emergence of adaptive mutations in the viral genome (1). Physical samples of SARS-CoV-2 were, however, unavailable until researchers in Australia isolated the virus from a traveler from Wuhan on 29 January and sent the isolate to the WHO and other laboratories (4).

The WHO's International Health Regulations (IHR, 2005) require all 196 States Parties to notify the WHO within 24 hours of all relevant “public health information” on any event that may constitute a Public Health Emergency of International Concern (PHEIC). The reporting obligation includes case definitions, diagnostic results, risk assessments, and case fatality data, as well as information on containment and mitigation measures. Countries could broadly interpret “public health information” to include GSD; however, WHO policy does not classify GSD as health information under the IHR, and States Parties do not appear to interpret “public health information” to include GSD (5). Furthermore, physical pathogen samples are not regarded as “health information” that must be shared with the WHO.

The main international instruments governing access to human pathogens were primarily designed not for public health, but to prevent the exploitation of biodiverse countries' genetic resources, ensuring that the benefits of research and development are equitably shared. The United Nations Convention on Biological Diversity (CBD, 1992) and its Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization (NP, 2012) recognize Parties' sovereignty over genetic resources within their borders. The CBD defines “genetic resources” as “genetic material of actual or potential value.” Genetic material is defined as “any material of plant, animal, microbial or other origin containing functional units of heredity.” These broad definitions are generally accepted to capture pathogens, including human viruses such as SARS-CoV-2 (6). However, the definitional focus on “material” suggests that Parties could interpret the CBD and NP to exclude the associated pathogen GSD.

These legally binding agreements allow countries to enact laws regulating access to their genetic resources and obtain a share of the benefits associated with their use (“access and benefit sharing” or ABS). The CBD and NP state that access to genetic resources should occur with the country of origin's prior informed consent and that such access should be on mutually agreed terms. Mutually agreed terms can include benefit sharing, such as recognition in publications, capacity building, training, intellectual property, and royalties. The CBD and NP default to a bilateral contractual arrangement between the provider party and the user party, negotiated on a case-by-case basis. In practice, the parties often negotiate a material transfer agreement (a contract governing the transfer of research materials), unless a specialized ABS instrument such as a multilateral agreement or framework exists for a specific category of genetic resources.

Although equity and fairness are common goals, the CBD and NP objectives are not necessarily aligned with the WHO's mission, especially during health emergencies where access to pathogen samples from multiple countries and for multiple users is time-sensitive. In these situations, negotiating a separate ABS agreement for each sample would result in high transaction costs and unacceptable delays. In December 2006, Indonesia refused to share H5N1 influenza virus samples with the WHO, claiming sovereign authority over these samples. Invoking the CBD, Indonesia argued for fairer distribution of vaccines and antivirals during influenza pandemics (7). In response, WHO Member States adopted the Pandemic Influenza Preparedness Framework (PIP Framework, 2011), a multilateral instrument that regulates access to influenza viruses with human pandemic potential and shares the benefits associated with their use, including diagnostics, vaccines, and antivirals. The PIP Framework was adopted as a nonbinding resolution, but provider and user parties agree to ABS terms through the use of standard material transfer agreements among provider nations, the WHO, and pharmaceutical companies and other users. The adoption of the PIP Framework meant that the ABS transaction cemented its place in global public health governance. Rather than treating these as separate issues, the PIP Framework has now linked access to pathogen samples to the reciprocal sharing of vital medicines and vaccines. Like the CBD and NP, the PIP Framework focuses on the sharing of physical samples. During negotiation of the PIP Framework, Member States specifically deferred consideration of GSD, and they have yet to reach consensus on how, if at all, GSD should interact with the Framework.

The PIP Framework and NP were negotiated concurrently by separate UN bodies—the World Health Assembly and the CBD's Conference of the Parties, respectively—but each influenced the other. The PIP Framework recognizes “the sovereign right of States over their biological resources,” using language influenced by the CBD. Despite contested negotiations, the NP did not explicitly address whether pathogens should be included within its scope, leaving it to countries to make future determinations. It did, however, include a special provision on “expeditious” ABS during “present or imminent emergencies that threaten or damage human, animal or plant health.” The NP Parties can determine whether and how to implement this special consideration in domestic legislation, such as delaying ABS documentation requirements during a PHEIC.

Read more:

https://science.sciencemag.org/content/368/6492/716

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