From the exclusion of pathogens from the international regime of ABS to its acknowledgement

Access to pathogens and benefit sharing arrangements have historically been informal, and have operated on the assumption that a party with custody over the pathogens also has the right to manage their use and disposal. For these reasons, most pathogens have been shared without written documentation on appropriate management and use, or without having obtained formal approval from national authorities.

The need to formalize access and sharing arrangements arose from a number of international political and professional developments that mainly revolved around concerns over transparency, fairness and equity, and trust. In international law, fair and equitable access and benefit sharing (ABS) arrangements for primarily non-human genetic materials have been emphasized by the CBD and the NP. Where human biological or genetic materials are concerned, separate but related developments in the context of influenza prevention, countermeasures and control have underscored a similar theme. Collectively, these developments have led to a call for systematization of requirements for ABS in relation to all genetic or biological materials, whether of human or non-human origin. In the section that follows, we first consider the ABS mechanism in the CBD and in the NP and its normative impact on practices in relation to non-human genetic or biological materials. We then consider a number of specialized access and sharing practices that have emerged in relation to specific human pathogens. This section concludes with an argument for the establishment of a framework under the NP as a comprehensive system for ABS that applies to both human and non-human pathogens, whether in material or de-materialized form.

Convention on biodiversity-NP framework

The CBD sets out as a key obligation the fair and equitable sharing of benefits from the use of genetic resources. The NP expands on the provisions of the CBD concerning access to genetic resources and traditional knowledge, and sharing of benefits that arise from them. The CBD as well as the NP, apply to the use of genetic resources and related traditional knowledge, and to the benefits that arise from such use. Under the protocol, access is subject to the informed consent of the country of origin and only on the basis of mutually agreed terms that include fair and equitable sharing of benefits arising from the genetic resources utilized. In order to access genetic resources, prior informed consent must be obtained from the relevant authorities (which would in practice be the local CBD National Focal Point or NP focal point) in the country of origin, and on terms that are mutually agreed. Benefits that arise from the utilization of genetic resources could be monetary or non-monetary, and may include joint ownership of intellectual property and acknowledgement of contributions, to system-level initiatives that support public health, provide access to affordable treatments or build capacity.

Regarding EIDs and according to the great benefit that could result from the study of various scientific collections, we should consider the implications of the NP. For instance, a voucher specimen that is composed of a material of plant, animal, microbial or other origin containing functional units of heredity will fall within the NP framework. A voucher, broadly defined as a representative sample of an expertly identified organism that is deposited and stored at a facility from which researchers may later obtain for examination and further study, is clearly critical for authentication and identification. Increasingly, academic publications require the submission of vouchers as a condition for the publication of articles (Schindel et al. Reference Schindel, Miller, Trizna, Graham and Crane2016). As the voucher would usually include certain information like the name of the person who collected the specimen, the date of collection, the habitat of the collection site and locality of the site, vouchers deposited over time form a valuable database that can be used for additional research. These vouchers could also be used to build barcoding reference libraries, as they are accompanied by richer and higher quality data. Biobanking arrangements or more broadly scientific collections could also expand barcoding datasets through the addition of new barcoding markers. Molecular and DNA vouchers could help link individual studies with other studies and inferences, and thereby greatly enhance taxonomic identification. While it seems clear that a specimen or morphological voucher falls within the scope of the NP, it is less clear if an e-voucher (i.e. a digital object that serves as a voucher), a molecular voucher or a DNA voucher could be accommodated within the CBD or the NP. Regarding specifically the use of digital sequence information, the CBD requested an ad hoc technical expert group to study the implications of this type of use in relation to the objectives of the CBD and the NP (CBD COP Decision 13/16, Digital sequence information on genetic resources and corresponding NP MOP Decision 2/14).

One view is that, like pathogens, it would be at the discretion of member states to determine if the implementation legislation should be sufficiently broad to cover such entities in material or de-materialized form. Hence, while the CBD or the NP do not explicitly include pathogens in its definition of genetic resources, the European Union (EU) has included it in its implementation regulation that is binding on all its member states (EU Regulation 511/2014). A shortcoming of this approach is that it could potentially hinder legislative harmonization that is necessary to enable access and sharing of materials and data across different jurisdictions. It is for instance, unclear if a EU member state is required to observe its commitments under the NP if it is to receive a pathogen from another jurisdiction that is not a signatory to the framework. It is further unclear if a non-EU party that has not contributed to the genetic resource pool within the EU should be allowed access, and if so, at what degree of priority in comparison with other EU entities. Until and unless there is a harmonized framework with normative requirements that apply to all parties, the default position appears to be bilateral ABS agreements, the utility of which may be limited by the lack of technical capacity or competence on the part of some jurisdictions and the high transaction costs that could be entailed.

Public health context and the role of the WHO

Different ABS schemes have emerged in relation to pathogens of public health concern. These schemes are directed at infectious diseases, and emphasize ongoing surveillance, timely risk assessment, implementation of public health control measures and access to medical interventions. Among these schemes, the WHO coordinated system of laboratories known as the Global Influenza Surveillance and Response System (GISRS) is the most developed and advanced. Information and materials from this network are used by vaccines manufacturers to produce influenza vaccines. In 2011, the GISRS was strengthened by the adoption of the Pandemic Influenza Preparedness (PIP) Framework by the World Health Assembly (World Health Organization, 2011, sections 5.1.1 and 5.1.2). The PIP Framework was established to share H5N1 and other influenza viruses with human pandemic potential, alongside assurance of access to vaccines and other (therapeutic) benefits. While the legality and legitimacy of the PIP framework are premised on the International Health Regulation, it has been argued to be consistent with the requirements of the NP and should, therefore, be regarded as a specialized international access and benefit-sharing instrument under Article 4.4 of the NP. Nevertheless, it should be highlighted that the study of the WHO on the implementation of the NP was contentious at the CBD COP of 2016 (personal communication of an anonymous referee) and resulted in an intersessional process to determine the criteria to identify what constitute a specialized international access and benefit-sharing instrument (NP-MOP, Decision 2/5 Cooperation with other international organizations, conventions and initiatives, 2016, para. 3). More specifically, the sharing of influenza or non-influenza pathogen should be based on core principles that include fairness, equity and protection of global public health.

Indeed, in a study on how the implementation of the NP might affect the sharing of pathogens and the potential public health implications, the WHO Secretariat recommended improving the harmonization between the NP and existing pathogen-sharing systems (World Health Organization, 2016b). The latter includes establishing new or specialized access and benefit-sharing instruments under the NP, introducing implementing legislation that supports public health (especially under Article 8(b) in response to present or imminent emergencies of a national or international scale) and raising awareness for as well as supporting international collaboration. In addition, the creation of a code of conduct for pathogen sharing to promote access for public health purposes, particularly when use is non-commercial, was proposed.

The basis of sharing of pathogens that are not directly of public health concern remains unclear due to a number of challenges that include: (1) uncertainty regarding the scope and implementation of the NP; (2) the high transaction costs of implementing a bilateral system for access and sharing; and (3) the complexity of varying domestic ABS legislations. Even where the pathogens are of public health emergencies of international concern (PHEICs), sharing was impeded by lack of clarity over which government entity could grant access to the pathogens after transfer, whether intellectual property rights could be sought over the pathogens, and whether benefit-sharing could be linked to access.

Interestingly, the WHO Secretariat noted that although WHO has not often been directly involved in negotiating a material transfer agreement (MTA) or a memorandum of understanding (MoU) to that effect, its involvement as a coordinator has reportedly led to increased regard for equity in the negotiation of bilateral instruments and the inclusion of benefit-sharing terms (World Health Organization, 2016b, p. 21). It is difficult to reconcile this position to the challenges (like high transaction costs for instance) that it identified, as well as its proposed actions including the use of standard contractual templates, which would be supported under Article 19 of the NP. Contractual templates that are applied within one context would only be practicable if another context is sufficiently similar. Likewise, such templates will be difficult to devise if the nature of access, benefit and sharing are diverse and difficult to adequately relate to each other.

Pathogens sharing and associated data: implementation of the NP and issues at stake

Insisting on the fact that the PIP Framework offers helpful insights for the sharing of other pathogens that require a rapid response and for the equitable sharing of benefits, the 2016 report suggested to adopt the pragmatic approach and to use ‘the PIP Framework or similar existing agreements as a template for creating new agreements for other infectious agents that have caused, or may potentially cause public health emergencies of international concern’ (WHO, 2016b).

As we have seen in part 2, pathogens fall clearly within the scope of the NP. If there is an emphasis on access to human pathogens for public health preparedness and response purposes in NP Preamble, the Protocol does not exclude non-human pathogens.

It shows that while the debates have been intense regarding the integration of pathogens just before the adoption of the NP, the concrete implementation of the NP regarding pathogens sharing is not clearly stated yet. Moreover, while the WHO precise the public health implications of the NP, there is a little study on the specific consequences of the NP on pathogens sharing in the specific context of non-commercial research.

Interestingly, the Secretariat of the Convention on Biodiversity will use the report of the WHO on how the implementation of the NP might affect the sharing of pathogens and its potential public health implications available for further study and examination during the third meeting of the Parties to the NP in 2018 (cf. NP-MOP, Decision 2/5 Cooperation with other international organizations, conventions and initiatives, 2016).

The report (2016) distinguishes the sharing of influenza pathogens, which combines two different but supportive regimes, the Global Influenza Surveillance and Response System (for seasonal influenza) and the PIP framework (influenza viruses with human pandemic potential), and the sharing of non-influenza pathogens.

It specifies that the sharing of non-influenza pathogens can occur on an ad hoc bilateral basis between researchers: conditions of access are then agreed to by the two researchers most of the time through a formalized agreement. It can also take place through an existing network of institutions and researchers on pre-arranged terms, through MTA or MoU.

The report notices a greater awareness of the importance of involving local researchers (from the country where the fieldwork is conducted) in collaborative research projects and recognizing their contributions but it appears that there is a lack of detailed provisions regarding benefit sharing in relation to non-commercial research in the national provisions implementing NP. As we have seen in Access to pathogens and related data, the report explicitly mentions that the involvement of the WHO as a co-ordinator has led to an increased regard for equity in the negotiation of bilateral instruments, and the inclusion of benefit-sharing terms.

In a One Health perspective, it would be crucial to associate with the study on pathogens sharing other international organizations concerned by pathogen sharing such as OIE (World Organisation for Animal Health (OIE)) FAO (Food and Agriculture Organisation) or even UN Environment.

Indeed, in a Tripartite concept note FAO, OIE and WHO entitled ‘Sharing responsibilities and coordinating global activities to address health risks at the animal–human–ecosystems interfaces’ (FAO-OIE-WHO, 2010) committed to ‘working more closely together to align activities related to the animal–human ecosystems interfaces in order to support member countries’. This collaboration should include a common study on pathogen sharing and associated benefits sharing under the NP and a joint collaboration with the Secretariat of the CBD to get involved in the COP-MOP meetings (decision-making process of the NP) on those issues.

As a matter of fact, the One Health approach is acknowledged by the CBD and other conventions related to biodiversity such as the Convention on International Trade in Endangered Species of Wild Fauna and Flora and the Convention on Migratory Species. The Agreement between the OIE and the CBD signed in 2013 promotes a One Health approach to manage the risks presented by animal diseases and zoonoses at the animal–human–ecosystem interface. Moreover, in 2015 the WHO and the Secretariat of the CBD signed a MoU to strengthen their collaboration notably in raising awareness of the complex linkages between biological diversity, ecosystems and human health (Lajaunie and Mazzega, Reference Lajaunie and Mazzega2016).

The One Health approach has been described as a necessary « paradigm shift » in global health (Bousfield and Brown, Reference Bousfield and Brown2011). As such, the increasing acknowledgement of the need to coordinate activities and decision-making at the human–animal–environment interfaces is shown notably by a greater interconnection between CBD (UNEP), OIE, FAO and WHO (Lajaunie et al. Reference Lajaunie, Morand and Binot2015). It should be led further by a joint consideration of the issues related to pathogens sharing.

Furthermore, pathogens sharing go with a wide range of information related to these pathogens especially within the One Health framework: GIS (geographic information system) or geographic data, climatic data, environmental, biodiversity or socio-economic data (Walther et al. Reference Walther, Boëte, Binot, By, Cappelle, Carrique-Mas, Chou, Furey, Kim, Lajaunie, Lek, Méral, Neang, Tan, Walton and Morand2016; Webster et al. Reference Webster, Gower, Knowles, Molyneux and Fenton2016). This data collected at a large-scale, interconnecting various data systems leading to a mass production of data from various fields can be referred to as Big Data.

The numerous possibilities of interconnection of data, associating individual information when it comes to human pathogens, to a multitude of other information challenge the traditional view of legal and ethical issues related to biological samples sharing.

Legal and ethical issues through big data lenses

The issues associated with pathogens sharing at the interface between animal-human and the environment resides in the fact that different regulations frameworks apply to human health, animal health or environmental/biodiversity conservation.

Various issues should be discussed in that perspective: if the prior informed consent is quite clear for the obtaining of pathogens in human health, which institution or person should be contacted when domestic animals or wildlife are concerned? There is no common quality process when it comes to animal health or environment. Consents can limit the accessibility to pathogens so which kind of consents could be used for wildlife or animal health that would allow working on pathogens?

The three fields presented above rely on different protocols and distinct systems of the database (Lajaunie and Morand, Reference Lajaunie, Morand, Morand, Dujardin, Lefait-Robin and Apiwathnasorn2015). There is a need for clarification regarding consents and accessibility of pathogens at the interface between animal-human and the environment (see Box 1).

As we have seen, research on EIDs is already affected by Big Data (Floridi, Reference Floridi2012) and non-biomedical data are also widely used in the context of EID. The possibility given by technology to link various data from pathogens samples challenges the existing legal and ethical principles. It questions aspects of the traditional conception of samples collections or biobanks such as the notion of individual consent or the protection of personal data in human health or the failure to create standard methods of access and sharing when collections concern animals especially wildlife and the environment.

Fig. 1.

Framework of the regulatory paths to be taken by a researcher working on pathogens in an international setting depending on the research context.

Table 1.

Comparison of the advancements in norms regarding barcoding-biobanking and associated data (ebanking) and sets of regulation (law and ethics) in relation to public health, animal health and wildlife conservation

CITES, Convention on International Trade in Endangered Species of Wild Fauna and Flora; CMS, Convention on the Conservation of Migratory Species of Wild Animals

There are rules applying to:

• • The researcher: from the validation of the research project to the field work;

• • Samples and samples collections or biobanks: constitution of collections and their linked data and their storage and sharing rules;

• • Associated data: while data have been collected within a specific project framework, Big Data technology challenges the fact that data remain linked to a specific project.

In human medicine, legal frameworks, governance mechanisms and ethical principles are regulating the collect and use of samples to protect individuals as research subjects and their personal information. Legal measures and ethical principles depend on national legal systems and are case specific. Nevertheless, data strictly associated with the samples are increasingly proximate especially in genomic research. Samples are distinct from data but they carry data and thus they should be considered by law as ‘data carriers’ (Hallinan and De Hert, Reference Hallinan, De Hert, Mittelstadt and Floridi2016).

Thus, as underlined by Woolley, it is time to conceive a governance system where dataflow itself is a ‘de facto framework for research’ (Woolley, Reference Woolley, Mittelstadt and Floridi2016) with a significant role given to metadata on consent. It challenges the traditional view of a framework shaped by national or institutional boundaries: this innovative approach seems the only way for law and governance on biomedical consent not to lag behind the reality of the practice driven by the possibility to aggregate or compile various data on the long term.

It questions the notion of informed consent and calls for new forms of consent in line with the explorative nature of data-driven research, which is not compatible with a well-defined single research project. It brings to light the tension (Kaye, Reference Kaye2012) existing between open access to data and the need for consent and researchers called for ‘ethical metadata’ (De Vries et al. Reference De Vries, Williams, Bojang, Kwiatkowski, Fitzpatrick and Parker2014) or for metadata procedures taking ethical, legal and social issues (ELSI) into consideration. For instance, consistent metadata standards might be a way to address the issues of Big Data research in biology. They might allow policy makers, scientists, legal researchers, ethical committees and ICT scientists working together on these issues and delineate the best practices and metadata standards for information sharing (Capua, Reference Capua2016).