Info Service on Intellectual Property Issues (Jun19/02)
London 10 June (TWN): In considering the public health implications of the implementation of the Nagoya Protocol on Access and Benefit Sharing related to genetic resources, the first step should be to unpack the current modalities for pathogen sharing under the World Health Organization’s stewardship.
Several Member States stressed this during the 72nd World Health Assembly (WHA) that met from 20 to 28 May 2019 in Geneva.
The WHO Director-General’s Report to the WHA (A72/32) for the agenda item the “public health implications of implementation of the Nagoya Protocol” sought a more open and broad mandate in paragraph 13 of the Report stating “WHO is ready to explore, in close dialogue and collaboration with all relevant partners, possible options, including codes of conduct, guidelines and best practices, and global multilateral mechanisms, for pathogen access and benefit sharing. Such work would be done in harmony with the Nagoya Protocol and its principles, under the overarching framework of reaching the objectives of the health-related Sustainable Development Goals, and in furtherance of the objectives of the International Health Regulations (2005) and WHO’s Thirteenth General Programme of Work, 2019–2023”.
The agenda item was included on the 72nd WHA, at the behest of the WHO Secretariat during the Executive Board meeting in January.
However, for many developing country delegations participating in the WHA, the WHO’s proposed approach was a non-starter. They countered that the starting point for discussion should be the provision of more information by the WHO leading to the adoption of a decision text which states:
“The Seventy-second World Health Assembly, recalling the Convention on Biological Diversity and its objectives and principle, and the Nagoya Protocol on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising from their Utilization to the Convention on Biological Diversity and its objective; and reaffirming the WHO Constitution and the International Health Regulations (2005); and having considered the report by the Director-General on the public health implications of implementation of the Nagoya Protocol, decided to request the Director-General, to broaden engagement with Member States, the Secretariat of the Convention on Biological Diversity, relevant international organizations and relevant stakeholders: implications of implementation of the Nagoya Protocol, decided to request the Director-General, to broaden engagement with Member States, the Secretariat of the Convention on Biological Diversity, relevant international organizations and relevant stakeholders:
(1) to provide information on current pathogen-sharing practices and arrangements, the implementation of access and benefit-sharing measures, as well as the potential public health outcomes and other implications; and
(2) to provide a report to the Seventy-fourth World Health Assembly, through the Executive Board at its 148th session, as well as an interim report to the Executive Board at its 146th session.”
According to diplomatic sources this decision text is the outcome of informal negotiations among a few delegations including Finland, US, India, Brazil and South Africa.
The final decision text is significantly different from the last minute decision text put forward by Finland during the WHA which gave a broad vague mandate to WHO “working horizontally across the WHO, to intensify engagement with the Member States, the CBD Secretariat, other relevant international organizations and stakeholders, and report to the Seventy-fourth World Health Assembly through the 148th meeting of the Executive Board, as well as to provide a mid-term report to the 148th meeting of the Executive Board, on relevant developments in facilitating timely sharing of pathogens for rapid response to epidemics”.
According to sources, the United States had also proposed to include “including associated economic impact” in sub-paragraph (1) of the decision text, but this was not acceptable to some delegations such as India. (The final decision refers to “other implications”.)
The Convention on Biological Diversity (CBD) has as one of its objectives, the fair and equitable sharing of benefits arising from the use of genetic resources. The CBD entered into force in 1993 while the Nagoya Protocol under the CBD entered into force in 2014. Presently the CBD has 196 Parties while the Nagoya Protocol has 116 Parties.
The CBD is premised on the notion that States have sovereign rights over their own natural resources and the authority to determine access to genetic resources rests with the national governments and is subject to national legislation (Article 15.1 of the CBD). Consequently Article 15 of the CBD conditions access to genetic resources to prior informed consent (PIC) of the Contracting Party providing the resources. It further requires fair and equitable benefit sharing arising from the commercial and other utilization of genetic resources with the Contracting Party providing such resources. Access and benefit sharing should be on mutually agreed terms (MAT).
Following the same premise, the Nagoya Protocol elaborates on the access and benefit sharing aspect of the CBD, with implementation details left to domestic legislation. Pathogens are included within the scope of the Nagoya Protocol.
The Director-General’s report notes that, “the Protocol has the potential to increase equity, promote trust and improve both access to pathogens and their benefits, including access to medical interventions and countermeasures for countries in need supporting the attainment of health-related Sustainable Development Goals.”
It further states that “the principles of global public health, including those enshrined in the Constitution of the World Health Organization, and the critical importance of timely access and fair and equitable benefit sharing can serve as a reference for future steps in developing collaborative arrangements to promote: both access and benefits; surveillance of pathogens; effective international response to outbreaks; and appropriate collective use of benefits and their distribution based on global public health needs”.
It also adds “[a]ddressing access and benefit sharing for pathogens may involve consideration of other topics, including, inter alia, intellectual property aspects of the sharing of pathogens, genetic sequence data, research and publication of results, traceability, biosecurity, monetary and non-monetary benefit- sharing elements, as well as international and domestic law and process matters”.
There have been many instances where pathogen sharing has not been reciprocated equitably. For instance, on 6 February 2019, the Daily Telegraph (UK) reported in an article titled “Ebola's lost blood: row over samples flown out of Africa as 'big pharma' set to cash” that valuable Ebola blood samples taken from patients during the 2014-16 epidemic in West Africa are held in secretive laboratories around the world. It reports “Now several African scientists and Ebola survivors accuse the laboratories of biological asset stripping. Despite the samples having been taken from thousands of Africans, scientists from these patients’ home countries - Sierra Leone, Guinea and Liberia - are unable to access them for their own research”.
The misappropriation of biological resources is not a new occurrence in the public health sector. Several cases of such misappropriation have occurred through the intellectual property system.
A WHO notification dated 29 May 2003 titled "Patent Applications for SARS Virus and Genes" reported that “teams of scientists in Canada, Hong Kong, and the US have filed patent applications on all or part of the SARS virus genome and on the virus itself. The detailed claims in these applications have not yet been made public but are reported to be sufficiently broad to allow their holders to claim rights in most diagnostic tests, drugs, or vaccines that have been or would be developed to cope with the outbreak […..] Some of the university and public health laboratories that have filed patents assert that they have acted "defensively." That is, by filing patent applications, they intend to pre-empt commercial applicants from obtaining intellectual property rights that might hinder further research and development on SARS. It has been reported, however, that some of the university or governmental patent applicants have themselves begun negotiations with commercial partners to develop diagnostic tests and other products.”
The note adds “In the longer term, the manner in which SARS patent rights are pursued could have a profound effect on the willingness of researchers and public health officials to collaborate regarding future outbreaks of new infectious diseases.”
In 2014 Edward Hammond in an article titled “MERS Virus Claimed in Dutch University's International Patent Application” reported that Erasmus University filed its first MERS patent application in September 2012, a few weeks after receiving the virus samples from Saudi Arabia. The university “delayed sending the virus to other laboratories while it prepared that application, eventually providing it only under a controversial material transfer agreement reserving intellectual property rights for the University. This provoked concern and, in May , under pressure, Erasmus said it would “change” its patent application - without specifying exactly how. While many understood that Erasmus would make its claims narrower, this did not turn out to be the case”.
During Member States’ interventions on this recent WHA agenda item, developed countries mainly focused on the impact of the Nagoya Protocol on pathogen sharing, especially expressing concerns over delay in sharing samples.
On the other hand, developing countries strongly supported the objectives and principles of the CBD and the Nagoya Protocol, seeing the latter instrument as an opportunity for equity globally, through fair and equitable benefit sharing which in turn will reinforce public health preparedness and response during an emergency.
Several developing countries such as Bolivia, Malaysia and Ghana emphasized that at this early stage of discussion it is better to collect information on the current nature and modalities of pathogen sharing.
Ghana on behalf of the members of the Africa Regional Office (AFRO) said while it welcomed WHO’s readiness to explore possible options, it would like WHO to provide full information on pathogen sharing. For example, what pathogen samples are being shared under WHO’s stewardship, the frequency and modalities of sharing, what terms and conditions govern the sharing. It called for a process open to a wide range of input instead of a limited WHO Secretariat-driven process.
India welcomed implementation of the Nagoya Protocol in view of emerging high threat pathogens such as the MERS coronavirus, nipah, zika, ebola as well as unknown future threats.
It emphasized that the public health implications of Nagoya Protocol implementation include sound risk assessment, initiation of evidence based intervention and subsequent development of countermeasures such as diagnostics, vaccines and therapeutics and improving access to affordable treatments. India stresses that “the Nagoya Protocol implemented in its true spirit will further strengthen the public health preparedness and response during declared imminent health emergencies”.
Brazil said it has the greatest biodiversity on the planet and recognized the principles enshrined in the CBD and Nagoya Protocol, above all the sovereign rights over exploitation of genetic resources and fair and equitable sharing of benefits. It further said that Brazil recognized the importance of genetic resources for public health, food security and for conservation of biodiversity and willing to collaborate to improve sharing of pathogens to promote research, development and equitable access to health products and the strengthening of response to outbreaks of diseases of infectious diseases in line with Brazil’s national legislation.
It highlighted that Brazil’s current access and benefit sharing (ABS) legislation already includes digital sequence information in the concept of genetic resources. It called on WHO to provide elaboration of the current instances where the Secretariat has identified problems with current pathogen sharing.
Saudi Arabia said that it appreciated the exchange of pathogens particularly as it helps sharing of benefits, linking Nagoya Protocol to strengthening of equity, in particular in cases of medical interventions and outcomes especially for countries that need support in implementation of SDGs.
Indonesia said that WHO should focus on catering information to better understand and unpack issues concerning pathogen access and benefit sharing under the WHO. It also highlighted several points for consideration in future consultations. It stressed that the right granted to States by the CBD and Nagoya Protocol i.e. sovereignty over biological resources, prior informed consent and fair and equitable benefit sharing on mutually agreed terms as well as their objectives and principles, should be respected and upheld and the requirements of national ABS legislation should be recognized and supported.
It also recalled Article 57 of the International Health Regulations on the “Relationship with other international agreements” stating: “The provisions of the IHR shall not affect the rights and obligations of any State Party deriving from other international agreements” adding this means that the IHR does not affect the rights of States under the CBD and the Nagoya Protocol.
Civil society organizations (CSOs) Medicus Mundi International, Peoples’ Health Movement and Third World Network in their statement recalled that the “Protocol recognizes States have sovereign rights over their natural resources including pathogens, and access is subject to prior informed consent and fair and equitable benefit sharing with the country providing the resources”.
“Pathogen sharing for public health with advanced laboratories as well as the pharmaceutical industry is often conducted in the absence of fairness and equity. R&D results are not shared with the country providing the biological materials. Instead, patent claims are made over the materials’ use and cost of treatment remains prohibitively high”, they added.
The elaborated on an example of inequity whereby “a new Ebola drug has been developed from genetic sequence of an Ebola virus from the 2014 West African epidemic, posted online by a European research institute. The company has attracted 400 million dollars in development and purchase commitments. The precise price of the patented drug is unknown, but likely to be unaffordable. While drug development is valued, there is no indication of any benefit sharing agreement with government from where sample was sourced, consistent with the Nagoya Protocol”.
The CSOs concluded by stating “access and benefit sharing principles of Nagoya Protocol are crucial to ensure fairness and equity and to prevent the misappropriation of biological resources and as such need to be recognized and safeguarded”.+