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TWN
Info Service on Health Issues (Apr25/03) Pandemic
Instrument: A Narrow Approach to Technology Transfer
A key focus of the resumed 13th session of the World Health Organization’s Intergovernmental Negotiating Body (INB) on the Pandemic Instrument is Article 11 which pertains to technology transfer. The proposed footnote under Article 11 stands out as the most contentious provision. The footnote arises from the insistence of developed countries, including the European Union. Developed countries have insisted that technology transfer should occur solely on a voluntary basis and under mutually agreed terms (VMAT). As a result, since the 77th World Health Assembly, the footnote was proposed under Article 11. The revised footnote for the 13th resumed session reads as follows: “For the purposes of this Agreement, transfer of technology refers to an agreed process where technology is transferred on mutually agreed terms. This understanding is without prejudice to and does not affect the measures that Parties may take in accordance with their domestic or national laws and regulations, and compliant with their international obligations.” Legally speaking, this footnote effectively serves as a definition of technology transfer, and undermines the efforts during the post-war period by developing countries to establish technology transfer regimes based on fair and equitable terms. This footnote emanates from a narrow understanding of technology transfer and does not reflect the realities of ways and means of technology transfer as well as dissemination, especially in the pharmaceutical sector. Article 11 The draft Article 11 contains 6 paragraphs, and the substantial parts have already been “greened”. [In the INB negotiation draft below, text highlighted in green indicates initial agreement, while yellow indicates text that is near to agreement. Proposals from the INB Bureau are in blue highlights.] Paragraph 1 sets out 6 actions by Parties to enable sustainable and geographically diversified production of pandemic-related products. These actions are: (a) Promote and otherwise facilitate or incentivize the transfer of technology and relevant knowledge, skills and technical expertise for pandemic-related health products, in particular for the benefit of developing countries, through measures which may include, inter alia, licensing, capacity building, relationship facilitating, incentives or conditions linked to research and development, procurement or other funding and regulatory policy measures; (b) Make available licences on a non-exclusive, transparent and broad geographic basis and for the benefit of developing countries of government-owned pandemic-related health technologies, in accordance with national or domestic, and international law and encourage private rights holders to do the same; (c) take measures to publish, in a timely manner the terms of its licensing agreements relevant to promoting timely and equitable global access to pandemic-related health technologies, in accordance with applicable law and policies, and shall encourage private rights holders to do the same; (d) Encourage holders of relevant patents or licenses for the production of pandemic-related health products to forgo or otherwise charge reasonable royalties in particular to developing country manufacturers during a pandemic emergency, with the aim to increase the availability and affordability of such products to populations in need, in particular people in vulnerable situations; (e) Promote the transfer of relevant technology and relevant knowledge, skills and technical expertise for pandemic-related health products by private rights holders, to established regional or global technology transfer hubs, coordinated by WHO, or other mechanisms or networks; and (f) During pandemic emergencies, urge manufacturers to share information relevant to the production of pandemic-related health products, in accordance with domestic or national laws and policies, on a voluntary basis. Paragraph 2 obligates Parties to be subject to the availability of resources and national law to support capacity building for developing country manufacturers. Paragraph 3 proposes to obligate Parties to cooperate to take certain time-bound measures to accelerate or scale up the manufacturing of pandemic-related products. Paragraph 4 reaffirms the right of World Trade Organization Members to make use of the flexibilities in the Trade-related aspects of Intellectual Property Rights Agreement (TRIPS). Paragraph 5 contains the obligation of Parties in collaboration with WHO to strengthen/develop mechanism/s to facilitate technology transfer for increased access to pandemic-related products. Paragraph 6 states that a Party “… should review and consider amending, as appropriate, its national and/or domestic legislation with a view to ensuring that it is able to implement this Article in a timely and effective manner”. It is important to note that no provision in Article 11 creates an obligation on the Parties to mandatorily transfer a technology owned by private companies. The sole provision that appears mandatory is the proposed Paragraph 1(b), which calls for making government-owned technologies available through non-exclusive licenses to benefit developing countries. It states: “Make available licences on a non-exclusive, transparent and broad geographic basis and for the benefit of developing countries of government-owned pandemic-related health technologies, in accordance with national or domestic, and international law and encourage private rights holders to do the same”. This provision does not make it mandatory for Parties to transfer the technologies to the manufacturers of developing countries. A license to a developed country manufacturer with a clause on supplying part of the production to developing countries could satisfy the requirement in Article 11.1(b). Moreover, in the absence of a definition, the term “government-owned” lacks clarity and there is ambiguity as to whether it includes technologies developed through publicly funded research initiatives. Often public funded R&D outcomes are owned by non-state actors including private sector using intellectual property rights. For instance, though Moderna’s COVID-19 vaccine was developed fully through public funding the proprietary rights are vested with Moderna. The United States government’s ownership can be asserted only by invoking “march-in” provisions under US law. Therefore, it is not clear that the term “government-owned” captures such situations. Further, these draft technology transfer provisions under Article 11 are entirely different from technology transfer provisions contained in the Convention on Biological Diversity (CBD) and the UN Framework Convention on Climate Change (UNFCCC) ( Article 4.5). For instance, Article 16.2 of the CBD states: “Access to and transfer of technology referred to in paragraph 1 above to developing countries shall be provided and/or facilitated under fair and most favourable terms, including on concessional and preferential terms where mutually agreed, and, where necessary, in accordance with the financial mechanism established by Articles 20 and 21. In the case of technology, subject to patents and other intellectual property rights, such access and transfer shall be provided on terms which recognize and are consistent with the adequate and effective protection of intellectual property rights. The application of this paragraph shall be consistent with paragraphs 3, 4 and 5 below.” Narrow approach to technology transfer Technology transfer is a dynamic process and takes place with or without the cooperation of the technology holder. This dynamic nature and diverse pathways for transferring technology is encapsulated in the definition contained in the Draft Code of Conduct on Technology Transfer. The definition reads. “Transfer of technology under this Code is the transfer of systematic knowledge for the manufacture of a product, for the application of a process or for the rendering of a service and does not extend to the transactions involving the mere sale or mere lease of goods”. This includes any process with or without the cooperation of the technology holder. According to the INB Bureau’s proposed footnote, technology transfer activities within the Pandemic Instrument can be carried out only through a mutually agreed process. It also implies that organizations such as the WHO cannot proceed with technology transfer initiatives under the pandemic instrument without the explicit consent of the technology holder. Further, technology transfer on mutually agreed terms does not reflect the realities especially in the area of pharmaceuticals. Frequently, generic manufacturers in developing countries independently produce generic versions of small molecules without any direct collaboration with or support from the originator companies. Similarly, biologics manufacturers also come up with non-originator biological products (biosimilar) without any assistance from the originator companies. Additionally, this definition assumes that technology transfer necessitates continuous, step-by-step involvement of the originator firm from start to finish. Often, critical technical details/information are sufficient to enable the replication of technology without any additional support from the originator firms. In fact, WHO’s work programme in the area of international pharmacopoeia, vaccine standardization or Reference Cell Bank etc. provides access to this critical information and facilitates the technology transfer. For instance, the International Pharmacopeia included the monograph of remdesivir, a medicine used during COVID-19. Thus the legitimacy of these activities of WHO with regard to pandemic-related products could be questioned citing the proposed footnote. Conclusion Article 11 does not insist on any mandatory technology transfer from the government or private entities concerned. It contains a set of obligations that are mainly best endeavors to facilitate technology transfer. Moreover, the footnote contained under Article 11 reduces the multiple ways of technology transfer making Article 11 ineffective. Most importantly the footnote redraws the hitherto understanding of technology transfer and reduces the idea of technology transfer to a process carried out only on mutually agreed terms between the technology holder and transferee. This does not reflect the realities of various activities resulting in technology transfer including access to critical information, capacity building etc. As discussed above the WHO itself is involved in various activities resulting in technology transfer. The proposed footnote would create constraints even for the WHO to carry out such activities in the context of pandemic-related products. Consequently, a revised framework for technology transfer is needed—one that aligns with practical realities and addresses existing gaps in equitable access.
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