Symposium | Building Resilience: Advancing Local R&D and Production of Health Products in the WHO Pandemic Agreement

Decoding Technology Transfer in the Proposed WHO Pandemic Accord

By Kashish Aneja
Published on 14 November 2024

Introduction

The COVID-19 pandemic exposed critical weaknesses in global preparedness, particularly in the equitable access and distribution of health technologies like diagnostics, therapeutics and vaccines. Vaccine research and manufacturing capabilities were largely concentrated in high-income countries, exacerbating disparities in vaccine availability across the world. Even as some regions faced crippling shortages, others hoarded supplies, revealing the detrimental effects of ‘vaccine nationalism.’ This phenomenon, combined with intellectual property (IP) restrictions, export bans and manufacturing bottlenecks, heightened global inequalities in the COVID-19 response.

One of the starkest lessons from the pandemic was the need for effective technology transfers, especially in the development and distribution of mRNA vaccines. Although several countries and manufacturers had the infrastructure to expand vaccine production, many low- and middle-income countries (LMICs) lacked the necessary expertise, know-how and access to cutting-edge technology. Even where IP restrictions could have been lifted through WTO-TRIPS flexibilities like compulsory licences, the technical knowledge required to produce vaccines remained inaccessible. For instance, despite the establishment of a WHO Vaccine Hub in South Africa, it struggled to gain traction due to the refusal of originator companies like Moderna to share key production knowledge.

The proposed WHO Pandemic Accord seeks to address these gaps by introducing provisions on technology transfers, capacity building and IP management. The following analysis delves into the technology transfer-related provisions in the most recent draft of the Pandemic Accord (dated May 27, 2024), examining both the opportunities and challenges inherent in this framework.

Provisions on Technology Transfer in the draft WHO Pandemic Accord

The proposed WHO Pandemic Accord introduces several key provisions aimed at ensuring the equitable distribution of pandemic-related health products. These provisions focus on promoting technology transfer, IP waivers and capacity building, particularly in LMICs.

Preamble: Para 14 and 14 bis

The preamble acknowledges the tension between IP protection and the need for equitable access to health technologies.

Para 14 recognises the importance of IP protection in driving innovation but also acknowledges concerns about its impact on prices. This balanced approach underlines that IP protections, and specifically the TRIPS Agreement and its flexibilities, should not prevent governments from taking necessary public health measures. The newly introduced para 14 bis emphasises the need to improve access to essential medicines through building local production capacity, particularly in developing countries. It explicitly mentions technology transfer and cooperation as crucial mechanisms for achieving this goal. Notably, the language around ‘voluntary and mutually agreed terms’ (VMAT) for technology transfer highlights ongoing debates over the extent to which such transfers should be obligatory versus negotiated.

These provisions lay the groundwork for addressing the broader challenges of IP management and technology transfer, but they leave unresolved key issues around the enforceability and scope of technology-sharing commitments.

Article 11: Transfer of Technology and Know-How

Article 11 is the central provision addressing technology transfer in the proposed Pandemic Accord. It introduces a framework for promoting the sustainable production of pandemic-related health products through the transfer of technology, skill and know-how. However, several contentious points remain unresolved.

1. Para 1(a): Measures for Promoting Technology Transfer

This paragraph provides a non-exhaustive list of measures that Parties should take to facilitate technology transfer, especially to LMICs. These measures include licensing, capacity-building, regulatory policies, fiscal policies and conditions linked to research and development. The provision also mentions technologies developed with public or government funding, emphasising the need for equitable access to publicly funded innovations.

One significant point of contention here is whether ‘know-how’ should be explicitly included in the list of transferable items. Know-how refers to the technical knowledge and expertise required to manufacture vaccines or other health products, and its exclusion could limit the effectiveness of technology transfer efforts. While there is general convergence on the language around transfers of technology and skills, know-how remains contentious.

Additionally, the use of VMAT for technology transfers weakens the provision. If technology transfers are voluntary rather than obligatory, specially during public health emergencies, developed countries could negotiate favourable terms, effectively limiting access for LMICs. This also risks undermining the use of TRIPS flexibilities (e.g., compulsory licences) by exposing countries to potential investor-state disputes.

2. Para 1(b) and (c): Licences for Government-Owned Technologies and Transparency in Licensing Agreements

This sub-paragraph encourages governments to make pandemic-related technologies developed with public funds available under non-exclusive, worldwide and transparent licences. The provision urges private rights holders to adopt similar practices. Ensuring compliance with this provision, particularly among private rights holders, will remain a challenge, as transparency and non-exclusivity are often at odds with commercial interests.

This provision also focuses on ensuring the timely publication of licensing terms to promote equitable access. It aims to prevent the opacity that characterised many licensing agreements during the COVID-19 pandemic.

3. Para 1(d): IP and Royalty Waivers

The provision encourages patent or licence holders to forgo or charge reasonable royalties to manufacturers in developing countries during a pandemic emergency. This aims to lower barriers to manufacturing and increase the availability of pandemic-realted health products.

Developed countries have expressed concerns over the mandatory nature of this provision. The debate over whether IP holders should be encouraged or required to waive royalties remains unresolved, and the final language will likely reflect ongoing negotiations.

4. Para 1(e): Technology Transfer Hubs

This provision promotes the transfer of technology and know-how to regional or global technology transfer hubs, coordinated by the WHO. These hubs aim to centralise and streamline efforts to expand local production capacities in LMICs. The success of these hubs will depend on the willingness of private rights holders to participate. Without binding obligations, these hubs may struggle to access the critical knowledge required for local production.

5. Para 1(f): Voluntary Sharing of Know-How

This provision encourages manufacturers to voluntarily share information necessary for the production of pandemic-related health products during emergencies. The provision introduces the requirement to share ‘know-how’ without using the term expressly.

The emphasis on ‘voluntary’ sharing weakens the enforceability of the provision. Without a mandatory framework, manufacturers may be reluctant to share valuable know-how, especially if it threatens their market position or future profits.

Para 2 and 3: Capacity Building and Scaling Up Manufacturing

Para 2 emphasises the need for capacity building, particularly for local, sub-regional, and regional manufacturers in developing countries. While the text reads that ‘each Party shall provide’ support, it adds qualifiers, such as ‘within its capabilities’ and ‘subject to available resources and applicable law.’ This language reflects the varying capacities of different countries to contribute, particularly those that may themselves require external support to meet the goals of the Accord.

Para 3 focuses on accelerating or scaling up the production of pandemic-related health products. It urges Parties to support appropriate time-bound measures to increase the availability, accessibility and affordability of such products during a pandemic emergency. This support is to be provided within the existing frameworks of international and regional organisations. The non-binding language of ‘consider supporting’ rather than mandating action could limit the effectiveness of this provision.

Para 4: TRIPS Flexibilities

This paragraph reaffirms the right of countries to use the flexibilities outlined in the TRIPS Agreement and the Doha Declaration, which allow for measures such as compulsory licences during public health emergencies. Also known as the ‘peace clause’, this provision aims to prevent developed countries from exerting direct or indirect pressure on LMICs that choose to exercise TRIPS flexibilities.

The use of compulsory licensing has in the past and would almost certainly elicit a backlash from the owners of the appropriated patents and their respective states. Patent holders and governments in developed countries may retaliate through trade sanctions, exclusion from trade agreements or withdrawing other products from affected countries’ markets.

For instance, Thailand faced significant backlash after issuing a compulsory licence for the AIDS drug Kaletra, with the United States placing Thailand on its ‘priority watch list,’ increasing the threat of trade sanctions. Similarly, Abbott Laboratories, the patent owner of Kaletra, announced it would withdraw certain products from the Thai market after the compulsory licence was issued. Similarly, after Egypt issued a compulsory licence for Viagra in 2002, Pfizer canceled plans to build a major production facility in the country. Compulsory licences have been a frequent point of tension in trade and policy discussions between India and the US, with the US pushing for stronger IP protections in India. When India issued a compulsory licence for the cancer drug Nexavar in 2012, it was met with considerable backlash from the United States, which argued that such licences should be restricted to public health emergencies and only for certain diseases.

Para 5: Multilateral Mechanisms for Technology Transfer

This paragraph calls on Parties to develop or strengthen multilateral mechanisms that promote and facilitate technology transfer, with a view to increasing access to pandemic-related products in developing countries. It specifically mentions pooling IP, know-how and data, and promoting non-exclusive licensing agreements. These mechanisms may, where appropriate, be coordinated by the WHO, in collaboration with other relevant international and regional organisations, ensuring equal participation of manufacturers from developing countries.

As promising as this provision is, its implementation will depend heavily on political will and international cooperation. The success of these mechanisms hinges on the willingness of both developed and developing countries to collaborate, share knowledge, and coordinate efforts through multilateral organisations like the WHO. The real challenge will lie in ensuring that these mechanisms are accessible and beneficial to all countries, not just those with existing manufacturing capacities.

Para 6: Implementation and Legal Review

This paragraph requires Parties to review and consider amending their national laws to ensure the timely and effective implementation of Article 11, including using TRIPS flexibilities to enhance access to pandemic-related health products. The requirement to align domestic legal frameworks with the provisions of the Accord is intended to ensure that countries can take full advantage of the IP and technology transfer flexibilities during future public health emergencies.

Key Challenges

The proposed WHO Pandemic Accord presents an ambitious framework for addressing the inequalities in access to pandemic-related health products. However, several key challenges could limit the effectiveness of its technology transfer provisions:

Transfer of Know-How: The failure to mandate the transfer of know-how could undermine the entire technology transfer framework. Without the technical knowledge required to manufacture health products, LMICs may continue to struggle with production even if they have access to IP rights.

Voluntary Nature of Technology Transfers: The voluntary nature of many of the technology transfer provisions, including the VMAT clause, weakens the overall impact of the Accord. Without enforceable mechanisms for transferring know-how, the effectiveness of expanding local manufacturing and exercise of TRIPS flexibilities could be undermined.
Capacity Building and Resource Limitations: While the Accord emphasises the importance of capacity building, its implementation will be constrained by available resources and the legal frameworks of individual countries. The ability of developing countries to build local manufacturing capacity and implement technology transfer provisions will depend heavily on international cooperation and financial support.
Voluntary Cooperation: Many provisions of the Accord rely on voluntary cooperation, particularly from private rights holders. This raises concerns about whether LMICs will truly benefit from the framework. Without stronger, enforceable mechanisms, there is a risk that the technology transfer provisions will fail to achieve their intended impact.

Refraining from Pressure against use of TRIPS Flexibilities: The provision on refraining from using direct or indirect pressure to discourage the use of TRIPS flexibilities is critical. The use of compulsory licensing may provoke economic or political retaliation from patent holders and governments, as evidenced by past actions taken against Thailand, Egypt and Brazil.

The Intergovernmental Negotiation Body (INB) recently concluded its 11th meeting on September 20, 2024. Some stakeholders advocated for stronger commitments to technology and know-how transfers, urging the replacement of ‘voluntary’ terms with binding obligations to prevent a hierarchy of commitments. Meanwhile, pharmaceutical industry groups argued that voluntary provisions were essential to the success of past cooperative efforts.

Conclusion

The proposed WHO Pandemic Accord represents a significant step forward in addressing the global disparities in pandemic preparedness and response. However, the current provisions on technology transfer, while laudable in ambition, face substantial challenges in implementation. The voluntary nature of many of the key provisions, coupled with the lack of mandatory know-how transfer, risks perpetuating the inequalities that characterised the global response to COVID-19. If the Accord is to succeed in its goal of equitable access, it must establish stronger, more enforceable mechanisms for technology transfer and protect countries from economic retaliation when using TRIPS flexibilities to ensure access to critical health products.

Kashish Aneja leads Initiatives in Asia at the O’Neill Institute for National and Global Health Law, Georgetown University; consults for the Centre for Outbreak Preparedness, Duke-NUS; and serves on the WHO Roster of Consultants for Public Health Law and Policy.