Guest blog by Ronald Eberhard
The Intergovernmental Negotiating Body, established by the World Health Assembly, aims to draft a global pandemic prevention, preparedness, and response framework. One of the most noteworthy aspects of the INB’s advance draft negotiating text is its focus on technology transfer, particularly in Article 11 and its surrounding context. This focus is timely and aligns closely with ongoing debates on how intellectual property can facilitate or hinder access to essential technologies.
The draft text encourages Member States to coordinate and incentivize manufacturers to transfer relevant technology and know-how. This provision is particularly significant for developing countries that often lack the technological infrastructure to produce pandemic-related products. The text also advocates for using technology transfer hubs and product development partnerships, which can serve as platforms for sharing technological expertise and resources. An example of such a hub is the WHO mRNA Hub. However, the draft text failed to address the challenges of manufacturing complex pharmaceuticals, which often require access to undisclosed information for effective production.
WHO mRNA Hub Problem with Trade Secret and Know-how
The World Health Organization’s (WHO) mRNA Technology Transfer Hub, established in South Africa, promises to be a game changer. The WHO Hub, facilitated by the Medicines Patents Pool (MPP) and South Africa’s Afrigen Biologics, aims to democratize vaccine technology. It seeks to transfer the technology for mRNA vaccines – arguably the most promising vaccine technology to emerge in recent years – to LMICs. The Hub has already developed a lab-scale Covid-19 mRNA vaccine, reverse-engineered from Moderna’s vaccine, and is gearing up for clinical trials.
The Hub’s mission is noble: to level the playing field by empowering LMICs to produce their vaccines. This statement is not just about COVID-19; it’s about preparing these nations for future pandemics and other public health emergencies. The Hub plans to train staff from 15 LMICs, including countries like Indonesia, Nigeria, and Bangladesh, in the complexities of mRNA vaccine production.
However, the Hub faces a daunting challenge in the form of trade secrets and know-how. Unlike patents, which are publicly disclosed, trade secrets are proprietary information that companies keep confidential to maintain a competitive edge. In the context of mRNA vaccines, this could include manufacturing processes, quality control procedures, and other technical know-how not covered by patents.
Moderna, one of the leading producers of mRNA vaccines, has been reluctant to share its complete dossier, which includes the vaccine formula and the manufacturing and quality control processes. While the company has publicly committed not to enforce its COVID-19 vaccine patents during the pandemic, this commitment does not extend to its trade secrets. The absence of this crucial information poses a significant barrier to the Hub’s efforts to democratize mRNA vaccine technology.
The implications of the reluctance to share undisclosed information are far-reaching, particularly for low-and middle-income countries (LMICs), which are the primary beneficiaries of the WHO’s mRNA initiative. Without access to a complete dossier, the Hub’s efforts to transfer technology to LMICs are hamstrung. This problem delays the production of vaccines and perpetuates the existing inequities in global health.
A crucial aspect that intensifies the debate around Moderna’s reluctance to share its trade secrets is the company’s substantial public funding to develop its COVID-19 vaccine. Moderna was granted close to $1 billion from the US Government, which raises ethical questions about the company’s obligations to the public good.
Since taxpayer money significantly contributed to the development of Moderna’s vaccine, there is a compelling argument that the company has a moral and ethical obligation to share its trade secrets, especially in a global health crisis. This obligation is not just a matter of corporate social responsibility but also a question of fulfilling ethical obligations arising from public funds.
The receipt of public funding should necessitate a level of transparency and accountability from Moderna. Governments should leverage this funding aspect to push for greater sharing of trade secrets by requiring conditions attached to future public funding agreements.
The Proposal for the Pandemic Treaty
Medicines Law and Policy recently proposed the text to address sharing know-how and trade secrets. The MLP proposal explicitly calls for a provision that compels the sharing of undisclosed information and trade specifics under specific conditions. The INB text, while mentioning “undisclosed information” as defined in Article 39.2 of the TRIPs Agreement, does not explicitly provide for compulsory sharing of such information. The MLP proposal cites existing legal frameworks in the US, the Defense Production Act, that have mechanisms for compelling the sharing of know-how and trade secrets. Under the DPA, the US Government has the authority to require companies to prioritize government contracts and can also push the sharing of “critical technology” for national defence. While the DPA is primarily geared toward national security, its framework could be adapted for public health emergencies.
The EU Trade Secrets Directive does offer some flexibility for national governments to require disclosure of trade secrets for reasons of public interest. This flexibility is particularly relevant in the pharmaceutical field, where third parties can access certain information submitted as part of a marketing authorization dossier, including clinical trial data. Further, the European Commission has proposed measures to access trade secrets in its draft legislation for an EU compulsory licensing regime.
These examples strengthen the argument for the feasibility of such provisions at an international level.
The challenges associated with manufacturing complex pharmaceuticals require access to undisclosed information for effective production. Access to know-how and trade secrets becomes crucial in such cases. Furthermore, entities benefiting from public funds have a moral and social responsibility to share know-how and trade secrets, especially during pandemics.
While the international community awaits the finalization of the Pandemic Treaty, national governments are not without options. They can take proactive steps to address the urgent need for technology transfer in the following ways. Governments can start drafting laws that allow for the compulsory licensing of trade secrets in cases of extreme public need or national emergency as well as the sharing of undisclosed data held by the medicines regulatory authority. TRIPS stipulates in Article 39.3 that disclosure of such undisclosed data is allowed when needed to protect public health.
While the TRIPs Agreement does not explicitly provide for the compulsory licensing of trade secrets, it also does not prohibit it. Expressly, TRIPs prohibit the compulsory licensing of trademarks but remain silent on trade secrets. This absence could be interpreted as an intentional omission, allowing national governments the latitude to enact laws permitting the compulsory licensing of trade secrets.