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The writer is director of research group Medicines Law & Policy
Discussions now taking place at the World Health Organization seek to reach consensus on a new pandemic agreement. The intention is to learn from mistakes made during Covid-19 to better prepare for the future. Unfortunately, a key intellectual property problem remains unaddressed, threatening to limit the scope of what the agreement can achieve in assuring timely and equitable access to pandemic countermeasures.
Pharmaceutical products such as medicines, vaccines and diagnostics can be protected by several types of intellectual property, including patents and trade secrets. Although a basic description of how to manufacture a product may exist in published patent documents, its manufacture at scale often requires access to associated trade secrets developed by the patent owner. This is especially true of complex products such as monoclonal antibodies or mRNA vaccines.
A future pandemic may well require the urgent manufacture of a complex pharmaceutical product on a very large scale, one beyond the capability of the intellectual property owner alone. Third parties would accordingly require access to both patents and associated trade secrets. The owner could enter into voluntary agreements granting patent licences and sharing these with others. However, Covid-19 demonstrated that, even during a global emergency, some intellectual property owners were unwilling or unable to do so. Given this, having an alternative mechanism is vital.
Patents are public instruments granted by national or regional authorities. During a pandemic, each country can decide for itself how to deal with them. The current draft agreement includes measures such as compulsory patent licences or pandemic-related patent waivers. By contrast, trade secrets are by their very nature not disclosed to the public and are likely to be located in a limited set of countries, for example, those in which the product is manufactured. Even during a pandemic, these countries cannot be required to compel the sharing of trade secrets.
The current draft does not address this and is thus essentially limited to enabling the manufacture of comparatively simple pharmaceutical products, which generally do not require access to information that is not publicly available. To extend its scope, countries must consider an additional measure that can compel the sharing of trade secrets in a pandemic emergency. Such a measure would be in the interest of high-income countries (HICs) just as much as low- and middle- income ones (LMICs).
The European Commission provided evidence of this in its recently proposed regulation for EU-wide compulsory patent licensing in an emergency. This envisages imposing a duty on patent owners to collaborate with licensees, including access to associated indispensable information which is kept secret, to ensure that production is effective and efficient. Given the democratisation of technologies such as synthetic biology and machine learning, it is likely that future pandemic countermeasures and associated trade secrets could be developed in present-day LMICs. Third-party manufacturers in HICs could then be the ones seeking such sharing.
We therefore propose a new measure requiring countries to compel intellectual property owners to share trade secrets when determined necessary in a pandemic emergency. It is based on powers already used in HICs in the context of antitrust law and national emergencies. Such powers are compatible with the World Trade Organization agreement, which only requires that trade secrets be protected against unfair competition.
The current WHO discussions represent a desperately needed opportunity to better prepare for the future. They must deliver a set of international rules robustly adequate to the task.
Christopher Garrison contributed to this article
Source: Economy - ft.com
