The Biden administration supports the temporary suspension of intellectual property for Covid-19 vaccines © AFP via Getty Images

Following support by the US for the temporary suspension of intellectual property for Covid-19 vaccines, there has been intense debate about how to best scale up manufacturing and boost global supply.

The US shift marked a U-turn from last October when a proposal by India and South Africa for a temporary waiver of the World Trade Organization provisions on IP rights in the Trade-Related Aspects of Intellectual Property Rights agreement (Trips) was opposed by high-income countries. The European Commission and the G7 have now become involved.

In the words of Katherine Tai, US trade representative, extraordinary times call for extraordinary measures, and against this backdrop, it is unsurprising that calls to set aside IP are gaining momentum. Yet whether IP is a barrier to access to Covid vaccines is a matter of debate, and IP can be both part of the problem and part of the solution.

Much of the research underpinning Covid vaccines has been funded by governments, while the private sector has taken commercial risks on the development manufacturing side, often with unprecedented levels of collaboration between companies. The investments and risks on both sides have been substantial.

While a well-governed IP system is essential for innovation, the Covid crisis has complicated matters. IP has been crucial for collaborations between companies and the public sector, and between rival companies, to facilitate rapid Covid responses.

Yet the agreements underpinning these collaborations remain shielded from public view, either for commercial or national interest reasons, making it difficult to have a more substantive public debate.

Greater transparency and further studies would be needed to provide a clearer understanding of the role that ownership of IP and access have played in the vaccine development, procurement and rollout.

Duncan Matthews
Duncan Matthews

Such increased transparency of ownership, licensing and advance purchase agreements would inform a better understanding of the effects of IP during the pandemic response. This would enable a more careful consideration of how best to improve policies for pandemic preparedness. Adequate standards on transparency must safeguard the public interest while paying due regard to the mechanisms that drive innovation.

The goals now are rapid responses and a fairer distribution of knowledge, innovation and manufacturing capacities, while keeping in mind the effects on global competition and access dynamics. IP waivers, even if temporary, would have impacts in both respects.

Waiving patents alone will not solve the vaccine access problem and scaling up production poses challenges, including an adequate supply of ingredients and complex technical expertise for overcoming scientific and regulatory hurdles.

Timo Minssen
Timo Minssen

Manufacturing knowhow, trade secrets and regulatory exclusivities might still present hurdles for the production of mRNA vaccines. It is unclear how these factors would be covered in a Trips IP waiver.

The Covid response requires a toolkit of policies to ensure adequate vaccine manufacturing and delivery. The significance of IP and its interface with collaboration and knowledge transfer in responding to these challenges must be key components of that approach.

Other elements of the policy toolkit should include an IP system with stringently applied requirements for IP protection, as well as appropriate limitations and exceptions.

Further consideration of incentives that promote knowledge and technology transfer should also be part of the solution. Careful analysis of the complex dynamics that drive innovation, conservation and access will be required to end the crisis — and to improve pandemic preparedness, pharmaceutical innovation and access in the future.

A focus on the role of IP should trigger greater transparency and further studies, more nuanced debates and innovative approaches for tackling future challenges.

This must include not only pandemic responses, but also global justice, climate change, antimicrobial resistance and the associated collective action problems.

Duncan Matthews is director at Queen Mary Intellectual Property Research Institute, Queen Mary University of London.

Timo Minssen is founding director at the Centre for Advanced Studies in Biomedical Innovation Law, University of Copenhagen

 

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