Trilateral symposium: WTO Director General Roberto Azevêdo highlights the opportunities and challenges faced in providing access to CAR T

On Thursday, 31 October 2019, the World Trade Organization (WTO) hosted the eighth trilateral symposium jointly convened by the World Health Organization (WHO) and the World Intellectual Property Organization (WIPO). The theme of this year’s symposium was ” “Cutting-Edge Health Technologies: Opportunities and Challenges” including developments in cell and gene therapies.

In his opening remarks, WTO Director General Roberto Azevêdo zeroed in on the “remarkable possibilities” provided by CAR T in “treating certain cancers” while noting that CAR T therapies were “costly and resource-intensive” which could “strain health budgets.” His full remarks can be found here.

A video clip of his remarks on CAR T can be found here:

    One question you will be exploring today is how IP settings relate to cutting-edge technologies such as gene-editing. This goes beyond technical details about patentability and the scope of rights and exceptions. It also concerns how these rights are deployed.
    For instance, consider CAR-T [(chimeric antigen receptor)] cell therapy, which offers remarkable possibilities for treating certain cancers. The therapy, which is still under development, involves taking a natural white blood cell and genetically transforming it so that it attacks cancerous cells when it’s reintroduced into the patient’s body.

    This is a promising area of medical research – one that involves both public and private actors. A recent survey showed that public sector research institutions held 40% of patents in this area, while private firms hold 49%. How they choose to license these technologies will be an important factor in how therapies are rolled out in practice.

    And while CAR-T cell therapy represents a dramatic breakthrough with enormous potential, it is also a costly and resource-intensive form of treatment that may strain health budgets.

    These are complex questions that will benefit from discussions like this one, bringing together a wide range of actors with a wealth of practical experience.

    Trade, in the sense of the cross-border movement of goods and services, also contributes to public health by helping ensure the availability of new technologies.

    No single country – and still less, vulnerable developing countries – will ever be fully self-reliant for the medical technologies they need.

    Facilitating trade also means facilitating access to medical technologies and inputs, which reduces the ultimate cost of treatment.

    Let’s take, again, that gene-editing T‑cell cancer therapy. In some forms of it, blood cells are taken from the cancer patient, sent to one of the few international centres with the necessary capacity to modify them, and then returned to the original location to be reinfused.

At fora including the Brocher Foundation, the World Health Assembly and the WIPO Standing Committee on the Law of Patents (SCP), Knowledge Ecology International (KEI) has encouraged policymakers to examine the implications of Article 27.3(a) of the WTO TRIPS Agreement on the patentability of gene- and cell-based therapies including those involving autologous T-cell immunotherapy (CAR T), CRISPR and other technologies when treatment can be described as a service or a medical procedure, rather than a product. In particular, policymakers should explore if certain cell- and gene-based treatments are, in fact, exempt from patentability when a country has an exception that mirrors Article 27.3(a) of the TRIPS Agreement.