On Wednesday, 8 December 2021, Knowledge Ecology International (KEI) delivered the following statement on patents and health at the 33rd session of the WIPO Standing Committee on the Law of Patents (SCP).
8 December 2021
We take note of WIPO’s response to COVID-19 as detailed in the program of work and budget for 2022 to 2023. Specifically, WIPO’s COVID-19 response states that “WIPO will review, analyze and advise Member States on the specific and systemic measures available that will assist Member States to address COVID-19 and future pandemics, including options available to Member States to implement international treaties in their laws, regulations and other legislative materials, for example using the TRIPS flexibilities.”
Providing legislative assistance to its Member States on TRIPS flexibilities is important, but for many countries, it is also important to address the challenges of making, importing, exporting and using products under exceptions to exclusive rights when there are bilateral or plurilateral trade agreements (PTAs). We request WIPO to engage in providing legislative advice on bilateral and plurilateral trade agreements that govern intellectual property, pharmaceutical, investment and other provisions that are relevant to the scaling of manufacturing of and equitable access to pandemic countermeasures.
In the COVID response, WIPO’s legislative advice should address rights in data or access to know-how or cell lines as they are important factors in scaling the manufacturing of countermeasures, as well as the challenges of regulatory pathways that feature linkages to rights in patents, test data and protect confidential manufacturing know-how.
As part of the WIPO Secretariat’s update of the review of existing research on patents and access to medical products and health technologies, we would request the International Bureau to include in its review, a WHO/UNDP publication, entitled, “Remuneration Guidelines for Non-Voluntary Use of a Patent on Medical Technologies” published in 2005, which may also benefit from an update, and WIPO’s 2014 study on alternatives to the patent system to support R&D efforts (CDIP/14/INF/12).
We reiterate our call for the SCP to discuss the role of patents in the development of and access to new cell and gene therapies. Among the topics to be considered are the extent to which patent exceptions for the treatment of humans apply, as well as the high costs and anti-competitive nature of licensing the emerging thickets of patents for these treatments.