By David Wallace 01 Mar 2021
Samsung Bioepis has announced that its SB17 proposed biosimilar ustekinumab rival to Janssen’s $7.7bn Stelara brand has moved into Phase...
The World Health Organization has announced the launch of the COVID-19 Technology Access Pool, or C-TAP, insisting that the initiative “will help ensure faster and more equitable access to existing and new COVID-19 health products.”
Last month, Costa Rican President Carlos Alvarado’s proposal on pooling rights to COVID-19 tests, medicines and vaccines, with free access or licensing on reasonable and affordable terms for all countries, was adopted by the WHO. (Also see "Patent Pool Expands Remit To COVID-19" - Generics Bulletin, 14 Apr, 2020.)
Over 30 countries have extended support to the C-TAP initiative. The WHO, Costa Rica and all the co-sponsor countries have also issued a “solidarity call to action” to ask for global support.
The WHO said that with supportive countries across the globe, C-TAP will serve as a sister initiative to the Access to COVID-19 Tools Accelerator and other initiatives to support efforts to fight COVID-19 worldwide.
WHO director-general Tedros Adhanom Ghebreyesus commented that “based on strong science and open collaboration, this information-sharing platform will help provide equitable access to life-saving technologies around the world.”
Outlining the elements of the initiative, the WHO said the C-TAP would include public disclosure of gene sequences and data and there would be transparency around the publication of all clinical trial results.
The WHO said that under the C-TAP initiative, governments and other funders will be encouraged to include clauses in funding agreements with pharmaceutical companies and other innovators about equitable distribution, affordability and the publication of trial data.
The C-TAP initiative also includes licensing any potential treatment, diagnostic, vaccine or other health technology to the Medicines Patent Pool.
The MPP – a United Nations-backed public health body that works to increase access to, and facilitate the development of, life-saving medicines for low and middle-income countries – recently announced temporarily expanding its mandate to “include any health technology that could contribute to the global response to coronavirus and where licensing could facilitate innovation and access.” (Also see "Patent Pool Expands Remit To COVID-19" - Generics Bulletin, 14 Apr, 2020.)
The WHO has specified that the aim of C-TAP is to promote innovation models and technology transfers “to accelerate the discovery of vaccines, medicines and other technologies through open-science research, and to fast-track product development by mobilizing additional manufacturing capacity.”
President Alvarado maintained that “vaccines, tests, diagnostics, treatments and other key tools in the coronavirus response must be made universally available as global public goods”.
Supporting the technology pool, the International Generic and Biosimilar Medicines Association has called for the sharing of “open relevant technologies, knowledge, intellectual property and data on a voluntary basis.”
“The IGBA invites generic and biosimilar medicines manufacturers to actively engage and commit to contributing to the global manufacturing capacity once an existing or newly-discovered therapeutic is proven to be effective against COVID-19,” the association said.
“As stipulated by this unique and time-limited new health technology pool, sharing of open relevant technologies, knowledge, intellectual property and data on a voluntary basis will facilitate their use in research and development and will mobilize and expand additional manufacturing capacity, since effective technology transfers and early access to key technologies would be permitted.”
“This should be complemented by a clear policy action by WHO member states to plan for future need in full transparency and cooperation with the pharmaceutical industry,” the IGBA suggested, covering “both rights holders and, where applicable, licensees.”
“A framework will be provided, allowing generic and biosimilar medicines manufacturers to actively contribute to the global manufacturing capacity by utilizing their expertise and know-how to produce and distribute generic and biosimilar versions of patented medicines at global level,” the IGBA said. Licenses will “provide the freedom to develop new treatments, such as fixed-dose combinations and special formulations for children.”
“Competition will help bring prices down and accelerate access to COVID-19 treatments and help to overcome this global pandemic,” the IGBA concluded.
However, leaders from big pharma companies have voiced opposition to the new patent pool plans. Speaking at a virtual press briefing of brand industry body the International Federation of Pharmaceutical Manufacturers & Associations, Pfizer CEO Albert Bourla called them “nonsense” and “dangerous,” while GSK chief executive Emma Walmsley and AstraZenecaPLC head Pascal Soriot also expressed their doubts. (Also see "Pfizer Chief Calls Patent Pool ‘Nonsense’, Fears Tussle Over Vaccine" - Scrip, 29 May, 2020.)
By David Wallace 01 Mar 2021
Despite turbulence in 2020 from the coronavirus pandemic as well as from difficulties relating to two of its key US...
Whether you’re a small biotech start-up, research firm, generic manufacturer or a global pharmaceutical giant, you need focused, independent insight and opinion on market developments.
Our team is always happy to hear from you. Please call us at:
Have an immediate and specific information need?
Browse and buy from 1000s of analysis and research reports now: