[Ip-health] NIH to launch public-private partnership to speed COVID-19 vaccine and treatment options | National Institutes of Health (NIH)

Paul Fehlner pfehlner at revisiontx.com
Sat Apr 18 11:28:24 PDT 2020

Creating a central entity to aggregate data, provide for high quality regulatory review precedent to approval, and find mechanisms for getting products manufactured and to market has the potential to effectively harness efforts for best impact in treating COVID-19. With the US leading this important effort, even with EMA involved, one might expect that property rights will significantly influence the conditions under which therapies are made available. This will leave those of us concerned with access in a reactive position, calling for compulsory licenses (a remedy that is only relevant for patent-protected drugs, and still requiring some company to make and distribute the drug under the compulsory license) and hoping stakeholders will voluntarily contribute key data and regulatory filings to the COVID-19 technology pool. 

Nature abhors a vacuum. NIH has stepped in to a space that an organization that prioritizes access, like WHO or Unitaid, might have led. We have been reaching out to various stakeholders for weeks with a proposal to create a coordination entity to bring together data, manufacturers, and established registration process in a way that also takes into account access, including managing IP rights (particularly regulatory exclusivities) for the public benefit. Our proposal has the potential to translate global effort into global reward. The proposed entity would publicly commit to support the COVID-19 technology pool proposed by Costa Rica an endorsed by the WHO. Such an entity could commit to sharing not only the data, but also the regulatory filings and any resulting approvals, globally. Unlike post investment pressure, whether large institutional shareholders asking pharma to let financial considerations take second place (as recently announced with frankly uncertain effect because these conditions were not the basis for funding pharma companies in the first place) or government appropriation of IP rights, funding for this initiative would be based on delivering transparency along with data-driven registration decisions. 

The access-oriented international community could and still should take a lead on ensuring that clinical studies around the world, including the SOLIDARITY trials in 70 countries, result in decisions (approval or rejection — both are important) for the benefit of all countries by supporting an entity to manage the work of connecting manufacturing, clinical data, and approval processes. Managing that process offers the greatest assurance that rights promote access. While this NIH initiative is better than uncoordinated parallel efforts, better to take the lead and control access to data and approvals, rather than plead for it after the fact.
Paul Fehlner
President & CEO
reVision Therapeutics, Inc.
pfehlner at revisiontx.com

> On Apr 17, 2020, at 10:45 AM, Manuel MARTIN <Manuel.MARTIN at geneva.msf.org> wrote:
> And "access" as it pertains to end products... 
> On 17/04/2020, 16:43, "Ip-health on behalf of James Love" <ip-health-bounces at lists.keionline.org on behalf of james.love at keionline.org> wrote:
>    Some words missing from the NIH announcement of its new partnership with
>    big pharma for COVID-19.,
>    Price
>    Affordability
>    Patent
>    Intellectual Property Rights.
>    https://www.nih.gov/news-events/news-releases/nih-launch-public-private-partnership-speed-covid-19-vaccine-treatment-options
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