[Ip-health] Buying Know-How to Scale Vaccine Manufacturing | by James Love | Mar, 2021 | Medium

Paul Fehlner pfehlner at revisiontx.com
Sun Mar 21 18:29:48 PDT 2021

The post below reinforces the principle that investment (“spending money”) to make vaccines available globally could result in an effective approach to accelerate protection from COVID-19. Generalized, investment could lead to COVID-19 solutions. And extrapolating from COVID-19, collaboration among Global South stakeholders could create an alternative to multinational biopharmaceutical domination of biopharmaceuticals. In short: strategic investment based on open innovation principles.

An open innovation platform like the COVID-19 Technology Access Pool could support effective collaboration. Investment by developing countries — especially through a syndicate or consortium, perhaps based on a traditional venture capital model for social and financial return — could fund this effort. And while $1 billion is a big number, split over tens or dozens or more than 100 countries it is a realistic number — even increased by a factor of 10. Capitalizing a Global South biopharmaceutical company could more than pay for itself through providing affordable therapeutics not only for the Global South, but through the competitive advantage of open innovation, challenge the incumbents. As pointed out below, “[t]hose who keep technology proprietary will be faced with competition from public domain alternatives that will eventually drive prices down.” 

There is a huge opportunity now to fund a public benefit corporation with global perspective. That company could license and develop the NIH vaccine technology in combination with other technology that is available but disseminated in the developing world. 

Like any investor syndicate, the stakeholders will need to agree on goals and returns, which requires a willingness to cooperate that developed market investors reach all the time. In this case, a willingness to defer returns for many years will be important. Support of open innovation to reduce development costs will be, as well. Finally, national stakeholder commitment to purchase products (albeit, at a lower cost to reflect that initial investment) will reduce commercial uncertainty for the operating company.

So while Jamie Love’s comments below lay out an effective strategy, there is one point where I think he misses the opportunity of the moment. It is focusing on the lack of leadership from heads of states of high income countries. Those leaders need to focus on their own constituents; no national leader holds power by helping other countries when their own country is in distress. And it ignores the untapped potential for middle and low income countries. So the real problem is the lack of financial leadership from middle and low income countries preventing generation of a competitive solution to the incumbent biopharmaceutical companies. 

There is still time for the Global South to divert the course of COVID-19. There is a fantastic opportunity for the Global South to divert the course of the next pandemic. There is a very real possibility for the Global South to shift the competitive situation with respect to biopharmaceuticals globally. Each of these require investing in private sector actors focused on developing solutions as a priority over profit protection. Moreover, these investments have the potential to positively benefit investors directly over the mid- to long-term in addition to addressing immediate healthcare challenges, provide competitive pressure to the existing industry, and build wealth in the developing world. Harnessing the resources of the Global South is a more potent solution than complaining that the US and EU failed to negotiate effectively with the private sector. Indeed, the unconditional financing by the developed world will undermine governments who provided it, further creating a competitive opportunity for investors interested in economic as well as social impact, more effectively protecting taxpayer as well as private sector economic interests.

> On Mar 20, 2021, at 1:35 PM, James Love <james.love at keionline.org> wrote:
> Simon Lester asked if we had something written up on buy-outs of know-how,
> so I wrote this. Jamie
> https://jamie-love.medium.com/buying-know-how-to-scale-vaccine-manufacturing-586bdb304a36
> Buying Know-How to Scale Vaccine Manufacturing
> March 20, 2021
> The development of a number of COVID 19 vaccines has been an impressive
> achievement, one that can be attributed to a genuine sense that this was an
> emergency, and the fact that governments spent billions of dollars to
> subsidize or completely pay for research and development, and de-risking
> the scale up of products through massive advanced purchase contracts. What
> has been less impressive has been the effort to scale the manufacturing
> efforts to meet demand. One tool that has not been used, and should be
> mobilized, right now, is to spend money to make the know-how a global
> public good.
> Buyouts of manufacturing know-how, access to cell lines, and rights in
> inventions and data, isn’t cheap, but it will be less expensive than trying
> to vaccinate the world without doing so.
> Buying manufacturing know-how in 2021 wasn’t the best approach. When
> governments started throwing money at companies to develop vaccines, they
> could have acquired the rights to inventions, data, know-how, and biologic
> resources, then, and it would not have been expensive. That did not happen.
> Now, once these assets are largely privatized, on terms unfavorable to the
> public that paid for the R&D, it’s going to be more expensive.
> The fact that there are now several vaccines in the market and more in
> development makes the task more manageable. If governments could
> collaborate to create a buyout fund, they can offer to pay for full
> technology transfer. This can be done with or without royalties from
> generic suppliers, although, to truly open source the know-how, and make it
> a global public good, royalties, if desired, can be replaced with payments
> from a fund to reward vaccines that become the most important in terms of
> their use and efficacy, such as was proposed by Barbados and Bolivia to the
> WHO in 2008. (see discussions here and here ) for a Priority Medicines and
> Vaccines Prize Fund (PMV/pf), as well as similar proposals (see discussions
> here and here)
> There are a number of sources of manufacturing know-how that would not
> require particularly expensive buyouts or future payments based upon future
> uses of a vaccine. Small firms, technology transfer consultants, academics,
> former employees of vaccine manufacturers, companies that don’t have a
> candidate themselves, all may have useful contributions that could be
> shareable more widely if compensated to do so.
> It’s not unusual for companies to buy know-how. Pfizer bought its vaccine
> know-how from BioNtech. The US government actually signed a contract with
> Pfizer in July 2020 that required Pfizer to acquire the manufacturing
> know-how from BioNtech in Europe and transfer the manufacturing to the
> United States, which Pfizer did. Likewise, AstraZeneca bought its vaccine
> technology from Oxford University, and the Canadian government is buying
> vaccine manufacturing know-how from Novavax. The U.S. Operation Warp Speed
> (OWS) contracts include a number of agreements to buy and share
> manufacturing know-how, although not necessarily to make it into a global
> public good.
> Each technology platform has its own challenges as regards technology
> transfer. Among the most interesting platforms right now are mRNA (the
> shiny new thing, by Pfizer, Moderna, Curevax), viral vector (J&J,
> AstraZeneca, Sputnik, CanSino, etc) protein subunit (Novavax, instituto
> finlay de vacunas, etc), as well as several others. There are vaccines in
> development that can be self-administered with a nasal spray, including one
> promising candidate from the Cuban Center for Genetic Engineering and
> Biotechnology (CIGB), an institution that may be open to sharing the
> manufacturing know-how.
> Governments don’t have to buy out everyone. Those who keep technology
> proprietary will be faced with competition from public domain alternatives
> that will eventually drive prices down. This downward pressure on prices
> makes the financing of know-how buyouts even more attractive, as should the
> recent announcements by companies like Pfizer, J&J and others that they
> plan to jack up prices in the not too distant future.
> In addition to the vaccines now on the market or in late stage clinical
> trials, there are a number of new 2nd generation vaccines that look
> promising. Two from the NIH are particularly interesting.
> A single dose VSV-EBOV-Based COVID-19 Vaccine is inexpensive and easy to
> replicate, and the NIH has the manufacturing know-how, which one NIH
> official said “a high school teacher” could do. The U.S. Federal Register
> notice for licensing this technology is here.
> ---quote--- The vaccine is inexpensive to replicate, elicits a high
> antigen-specific antibody titer within the host, and provides protective
> efficacy after a single dose. -----end quote
> The NIH also has a license opportunity for “Replication-Competent
> Adenovirus Type 4 SARS-CoV-2 Vaccines,” which it describes as follows:
> ---quote--- These recombinant vaccines permit rapid development of high
> levels of neutralizing antibodies to SARS-CoV-2 in experimental animals.
> This vaccine is designed to improve the durability of the immune response
> by inducing mucosal and systemic immunity. Further, this system should be
> incredibly simple and efficient when producing vaccine at scale. ---end
> quote
> If the NIH does not bind these technologies to exclusive agreements with
> companies in the coming weeks, policy makers should ask, why not retain
> ownership of the vaccines, as opposed to paying for the trials but
> privatizing ownership, as was done in 2020?
> A buyout of know-how will cost money, particularly if the know-how is put
> into the public domain as a global public good. The whole world will
> benefit, but not everyone will pay. Past efforts to have a global treaty or
> agreement on biomedical R&D have been met with stiff opposition from Bill
> Gates and large drug companies. But in this pandemic, with so much at
> stake, and a recognition that the failure to get vaccines to everyone is a
> “catastrophic moral failure,” it should be a manageable task. I would put
> the initial resources necessary to start the process fairly low, as little
> as $20 million, but aim for an initial $1 billion to start negotiations to
> see what can be bought. The more money the better, but if one starts with
> the notion than tens of billions are required, it just won’t get off the
> ground.
> (Even when governments are spending trillions on stimulus packages to
> address the economic harm from the pandemic.)
> In the longer run, governments need to better collaborate on the terms to
> include in government funded R&D grants and contracts, and to create
> mechanisms that ensure important medicines and vaccines can be made
> available as global public goods. This could include embracing the call for
> the WTO to create an opt-in agreement on the supply of public goods, where
> members can making binding commitments, similar to GATS commitments, to
> fund or supply public goods. And the WHO should revise the proposals to
> have a global treaty or agreement on biomedical R&D, and address a range of
> issues, including but not limited to funding of pandemic countermeasures.
> To be sure, there is considerable opposition to any effort to delink R&D
> incentives from the grant of monopolies or to create global mechanisms to
> make drugs, vaccines or other biomedical inventions into global public
> goods.
> Bill Gates intervened with Oxford to abandon a promise to openly license
> its vaccine in favor of an exclusive agreement with AstraZeneca, a company
> that made serious mistakes in the clinical trials and has experienced
> production problems, missed delivery deadlines, and price gouging of the
> technology in Africa. Gates pressured the World Health Organization in 2020
> to block a proposal to include vaccines in the COVID Technology Access
> Pool, and has been making statements that vaccine manufacturing is too
> complex and difficult to have open licensing, and Gates funded
> organizations have been flooding social media and new stories with similar
> claims.
> Big drug companies and their trade associations have also been actively
> bashing proposals for a WHO biomedical R&D agreement and the WHO C-TAP open
> licensing proposal. Companies have commercial reasons to hold manufacturing
> know-how close, particularly for new platforms like mRNA products.
> This combination of big pharma and Bill Gates’ outsized presence in public
> health, as the largest or second largest donor to the WHO and the main or a
> major beneficiary of countless academic, journalism and non-government
> organizations working on global health, make it difficult to do many of the
> things that are obviously needed right now.
> The biggest obstacle to making vaccines global public goods, however, is
> not the opposition, but a lack of leadership from heads of states,
> particularly in high income countries. What we have seen in the past 14
> months, is government after government protecting the commercial interests
> of vaccine manufacturers, instead of the public, and we are paying an
> enormous price for this policy failure.
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