[Ip-health] New Analysis: "Getting it right: COVID19 vaccines procurement"

Baker, Brook b.baker at northeastern.edu
Fri Jul 3 12:00:21 PDT 2020


Thanks for this analysis and the recommendations you have made for the EU being a wise investor instead of a passive donor.  However, the EU and many of its leaders have rhetorically espoused equitable global access and treating COVID-19 health products, especially vaccines, as global public goods, but your analysis neglects to say anything about how the EU should avoid European vaccine nationalism by jumping to the head of queue (ok maybe after the US) ahead of LMICs that comprise almost 80% of the global population.  Shouldn't there be a recommendation that "wise investments" should be informed with principles of global solidarity and global health security against a pandemic that is ravishing the world?  Shouldn't the EU look to commitments for equitable global access in exchange for funding R&D, clinical trials, manufacturing scale-up, and advance purchasing agreements?


Professor Brook K. Baker
Northeastern U. School of Law
416 Huntington Ave.
Boston, MA 02115
Honorary Research Fellow, University of KwaZulu Natal
Health GAP (Global Access Project) Senior Policy Analyst
(w) 617-373-3217
(c) 617-259-0760
b.baker at northeastern.edu
Skype:  brook_baker

On 7/3/20, 5:33 AM, "Ip-health on behalf of Yannis Natsis" <ip-health-bounces at lists.keionline.org on behalf of yannis at epha.org> wrote:

    Dear IP-Health readers,
    For those interested, in the ongoing European COVID19 vaccine procurement
    discussions, you may find my latest analysis interesting. Please see the
    text below and here is the link to the publication:
    Getting it right: COVID19 vaccines procurement
    In recent weeks, there have been some notable developments in relation to
    the procurement of potential vaccines against COVID19. On June 3, France,
    Germany, the Netherlands and Italy announced the formation of the Inclusive
    Vaccine Alliance (IVA) in order to negotiate with pharmaceutical companies
    for the procurement of a possible vaccine. Just ten days later, these four
    countries were quick to announce that a deal was sealed with AstraZeneca
    (AZ), an Anglo-Swedish pharmaceutical company for the gradual supply of
    300-400 million doses to the EU at “cost price”. Others are encouraged to
    join “under the same conditions as the alliance members” should they wish
    so. Moreover, the IVA made it clear that due to all the virus-related
    worries, the deal with AZ would not be exclusive and that the alliance
    would be in talks with other manufacturers as well.
    The contract with AZ was announced on the eve of the launch of the European
    Commission’s vaccines strategy. One of the main tools foreseen in the
    strategy is the use of funds to be used as a deposit in the context of
    Advance Purchase Agreements (APAs) for promising products against the
    Be it through the IVA or the Commission-driven pooled procurement
    initiative, by paying up front, governments are committing today to
    de-risking the vaccine development and manufacturing process. This means,
    put simply, public money will be used to cover most of the losses
    pharmaceutical companies may sustain in case of failed products. What
    governments get in return is some sort of a priority voucher which offers
    them privileged access and the right to buy “promising” products in the
    future when/if they are authorized. They get to “jump the queue,” which
    seems to be the top political priority right now for Brussels and many EU
    capitals in the global race and competition for COVID19 therapeutics.
    Joint, pooled procurement is undeniably the right way forward given the
    specificities of a pandemic and the intricacies of the vaccines market.
    Hence, the EU brings clear added value and a convergence of the two
    initiatives is inevitable, especially as the European market is not big
    enough for two competing procurement initiatives. Nonetheless, there is a
    real danger of considerable amounts of public investment being squandered.
    The public as a wise investor, not a passive donor
    Taking into account the massive mobilization of public investment and
    resources in sharing the risk with pharma developers, while decreasing the
    liability of producing vaccines against the coronavirus, the EU as a whole
    needs to act as a wise investor, not a passive donor. It needs to take
    steps to guarantee a fair return on this substantial and multifaceted
    public support by attaching public-interest conditionalities.
    Insurance policy or a blank cheque?
    The European Commission needs to be applauded for designing an EU response
    to the conundrum of COVID19 vaccines. Member States should better stick
    together as pharma companies will once again try to play one off against
    the other by offering what they claim to be better deals. That said, this
    “insurance policy” as it is described by the Commission in the strategy
    should not become a blank cheque for the pharmaceutical companies.
    To this end, the European Commission and Member States need to:
    1.       Be fully transparent about the terms and conditions of the APAs,
    the system of negotiation and governance, the contracts with the companies,
    the timeline of payments, the selection of vaccine candidates and the
    principles for allocation and distribution
    2.       Guarantee affordable prices for all end products against COVID19
    while reflecting the public’s multilayered contribution to the research and
    development (R&D) process. Affordability needs to be ensured well beyond
    the context and timeframe of the APAs and it cannot be left up to the
    companies’ interpretation
    3.       Provide clarity on the liability provisions in case things go
    wrong (patient safety & adverse effects). Companies should shoulder most of
    this responsibility
    4.       Offer the possibility for opt-ins, opt-outs and refunds to Member
    States who decide not to purchase the vaccine for reasons such as changes
    in the epidemiological situation
    5.       Don't take companies’ claims for financial support to boost their
    manufacturing capacity at face value. Any industry requests for financial
    or other incentives and rewards in this direction should be independently
    verified and conditioned to concrete performance indicators
    6.       Ensure that the regulatory framework is not jeopardized in the
    approval of prospective products. Only safe and effective products should
    be authorized. Maximum clinical trials data transparency must be guaranteed
    by regulators for any COVID19-related products approved
    7.       Explain in detail how the down payment(s) will be used by whom and
    what for (will the funds be used exclusively for COVID19 R&D?) and what
    will happen to these funds in case of non-completion or attritionInsert
    provisions for paybacks and rebates
    8.       Outline how intergovernmental initiatives (such as the IVA) and
    the already announced deals (such as the one with AZ) will merge with the
    plans of the European Commission.
    It is clear that in light of the scale of the crisis, national governments
    and the European Commission are under pressure to act. In doing so, they
    should be careful not to take a shot in the dark. Pharmaceutical companies
    on the other hand are keen on working with governments, consolidating the
    avenue of public-private partnerships, to share the risk of drug
    development well beyond the present coronavirus crisis. Since the onset of
    the public health emergency they have been knocking on the open doors of
    both national governments and the EU institutions. As the Commission
    confirms, there have been numerous discussions with pharma trade
    associations as well as individual companies. Pharma is indeed part of the
    solution but one cannot be oblivious to the agenda of the profit-driven
    business sector and the significant financial opportunities COVID19
    presents for the industry. Additionally, there is very little transparency
    on the proposals put forward by industry, and on what has been discussed
    and agreed so far. Overall, as far as COVID19 therapeutics are concerned
    (be they treatments or vaccines), promissory science and speculation need
    to be approached with caution. If not, we risk a much more dangerous and
    expensive repetition of the Tamiflu fiasco.
    Happy to hear your thoughts! Many thanks,
    [image: European Public Health Alliance (EPHA)] <https://nam12.safelinks.protection.outlook.com/?url=https%3A%2F%2Fwww.epha.org%2F&data=02%7C01%7Cb.baker%40northeastern.edu%7C9f366fcd128249a0451d08d81f3411c2%7Ca8eec281aaa34daeac9b9a398b9215e7%7C0%7C0%7C637293655803917449&sdata=JunHDD0xDZkz0ZR1vyIgWbh%2FyX2ocydmcrfPMNECpeg%3D&reserved=0>
    Yannis Natsis
    Policy Manager for Universal Access & Affordable Medicines
    Management Board member, European Medicines Agency (EMA)
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