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

Yannis Natsis yannis at epha.org
Fri Jul 3 01:51:32 PDT 2020

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://www.epha.org/>

Yannis Natsis

Policy Manager for Universal Access & Affordable Medicines

Management Board member, European Medicines Agency (EMA)

+32 (0) 2 233 38 86 <+32%202%20233%2038%2086> | +32 478 77 83 45
<+32%20478%2077%2083%2045> (Mobile)

European Public Health Alliance (EPHA) www.epha.org

[image: Twitter] <https://twitter.com/@YNatsis>

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