EUU, Alm.del - 2020-21 - Endeligt svar på spørgsmål 69: Spm. om, hvordan Danmark i regi af EU kan være med til at sikre produktion og distribution af vacciner til lavindkomstlande, til sundheds- og ældreministeren, kopi til udenrigsministeren

Europaudvalget 2020-21
EUU Alm.del
Offentligt

EUROPEAN

COMMISSION

Brussels, 18.6.2020

C(2020) 4192 final

ANNEX

to the

Commission Decision

on approving the agreement with Member States on procuring Covid-19 vaccines on

behalf of the Member States and related procedures

EUU, Alm.del - 2020-21 - Endeligt svar på spørgsmål 69: Spm. om, hvordan Danmark i regi af EU kan være med til at sikre produktion og distribution af vacciner til lavindkomstlande, til sundheds- og ældreministeren, kopi til udenrigsministeren

16.06.2020

Agreement

Preamble

Having regard to Article 4(5)(b) of Council regulation (EU) 2016/369 on the provision of

emergency support within the Union

as amended by Council regulation (EU) 2020/521

of 14 April 2020 activating the emergency support under regulation (EU) 2016/369, and

amending its provisions taking into account the COVID-19

outbreak (hereinafter “ESI”

or “ESI regulation”);

***

The European

Commission (“the Commission”)

and

The following Member States: (XXX), hereinafter referred to as “the Participating

Member States”

Together referred to as “the Parties”

Agree on the Following:

Article 1: Objective and mandate of the Commission

On the basis of the present agreement, the Commission is mandated to conclude, on

behalf of the Participating Member States, Advance Purchase Agreements (“APA”) with

vaccine manufacturers with the objective to procure vaccines for the purposes of

combatting the COVID 19 pandemic at Union level.

The Annex to this agreement sets out the negotiating directives for this purpose.

Article 2: Acquisition of vaccine doses

It is the Participating Member States, and not the Commission, that shall acquire vaccine

doses from the manufacturers on the basis of the APAs unless otherwise agreed. All

relevant vaccination policies shall therefore remain matters for the Participating Member

States.

Article 3: APAs containing a right to acquire vaccine doses

Where the Commission concludes an APA in conformity with the present agreement that

provides the right for the Participating Member States to acquire vaccine doses, the use

of such a right shall take place by means of the conclusion of contracts between the

Participating Member States and the vaccine manufacturers. There shall be no obligation

for any Participating Member State to conclude such a contract on the basis of the APA.

The APA shall contain a clause to this end.

Article 4: APAs containing an obligation to acquire vaccine doses

Where the Commission intends to conclude, in conformity with the present agreement,

an APA containing an obligation to acquire vaccine doses, it shall inform the

Participating Member States of such intention and the detailed terms. In case a

Participating Member State does not agree with the conclusion of an APA containing an

obligation to acquire vaccine doses or its terms, it has the right to opt out by explicit

notification to the Commission within 5 working days after the Commission has

communicated its intention to conclude the APA. All Participating Member States not

having opted out within the period of 5 working days are deemed to have authorised the

Commission to negotiate and conclude the APA with the vaccine manufacturer in their

name and on their behalf.

Article 5: The legally binding nature of APAs

Once concluded, the terms of the APA shall be legally binding on the Participating

Member States, except for those who have exercised their right to opt out.

Article 6: Responsibility and liability

The present Agreement regulates only the division of potential liability and

indemnification between the Commission and the Participating Member States. It does

not regulate the extent to or the conditions under which potential liability of the vaccine

manufacturer may be taken over or indemnified under the APAs.

The Commission shall be exclusively responsible for the procurement process and the

conclusion of APAs including any liability arising out of the conduct of the negotiations.

Participating Member States acquiring a vaccine shall be responsible for the deployment

and use of the vaccines under their national vaccination strategies, and shall bear any

liability associated with such use and deployment. This shall extend to and include any

indemnification of vaccine manufacturers under the terms and conditions of the relevant

APA for liability related to the use and deployment of vaccines normally borne by such

manufacturer.

Article 7: Obligation not to negotiate separately

By signing the present Agreement, the Participating Member States confirm their

participation in the procedure and agree not to launch their own procedures for advance

purchase of that vaccine with the same manufacturers.

In case an APA containing an obligation to acquire vaccine doses has been concluded

with a specific manufacturer, the Member States having made use of the opt-out provided

under the present Agreement can enter into separate negotiations with the same

manufacturer after the APA under the present Agreement has been signed.

Annex

Initial considerations

A permanent solution to the COVID-19 crisis is most likely to be brought about by the

development and deployment of a safe and effective vaccine against the virus. Every

month gained in the deployment of a vaccine will save many lives, many jobs and

billions of euros.

Therefore, it is the objective of the present Agreement that the EU takes steps to secure

sufficient supplies of a safe and effective vaccine for Member States.

Structure and purpose of the procurement

Work on a COVID-19 vaccine is challenging for many reasons: the shortened

development timeframe, the large upfront costs for manufacturers, the high failure rate

during clinical trials. If vaccine producers follow their usual practice of making

investments in production capacity only when they are sure of a viable product, this will

result in considerably longer waiting times for a vaccine. Investments need to be made

now in order to ensure that vaccines are being produced at the scale required as early as

possible.

Under the present agreement, this challenge will be addressed through concluding EU-

level Advance Purchase Agreements (“APA”) with vaccine manufacturers

when

necessary, to secure access to vaccine candidates where they are successful, including

up-front EU financing to de-risk essential investments to increase the speed and scale of

manufacturing successful vaccines. Funding for the up-front payments will come from

the Emergency Support Instrument (ESI).

The Parties understand that developing a safe and effective vaccine is a highly complex

process and the risk of failure in any such venture is very high. Therefore, the aim is to

put in place APAs with a number of manufacturers of leading vaccine candidates, to

maximise the chances of having access to at least one successful vaccine.

The Commission will invite all vaccine manufacturers to manifest interest. In general, the

Commission will give priority to negotiating specific APAs with those manufacturers

that (a) have entered or have firm plans to enter clinical trials still in 2020, (b) have the

capacity to develop a successful vaccine and (c) have a proven capacity to produce at

scale already in 2021.

Process and governance

In order to run the procurement centrally and efficiently, the European Commission will

set up a steering board for the process subject to Article 6 of the present Agreement. It

will be co-chaired by the European Commission and a Participating Member State with

experience in the negotiations and production capacities for vaccines. The steering board

will include senior officials from all Participating Member States to assist and provide

guidance throughout the evaluation process.

The co-chairs of the steering board will propose a team of a limited number of experts

with relevant experience for the ongoing negotiations from six Participating Member

States with production capacities for vaccines. These experts will join with the European

Commission in a negotiation team (“joint negotiation team”), which will work on a

continuous basis as one unit. That joint negotiation team will start work immediately

building on previous contacts with individual companies by the European Commission

and Participating Member States. In order to launch negotiations with a specific

manufacturer, there needs to be support from at least four Participating Member States.

The joint negotiation team will make its best effort to take the advice of the steering

board into account in the negotiations and will report back to the steering board on a

regular basis on the progress made in negotiating with individual companies.

For compliance with the applicable rules, all members of the steering board and the joint

negotiation team will obtain the status of experts associated to the procurement process

as provided in the Financial Regulation. Given their access to highly sensitive business

information, all those members will be required to sign strict confidentiality and no-

conflict-of-interest agreements.

Assisted by the steering board, the European Commission will then decide which of the

resulting APAs should be concluded, in particular if financing under ESI is insufficient to

finance all relevant packages. The Commission will only consider those APAs for

financing where at least four Participation Member States have expressed agreement.

Before making any final decisions, the Commission will seek independent scientific

advice on the state of progress and the available data on quality, safety and efficacy for

the vaccine candidate in question.

Should financing under ESI be insufficient, Participating Member States can decide to

top up ESI funding to make up the gap to finance all packages. In such a case where there

are opportunities to conclude further APAs but money from ESI is no longer sufficient,

Participating Member States will have the opportunity to express their interest in such

opportunities. If at least four Participating Member States express interest, those

Participating Member States will make use of the possibility of a voluntary contribution

to ESI to the required amount allowing the Commission to proceed with signing the APA

only on behalf of those Member States that have expressed interest and contributed the

funds to ESI.

For full transparency, the European Commission will report to the IPCR at least once

every two weeks on overall progress more generally.

Advanced Purchase Agreements and conditions

To conclude APAs, the joint negotiating team will negotiate funding packages with

individual vaccine producers in return for the right to buy a specific number of vaccine

doses in a given timeframe and at a certain price.

As outlined in the present Agreement, the European Commission also has the possibility

to conclude APAs including an obligation to procure the vaccine if it becomes available,

where the conditions (notably the pricing) of those APAs make this worthwhile and in

line with the conditions in the present Agreement. If in such a case the distinction

between upfront payments and purchase price is difficult to draw, the Commission will

share the total cost related to the vaccine purchase but will in any case contribute no

more than 50% of the total cost.

Funding provided up front will be considered as an advance payment for any eventual

purchase by Member States, thus reducing the amount that Member States will have to

pay when eventually purchasing that vaccine.

The up-front payments under the APAs shall be used by manufacturers to de-risk the

necessary investments related to both vaccine development and clinical trials, and the

preparation of the at-scale production capacity along the entire vaccine production value

chain in the EU required for a rapid deployment of millions of doses of an eventual

vaccine. The relevant payments should be structured according to the need of the

manufacturer, but subject to the state of the vaccine development, in particular relying on

transparency of the associated clinical data and its assessment, at the time of payment.

This is in order to avoid obligations to pay in situations where the development work has

shown a vaccine candidate likely to be unsuccessful.

The purchase price of the vaccine, as well as the amount of funding provided up front

will take into account a transparent estimation of production costs (supported by

independent audits where available), as well as the resources already granted from other

public sources. Under the APA, the manufacturer can be asked to provide ex post proof

supported by independent audits concerning the activities financed by these payments.

The aim of the negotiation is to conclude APAs with individual companies under the best

possible conditions. These APAs should specify details with respect to:

a) Payments to be made, such as payment amounts, payment schedules, type of

payments requested and the use of those payments related to de-risk investment,

financing clinical trials, providing working capital and scaling-up production

capacity;

b) Delivery details of the vaccine if successful, such as price per person immunised

(or alternatively, number of doses required per person immunised and price per

dose), quantity of doses to be delivered and delivery timeline following approval;

and

c) Any other relevant conditions, such as production capacity built or used in the EU

or liability arrangements.

For liability arrangements, the joint negotiation team will make its best effort to limit

what is required by individual companies for the purpose of indemnification to be

included in the terms and conditions of the APA.

The APAs will contain provisions to clarify the law applicable to both the APA and

resulting purchase orders as well as the competent courts. The Participating Member

States agree that each APA negotiated by the Commission on their behalf with a vaccine

manufacturer will have the same applicable law for all Participating Member States, and

that the courts corresponding to that applicable law will be competent to hear disputes

arising from that APA.

When taking a decision to finance individual APAs, the European Commission, in

consultation with the steering board, will take into account the following elements: any

available data on quality, safety and efficacy of the vaccine at time of negotiation of the

contract, speed of delivery at scale, cost, risk-sharing, diversification of technologies,

capacity to supply through development of production capacity within the EU, possible

flexible future use of any capacity funded, engagement at an early stage with EU

regulators with the intention to apply for an EU marketing authorisation for the candidate

vaccine(s), commitment to supply vulnerable countries.

The procedure outlined above complies with the ESI Regulation and the Financial

Regulation. The latter is aligned to the European procurement Directives, which also

provide the basis for national procurement rules. Participating Member States may rely

on the procedure run by the European Commission to directly purchase vaccines from the

manufacturers as and when any of the vaccines becomes available based on the

conditions laid down in the APA. Access to vaccine doses will be allocated to

Participating Member States according to the population distribution key.

In the negotiations with the pharmaceutical industry under the present Agreement, the

Commission will promote a Covid-19 vaccine as a global public good. This promotion

will include access for low and middle income countries to these vaccines in sufficient

quantity and at low prices. The Commission will seek to promote related questions with

the pharmaceutical industry regarding intellectual property sharing, especially when such

IP has been developed with public support, in order to these objectives. Any vaccines

available for purchase under the APAs concluded but not needed and purchased by

Participating Member States can be made available to the global solidarity effort.