Dear President von der Leyen,
Dear Secretary General,

Under the right of access to documents in the EU treaties, as developed in Regulation 1049/2001, we hereby request access to the different contracts - advanced purchase agreements- signed between the Commission and the pharmaceutical companies for the purchase of COVID 19 vaccines.
We understand that the contracts signed are so far the ones with AstraZeneca, Sanofi-GSK, Johnson and Johnson, BioNTech-Pfizer, CureVac and Moderna. Therefore, we would like to request access to these contracts, as well as to those that might be concluded after our request such as the one with Novavax.

There is a clear public interest in disclosure of these documents and it is the right of European citizen’s representatives to access them, considering that a total of € 2,85 billion of public money have been spent on behalf of European citizens. It is especially important than we can have a clear understanding of : the cost structure of production of the different vaccines, how the advanced public money was used by the companies, the prices to be paid - not officially revealed - , the production sites, the number of doses to be delivered per quarter, the agreements relating to intellectual property, including any agreement relating to a non-exclusive licence, the liability and compensation for any damage caused by a vaccine, and the clauses regarding access to vaccine in Europe, but also in line with Europe's commitment to find a global response to this pandemic and to promote access to and exchange of know-how for COVID 19 treatments in third countries.
From our understanding of the redacted contract that has been made accessible and now published, it may be the case that European taxpayers' money will be used to reimburse the producing company if it has to pay for damage to citizens due to adverse effects of the vaccine. Unfortunately, the decisive paragraph is completely redacted. In our opinion, this is prone to create mistrust and even disinformation

The transparency rules as set out in the Lisbon Treaty oblige the EU institutions to work as openly and as closely as possible to citizens. However, the Commission did not demonstrate good will in the application of the principle of good cooperation with the European Parliament, when overseeing many times our request to know more about the COVID 19 vaccines contracts and our call to make them public. The disclosure of a redacted version of the CureVac contract was not satisfactory as the elements listed above were not visible or incomplete.

We recognize the success of the signature of the COVID 19 vaccines contracts and we welcome the Commission’s efforts to ensure that all EU citizens will have access to a vaccine. This is a great success for the European Union and showed that cooperation was key in the management of this pandemic. However, we regret the secrecy around the negotiations of the advanced purchase agreements. The lack of information is undermining citizens’ confidence in the action of the European institutions. In the past, such secrecy had long-term effects on citizens’ confidence in political action and we must do everything we can to be exemplary.

As representatives of citizens, it is our role and right to scrutinize the action of the European public institutions. We therefore ask you to send us the signed advance purchase agreements as soon as possible. Private companies are not entailed to dictate what citizens should or should not know when public money has been used to conclude these deals. This is not how democracy works and we believe we should stand together to defend this principle.

Yours sincerely,

Tilly Metz
Margrete Auken
Ville Niinistö
Jutta Paulus
Michèle Rivasi
Kim van Sparrentak

European Commission
Att. Sandra Gallina
Rue de la Loi / Wetstraat 200
1049 Bruxelles
Belgium

Brussels, 31 March 2021

Subject: Confirmatory application for access to documents – GESTDEM 2021/0389

Dear Director-General,

We acknowledge your reply of 11 March 2021 (your reference GESTDEM2021/0389) to our request for access to documents of 20 January 2021. We requested access to the agreements signed between the Commission and pharmaceutical companies with regard to the advance purchase of COVID-19 vaccines, as well as to those that might be concluded after our request.

In your response, you have identified so far eight documents which fall within the scope of our request. You informed us about the public disclosure of redacted versions of three agreements on the website of the European Commission (CureVac, AstraZeneca and Sanofi-GSK). You furthermore informed us that you were progressing with the assessment of the other documents.

At the end of last week, the European Commission published redacted versions of two further advance agreements (Pfizer-BioNTech and Moderna), as well as of one purchase agreement (Pfizer-BioNTech II) and informed a staff Member of the Greens/EFA about it.

As such, to date you have granted partial access to six out of eight documents in the scope of our request, while failing to reply with regard to the other two documents within the deadlines set out by Regulation 1049/2001 (Janssen and Moderna II).

While you share our views with regard to the need for a transparent process, following consultations with the vaccine manufacturers concerned, you have decided to redact the agreements that you have released. You indicate the following reason for doing so:

“As explained in previous occasions, it is also in the interest of the Union and in line with applicable EU legislation, to protect the tendering process, not only for reasons linked to contractors’ commercial interests, but also because disclosing sensitive business information would weaken the position of the Commission in the negotiations that are currently being held with other companies, thus nullifying the beneficial effects of fair competition.”

We would like to submit a confirmatory application asking you to reconsider your position and to release all the documents concerned without redactions.

1. Undue application of exceptions under Article 4 of Regulation 1049/2001
Thanks to the investigative work of the Italian broadcaster RAI, the agreement with AstraZeneca has been released in its entirety. This allows identifying the parts that have been blacked in the redacted versions. In the redacted versions published, all information related to prices, payment and delivery schedules, production sites, as well as key information with regard to liability and indemnification, IP rights and termination clauses have been blacked.

Furthermore, the definition of “willful misconduct”, provisions with regard to timelines for audits and data storage, expenses with regard to post-launch safety and risk management studies as well as liability clauses in case of breach of personal data protection have been hidden.

It is difficult to understand why e.g. provisions with regard to definitions as well as timelines for audits and data storage should be considered to be of commercial interest.

2. Failure to justify the application of exceptions under Article 4 of Regulation 1049/2001
Under the first indent of Article 4(2) of Regulation No 1049/2001, the institutions may refuse access to a document where its disclosure would undermine the protection of ‘commercial interests of a natural or legal person, including intellectual property’, unless there is an overriding public interest in disclosure. Since exceptions derogate from the principle of the widest possible public access to documents of the EU institutions, the exceptions must be interpreted and applied strictly.

You indicate as one reason for refusing full access that “disclosing sensitive business information would weaken the position of the Commission in the negotiations that are currently being held with other companies”.

In order to justify a refusal to grant full access to a document whose disclosure has been requested, it is not sufficient, in principle, according to the case-law, for the requested document to be covered by an activity mentioned in Article 4(2) of Regulation No 1049/2001. As a rule, the institution to which the request has been addressed must also provide explanations as to how access to that document could specifically and actually undermine the interest protected by the exception or exceptions relied on. Moreover, the risk of that interest being compromised must be reasonably foreseeable and not purely hypothetical.

With regard to the requested information, there is no general presumption of confidentiality comparable with the presumption related to access to bids submitted by tenderers in the context of the performance of public contracts. The Commission may arguably indicate that the agreement finally concluded contains elements that are commercially sensitive both for the company as for the Commission. Furthermore, in the concrete case of COVID-19 vaccines, negotiations take place for further agreements with other companies, and more might follow. However, this argument does not stand. As indicated above, the agreement with AstraZeneca has been publicly released entirely by a third party on 19 Februrary 2021, and the prices indicated in all agreements have already been publicly released by another third party on 18 December 2020. So far, to the best of our knowledge, the Commission has not reported any issues in the ongoing procurement process due to such disclosures. Therefore, the risks are purely hypothetical. And you omitted to state any facts that could lead to the conclusion that the full disclosure of the information concerned would specifically and actually undermine commercial interests.

3. Incoherent application of Regulation 1049/2001
A superficial comparison between redacted versions of different agreements released shows that the agreements with Pfizer-BioNTech and the agreement with Moderna are far more redacted than the other ones.

Moreover, similar parts are blacked in one agreement but not in another e.g.:
- the definition of “best reasonable efforts” - available in the redacted version of the agreement with AstraZeneca, is blacked in the redacted version of the agreement with Pfizer-BioNTech
- timelines for audits - available in the redacted version of the agreement with CureVac, are blacked in the redacted version of the agreement with AstraZeneca.

This discrepancy illustrates that the Commission did not follow a coherent approach with regard to the application of Regulation 1049/2001, which in turn raises questions to which extent the Commission actually applied the provisions thereof, or rather left it to the companies concerned.

4. Overriding public interest
Even if the protection of the contractors’ commercial interests had been specifically shown to exist - which is not the case - we consider that there would clearly be an overriding public interest in the disclosure of the documents concerned pursuant to Article 4(2) of Regulation No 1049/2001.

As you rightly observed, we are currently in the middle of the most severe public health crisis in modern times. Public health measures taken to contain the spread of the virus are affecting fundamental rights of all people living in the EU. The Commission is taking a leading role in addressing this crisis. We agree with your statement that access to, and smooth deployment of safe and effective COVID-19 vaccines is “key in containing the pandemic, saving lives, protecting health care systems and helping to restore our economy”.

As such, public confidence in the actions by the Commission with regard to the purchase of vaccines is of key importance - all the more so as this is the first time that the Commission adopts advance purchase agreements on vaccines.

Moreover, according to a global survey undertaken by the Vaccine Confidence Project, the European region has the highest negative responses in terms of perception of the importance of vaccines and their safety and effectiveness, leading to the highest degree of vaccine hesitancy in the population (see Recital F of the European Parliament resolution of 19 April 2018 on vaccine hesitancy and the drop in vaccination rates in Europe). In the resolution, the European Parliament therefore “recalls the importance of transparency in building and maintaining public trust in medicines” (see Paragraph 14).

In addition, based on a survey published by the Commission in December 2020, in 24 Member States, respondents agree that public authorities are not sufficiently transparent about COVID-19 vaccines (see page 10).

It is obvious that confidence can only be established when there is full transparency. The obligations of both sides of the contractors and the way public money is spent need to be open to public scrutiny in the interest of public confidence in the vaccines concerned, as will be set out further below.

However, the redaction of the agreements makes it impossible to understand the agreements. The release of the redacted agreements therefore does not help to build confidence in the Commission’s key role in addressing the crisis and its capability to obtain the best result in the interest of public health when negotiating and making agreements with companies.

To the contrary, lack of public information about the agreements, in particular with regard to key information such as delivery schedules and liability provisions, led to serious attacks on the Commission since the beginning of 2021 with regard to the joint procurement of vaccines for the European Union. In many Member States, the Commission was attacked for acting too slowly, or for being too conservative.

While the approval of the first vaccines in December 2020 had created major expectations, lack of public information about the actual delivery schedules led to strong criticism of the joint procurement. The Commission defended the benefits of a joint procurement system, and explained in public that the deliberate decision to go for conditional market authorisations instead of emergency authorisations led to certain delays, as some companies did not want to be liable whatsoever. However, to reassure the public, it is of paramount importance not only to explain what happened, but also to disclose the provisions with regard to delivery schedules and liability.

In the past months, we have been seeing high-level discussions about alleged parallel negotiations between Member States and companies with whom the Commission had adopted agreements. We continue to discuss the failure of AstraZeneca to honour its contractual obligations, which in turn has triggered a debate on export bans. Such discussions were fuelled by the failure of the Commission to disclose the agreements.

In the European Parliament resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19 July 2020, the European Parliament called on the Commission and the Member States “to incorporate collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for the exploitation of the final products, in all current and future calls for funding and investment”

A total of at least € 2,85 billion of public money has been spent by the Commission on behalf of European citizens in the context of the adoption of the agreements. This alone should be sufficient to invoke an overriding public interest in the disclosure of these agreements.

On 22 October, Pascal Canfin, the Chairman of the Committee on the Environment, Public Health and Food Safety, wrote to Commissioner Stella Kyriakides on the need for transparency on the Advance Purchase Agreements concluded with vaccine producers:

“Against the backdrop of the significant EU funding already committed to the creation of a portfolio of potential vaccines, and the high number of transparency demands, not only from Members of Parliament, but also from EU citizens, I would like to convey the message, on behalf of a majority of coordinators, that the ENVI committee expects the Commission, the Member States and the pharmaceutical companies involved to increase the level of transparency with regard to the contracts concluded. The minimum would be that following provisions in the contracts are made public:
• the cost structure for the production of the various vaccines, and the prices to be paid,
• the production locations,
• the intellectual properties arrangements, including any arrangements linked to non-exclusive licensing,
• the liability and indemnification linked to any damage caused by a vaccine, and
• access to the vaccine.”

Pascal Canfin followed up with another letter to Commissioner Kyriakides on 21 December 2020:

“Furthermore, ENVI coordinators continue to underline the need for more transparency on the specific demands included in our previous letter, and especially for more clarity with regard to the legal rules regulating the liability and indemnification linked to any damage or side effects caused by a vaccine and the conditions laid down in the APAs with regard to this. We point out that this transparency should allow us to explain to the EU citizens the aspects of the contracts for which information will be made available.”

On 12 January, MEPs of the Committee on the Environment, Public Health and Food Safety called for more clarity and transparency, finding that the “Lack of transparency has recently fuelled uncertainty and disinformation regarding COVID-19 vaccination in Europe” (see EP press release here).

A plenary debate was held with Commissioner Kyriakides on 19 January 2021, during which MEPs from all groups stressed the need for transparency (see verbatim report here).

A plenary debate was held with Commission President Von der Leyen on 10 February, during which many MEPs recalled the need for transparency with regard to contracts, and called for EU and global solidarity (see EP press release here, verbatim report first part here and second part here).

The Commission reacted to this over time by first making one of the redacted agreements available in a reading room, then gradually making more and more redacted agreements available on line, and then accepting to set up a Contact Group with selected MEPs to provide further information in a confidential setting. In other words, while the Commission gradually reacted to the pressure for public information, it still keeps the most important information in the agreements confidential despite the long-standing and repeated calls by the European Parliament for transparency.

5. The overriding public interest due to the global dimension
On 22 June 2020, the Commission adopted the EU-strategy for COVID-19 vaccines. It says the following:

“This is not only a European challenge, it is also a global one. All regions of the world are affected. The spread of the virus has shown that no region is safe until the virus is under control everywhere. In addition to it being in their clear self-interest to do so, high-income countries have a responsibility to accelerate the development and production of a safe and effective vaccine and make it accessible for all the regions of the world.”

As stated above, the European Parliament had called on the Commission and the Member States “to incorporate collective safeguards in favour of the public regarding public funding, such as transparency, accessibility and affordability clauses and non-exclusive licences for the exploitation of the final products, in all current and future calls for funding and investment” (European Parliament resolution of 10 July 2020 on the EU’s public health strategy post-COVID-19 July 2020).

To see whether the Commission has effectively delivered on its commitment to “accelerate the development and production of a safe and effective vaccine and make it accessible for all the regions of the world”, it is of paramount importance to be able to see the provisions in the agreements with regard to intellectual properties arrangements, including any arrangemens linked to non-exclusive licensing (see also the latter by Chairman Canfin referred to above).

6. Overriding public interest based on the Charter of Fundamental Rights
In accordance with Article 51(1) of the Charter of Fundamental Rights, the Charter is binding on the Commission. The right to freedom of expression in accordance with Article 11(1) of the Charter includes freedom to receive information, and the Charter guarantees a right to access to documents in Article 42.

Article 52(3) of the Charter stipulates that, insofar as the Charter contains rights, which correspond to rights guaranteed by the Convention for the Protection of Human Rights and Fundamental Freedoms, the meaning and scope of those rights shall be the same as those laid down by the said Convention. Article 10(1) of the Convention indicates that everyone has the right to freedom of expression; this right shall include freedom to receive information.

Whether and to what extent the denial of access to information constitutes an interference with the freedom-of-expression rights must be assessed in each individual case and in the light of its particular circumstances.

The following criteria are relevant:
- The purpose of the information request
- The nature of the information sought
- The role of the applicant
- The availability of the information

As regards the purpose, the disclosure of documents under Regulation No 1049/2001 is reputed to have erga omnes effect and therefore considered as disclosure to the general public. The applicants, apart from using the information for the purposes of the activities as Members of European Parliament, also seek to constitute an essential element of public debate.

As regards the nature, there is a clear public interest in disclosure of the agreements. The transparency rules as set out in the Treaties oblige the EU institutions to work as openly and as closely as possible to citizens (Article 15 TFEU). There is clearly a lot at stake for EU citizens in the vaccine deal negotiations. Citizens have the right to know about the negotiations that are happening on their behalf, involving billions of euros of public money to be spent for the development of vaccines. Secrecy around the negotiations about the vaccines, moreover, may undermine public confidence in the EU, but also in the vaccines themselves. Considerable amounts of public money and public guarantees are invested into the R&D and manufacturing process. This makes the need for transparency and public accountability even stronger.

As regards the applicants, they are Members of European Parliament. In accordance with Article 10(2) TEU, they directly represent citizens. On the citizens’ behalf, they ensure oversight of the Commission, which is responsible to the Parliament (Article 17(8) TEU). In such a way, they have a special role in enhancing the public’s access to information and facilitating the dissemination of information assimilated to that of “public watchdogs”.

As regards the availability of the information, the partial publication of several agreements, demonstrates that the requested information is fully available to the Commission.

7. Non-respect of the legal time-limits for deciding on the access to documents request
The Commission did not entirely respond to our request for information of 20 January 2021 within the time-limit prescribed in Article 7 of Regulation 1049/2001. Article 7(1) of Regulation 1049/2001 provides that an application for access to a document shall be handled promptly. Within 15 working days from registration of the request for information, the institution shall either grant access to the documents requested and provide access or, in a written reply, state the reasons for the total or partial refusal and inform the applicant of the right to make a confirmatory application. In your letter, you have informed us about the partial access to three out of eight documents in the scope of our request, and subsequently by mail of the partial access to three other documents in the scope of our request, while failing to reply with regard to the remaining other two documents within the deadlines set out by Regulation 1049/2001.

The above cited letter of 11 March 2021 therefore does not constitute a sufficient reply to our request that we are entitled to according to Article 7(1) of Regulation 1049/2001. Based on the failure of the Commission to reply within the prescribed time-limit we are entitled, based on Article 7(4) of Regulation 1049/2001, to make a confirmatory application regarding the non-respect of Article 7(1) of Regulation 1049/2001. As it remains the Commission’s duty to handle our request promptly, we call on the Commission to take a decision on our request and to end the non-respect of the time-limit as soon as possible.

Conclusion
To conclude, we would like to ask you to reconsider your position and make fully available all agreements between you and pharmaceutical companies with regard to COVID-19 vaccines.

Yours sincerely,

Tilly Metz
Margrete Auken
Ville Niinistö
Jutta Paulus
Michèle Rivasi
Kim van Sparrentak