The European Commission's refusal of public access to text messages exchanged between the Commission President and the CEO of a pharmaceutical company on the purchase of a COVID-19 vaccine.
Decision in case 1219/2020/MIG on how the European Council dealt with a request for public access to mobile phone based messages supposedly sent by its then President to heads of state and government.
CASE 1316/2021/MIG
OPENED ON Thursday | 16 September 2021
INSTITUTION CONCERNED European Commission.
How Europe Sealed a Pfizer Vaccine Deal With Texts and Calls
The European Union is about to sign a deal for 1.8 billion doses of the Pfizer-BioNTech vaccine after a dispute with AstraZeneca derailed its vaccination campaign. Here’s how it came about.
Ursula von der Leyen, the president of the European Commission, in Brussels, on Sunday.Credit...Ksenia Kuleshova for The New York Times
By Matina Stevis-Gridneff
Published April 28, 2021Updated Sept. 15, 2021
Albert Bourla, the Pfizer chief executive, during a visit last week, at a Pfizer factory in Belgium.Credit...Pool photo by John Thys
Much of Europe was in lockdown, people were dying and the bloc was running low on doses of vaccines after its biggest supplier, AstraZeneca, announced production problems. Critics inside and outside the European Union questioned Ms. von der Leyen’s leadership and accused her of mishandling the crisis.
It was at that low point that she caught a break.
For a month, Ms. von der Leyen had been exchanging texts and calls with Albert Bourla, the chief executive of Pfizer, another vaccine supplier to the bloc. And as they spoke, two things became clear: Pfizer might have more doses it could offer the bloc — many more. And the European Union would be thrilled to have them.
That personal diplomacy played a big role in a deal, to be finalized this week, in which the European Union will lock in 1.8 billion doses from Pfizer, which, with its smaller German partner, BioNTech, made the first Covid-19 vaccine to get regulatory approval in the European Union.
The new contract will include a 900-million-dose order through 2023, with an option for another 900 million, Ms. von der Leyen said in an interview.
“I am convinced that we are in this for the long haul,” she said.The deal will establish the European Union as Pfizer’s biggest single client by far; the company has so far sold 300 million doses to the United States. The contract will permit the European Union to resell or donate the vaccines to partners, empowering it to conduct vaccine diplomacy and support struggling efforts to immunize people in poorer countries.
Ms. von der Leyen and Mr. Bourla first connected in January, when the pharmaceutical boss had to explain why his company had to cut vaccine supplies temporarily while it upgraded manufacturing facilities in Belgium. In November, the European Union signed an initial deal with the company for 200 million doses, with the option to add 100 million.
As the improvements at the Belgium plant moved along with relative ease, the discussions between the E.U. leader and the pharmaceutical chief continued, both recounted in interviews with The New York Times.
As they talked, the pandemic was raging across Europe, and Pfizer and BioNTech were hard at work trying to step up production. To increase the companies’ production capacity even further, the chief commercial officer at BioNTech, Sean Marett, was lining up regulatory approval for a newly acquired plant in Germany, which was already producing vaccines and stockpiling them in anticipation of getting a green light.
By the end of March, when the plant got its authorization, it had already produced 11 million doses, which were soon directed to the European Union.
An overcrowded emergency room in Bergamo, Italy, in March 2020. Credit...
Fabio Bucciarelli for The New York Times
The calls resulted in a string of deals between the European Union and the companies. On Feb. 17, the bloc announced an order for another 200 million shots. On April 19, it activated an option to get yet another 100 million.
Accounts of how the deals came about, related by Ms. von der Leyen, Mr. Bourla, Mr. Marett and another nine officials and experts involved, reveal a striking alignment of political survival and corporate hustle.
In her interview, Ms. von der Leyen played down the political pressures she had faced, and said she had been confident things would improve.
“I knew that the upscaling of the deliveries would have a slow start by nature in the beginning, and therefore, I also knew the first quarter was going be tough,” she said. But, she added, “I did not expect it to be as tough, because we did not include the possibility that AstraZeneca would reduce deliveries by 75 percent. That was a heavy setback.”
vaccine this month in Barcelona, Spain.Credit...
Emilio Morenatti/Associated Press
“Multiple leaders of the world, they would reach out to me, from presidents or prime
ministers and kings, and general secretaries of organizations,” Mr. Bourla said.
got into deep discussions.” He said: “She knew details about the variants, she knew
details about everything. So that made the discussion, way more engaged.”
Despite the deals with Pfizer and BioNTech, Europe is still playing catch-up when it
comes to vaccinating its citizens. As of this week, 22 percent of European Union
nationals have received at least one dose of a Covid-19 vaccine, in contrast to half
of Britons, 42 percent of Americans and more than 62 percent of Israelis, according
to Our World in Data.
A vaccination center at a velodrome near Paris. Credit...Dmitry Kostyukov
for The New York Times
But the European Union has now made up for the vaccine it did not get from AstraZeneca — the bloc is suing over the missed doses — and has moved forward its target date for getting 70 percent of its adults fully immunized. It is now July, instead of September.
The bloc is already one of the world’s biggest producers and exporters of Covid-19 vaccines, with just over 159 million doses shipped to 87 countries since December. That is almost exactly as many as it has kept at home to immunize its own people.
The agreement with Pfizer and BioNTech will stipulate that the shots be produced in Europe, bringing home not just the finished product, but also most of the 280 components that go into making it, Ms. von der Leyen and Mr. Bourla of Pfizer said.
The contract will also allow for a range of different vaccine products.
An internal European Commission assessment of the bloc’s needs over the next two years, which is still being reviewed and was seen by The Times, lays out ballpark figures for how many doses might be necessary under different scenarios, although not all these needs would necessarily be covered by the Pfizer contract. According to the draft assessment, the bloc might require up to 510 million booster doses in 2022 and 2023.
Mr. Bourla said he expected a booster would be needed six to twelve months after people get their second shot, although some public health experts note that it is not clear yet whether that will be necessary. And the assessment includes a worst-case scenario for a new vaccine to target an “escape mutant,” a variant of the coronavirus that is too resistant to existing shots. The draft says the European Union would require 640 million doses of this type of vaccine for two doses per adult. And it puts the number of pediatric vaccines at 130 million for 2022 and 65 million for 2023.
Vaccinations taking place at the velodrome near Paris in April.Credit...
Dmitry Kostyukov for The New York Times
The deal is not without risks, or critics. Countries and experts worry that the European Union may be becoming too dependent on Pfizer, and failing to hedge its bets in the event of problems with the vaccine or its production.
“I would caution against going for Pfizer/BioNTech only,” said Prof. Peter Piot, a microbiologist who advises Ms. von der Leyen. “That is too high risk for me, scientifically,” he said, though he noted that mRNA technology vaccines like Pfizer’s have so far been working well.
Of the new E.U. deal with Pfizer, Professor Piot said, “My interpretation is, what works is who can deliver.”
Ms. von der Leyen said the European Union could still procure doses from other companies.
She said the bloc was following the development of protein-based vaccines made by Novavax and Sanofi, as well as mRNA vaccines from Moderna, which are already being used in Europe, and CureVac, which is under review by the E.U. regulator. The Johnson & Johnson vaccine, which was rolled out in Europe this month, is also attractive because of its single-dose regimen and easy storage, she said.
The Pfizer shot is also expensive. While the financial details of the new agreement have not been disclosed, the previous contract priced the shot at approximately 15.5 euros, or about 19 dollars, making it the second-most expensive vaccine in the region after Moderna.
European Union members will each decide whether they want to use their full allocations of doses, or leave some for others to absorb, or to be resold or donated. They will also be free to make bilateral agreements with other pharmaceutical companies for vaccines in the future.
The new contract does little to address mounting global calls for the release of patents or for technology transfers to ensure that more of the world gets vaccinated soon. With India in the throes of a catastrophic wave of the virus, and the majority of the world’s population still far from getting access to a first dose of any vaccine, Europe’s talk of doses for children and boosters seems out of step with global needs, health experts say.
And while Ms. von der Leyen says the deal will enable the European Union to help poorer regions, it reinforces the fact that the rich are still coming first in the global scramble for vaccines.
Ms. von der Leyen at the European Parliament in Brussels on Tuesday.
Credit...Pool photo by Olivier Hoslet
Siddartha Sankar Datta, a senior official with the World Health Organization in Europe, said he worried about how the deal would affect gloal supply.
“I think the bottom line should be that the access to this vaccine should not be a prerogative of the purchasing power of the country,” he said. He said, “As countries make the effort to ensure their population base gets benefits, we have to still keep pushing ourselves to ensure more equitable access.”
Still, for Ms. von der Leyen, and for the European Union, the deal with Pfizer and BioNTech offers a chance to remedy past mistakes.
“Europe has decided to make sure that, under any circumstances, they will be prepared if there’s more need, and as a consequence of that political decision, they are now prepared to take much bigger risks,” said Moncef Slaoui, who led the U.S. vaccine effort Operation Warp Speed, and is in frequent contact with Ms. von der Leyen on E.U. strategy.
“Politics and science are intertwined here,” he said.
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The European Commission's refusal of public access to text messages exchanged between the Commission President and the CEO of a pharmaceutical company on the purchase of a COVID-19 vaccine
CASE 1316/2021/MIGOPENED ON Thursday | 16 September 2021INSTITUTION CONCERNED European Commission
The complainant sought public access from the European Commission to text messages and other documents concerning discussions between the Commission President and the CEO of a pharmaceutical company on the purchase of a COVID-19 vaccine. The Commission said it could not provide access to any text messages, as no record had been kept of any such messages. The complainant maintains the Commission has an obligation to record instant messages relating to important policy or political matters, such as the procurement of COVID-19 vaccines.
The Ombudsman opened an inquiry and sought to meet with representatives of the Commission to discuss the applicable procedures and practice.
Decision in case 1219/2020/MIG on how the European Council dealt with a request for public access to mobile phone based messages supposedly sent by its then President to heads of state and government
DECISION
CASE 1219/2020/MIGOPENED ON Monday | 26 October 2020DECISION ON Monday | 26 October 2020INSTITUTION CONCERNED European Council (No maladministration found )
The case concerned a request for public access to text messages sent in 2018 by the then President of the European Council to heads of state and government. The European Council said that it did not hold such text messages. The complainants expressed doubts that no documents falling within the scope of their request for access were in the possession of the European Council.
The Ombudsman noted that there is a legal presumption that the European Council does not hold the relevant documents, and that this presumption had not been rebutted by the arguments and evidence put forward by the complainants. As such, she found no maladministration in this particular case.
Having said that, the complaint raises important issues, notably the need for adequate record-keeping when it comes to instant messages. It is clear that text and instant messaging is increasingly used for professional communication, including communication of substantive information. In light of their duty to draw up and retain documentation pertaining to their activities, EU institutions should reflect this reality in their respective rules on the registration of documents, ensuring that relevant communication is properly recorded.
Background to the complaint
1. In November 2019, the complainants made a request[1] for public access to documents to the European Council, asking for
“[a]ll text messages (i.e., SMS messages) and other mobile-phone based text communications (e.g., WhatsApp, Telegram, iMessage, Facebook Chat, Snapchat, Slack, Facebook and Twitter “direct messages”, Signal Messenger, Wire, etc.) sent by - or on behalf of - Council President Donald Tusk in exchange with EU and foreign heads of state or heads of government in 2018.”
2. The European Council said that it did not hold any documents matching the description in the complainants’ access request.
3. The complainants asked the European Council to review its decision to refuse access.
4. The European Council then examined again whether it was holding relevant documents and confirmed that it could not identify any.
5. Dissatisfied with the European Council’s reply, the complainants turned to the European Ombudsman in July 2020.
Arguments put forward
by the European Council
6. The European Council acknowledged that text messages and other mobile-phone-based communication could qualify as a ‘document’ in the meaning of the EU’s rules[2] on public access to documents. However, it said, two conditions must be met:
7. First, the content of the message at issue must concern a matter relating to the policies, activities and decisions falling within the institution’s sphere of responsibility.
8. Second, to constitute a document, a content must have a minimum degree of stability and formality, meaning that it must not be short-lived but substantive. If this is the case, it argued, the message at issue would need “to be exchanged, registered, saved and eventually archived”.
9. The European Council said that, taking the above considerations into account, it had examined whether it was holding documents that fall within the scope of the complainants’ request, but could not identify any.
10. The European Council added that it was not its practice to exchange significant information about matters falling within its sphere of responsibility via instant messages of its President.
by the complainants
11. The complainants argued that any text message exchanged between the President of the European Council and heads of state or government concerned - at the very least - the activities (if not the policies and/or decisions) of the European Council.
12. While the complainants contested the argument that a document must not be “short-lived”, they argued that if text messages exchanged between the President and heads of state or government contained significant information pertaining to his institutional role, the European Council would hold the relevant documents.
13. The complainants also claimed that it was public knowledge that text messages on policy matters are exchanged between European leaders. To prove this, the complainants referred to three online articles about (i) text messages exchanged between the European Commission President and the British Prime Minister[3], (ii) a text message sent by someone participating in a meeting of the Council of the EU[4], and (iii) a text message sent by the Dutch Prime Minister to the President of the European Council[5].
14. The complainants therefore expressed doubts that no instant messages sent by the President of the European Council to heads of state or government in 2018 were held by the European Council. They considered that the European Council must have failed either to conduct a thorough search of its records or properly to retain relevant text messages.
The Ombudsman's assessment
15. The right of public access to documents applies only to documents in the possession of the institution concerned.[6]
16. In this case, the European Council refused to give public access on the grounds that it does not hold any documents that would fall within the scope of the complainants’ request.
17. According to settled case-law, if the institution concerned asserts that it does not hold specific documents, there is a legal presumption that this statement is true and accurate.[7] Whilst this presumption may be rebutted by relevant and consistent evidence that the requested documents exist and are held by the institution concerned, it is for the applicant to provide such evidence.[8] This evidence must go well beyond a mere belief or suspicion that the documents should be held by the institution. The presumption of legality cannot be rebutted by an assertion that the alleged lack of documents runs contrary to good administrative practice.[9]
18. The complainants challenged the presumption of legality by claiming that such exchanges between European leaders generally take place, which they based on information published in three online articles.
19. However, a general reference to that reality is not sufficient to challenge the European Council’s statement that it was not holding relevant documents in this case. The European Council’s statement holds true even if communication as described in the complainants’ access request had taken place, but was not registered at the time.
20. The Ombudsman therefore does not consider that the evidence put forward by the complainants is sufficient to call into question the European Council’s statement that it does not hold the messages sought by them. Thus, the legal presumption, established by EU case-law, holds. The European Council also stated that it examined its records twice, and there is no reason to doubt that it has indeed conducted a thorough search. That the European Council’s search did not lead to relevant results is not in itself sufficient to cast any doubt on this.
21. Having said that, the complaint raises important issues, notably regarding text and instant messages. While the EU’s rules on public access to documents were drawn up more than two decades ago, the notion of ‘document’ under those rules covers “any content whatever its medium (...).”[10] Thus, text and instant messages are clearly covered under these rules.
22. It is also clear that text and instant messaging is increasingly used for professional communication, including communication of substantive information, also by the EU administration. However, if the content of these messages is not retained and held by the institution, it will never be possible for the public to access this content.
23. Thus, while the Ombudsman finds that there was no maladministration by the European Council in this case, she believes that the EU institutions should make every effort to reflect the reality of modern communications, and the increased use of text and instant messaging, in their document management rules and practices. This reflects their duty to draw up and retain documentation pertaining to their activities[11]. They should do so, as far as possible and in a non-arbitrary and predictable manner.
Conclusion
Based on the inquiry, the Ombudsman closes this case with the following conclusion:
There was no maladministration by the European Council in denying public access based on the ground that it does not hold relevant documents.
That having been said, the EU institutions should make every effort to reflect the reality of modern communications, and the increased use of text and instant messaging, in their document management rules and practices.
The complainants and the European Council will be informed of this decision.
Emily O'Reilly
European Ombudsman
Strasbourg, 26/10/2020
[1] Under Regulation 1049/2001 on public access to European Parliament, Council and Commission documents: https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32001R1049&from=EN, applicable to the European Council pursuant to Article 10(2) of its Rules of Procedure: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32009D0882.
[2] Regulation 1049/2001.
[3] https://finance.yahoo.com/news/may-calls-eu-leaders-cross-party-talks-break-brexit-impasse-142426594.html?guccounter=1.
[4] https://www.theguardian.com/politics/2019/mar/22/it-was-not-clear-if-she-had-a-plan-at-all-how-mays-night-at-the-summit-unfolded.
[5] https://apnews.com/420b699b2dae44808f148699781d642a.
[6] In accordance with Article 2(3) of Regulation 1049/2001.
[7] See, for example, judgment of the General Court of 23 April 2018, Verein Deutsche Sprache v European Commission, T-468/16, paragraph 35: http://curia.europa.eu/juris/document/document.jsf?text=&docid=201394&pageIndex=0&doclang=DE&mode=lst&dir=&occ=first&part=1&cid=6275817.
[8] Ibid, paragraphs 36 f.
[9] Order of the Court of Justice of 30 January 2019, C-440/18 P, Vereine Deutsche Sprache v European Commission, paragraphs 23f:
[10] Article 3(a) of Regulation 1049/2001 [emphasis added].
[11] Judgment of the Court of First Instance of 26 April 2007 in case T-264/04, WWF European Policy Programme v Council, paragraph 61: http://curia.europa.eu/juris/document/document.jsf?text=&docid=61308&pageIndex=0&doclang=en&mode=lst&dir=&occ=first&part=1&cid=5501506.
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