Vaccine scarcity: how the EU’s appeasement of Big Pharma damages COVID-19 response

The Ombudsman’s inquiry was launched in January 2021. This was following two complaints by Corporate Europe Observatory against the Commission's handling of two September 2020 Freedom of Information (FOI) requests we submitted regarding the EU’s negotiations with pharmaceutical companies for COVID-19 vaccine purchases. The FOI requests were submitted just as we published our report ‘Power and profit during a pandemic - why the pharmaceutical industry needs more scrutiny not less’.

As that report notes, “In a pandemic the pharmaceutical industry is hailed as a saviour; yet the industry is using the crisis to lock in its problematic, profit-maximising model. Pushing for public money with no-strings-attached, and stronger monopoly patent rules, the industry’s wish-list could restrict access to COVID-19 drugs and vaccines, prolonging the pandemic in the name of profit.”

"Administrative virtue"

The inquiry covers the Commission’s refusal to disclose its COVID-19 vaccine purchase contract with AstraZeneca, the first such contract which the Commission signed last year. The Commission rejected Corporate Europe Observatory’s FOI request, referencing protecting the “commercial interests” of AstraZeneca and claiming there was no overriding public interest in transparency. We appealed this decision, but the Commission repeatedly failed to respond within the deadlines outlined in the EU’s FOI legislation. The Commission also refused to disclose any other documents related to the vaccine negotiations, including notes of meetings and correspondence with the pharma companies (as well as the names of the members of the Joint Negotiation Team, which consists of seven experts designated by member state governments).

Since then the Commission has published the AstraZeneca contract (as well as the CureVac and Sanofi-GSK contracts). The contracts were published in redacted form with key paragraphs crossed out (although the full text of the AstraZeneca contract is in the public domain, due to a blunder with the format of the pdf that the Commission first uploaded and since replaced). The Commission also announced that they have also asked three other pharma companies to agree to disclose their contracts. The Commission’s sudden willingness to reveal the details of these contracts ­– after unbearable public pressure – belies their claim in October 2021 that there was “no overriding public interest” in transparency.

The Commission’s U-turn came after AstraZeneca announced delays in vaccine delivery, which sparked a high-profile row over the company’s contractual obligations. European Ombudsman Emily O’Reilly commented earlier this week: “Suddenly transparency was the order of the day as a redacted version became public, the Commission using it to argue its contested case of bad faith against the pharmaceutical company”. O’Reilly continued, “But if the Commission wanted more transparency in this area, in order, as it says, to increase public trust and confidence in the vaccines, then presumably such transparency could have formed part of the negotiations with the pharmaceutical companies? It should not take a crisis for transparency to become an administrative virtue.”

“softball approach”

The Ombudsman’s inquiry will now assess the Commission’s secrecy around the contracts and other documents related to the vaccine negotiations, including how this compares with its obligations under EU’s freedom of information law and the Lisbon Treaty (to be as transparent as possible). In addition to drawing conclusions on the Commission’s secretive approach, the inquiry will hopefully result in large numbers of other documents being disclosed (including notes of meetings and correspondence with the pharma companies), documents that will throw unprecedented light on the negotiations and help answer many burning questions. Indeed, as mentioned above, Corporate Europe Observatory’s original FOI request for these documents were also refused.

The first legal assessments of the published contracts show that they suffer from major weaknesses, including ambiguous delivery dates and a lack of sanctions should the companies fail to comply. Investigative journalist Stefano Valentino, who consulted several legal experts, concludes that the EU used a “softball approach” in the negotiations and now “has its hands tied” when the pharma companies announce delays in delivery and is left to “rely on the goodwill” of the companies. "The only real certainty”, Valentino argues, “is the weak position in which the EU and the member states have placed themselves, taking high-margin financial risks and a less demanding attitude toward suppliers".

As Viviana Galli of the European Alliance for Responsible R&D and Affordable Medicines told VoxEurop: "When negotiating the contracts, the European Commission and the Member States should have put much more care in protecting the public interests with specific clauses giving responsibility to the companies in case of non-compliance”.

Global health before profits

While joint procurement by the 27 EU member states was clearly the right approach, it appears that the EU negotiators could have achieved far better results considering the strong negotiating position they had. They were negotiating on behalf of 27, mostly very wealthy, European countries, during a pandemic in which pharmaceutical companies had pledged to put global health before profits. The negotiators moreover had a very sizeable budget available for the pharmaceutical companies, in order to fund research and development and manufacturing capacity. The negotiators committed public money to remove financial risk and – to some extent – liability for the pharma companies working to develop COVID-19 vaccines. They should have at least insisted on very strong public interest conditions in return.

The Commission’s conflict with AstraZeneca (and previous announcements by Pfizer of reducing promised deliveries) has revealed the weakness of the EU strategy to rely on just a handful of pharmaceutical corporations not only for the research and development of the vaccines, but also for the manufacturing. The negotiators should have used the negotiations to secure a deal that would enable many more companies to prepare for production and thereby make far larger amounts of vaccines available in Europe and across the world. Instead they agreed to a flawed monopoly patent model that only benefits Big Pharma and unnecessarily prolongs the pandemic by leaving many countries unable to access vaccines.

The approach chosen by the EU (as well as the US and other OECD countries) results in vaccines becoming available at far too slow a pace, both in Europe and even more starkly in the rest of the world. The populations of most African and many Asian countries will likely only be vaccinated in 2023 or later. As Director General of the World Health Organisation Dr Tedros Adhanom Ghebreyesus warns, the “world is on the brink of a catastrophic moral failure”.

And it’s not just a moral failure, but a practical one too. The emergence of new dangerous mutated virus strains, for which vaccines may offer less protection, shows that speed of vaccination is of utmost importance and that a global solidarity approach is needed. Allowing pharmaceutical corporations to decide how and when to manufacture vaccines, and for who, creates artificial scarcity with devastating effects. Relying on these companies to voluntarily allocate vaccines to global distribution pools like Covax has proven disastrous.

"Vaccines as a universal public good"

In the early months of the pandemic, Commission President Von der Leyen repeatedly stated that vaccines against COVID-19 should be treated as a universal public good; yet the model agreed with Big Pharma in the vaccine contracts fundamentally contradicts these promises. Von der Leyen has defended the global dimension of the EU’s strategy arguing that “our vaccines will be given to other countries”, but considering the slow pace of manufacturing this is hardly convincing. Moreover, the CureVac contract, for instance, prohibits European countries from reselling, exporting, or donating doses — including to Covax — without permission from the company. Giving the company a veto on the transfer of vaccines is clearly at odds with the stated goals of the EU strategy.

The EU’s softball stance with Big Pharma – the continuation of a decades-long habit of granting the sector excessive power over medicines policy – has resulted in one of the EU’s worst ever own goals. Only now, far too late, the Commission has started to realise it has to intervene to ramp up vaccine production. On 10 February 2021 Commission President Von der Leyen informed MEPs about the creation of a new "Task force to increase the industrial production of vaccines, under the authority of our Commissioner for the Internal Market, Thierry Breton. The aim is to detect problems and help solve them."

As James Love of Knowledge Ecology International concludes, “the world has basically lost a year when it comes to scaling manufacturing know-how for vaccines”. Upscaling production in Europe and the rest of the world is now clearly matter of utmost urgency. The pharmaceutical industry meanwhile, despite the global health emergency, is still trying to prevent any departure from the monopoly patent model. And despite the vast costs in terms of deaths and disability due to COVID-19, not to mention the economic damage, and the real risk of more vaccine-resistant mutations arising as the virus runs rampant through populations, the EU so far is playing along with Big Pharma.

A crucial battle is currently playing out at the World Trade Organisation (WTO), where the governments of South Africa, India, and some 100 other countries are calling for the temporary suspension of the patent system for COVID-19-related medical products until worldwide immunity is achieved. The proposed ‘TRIPS waiver’ (Trade-Related Aspects of Intellectual Property Rights) would lift monopoly patents by Big Pharma, and is vital in order to boost global production of COVID-19 vaccines, tests, and treatments, but the EU, together with the US and Japan, again blocked this at a recent WTO meeting in early February. The EU still refuses to waiver patent protection and argues for 'voluntary' sharing, an approach that has so far failed miserably. Criticism of this deeply irresponsible stance is mounting and there are even signs that some European governments are having a change of heart. The next round of negotiations will take place in the second week of March 2021 and civil society is mobilising for the EU to stop blocking the TRIPs waiver.

All of this shows why the Commission and member state governments should have listened to MEPs and civil society and provided transparency around vaccine purchasing negotiations from the very beginning. Transparency around the negotiations would have enabled public debate and parliamentary scrutiny, and the weaknesses in the EU approach would have been made evident before it was too late to correct them. Transparency, moreover, would arguably have strengthened the hand of EU negotiators vis-a-vis Big Pharma, as public opinion would without doubt have supported attempts to force pharmaceutical companies to – in return for the generous public funding provided – agree on making the vaccines a global public good.

The ‘Right to Cure' campaign has launched a European Citizens' Initiative calling upon the EU to "make anti-pandemic vaccines and treatments a global public good, freely accessible to everyone". The campaign is collecting one million signatures in EU member states, encouraging the European Commission to implement this crucial demand. Sign the initiative here: https://noprofitonpandemic.eu/

Corporate Europe Observatory has filed several new Freedom of Information (FOI) requests to the European Commission to throw light on the COVID-19 vaccines. We have requested access to all correspondence and minutes from meetings between the EU's vaccine deal negotiators and the pharmaceutical companies from September 2020 onwards (including during the turbulent last few weeks). We have also sent FOI requests for the Commission’s and EU governments’ contacts with pharma lobbyists concerning the TRIPS waiver debate, as well as for documents concerning McKinsey’s advisory work for the Commission regarding the EU’s COVID-19 response strategy.