Covid vaccine with syringe

TRIPS ‘Waiver failure’: EU betrayal of global south on vaccine access obscured by lack of transparency

Last month, almost two years after we filed Freedom of Information (FOI) requests concerning COVID-19 vaccine contracts and negotiations between the EU and pharmaceutical companies, Corporate Europe Observatory (CEO) experienced a small breakthrough in our ongoing fight for transparency. The European Commission published a final batch of more than 200 documents that we had requested access to. Many of them were heavily redacted however, something we have appealed. In the end of June, the World Trade Organization (WTO) Ministerial Conference approved a decision on the Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, aka the "TRIPS Waiver".

The TRIPS waiver, first proposed by the India and South Africa in 2020, would involve a temporary global easing of intellectual property rights on COVID-19 vaccines and treatments to enable them to be produced on a far larger scale, to support global health and a way out of the pandemic. But due to strong resistance from the EU, the UK and other Northern governments, it took a year and a half to reach agreement on a weak text, the benefits of which for the global South are yet to be seen. The EU’s approach stands in stark contrast to its original pledge that COVID-19 vaccines would become a global public good. More transparency is still very much needed, to fully understand why the EU played such a problematic role internationally on this issue, and how and why the global dimension of the EU’s vaccine strategy failed so spectacularly.

Secrecy has been the cornerstone of the EU’s Vaccine Strategy. In documents released to Corporate Europe Observatory as a result of our Freedom of Information requests, we read: “Some Member States asked when details of the contracts could be made public. The members were reminded that the contracts contained confidentiality clauses that could only be waived with the agreement of companies. Furthermore, caution was called for not disclosing contract clauses while negotiations were ongoing, as companies may wish to ‘’cherry pick’’ on the best conditions. As a conclusion, disclosing elements from contracts once the negotiations were finalized required the agreement of the companies and ultimately of all Member states, as buyers of the vaccines.”

Not a TRIPS waiver: Too little, too late

The final outcome of the WTO negotiations on a TRIPS waiver, in mid-June 2022, is too little, too late. As the experts from Medicines Law & Policy wrote: “This decision is no longer a TRIPS waiver in the sense it was proposed by South Africa and India in October 2020, but several issues that were still up in the air are now resolved. The Decision as it stands only concerns vaccines, while it would have been most useful for therapeutics and other health technologies.”

Dr Christos Christou, International President of Medecins Sans Frontieres (MSF) reacted to the decision by saying: “Overall, we are disappointed that a true intellectual property waiver, proposed in October 2020 covering all COVID-19 medical tools and including all countries, could not be agreed upon, even during a pandemic that has claimed more than 15 million people’s lives. […] The measures outlined in the decision will not address pharmaceutical monopolies or ensure affordable access to lifesaving medical tools, and will set a negative precedent for future global health crises and pandemics. […] Despite lofty political commitments and words of solidarity, it has been discouraging for us to see that wealthy countries failed to resolve the glaring inequities in access to lifesaving COVID-19 medical tools for people in low- and middle-income countries. “

The approach the EU took to this crucial global debate was not only deeply Eurocentric, but has essentially seen the EU siding with, and advocating for, Big Pharma demands. Internationally renowned medical law expert Ellen ‘t Hoen wrote: “Let’s not forget that the waiver discussions at the WTO have their origins in the refusal of companies such as Pfizer and Moderna to share their Covid-19 vaccine manufacturing intellectual property, technology, and know-how.” 

During the past two years Corporate Europe Observatory has published extensive research showing that the EU response to the pandemic was heavily influenced by the commercial interests of Big Pharma. At the same time, in our 25 years of making Freedom of Information requests, it is notable that we have rarely seen such a level of opacity.

Redacted Commission file COVAX

Redacted documents, 18 months wait for release

Corporate Europe Observatory submitted two Freedom of Information requests in September 2020. In March 2021, after the European Ombudsman intervened on our behalf, the Commission sent a list of 365 relevant documents, announcing that those that could be disclosed "will be made progressively available online on a Commission website".

But the Commission failed to deliver on its commitment: after a first batch of 80 documents was released in June 2021, nothing further followed for six months, leaving Corporate Europe Observatory with no option but to submit a new complaint. Following this complaint, the European Ombudsman in January 2022 re-opened her inquiry into the Commission's failure to disclose these documents.

In April 2022 we received over 90 new documents related to the EU vaccine strategy. The documents, often very heavily redacted, are primarily agendas and minutes from 53 meetings of the Steering Board (made up of European Commission and Member State representatives) that was responsible for the EU’s vaccine strategy and the negotiations with pharmaceutical companies. The meetings took place between 18 June 2020 and 16 February 2021.

These documents have never been released before, and they provide unique insights into how the EU’s vaccine strategy took shape and how the negotiations with pharma companies played out. Key words, sentences and paragraphs have been blacked out, which limits what can be concluded from the documents. But still, there is no doubt that these minutes provide important insights on many issues, such as the heavily publicised troubles with Astra Zeneca’s vaccine deliveries, and a different set of tensions around Pfizer’s deliveries, both in early 2021.

EU betrayal on promise of vaccines as “global public good”

We read the minutes of the meetings of the Steering Board with a particular interest in finding out what happened to the EU’s commitment to vaccines as a global public good, which was explicitly part of the agreement between EU member states and the Commission on the joint procurement of vaccines in mid-June 2020. This agreement stated that:

"the Commission will promote a Covid-19 vaccine as a global public good [our emphasis throughout]. 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 [intellectual property} has been developed with public support, in order to these objectives. Any vaccines available for purchase under the APAs [Advance Purchasing Agreements] concluded but not needed and purchased by Participating Member States can be made available to the global solidarity effort.”

In spring 2020 the EU had actively championed the global public good approach in international discussions about how to ensure vaccination took place worldwide. As Nerina Boschiero from the University of Milan points out: "During the negotiations of the World Health Assembly (WHA) resolution on COVID-19, finally adopted on May 19, 2020, the EU submitted a proposal for a consolidated zero draft on a WHA73 "COVID-19 response", according to which the Seventy-third World Health Assembly, would have had to recognize "population-wide immunization against COVID-19 as a global public good for health and the crucial role of quality, safe, and efficient vaccines therein”. The proposal was watered down after pushback from the US government, but the EU’s commitment to a ‘global public good’ approach appeared very clear.

But, when examining the EU’s COVID vaccine contracts with pharmaceutical companies and the  role it played in the TRIPS waiver negotiations, Nerina Boschiero concluded that “it is abundantly clear that Europe is in no way pursuing the announced negotiating objective of promoting COVID-19 vaccines as global public good."

The EU’s u-turn, abandoning the global public good approach and instead treating the vaccines as private monopolies owned by a handful of pharmaceutical corporations, happened in the summer of 2020, as can be seen from the minutes of the EU Vaccine Strategy Steering Board meetings. In the first months after the Steering Board commenced its work, the objective of vaccines as a “public good” was mentioned several times in minutes of Steering Board meetings, for instance on July 17 2020: “the Commission concluded that the EU is fully committed to an international mechanism that makes vaccines a ‘public good’”. But these notes then continue by referring only to “the creation of the COVAX Facility and the ACT Accelerator”, global mechanisms for sharing donated vaccines. There is no mention whatsoever of promoting intellectual property sharing in talks with pharmaceutical companies, not in these minutes, nor in any of the other meeting minutes.

At the Steering Board meeting a week later (July 24 2020) there is a further backtracking from the goal of vaccines as a global public good, referring to a meeting of COREPER (which brings together EU members states’ ambassadors and diplomats): “the Commission noted that COREPER has emphasised that the EU fully supports the international dimension of COVID-19 vaccines. Nevertheless, it is important to separate involvement in the COVAX Facility and the ACT Accelerator from the scheme to purchase vaccines for the EU citizens”.

In the summer of 2020 there was thus a clear shift away from a global public good approach (which would require lifting of patents and sharing of intellectual property and technology to enable production on a larger scale) to a narrow EU-focused strategy, combined with donations of vaccines bought by the EU to COVAX - a charity approach. The notes include a statement that reads like an attempt to justify this Eurocentric approach: “the strong support given by the EU through the upfront financing of the vaccines producers will support the COVAX Facility and the ACT Accelerator in making vaccines available and affordable globally”.

In hindsight, this approach was clearly problematic and unsuccessful. COVAX has failed to make anywhere near sufficient vaccines available to low-income countries during the pandemic. Vaccine scarcity prolonged the pandemic and caused tens of thousands of preventable deaths. For a critique of the EU’s reliance on COVAX, see for instance the analysis published by Medecins Sans Frontieres. It appears as if the COREPER meeting in the third week of July 2020 could be where the “global public good” approach was finally buried and replaced by the charity approach that we now know failed to deliver for the Global South.

Organised scarcity: EU abandons global good to support Big Pharma line

After July 2020, there is no reference to vaccines as a global public good in any of the meeting minutes, and all discussions about the international dimension are focused on COVAX and vaccine donations. The justification mentioned above is repeated several times, for instance on August 19 2020: “the EU is also indirectly supporting the availability of the vaccines for the global community by giving money to vaccine producers for development and manufacturing vaccines via APAs [Advance Purchasing Agreements]. Once vaccines are developed, everyone will benefit from them”.

This is not what actually happened: vaccines were developed, but remained scarce because a handful of pharmaceutical companies with monopoly control of the technology were allowed to decide how many vaccines to produce, at what price, and to whom to sell them. These companies refused any intellectual property sharing, and the EU seems to have made no effort to change that position, despite this being ostensibly one of its official goals. As earlier Corporate Europe Observatory research has shown,Big Pharma has lobbied against sharing of Intellectual Property rights and called this a proposal which “represents an extreme measure for an unidentified problem and leads towards a significant escalation in anti-IP [Intellectual Property] positioning in multilateral fora, with potential consequences around the globe.”

The Steering Board meeting on September 17 2020 was fully dedicated to COVAX. The Commission stated “that Team Europe was ready to put its expertise and resources at work within COVAX to accelerate and scale-up development and manufacturing of a global supply of vaccines for citizens across the world. Member States called for an EU consolidated approach and not 27 individual commitments in COVAX”.

Also at this meeting the justification of the departure from the principle of vaccines as a global public good was repeated: “We are committed to universality of vaccines - one example being the almost €2.7 billion upfront payment the EU was investing, that secures not only the interest of the EU citizens but also production capacity for the whole world”. On October 30th 2020 COVAX was again the main topic of the Steering Board meeting. These minutes are unfortunately excessively redacted. The minutes of the November 24 2020 Steering Board meeting mention that work was ongoing to “establish an EU-wide approach on donations”. At this stage the EU’s international vaccine strategy was fully focused on COVAX and donations of vaccines, in other words charity instead of vaccines as a global public good. A concept paper on donations was presented at the Steering Board meeting on 27 November 2020 and a subgroup on vaccine donations was set up. The Commission underlined that “the EU MSs [Member States] should donate together thus to build a common EU pot of vaccines”. Key sentences are again redacted. The Steering Board minutes of December 4 2020 contain a whole page about COVAX that has been redacted, at the end of the document. The minutes from a meeting on 11 December 2020 mention that the contract with Moderna “has a new column on resale/donation due to many requests from third countries caused by COVAX difficulties to secure doses”. This reads as a first acknowledgment that things were not going well with COVAX - although we cannot know if this was discussed earlier, due to significant redactions on many documents.

Cracks with Covax: vaccine scarcity and avoidable excess deaths

The minutes of the Steering Board meetings on 17 and 18 December 2020 mentioned that “COVAX was delayed in securing supplies of vaccines”. Again on December 23 2020 the Steering Board discussed COVAX and the “high need and demand on vaccines in the rest of the world”. On January 15th 2021 the Steering Board discussed COVAX and “the Commission underlined that the resell/donations needed to respect the contractual provisions of the APAs”. These Advanced Purchase Agreements were signed between the EU and pharmaceutical companies, and at least some of these contracts contain provisions requiring approval from the vaccine producers before surplus doses can be donated.

The implications of abandoning the ‘global public good’ approach have been extreme and severe for the Global South. Failing to force the pharmaceutical industry to enable generics production, and leaving key decisions about how much to produce and who to sell to in industry hands resulted in a disastrous vaccine scarcity that prevented the world’s poorest people from getting vaccinated. In particular African countries suffered from this injustice. Whereas a large majority of EU citizens are vaccinated, only 18.3% of Africans are fully vaccinated today. A study by Imperial College London, published last month, estimates that around 600,000 deaths could have been avoided if the World Health Organization's target of vaccinating at least 40 percent of the population in all countries by the end of 2021 had been met. The EU, as one of the key powerful actors in the global negotiations on approaches to global vaccination and the vaccine waiver, clearly failed to deliver on its early promises to prioritise global public health, and bears a very significant responsibility for this outcome.

Key questions that arise from our examination of the above-mentioned documents are:

1) Did the EU negotiators actually pursue the stated objective of vaccines as a global public good and did they demand a commitment to intellectual property sharing in the negotiations with the pharmaceutical companies? The documents seem to indicate that this did not happen at all.

2) Did the pharmaceutical companies simply refuse intellectual property sharing and other steps towards ensuring that the vaccines would become a global public good? The documents are too heavily redacted to answer this question.

More than 200 new documents were finally released last month, which will hopefully shed new light on these important questions. Corporate Europe Observatory will carefully examine all of these documents in the coming weeks, but you are also warmly invited to explore the hundreds of (redacted) documents along with us. Don’t hesitate to contact us with any proposals for cooperation that you might have.

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