EU Cannot Sue AstraZeneca – Germany Commits to Sharing Doses Briefs 22/02/2021 • Madeleine Hoecklin & Kerry Cullinan Share this:Click to share on Twitter (Opens in new window)Click to share on LinkedIn (Opens in new window)Click to share on Facebook (Opens in new window)Click to email this to a friend (Opens in new window)Click to print (Opens in new window) Threats from the European Commission to sue AstraZeneca over the delay in deliveries of COVID-19 vaccines hold no weight, according to the EU’s contract with the pharma company in which the right to sue was waived. Following the drugmaker’s announcement in late January of a 60% shortfall in vaccine deliveries for the first quarter after its manufacturing plants in Europe hit a number of snags, furious EU officials examined possible legal avenues to resolve the issue. The release of the full contract by RAI, an Italian broadcaster, makes public several key elements that were redacted from a version previously published by the European Commission. In particular it reveals that the Commission is unable to sue for issues with the storage, transport, and administration of vaccines, including delays in the delivery of vaccines. The exception to the restrictions on the right to legal action is AstraZeneca’s “wilful misconduct or failure to comply with EU regulatory requirements…including manufacture.” While the EU’s hands are tied in terms of filing a lawsuit, there are other pathways open, including suspending payments to AstraZeneca. The initial funding for the doses promised to the EU totals €336 million, of which the Commission already paid two-thirds. The remaining €112 million is supposed to be paid within 20 days of receiving the first installment of doses, however, with the lack of evidence of progress towards manufacturing the doses, “the Commission will have no obligation to pay the second installment and may seek to recover the first installment or a portion of it,” states the contract. It appears that AstraZeneca overestimated its manufacturing capacity and supply to the EU, setting a goal of delivering 300 million doses by the end of 2021, with 30 million doses by the end of 2020, 40 million in January, 30 million in February, 20 million in March, 80 million in April, 40 million in May, and 60 million in June. The company agreed to use its “best reasonable effort” to manufacture the initial doses ordered by the EU and to build its manufacturing capacity. AstraZeneca recently announced that it can deliver 41 million doses by the end of March with its “best reasonable effort.” That estimate is 20 million fewer doses than initially predicted, meaning the drugmaker is over two months behind schedule. Germany Commits to Sharing Vaccine Doses WHO’s Tedros and Germany’s President Frank-Walter Steinmeier address the media. German President Frank-Walter Steinmeier committed his country to sharing some of the vaccines it has ordered with low-income countries at a joint press conference with World Health Organization Director General Dr Tedros Adhanom Ghebreyesus, on Monday. However, Steinmeier said how this would be done and how many vaccines would be shared was still under discussion. Last Friday, Germany announced that it would be contributing an additional €1.5 billion in funding for the multilateral response to the pandemic, including the ACT Accelerator, at the G7 leaders’ meeting last week. Steinmeier also used the briefing to restate Germany’s opposition to the proposal of a waiver on patent protection for COVID-19 related products, as mandated by the Agreement on Trade-Related Aspects of Intellectual Property Rights, known as the TRIPS waiver. “The interest of public institutions and private companies have to be kept alive to invest in research and the development of drugs medicines and vaccines,” said Steinmeier. “So I don’t think the proposal some have made that we have waiver for patents or licensing would be the right approach.” The TRIPS waiver, currently being discussed by the World Trade Organization, has wide support including from the WHO, but it is floundering because of opposition from wealthy countries with powerful pharmaceutical industries, like Germany, the US and the UK. While Tedros welcomed Germany’s financial contribution, he pointed out that while many wealthy countries claimed to support the global vaccine access facility, COVAX, they were still trying to do bilateral deals with manufacturers for more vaccine doses “without stopping to ask whether this was undermining COVAX”. “This pandemic is really unprecedented, and we have to do everything to defeat this common enemy including waivers on intellectual property to increase production,” said Tedros. He added that the WHO was engaging directly with manufacturers and encouraging pharmaceutical companies to “turn over their facilities to produce other companies’ vaccines as Sanofi has done for the BioNTech vaccine”, and issue non-exclusive licences to enable other manufacturers to produce their vaccines. 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