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EU publishes redacted AstraZeneca advance purchase agreement

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Following heated debate on the content of the EU’s contract with AstraZeneca (AZ), the company agreed to the publication of a redacted version of the advance purchase agreement (APA) it reached with the EU. The contract appears to confirm the EU’s position. 

Earlier in the day, European Commission President Ursula von der Leyen, reportedly said on German radio that the commitments in the contract were binding and crystal clear, and that all production facilities, including those in the UK, are mentioned in the contract. 

The publication followed a renewed request from the European Commission (27 January) for AstraZeneca to publish the contract signed between the two parties on 27 August 2020. A European official informed journalists that the vast majority of redactions had been at the companies request, with only two small redactions concerning ongoing negotiations requested by the EU-side. While the Commission would have preferred a more complete document, including the schedule of dose delivery to be included, it decided that it was preferable to publish what it could as quickly as possible. 

‘Best efforts’

The contract repeatedly refers to ‘best reasonable efforts’, in his interview with La Repubblica (26 January), the AstraZeneca CEO Pascal Soriot claimed that his company had "no obligations, just best efforts" to meet the delivery schedules of vaccines to the EU. He said that AstraZeneca would:  “try our best, but we can't guarantee we're going to succeed.”

A senior European official directed journalists to an article in The Guardian. In the article David Greene, the president of the (English and Welsh) Law Society speculated: “If they [AZ] gave assurances that they made reasonable best efforts to supply the EU but were in fact diverting material from one place to another, that would on the face of it be a potential breach of obligations to use reasonable best efforts.” In the same article legal commentator, David Allen Green familiar with government public procurement is quoted: “The existence of that ‘best efforts’ provision may not be that helpful to AstraZeneca, if the correct construction of the contract is that it does not cover diverted capacity as opposed to lack of capacity.”

The Commission made an analogy with intent (mens rea) in criminal law saying that it would be for a judge to decide, for example, if AZ in comparison with another similar company, had made ‘best reasonable efforts’, or if it was acceptable that the EU had only received vaccine doses from one plant. 

Britain first?

In his interview, Soriot said that since the UK signed first it would be supplied first, describing it as “fair enough”. However, in the contract, AstraZeneca made an explicit commitment that they are under no obligations that are in conflict with the obligations it has to the EU:

Article 13(1)e AstraZeneca, Advanced Purchasing Agreement with EU

Soriot also claimed that the UK manufacturing plants were specifically dedicated to the UK’s contract and supply, with the possibility of the EU benefitting from UK production later on. However, the contract is explicit that the UK plants are included in the agreement.

Article 5.4, AstraZeneca, Advanced Purchasing Agreement with EU

 The same official directed journalists to Schedule A, which while redacted indicates the plants involved. 

Schedule A, AstraZeneca, Advanced Purchasing Agreement with EU

The Commission hopes to be able to publish all contracts under the Advance Purchase Agreements in the near future.

Later today (29 January) the Commission will publish an implementing regulation allowing greater transparency and clarity on the movement of vaccines, with the possibility of export restrictions.

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EU says it has resolved 17-year aircraft battle with US

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A worker adjusts European Union and U.S. flags at the start of the 2nd round of EU-US trade negotiations for Transatlantic Trade and Investment Partnership at the EU Commission headquarters in Brussels November 11, 2013. REUTERS/Francois Lenoir/File Photo
European Commission President Ursula von der Leyen holds a news conference with European Council President Charles Michel and Canada's Prime Minister Justin Trudeau after a EU-US summit, in Brussels, Belgium June 15, 2021. REUTERS/Yves Herman

The European Union and the United States have resolved their near 17-year conflict over aircraft subsidies, the EU said today (15 June), bringing to a close one set of Trump-era tariffs which had soured relations between them.

The two sides have been battling since 2004 in parallel cases at the World Trade Organization over subsidies for U.S. planemaker Boeing (BA.N) and European rival Airbus (AIR.PA).

They agreed in March to a four-month suspension of tariffs on $11.5 billion of goods from EU wine to US tobacco and spirits, which they had imposed in response to the row. On Tuesday they were set to remove them for five years, while still working on an overall deal on what subsidies to allow.

"This meeting has started with a breakthrough on aircraft. This really opens a new chapter in our relationship because we move from litigation to cooperation on aircraft - after 17 years of dispute," European Commission president Ursula von der Leyen said before an EU-U.S. summit with U.S. President Joe Biden.

The agreement should allow them to focus on the threat posed by China's nascent commercial aircraft industry.

It will also remove one of two major trade irritants left over from Donald Trump's presidency, the other being tariffs imposed on grounds of national security on EU steel and aluminium imports.

The European Commission, which oversees EU trade policy, last month suspended for up to six months a threatened June 1 doubling of retaliatory tariffs on Harley-Davidson motorbikes, US whiskey and motorboats, and refrained from slapping tariffs on more US products from lipstick to sports shoes.

Brussels and Washington have said they would seek to address excess global capacity largely centred in China.

The United States may find it tougher to remove the metals tariffs, which also apply to other countries such as China, because they are still backed by many US metal producers and workers.

Brussels is also pushing what is dubs a new "positive agenda" on trade with Washington, including forging an alliance to drive WTO reform.

The two are also likely to agree to co-operate on trade and technology, such as for setting compatible standards and facilitating trade in artificial intelligence.

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EAPM: A conference ‘bridge’ to better health during Slovenian EU Presidency, register now!

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Greetings, and here we are with the European Alliance for Personalised Medicine (EAPM) latest update. Before we get into what’s been going on of late during these testing times (pun intended) here’s a quick reminder that registration is open for our virtual EU Presidency conference, which takes place on Thursday 1 July, writes EAPM Executive Director Dr. Denis Horgan.

Entitled “Bridging Conference: Innovation, Public Trust and Evidence: Generating Alignment to facilitate personalized Innovation in Health Care Systems – Registration Open”, it acts as a bridging event between the EU Presidencies of Portugal and Slovenia.

Alongside our many great speakers, attendees will be drawn from leading experts in the personalised medicine arena – including patients, payers, healthcare professionals, plus industry, science, academia and the research field. We’ll be discussing, at some point during the day, most or all of what we’ll be talking about below. The conference is divided into five sessions which cover the follows areas: 

  • Session 1: Generating alignment in the regulation of Personalized Medicine: RWE and Citizen Trust
  • Session 2: Beating Prostate Cancer and Lung Cancer - The Role of the EU Beating Cancer: Updating EU Council Conclusions on Screening
  • Session 3: Health Literacy - Understanding Ownership and Privacy of Genetic Data
  • Session 4: Securing patient Access to Advanced Molecular Diagnostics

Each session will comprise panel discussions as well as Q&A sessions to allow the best possible involvement of all participants, so now is the time to register, here, and download your agenda here!

Presidency of health

And the upcoming conference ties in very well to the priority of the incoming Slovenian presidency, which is very much a question of health, said the country’s EU Ambassador Iztok Jarc on 10 June, speaking at an event organized by the European Policy Centre. The diplomat described the presidency, which will start at the beginning of July, as a “transitional” one: a bridge to a much-hoped-for return to normality. Jarc said that the hope is to hold an increasing number of diplomatic meetings in person starting in September, particularly high-level ones. 

Health care de-‘Luxe’

Luxembourg is playing host to the bloc’s health ministers on day two of the Employment, Social Policy, Health and Consumer Affairs Council. Up for discussion are the three planks of the health union legislative file: There will be an update on the proposal to amend the regulation establishing the European Centre for Disease Prevention and Control (ECDC), as well as the proposal on serious cross-border threats to health. Meanwhile, the Portuguese Presidency is aiming to reach a Council consensus during the meeting on draft rules to reinforce the role of the European Medicines Agency. 

Better access to medicines is paramount, EU capitals to urge as an outcome of Luxembourg ministers' meeting 

The EU needs to put in more work to ensure access to fairly priced medicines throughout the bloc, according to a draft text authored by EU ambassadors. When it comes to equity and access to health care, the EU could do better. Inequalities around diagnosis and access to drugs and treatments persist; European citizens are not all benefiting equally from universal healthcare services. In addition to these inequalities, one can add another: the discrepancy in detection and diagnosis according to one’s country of residence. Thus, cancer survival rates are often worse for patients in eastern Europe than those being treated in western Europe. Member states do not have the same management tools at their disposal because they do not benefit from the same investment capacities. 

Rather than making sustainable investment in community-based services and facilities and re-establishing equality of access to treatment and the early detection of diseases, the European Commission is moving to a ‘Europe of digital health’ model, relying on ‘virtual’ consultations, based on a telemedicine or telesurgery approach. Ryan Reynolds wants to destigmatize mental health “The pharma industry emerges the winner in this misguided system, but what are the benefits for European public health?” 

Furthermore, between 2000 and 2008, shortages of medicines increased by 20 percent, and - according to the European Commission in April 2020 - these were continuing to increase. In France, for example, supply interruption has trebled in just three years. 

More than half of the medicines in short supply are for cancers, infectious diseases and neurological disorders such as epilepsy and Parkinson’s disease. How can we explain these shortages? The relocation of production sites, particularly of active ingredients, to countries outside Europe, has weakened our healthcare sovereignty. Among the solutions undertaken by the EU, it is essential that the wholesalers provide a reliable, controlled distribution chain for pharmaceutical products to the pharmacies. However, we have seen an increase in alternative and direct channels of distribution between the pharmaceutical industry and pharmacies.

Focus on own failures, not Commission

German MEP Peter Liese of the European People’s Partythinks individuals should focus on their own failures during the pandemic, rather than the Commission’s. Commission Vice President Margaritis Schinas is set to present a Commission document on early lessons learned from the pandemic. Liese pointed to MEP Beata Szydło, former Polish prime minister and vice-chair European Conservatives and Reformists Group, as an example: “She very much criticized the European Commission, but the truth is that the main problem in this advanced purchase agreement with vaccine companies was that some member states, and among them very prominently the Polish government, argued against any contract with BioNTech/Pfizer.” 

EU proposes extending vaccine export scheme to September

The European Commission is proposing to extend its temporary vaccine export authorization program for an extra three months through September, according to EU diplomats.  

The Commission has taken the decision to support various vaccines based on a sound scientific assessment, the technology used, and capacity to supply the whole of the EU. Vaccine development is a complex and lengthy process, which normally takes around 10 years. With the vaccines strategy, the Commission supported efforts and made the development more efficient, resulting in safe and effective vaccines being distributed in the EU by the end of 2020. This achievement required running clinical trials in parallel with investments in production capacity to be able to produce millions of doses of a successful vaccine. Strict and robust authorisation procedures and safety standards are respected at all times.

EU diplomats are expected to vote on the Commission’s proposal this Friday (18 June).

And EU institutions to get cyber bill…

The European Commission is also “preparing a proposal for cybersecurity for the EU institutions, bodies and agencies, which is expected for October this year,” Administration Commissioner Johannes Hahn told MEPs earlier this week. Such a bill would fix a hole in the Commission’s proposed NIS2 Directive for cybersecurity in critical sectors, like health care.

And that is all from EAPM for now – enjoy your start to the week, and don’t forget, now is the time to register for our upcoming conference on 1 July here, and download your agenda here. Have a great week

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coronavirus

Joint statement by EU institutions: EU clears way for the EU Digital COVID Certificate

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On 14 June, the presidents of the three EU institutions, the European Parliament, the Council of the EU and the European Commission attended the official signing ceremony for the Regulation on the EU Digital COVID Certificate, marking the end of the legislative process.

On this occasion Presidents David Sassoli and Ursula von der Leyen and Prime Minister António Costa said: “The EU Digital COVID Certificate is a symbol of what Europe stands for. Of a Europe that does not falter when put to the test. A Europe that unites and grows when faced with challenges. Our Union showed again that we work best when we work together. The EU Digital COVID Certificate Regulation was agreed between our institutions in the record time of 62 days. While we worked through the legislative process, we also built the technical backbone of the system, the EU gateway, which is live since 1 June.

"We can be proud of this great achievement. The Europe that we all know and that we all want back is a Europe without barriers. The EU Certificate will again enable citizens to enjoy this most tangible and cherished of EU rights – the right to free movement. Signed into law today, it will enable us to travel more safely this summer. Today we reaffirm together that an open Europe prevails.”

The full statement is available online and you can watch the signing ceremony on EbS.

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