AstraZeneca/EU contract
fragdenstaat.de
fragdenstaat.de
The doses that exist in the UK only exist because of a manufacturing ramp up done under their own contract during the period of time that the EU was still negotiating a lower price. How does it make sense that a separate contract with AstraZeneca allows them to then get the doses produced for the UK re-allocated to another contract?
The Commission is only entitled to those doses that AZ have, after best reasonable efforts, produced for them under their contract. This attempt to grab doses only in existence because of another prior contract is a disgrace.
[0] https://committees.parliament.uk/oralevidence/1505/html/
IANAL but it seems to be part of the agreement. From the posted pdf:
5.4 Manufacturing sites
AstraZeneca shall use its Best Reasonable Efforts to manufacture the Vaccine at manufacturing sites located within the EU (which, for the purpose of this Section 5.4 only shall include the United Kingdom) (...)
In short, AstraZeneca agreed to use UK facilities to manufacture doses for the EU.
>> The doses that exist in the UK only exist because of a manufacturing ramp up done under their own contract while the EU was still negotiating a lower price.
Presumably, AstraZeneca agreed to provide a certain number (censored in the pdf above) of doses to the EU after AstraZeneca had initiated the "ramp up" you describe. They did not object to selling those doses that were manufacture during the "ramp up" to the EU. The contract doesn't mention any ramp up at all.
> In short, AstraZeneca agreed to use UK facilities
> to manufacture doses for the EU.
Section 5.4 which you quote from specifies that "this section only shall include the United Kingdom". As written, this section does not relate to the distribution of the initial doses in Section 5.1, but instead is about where AstraZeneca _could_ choose to manufacture the vaccine. That is why it explains the process by which they might get prior written notice for non-EU manufacturing sites, and discusses how they could be contracted with if they are unable to deliver doses.
I think that gives them some leeway to ask AstraZeneca to increase capacity in the EU, but it strongly suggests to me that the capacity has meant to come from EU facilities, particularly for the "Initial Europe Doses".
Somebody also linked to this [1] which implies that AstraZeneca stated that they would have no other contracts that should conflict with the "Initial Europe Doses", however, I can imagine AstraZeneca will argue that this is achieved by segregating production in the initial doses stage and that the problem is due to low yields in the EU facilities and not due to competing arrangements.
[0] https://twitter.com/faisalislam/status/1355120024378335238
[1] https://twitter.com/antoguerrera/status/1355137923411279878I'm not sure. You might be right. However section 5.4 also says:
If AstraZeneca is unable to deliver on its intention to manufacture the Initial Europe Doses and/or Optional Doses under this Agreement in the EU, the Commission or the Participating Member States may present to AstraZeneca, CMOs within the EU capable of manufacturing the Vaccine Doses, and AstraZeneca shall use its Best Reasonable Efforts to contract with such proposed CMOs to increase the available manufacturing capacity within the EU.
"Within the EU" in this particular paragraph encompasses the UK, so my reading of this is that if AstraZeneca can't deliver the Initial Europe Doses as it plans, the Commission can propose alternative manufacturing sites that include UK sites. Which seems to cover the Comission's current request that AstraZeneca use UK-made doses to honour its commitment to deliver the Initial Europe Doses (to its best reasonable efforts etc).
Again, IANAL, so I don't know how to interpret this document correctly. I'm reading it as a lay person who does not understand the technicalities of legal terminology.
> "Within the EU" in this particular paragraph encompasses
> the UK, so my reading of this is that if AstraZeneca
> can't deliver the Initial Europe Doses as it plans,
> the Commission can propose alternative manufacturing
> sites that include UK sites. Which seems to cover the
> Commission's current request that AstraZeneca use UK-made
> doses to honour its commitment to deliver the
> Initial Europe Doses (to its best reasonable efforts etc).
IANAL also, but I have tried my best to avoid making my own interpretations, and have generally been relaying my understanding of comments by lawyers on Twitter (e.g. https://twitter.com/ShipBrief/status/1355134952405397508). Writing my initial comment kind of forced me into a rabbit-hole of reading what people were saying...
[0] https://www.ft.com/content/5c15d7ea-aaf6-46f4-924e-30f168dd1...
You are completely misreading it. That's not at all what section 5.1 implies. Section 5.1 says AstraZeneca should make its best effort to manufacture in the EU after market approval. That's in opposition to improving and relying on foreign production something expressly permitted by the contract. That has no bearing on where the dose should come now.
> Section 5.4 which you quote from
That's the section about where the dose can come and point that all AstraZeneca production capacity are part of agreement.
But the real sinker for AstraZeneca is section 13.1.e.
"[AstraZeneca represents, warrants and covenants to the Commission and the Participating Member States that: ] it is not under any obligation, contractual or otherwise, to any Person or third party in respect of the Initial Europe Doses or that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the complete fulfillment of its obligations under this Agreement;"
At this point, it is clear that AstraZeneca is trying to weasle out of its contractual obligation (unsurprisingly they are a pharma company after all). Short of an agreement being found and considering the EU doesn't have the time for a protractor trial, I think mandatory licensing or nationalisation of the production facilities are in order. But then again, this commission seems extremely weak so who knows.
> You are completely misreading it. That's not at all
> what section 5.1 implies.
Searching around on Twitter, I've not yet been able to find legal opinions that say the Commission is in the right. Since you are apparently french, what are legal experts saying there? Perhaps they see it differently. Can you show me these opinions?
> But the real sinker for AstraZeneca is section 13.1.e.
>
> "[AstraZeneca represents, warrants and covenants to
> the Commission and the Participating Member States
> that: ] it is not under any obligation, contractual
> or otherwise, to any Person or third party in respect
> of the Initial Europe Doses or that conflicts with or
> is inconsistent in any material respect with the terms
> of this Agreement or that would impede the complete
> fulfillment of its obligations under this Agreement;"
Even if they're not letting on, I think it's likely that the Commission understands that they have a different allocation. Their actions show this -- they recently raided AstraZeneca's Belgian Vaccine Plant in an attempt to evidence the claim that AstraZeneca gave away EU doses to the UK. If AZ did this, that would have been an actual breach of 13.1.e of the contract.
A moment there I was worried my reading comprehension was failing me, thankfully none of the link you posted so authoritatively talk about section 5. They are mostly about down payments. Stop pretending you are posting a summary of things when you are talking about something else.
> It seems likely to me that (when taken in context of the rest of the contract) this actually proves the opposite of what you're saying. The most bullet-proof way that AstraZeneca could comply with this section is by segregating production of vaccines by country.
And what seems likely to you would be wrong. The contract says the opposite of what you are writing.
> I think the EU reading this as saying "there is no contract between AstraZeneca and the UK" is absolutely nonsensical since the UK's purchase order was widely publicised way before the EU signed
The EU experts wrote the contract. They don't have reading comprehension issue. AstraZeneca signed that their contract with the UK didn't contain conflicting obligations.
> AstraZeneca gave away EU doses to the UK
There are no EU doses and UK doses. AstraZeneca is manufacturing doses from different plants and has contractual obligations with multiple clients. The EU thinks their deliveries were mismanaged.
I assume a lot of people are reading it as “the EU is defined as just the U.K. for the purpose of this section” but you are right that it’s just saying “this section is about the U.K., not the EU”
Also it doesn't seem reasonable to expect AZ to ignore other contracts.
> As soon as we have reached a sufficient number of vaccinations in the UK, we will be able to use that site to help Europe as well. But the contract with the UK was signed first and the UK, of course, said “you supply us first”, and this is fair enough. [1]
It’s just an out of context quote and the problem is more complex than this, but I think it’s fair to say that you could interpret this statement as “first come first serve” and since the contents of the contract with the UK are still unknown, this also raises some questions.
[1] https://www.repubblica.it/cronaca/2021/01/26/news/interview_...
Assuming this aspect of Belgium contract law sufficiently resembles its US counterpart, the interpretation of variants of "reasonable efforts" is a rabbit hole with few rivals. In the book written by a leading authority on US contract drafting[1], the topic commands its own chapter:
Chapter 8 Reasonable Efforts and Its Variants
[0] per sections 18.4 and 18.5 of the AstraZeneca/EU contract linked to here
[1] A Manual of Style for Contract Drafting by Ken Adams (https://www.americanbar.org/products/inv/book/297140045)
> 1.9. “Best Reasonable Efforts” means (a) in the case of AstraZeneca, the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a Vaccine at the relevant stage of development or commercialization having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world but taking into account efficacy and safety; and (b) in the case of the Commission and the Participating Member States, the activities and degree of effort that governments would undertake or use in supporting their contractor in the development of the Vaccine having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world.
On this basis, AZ can argue that they have indeed made reasonable best efforts to manufacture the vaccine within the EU: I believe most vaccine companies are struggling to fulfil their targets at the moment because of things like a shortage of supplies, worker sickness because of coronavirus, etc. It would seem to be difficult for the Commission to point to a company who's doing it any better except perhaps US-based companies.
Furthermore the contract does not mark their UK manufacturing facilities as being exclusively for the EU - AZ can then argue that this contract is naturally subject to available resources in their UK manufacturing facilities and so, given this is a condition precedent, their obligations under this part of the contract have not become due just yet.
1.9. “Best Reasonable Efforts” means (a) in the case of AstraZeneca, the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a Vaccine at the relevant stage of development or commercialization having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world but taking into account efficacy and safety; and (b) in the case of the Commission and the Participating Member States, the activities and degree of effort that governments would undertake or use in supporting their contractor in the development of the Vaccine having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world.
What is now true is that Europe has staked itself to a inadequate short term supply, and is now hell bent on limiting vaccine to the UK to make up for its distribution woes.
In the United States it’s looking like a half of project warp speed failed. The GSK vaccine is dead on arrival (2.1 billion) and novavax hasn’t even fully recruited their US study. 4 out of eight billion for vaccines unlikely to make a difference in the USA but the other 4 looks like enough to vaccinate the whole population by late summer.
Hopefully it looks like Europe is going to get Novavax. Despite the USA spending $2 billion prepping that vaccine, it probably won’t be available until early fall in the states at best - so the US company will instead supply Europe. Astra Zenca made mistakes on their studies, and we still don’t know what the over 65 response rate is. It’s being approved because people are hoping that it’s effective. It’s a crappy place to be. But between those two vaccines, there might be enough. The
The entire vaccine mass is a reflection of lack of cooperation between Europe and USA right now.
open-source the vaccine, the recipes, processes, etc. everything needed so EU can look for a capable manufacturer on its own?
As such I’m skeptical...
Regardless of the fact that, this contract does not, to my reading (IANAL), support their position that they have a claim over the UK-produced vaccines: pursuing a legal resolution seems silly because getting a judgement in your favour will take weeks or months. That is far too long for the timelines the EU wants.
Then, even if such a judgment is forthcoming - you still aren't that much closer to getting more doses because as any solicitor will tell you, possession is nine tenths of the law and the doses are in the UK. There is no realistic chance of any export occurring without the approval of the UK government. The UK has a very serious outbreak of coronavirus too.
Instead of getting on their high horse and starting an enormous public row why don't the EU: a) recognise that this is one of many vaccines and that perhaps, while important, is not singularly important to the effort b) make an arrangement with the UK government to have some kind of expedited access to vaccines? The UK will soon have a surplus of vaccines (and in fact has extra stock already by some accounts - people are being given unused doses). There is an existing trade issue that is causing problems for the UK that I am sure that the UK would like to get sorted...
This kind of over-legalistic attitude is how the EU got into this hole in the first place. Waiting for a single purchase agreement was a mistake because the vaccines have (mostly) turned out to be extremely cheap and the fact that many companies are working on vaccines likely means that none will be able to charge over the odds.
I think the EU's behaviour is mostly driven by internal political reasons. Their vaccination programme has been highly inept so far, partly due to the failure of the commission. But no government admits failure when there's a possibility of assigning blame elsewhere. The more EU citizens can be convinced that it's all AZ's fault for missing deliveries, and the dastardly post-Brexit UK holding doses hostage, the less scrutiny will be be applied to their own role in creating the situation.
Eh, that's just a sign that you have to administer an entire box of vaccines after opening the box.
After all, some no-shows are inevitable and it's not like they can turn away the people at the end of the queue to avoid starting a new box given the people in the queue are there by invitation.
Johnson has refused to commit to blocking exports of the vaccine. He's a long way from my preffered politician, but people who describe him as a British Trump are wrong. He is no idiot (1). He knows he's been handed a politically interesting situation and is also aware of what state the UK is in with regard to vaccine supply (one of the best in the world at this time) and what benefits some careful political manoeuvering will be able to bring in this time.
Allow me some hyperbole, but the optics of 'Generous UK offers salve to unfortunate vaccine-poverty stricken EU' - whilst sickening would make for some lovely press in the right-wing tabloids and might even go a little way towards his desired 'comming together' of a divided nation.
(1) Yes - Brexit was indeed idiotic but I truly believe he never actually wanted it, and it just got him his longed-for premiership by unfortunate accidental means.
Bibi in Israel is facing intense political ambiguity, and they are paying 3-4x (for the vaccines) what other countries are paying, and have apparently been doing some behind the scenes shenanigans for acquisition, I mean it's Isreal, that's what they do (no offence to those who might take it that way but they are the most realpolitik country on planet earth). They are way ahead of anyone else and I suggest this is Bibi's political salvation plan.
Boris, similarly.
It's a little bit conspiratorial, but wouldn't be surprised if there are some behind the scenes actions by UK gov. to make sure the UK is first.
Also consider that the EU is frankly playing a losing hand and they look really bad from this.
This is a major existential crisis and if China, US and UK end up with full vaccinations months ahead of the EU it's going to be very, very damaging.
At minimum, the EU has to make a very big public stink about it to ensure people know/believe that the EU is doing what is possible, to mitigate the damage and possibly to be able to push the blame a little bit to others.
Finally - there's nothing wrong with the UK offering the EU help, and that it would also end up being good PR. The problem with the claim is not that it's 'sickening' but rather it's frankly not a huge material PR win. It's a nice thing but it's only worth a news cycle or two.
Having the UK immunized a few months ahead of the EU, irrespective of the underlying realities, is going to be something that will be remembered and analyzed for a decade.
Frankly, in the end, I actually think it's far too risky for any EU/UK politicos to be playing underhanded games, the blowout would be devastating. I just think it's a matter of operational reality that the UK is doing well on this (note they are doing very poorly on infections), though I do feel EU has dropped the ball on securing vaccines from a wider base. Even Canada has put in options to purchase from a variety of sources.
But the EU also bought from pfizer and moderna?
I agree entirely with your last paragraph, I do hope that cool heads prevail.
He took a razor-thin majority and turned it into a huge one. He’s PM because he ruthlessly executed a plan to become it. He won almost every brinkmanship point with the EU that he took on over the last year.
He’s not who I want as PM, and I think his record is dismal, but if you think he “fumbled and stumbled” his way in then you’ve fallen for his con: he’s bright and ruthless.
*Edit: That said, speaking as a staunch remainer, as much as we need to accept that we can't have our cake and eat it, the EU must recognise the same. It's their own fault that they're in this position.
All of which was also present in 2017 when May squeaked to victory
> Campaigning solely on the notion of “Getting Brexit Done”
which ... was effective and led to the largest landslide in 40 years.
I think he’s been a crap PM but the idea that he’s not a sharp political mind with a keen sense of the political mood is insane.
They were extremely popular with a small vocal minority but when you’ve got Dianne Abbott having say she no longer believes that “every defeat of the British state is a victory for us all” why would anyone vote for them to be in charge of the British state?
So instead we’ve got the Tories and ministers like Nadhim Zahawi, who changed his family office rental company into “Warren Medical Limited“ ...right around the time he was put in charge of vaccine contracts.
It was a choice between the openly corrupt right and anti-British, student politics of the hard-left.
I don't disagree on this, but Corbyn predated the Brexit referendum, and BoJo made his series of choices that left him in power knowing full well what the opposition looked like. He certainly had a fair share of luck, but the idea of him bumbling accidentally into No 10 is both naive and playing exactly into his hands.
But none of this happened thanks to his careful planning. Johnson was lucky to be associated with the Euroskeptic Tory right as an attack journalist writing defamatory pieces for EU institutions, before he joined the party. Then he struck gold when David Cameron put his head in the mouth of the wolf with the 2016 referendum.
He's an opportunist who got lucky.
He'll do what he thinks is best for his vote share, and my, admittedly amateur, reading of this situation is that he might well make a trade off in that direction. Although the latest news from Northern Ireland might be rocking the boat a bit too much. We'll just have to see I guess - but these days I'll expect anything.
See my other comment here. IANAL either, but it seems this was part of the agreement. From the pdf above:
5.4 Manufacturing sites
AstraZeneca shall use its Best Reasonable Efforts to manufacture the Vaccine at manufacturing sites located within the EU (which, for the purpose of this Section 5.4 only shall include the United Kingdom) (...)
AstraZeneca agreed to use the UK sites to produce vaccines for the EU.
Anyway, as I said: it's totally irrelevant as no amount of litigating the contents of their contract will get them what they want. They want doses that are inside the borders of a third country. That third country also has designs on those doses the EU is not in their good books.
It requires a political solution, not a legal one - but try telling the commission that, apparently.
IANAL either, but from including similar wording in numerous contracts on the advice of lawyers, I'm reaosnably sure that committing on a best efforts basis would not require breaking your other contractual obligations.
The EU probably isn't going to finish vaccination this year.
This version has those included in red.
Anyway it seems that orgs keep falling for the "PDF redaction" caveats
As proof, I offer: can't grep on it.
Which, BTW, if it was possible, would have prevented this mess.
To me that section seems so suggest that production facilities in the UK should/could indeed be used to supply the EU, which is what the EU seems to want and AZ/UK are denying. But I'm sure there are a lot of highly paid lawyers looking at this from all sides right now.
https://twitter.com/JeremyC64/status/1355156181753475073?s=1...
Awkwardly it seems Pfizer might shift to supplying the UK from the US and the UK seem content that they have no contractual need to share the AZ doses from the UK facility. So the EU don't seem to have any leverage on this issue.
Some have tried to say this debate is EU vs AZ but this map suggests otherwise.
And I'd also like to hear from more reliable lawyers than "a guy on Twitter".
Pretty smart stipulation by the UK government but it may be putting AstraZeneca, which agreed to it, in an awkward position...
Obviously the Commission (publically) disagrees and is using AstraZeneca as a scapegoat for its incompetence.
But if that's true it seems very hypocritical of the UK to complain so much about the EU's plan to introduce vaccine export controls, since they are doing the exact same thing already...
EU diversified their vaccine contracts, negotiated fair prices, generously funded the manufacturing rollout, avoided vaccine nationalism between member states, equitably distributed the vaccines amongst their members and the key point - holds the manufacturers liable for possible damages.
All of those points are entirely reasonable. One could argue that EU should have paid more, but there are two counterarguments: Firstly, it doesn't really move a needle, as both US and UK have home-front-first clauses, leaving only Israel and Arab oil producers skipping the queue. Secondly, said countries could just amend their contracts, bid up the price, and everyone is back at square one.
Date of contract signing doesn't really matter either - a credible commitment to massive orders has been there from the very beginning.
European Medical Agency gets a lot of undeserved flak for being slow and bureaucratic. Pfizer was approved mere 10 days later than in the US, Moderna got approved earlier than in the UK, and now AstraZeneca earlier than in the US. Allegedly, even those slippages were caused by the companies simply prioritizing their US/UK approvals.
Partially, EU got unlucky - Sanofi vaccine flopped, AZ plant has technical problems, Curevac got delayed. In a world where Pfizer and AZ wouldn't underdeliver by an order of magnitude, EU plan would be praised and touted as a gold standard. Partially, EU was always fighting an uphill battle - the corporations that cleared the approvals simply care more about their image in the US/UK, don't like to face competent regulators, and really dislike being liable. Afaik, they face no liability in US and Israel.
That being said, absent the EU policy, I'm quite confident that small countries like Latvia, Slovenia or Finland would end up with the short end of the stick.
That would be "doing very well"?
Because it seems that's what UK is doing with AZ, their production stays in the UK. And that's doing well?
If so, then EU should most definitely lock out exports of vaccines.
I'm usually not much of an aficionado of free market radicalism, but I suspect that the vaccine ramp-up would go better, eventually better for everyone, if it had started with a honest commitment to the highest bidder mindset that we can't goodwill out of existence anyways. Only suspect, because who knows what failure modes the other path would hold, but I think that for example early arrangements for mandatory sublicensing (in case of research success) would have been much more likely to have found their way into research subsidy contracts if nation state representatives had been in a gloves-off situation from the beginning.
The EU signed second and, to my knowledge, did not include similar language in their agreement. They are also paying less than the UK and US.
BigPharma is screwing up UE big time and that is unacceptable.
Source for downvoters : https://www.mediapart.fr/journal/france/290121/retards-de-va... (FR)
But wasn't the source of the whole argument that doses produced in the EU (with EU money and for which the EU assumed they were reserved for EU use) were exported to the UK before EMA approved the vaccine, so that now only 31 vs 80m promised doses are delivered in Q1 for the EU while AZ delivers everyone else in full?
I can get behind the critic of the tone, but if this description is correct, AZs went at least against the spirit in the contract.
Everyone else (US, UK with AZ contract) prohibits exports of domestically produced vaccines, while e.g. Pfizer/Biontech supplies everybody out of the EU.
I don't think you can blame the EU now to follow everyone's example as their (naive) idea of generous grants but few rules obviously didn't work out to get the population vaccinated asap.
If the EU had done the same with the Pfizer/BionTech vaccine, then the only countries with any vaccination success would have been the US, the EU, and whoever made a deal with either China or Russia (assuming efficacy there).
The EU has a moral obligation to supply the world, given that the BionTech vaccine was the first to be available and still is the one with the highest success rate.
So, personally, I am glad that the EU did not follow the UK with an exclusivity contract. It would have been a literal disaster for many countries, including the UK.
I am less happy about the EU's reaction. There is really nothing to be done right now, AZ played the UK and EU against each other. The EU should remember this - and also the UK's "Britain first" contracting very well indeed. However, this grandstanding and sable-rattling is unbecoming and will accomplish nothing.
Several British people, even here, don't even acknowledge that the overwhelming success of the UK's vaccine efforts are in large part due to a vaccine funded, developed and produced in the EU, and the EU's unwillingness (or inability) to prioritize its own population. In turn, they also don't acknowledge the qualitative difference of the UK's priority contracting with their own vaccine. Lacking such perspective, how would one perceive the idiocy that the EU now perpetrates?
What is happening now is a diplomatic disaster. The EU should have just published the numbers of how much vaccine was sent elsewhere, how much of the vaccine successes are due to doses produced in the EU, how the "trade balance" of vaccines looks between different countries (say with the UK), and how the EU's deficient vaccine program can be seen in that light. Then, the reader could eventually draw their own conclusion about the moral and ethical behavior of certain countries in a global pandemic.
No matter what AZ did, cutting large parts of the world off from the main supply of the most efficient vaccine is still not justifiable. And threatening this is simply absurd. Yet, the EU commission did just that. That's the shameful part.
The naive contracts are not, at least not in the bigger picture.
> If the EU had done the same with the Pfizer/BionTech vaccine, then the only countries with any vaccination success would have been the US, the EU, and whoever made a deal with either China or Russia (assuming efficacy there).
Nope. The AZ vaccine has been massively deployed in the UK - I know because several members of my family had the AZ vaccine weeks ago and long before it was approved in the EU.
> So, personally, I am glad that the EU did not follow the UK with an exclusivity contract. It would have been a literal disaster for many countries, including the UK.
Completely wrong - there is no exclusivity over the AZ vaccine. AZ/Oxford have been working with manufacturers around the world to build capacity and it's being sold at cost (unlike the other vaccines). Given the lower cost and easier storage it's will be hugely deployed in the developing world.
The truth is that uniquely, the AZ vaccine's development and initial manufacturing was fully funded by the UK government and then being made at contractors to be sold at cost in 12 countries (including in the EU).
Many months later, with manufacturing in the EU having ramp-up problems, the EU commission panic about their lateness, spot doses being manufactured in the UK for the UK population and say "we'll have those" using a dubious interpretation of their contract.
Not surprising we've seen a U-turn today.
> Isn’t the logical absurdity of their interpretation that if AZ were only producing 10 doses a month the Commission is entitled to all of them - notwithstanding that they knew that the UK had entered into a contract months before them.
https://twitter.com/pcavin2/status/1355235189648224260
And note that those 10 doses are of a UK developed vaccine being made in the UK and probably in a manufacturing facility funded by the UK government months before the commission decided to sign this contract.
(And this is not a comment on where the vaccines should go just that the Commission are on very dubious ground with this line of argument - that their contract unilaterally overrides all others).
Fraud implies bad faith which I expect is a long, long way from the truth.
The EU is acting like it has first call because of its size as a bloc.
Sorry, that's not how it works. Not forgetting they broke the Good Friday agreement to try and force the point.
The fact that the vaccine was developed in the UK and is produced in the UK can not be an argument. In light of the UK's reliance on the EU vaccine, all this does is show the UK contract with AZ as ethically deficient.
After all, the EU is currently the only supplier for the UK for the Pfizer vaccine - the one that kickstarted the UK's early success. How would the UK's vaccine program look now, if the EU had acted similarly from the start?
Sure, the EU could have mandated exactly this last year. But they shouldn't have. It would have been wrong and morally despicable.
The EU SHOULD now deal with their choices with grace. They don't, which is the real shame.
But if you are British and feel smug about your government's cunning, then I seriously doubt your moral compass.
https://www.spiegel.de/international/europe/europe-s-vaccine...
> The problems began soon thereafter. Negotiations with vaccine producers bogged down, and it wasn't until November that the EU was able to reach a purchase agreement with BioNTech/Pfizer and with Moderna, the manufacturers of the two most successful vaccines thus far introduced. The EU negotiating team, according to people familiar with the talks, was intent on pushing down the price. There was also allegedly an extended disagreement on liability issues, particularly with Pfizer.
> While others simply acted with expedience and placed huge orders, the EU – right in the middle of the worst pandemic in a century – decided to bargain like they were at the bazaar. Von der Leyen, of course, didn't lead these negotiations personally. But she is the boss, and carries the political responsibility.
And raiding the company is sure to help things out.
https://www.euroweeklynews.com/2021/01/28/eu-bosses-order-ra...
I’m very happy they failed. I’m still scandalized they tried.
Where I’m unsure is whether or not there is a good reason for doing this that I’m unaware of. This feels like the kind of outrage where I might be wrong.
Now that is super weird, who would do something like this and communicate something like that in the last moment.
The EU is of course now under intense pressure because people are calling them every day and telling them that they are killing their citizens. I think comparisons between the strategy of the UK and the EU or even better Israel are stupid, of course the UK and Israel are able to be faster...they are smaller. But the total volume of available vaccine limits the possibilities for the EU. If the total volume of the UK would be avalailable for the EU it would be a drop in the bucket. And I really don't get all the "race" reporting, it's highly unlikely that vaccination speed differences between one to 3 months will make any difference in mortality.
There is also a mention of a cost of good estimate and how if the cost of good was off by more than 20%, the EU should pay the difference...
During the pandemic period, which is defined to expire on 1 July 2021. A stupid contractual provision to include, since it creates monetary incentives to delay delivery.
(Not saying that's why this is happening. But if I were negotiating something like this, I'd include a bonus for early deliveries. It keeps interests aligned, and gives the supplier ammunition with which to add redundancies.)
WSJ reports:
“ AstraZeneca says it hasn’t sent vaccines or raw materials meant for the EU market elsewhere. The company has used a German plant to pack bulk vaccine made in the U.K. into vials and ship it back to the U.K., people familiar with the arrangement said. That “fill and finishing” step isn’t the source of bottlenecks, they said.”
https://www.wsj.com/articles/behind-astrazenecas-covid-19-va...
I am interested in any other sources for this.
I am surprised by the polarization and demonization of the EU they are promoting. Was not expecting that from BBC. And then they wonder why British people voted for Brexit.
That said, my sympathy for the EU (as an opponent of Brexit) has been diminished by their attempted bullying behaviour.
They initially wanted the UK in on their EU procurement. Unlike the EU members of the grouping we were to be excluded from any say in the vaccines chosen, the quantities, the pricing, the manufacturing, and the distribution. No say on anything; take what you're given. They left us with no choice but to do our own deals.
We did those deals faster and with less guarantees at that early stage, fronted virtually the whole cost of the AstraZeneca UK production, accepted liability rather than insisting (as per the EU) that the vaccine makers did, and paid much more, just to get a faster agreement (and we still had the same teething issues the EU are facing now; we weren't special in that regard). Despite all that risk, up front cost, higher prices, and accepted liability, the EU is now demanding that the instant they approve the vaccine they can dip into the supply that has cost the UK far more than most people realise we gave up in order to get that swift delivery.
The EU stumbled by not realising the urgency last year, then stumbled again by badly insulting the UK with the EU procurement "offer" terms which forced us to negotiate separately.
I have a great amount of sympathy for the EU people (I may not be in the EU any more, but I'm still European) but none of this is the doing of the UK - who are simply carrying on using the vaccines delivered - and the first 'shot' at actual vaccine nationalism has been fired not by the mad brexiteers but by the EU with their Northern Ireland border statements and not-export-control-really new 'monitoring' and 'agreement' position.
I really expected coming into this year to find myself part of a massive UK villain state facing a more reasonable EU. I didn't foresee a desparate EU attacking a UK just going about it's own business.
I'm a EU citizen and I'm with you on this one. Also, I now realise (meaning after Brexit has been actually put in place) that the officials in Bruxelles could have been more forthcoming towards us, the remaining EU citizens, about how UK's exit will effect us. All I was hearing were things like "those dastardly British, they'll pay for it!" while now one cannot receive a package from a relative or close friend in the UK without being flooded with customs forms to fill, to say nothing of the extra money one has to pay for the privilege.
About the vaccin buy-in, I never heard that story, but I might be one-sided here. I listened from the Brexit side of the media and the final argument was officially 'they did not receive the email (three times)' The unofficial assumption was that the UK wanted to prove something on their own. This time it worked out, both from securing the vaccins and delivering them. (Good on them, less people dying is a good thing in my book) But the different risk appetite I imagine hard to replicate to the continent, see the German advise for az vaccins above 65.
You're right the expected pre production did not happen, and we can talk all year about what happened. And the UK, approving it sooner, but also in a worse situation, could dip in first. The way forward is to find a fair balance in sharing these resources again, until the issues are solved. Maybe by vaccination degree of the vulnerable, maybe by population size, maybe recognising the UK ordered about 2 dosis per capita, and the EU only 1.
I heard AZ offered 39 million in q1 and the commission not yet being satisfied. But if we're talking numbers, we can get some way out. I just hope the export ban threat or the article 16 hasn't damaged too much.
The EU bungled this and it would not be fair if we were to bully our way out of it.
It's sad to see this being a zero sum game, and no way you cut it people are going to suffer (already are) somewhere.
I was expecting a bit more decency on our side. Shattered superiority complex after Brits mismanaged Brexit, maybe?
Our lack of coordination and flailing in this regard is equally impressive.
That's imo a narrative from AZ pitting EU against UK, fueled by a susceptible UK media. US articles on this appear a little more measured. Is the EU attacking the UK? I think they are attacking AZ. It is an utter shame how this is turning political, and there are no excuses for the debacle wrt N. Ireland.
Having said this, as I wrote in a different comment, the way I currently understand the situation is that EU demands AZ proportionally reduce fulfillment of orders given their production problems. AZ would thus have to also breach their contract with UK on top of the breach of contract with the EU. AZ pushes the "first come first serve" logic of UK having ordered 3 months sooner, and the UK media, also the left leaning outlets, know that their readers are starved for some news that at least SOMETHING worked in the UK after the recent mess and gobble this narrative up. I don't know if the logic of who orders first gets deliveries first applies in these kind of contracts (IANAL), but I suspect it does not. If it does not, the EU seems to demand something from AZ that they want to avoid, but not attack the UK.
I find it extremely hard to navigate the media on this as it is a disgraceful, loaded, dishonest, political shouting match. Instead it should all be about how to best combat the pandemic of course.
I am not saying EU was/is always right, as they don't seem to be right in this case, but I was just hoping that BBC would be more subtle about it. I am totally fine with UK/AstraZeneca pushing back hard.
Just don't see the need for BBC to turn it to a "us vs them" thing. I think I am still living in denial in regards to Brexit. I guess I will have to get used to it.
This is why when britain passed 100,000 coronavirus deaths, with the worst death rate in the world, nobody resigned, and nobody called for anybody to resign.
The BBC is part of this kind of tight, teflon kernel that's at the heart of why the UK is such a dysfunctional country these days.
This is very true, I chatted at length with my neighbor who lived his entire life in the UK(up to a few years ago) and was shocked how stratified the society is. Basically there is small group of people(who went to Eton, are lords or knighted, from famous families) that form a clique that runs everything in the country. No matter how much money you make or how successful you are, you can never join that circle.
An example was told to me that even David Beckham (famous soccer star) is looked down upon by that segment and does not associate with them and could never join that part of society.
Your mate is also massively over-egging how bad it is, there is still an Eton clique (the present/last government being a good example), but we've had a range of recent prime minister's educated normally, outside of the Eton clique. Brown, Blair, even Thatcher just went to a Grammar school (generally a better school you have to pass exams to qualify for, which is semi-meritocratic, though gamed by the rich)
Our election system is even worse than America's though so we keep getting conservative governments who win 40-45% of the popular vote but somehow get landslide majorities.
Also, what do you mean by "small", it's got 70 million inhabitants. At worst a country with a population of a size of France and Germany might be called "medium".
In the UK, I think Eton is more a symptom than a cause. The problem is, London is a world-class city that concentrates the entire political and financial establishment. It's also a city with very obvious parallel worlds, where if you move in certain circles, you meet the same people, so while it is a massive city, it sometimes feels quite small.
To me, the worst part is not that both Johnson and Cameron went to the same school, the same university, or even the same exclusive dining club - the bad bit is that because any given person with political, social or economic power in the UK is so closely connected with any other, there's a real incentive not to rock the boat. You get an enormous amount of cohesion, because if you go around making enemies, you're ultimately making things awkward for a lot of your friends and acquaintances.
On top of that, the fact most people in this world have similar backgrounds makes a lot of them 'on the same page' by default.
While the Bushes, Kennedys, and Trumps came from wealthy backgrounds, the rest of the recent presidents came from lower-income brackets.
Ronald Reagan grew up poor in Illinois. Bill Clinton grew up poor in Arkansas and went to college and law school on scholarship, and his wife grew up in a middle-class family in Illinois and attended public schools.
Obama and his wife grew up middle-class in Hawaii and Illinois, respectively. Biden also grew up middle-class, in Pennsylvania; his second wife came from an upper-middle class background.
In a system with four major parties, 43% is an absolutely huge popular landslide. How can you describe it as anything else? Ten percentage points above their nearest rival? How much more of a majority do you think it could possibly be?
Perhaps you've heard of the problem of "vote splitting":
https://en.wikipedia.org/wiki/Vote_splitting
> How much more of a majority do you think it could possibly be?
Well, try 51% for a start.
If we had a popular vote then UKIP would've had nearly 70 seats back in 2015, with a huge swath of representation for London. Somehow that sounds even worse than what we have now.
My neighbors wife knew Eddie Redmayne and his brother(I think both went to Eton) and although she said they were nice, they were in a totally different world and only really associated with people who also went to Eton/had large trustfunds. In England you would never see people like Elon Musk, Sergey Brin, Steve Jobs etc who came from middle class families move to the highest strata of society and be accepted by those in that highest strata.
I am by no means bashing England, I think the country is awesome and have family that lives there, I am just not keen on the stratified nature of its society.
Old money vs new miney strife is an age old thing and I can assure you none of the tech barons is rubbing shoulders with former barons let alone American gentry.
There isn't "the" Man. Why would there be when even positions of petty power are contested for so tightly and dirtily and there are so many striving to rise? Consequences are not a strong deterrent - if they were the world would look very different.
Wealthy individuals may have power but nobody has control over the a process of contention across all layers with nominal goals served imperfectly with cargo-culting and skewed priorities.
All of this and there is nothing inherently special about the people - human nature and control oppose each other.
Can you explain more about this? Is the UK heavily gerrymandered?
EDIT: It's an honest question. I don't know anything about UK politics, other than that it's a parliamentary constitutional monarchy.
No it isn’t gerrymandered. And if it is very slightly accidentally gerrymandered in some places, that works against the Conservatives - Labour MPs often have smaller constituencies.
So no that’s not relevant or part of what is being talked about here.
The reality is that 43% popular vote for a single party in a system with four major parties, 10 percentage points more than their nearest rival, is nothing but an enormous popular vote landslide. The Conservatives are popular amongst broad sections of society, incomes, ethnicities, regions. All other parties serve limited niches so are fundamentally constrained.
Why don’t they form a coalition? Well I’m not sure they really have deeply shared values to do that. Many struggle to share values internally!
Long story short; it’s complicated.
It’s not entirely related wealth or education but they are big factors.
You can’t join the aristocracy via wealth alone.
At best you’d probably end up upper middle class if you were educated i.e. Public School followed by Oxford or Cambridge. Maybe your children or grandchildren could if you really have enough money. Becoming an MP would probably help you turn money into a title.
“Public” schools, like Eton, are the fee paying alternative to a “private” tutor. They’re not be confused with schools “for the plebs”.
You’ll certainly need land if want to join the Gentry.
Traditionally, the difference between a Forest and a Wood is that the Forest was once land populated by Commoners (that’s the middle and working class) that someone in the Aristocracy put a fence around and claimed exclusive right to hunt deer on.
To this day councils have to pay people to walk the ancient Footpaths and Bridleways every year to stop would be aristocrats claiming the as part of their land.
And if you wear brown shoes and a white shirt to the wrong interview in the City you’re not getting the job.
As I said, it’s complicated. Complicated and silly.
It's not fair. But neither is the UK and EU getting wildly more doses per capita than Africa, South America or Oceania.
EU is claiming that AZ is breaching the contract it had with them. Whether they are in the right or not, what does the UK's relationship with AZ have to do with it?
Because the EU wants AstraZeneca to export doses made in Britain to the EU.
Correct. Just pointing out why Britain is relevant.
I believe the UK has made the claim that they have exclusive contractual right to domestically-made vaccines until a certain point. Not sure if AstraZeneca corroborated.
Why would they be obliged to export even one dose of something they produced, before they have provided for every single one of their citizens?
My point is fairness is in the eye of the beholder. What we're left with are contracts. And contractually, AstraZeneca seems to be in the right. The EU negotiated, at first glance (and to this non-expert), a poor agreement.
Whatever the means, as long as they are legal, we can and should force equal burden of delays.
I guess EU didn't play it the best way from political perspective, since we are now labeled as bad.
Still, I'm personally impressed that EU is actually able to do something of consequence in somewhat short time frame.
It's different--one is an executive action, the other contractual duty--but yes. Moreover, it doesn't solve the problem. The EU wants doses made in the UK. The EU doses have already been exported to the UK.
This whole thing looks incompetent on the EU's part, from the outside. First, the delays in signing. Second, the sloppiness of the contract. And third, the incompetence of the post-problem situation. The EU has something Britain wants--a trade deal. Strike a deal with the UK to get their vaccines. Instead, we have a song and dance, empty threats and name calling.
If the both the UK and the EU wanted a million doses each and AZ has the capacity to manufacture 5 million, then nothing stops them from entering into other agreements with countries in Africa, South America, or Oceania.
They probably overestimated their capacity and are now pushing back on deadlines. I don't have much to criticise AZ for on that since we've all been there, but you can't tell a paying customer that you have other customers that paid you first, when you signed a contract agreeing to meeting certain deadlines. It simply does not matter. Did AstraZeneca lie in their negotiations regarding their capacity? Let's also remember that this was likely brought up when discussing the funding for manufacturing sites in Europe and the UK.
If there is suffering, and if we can, we ease the suffering. The US and EU have bought way more vaccine doses than they need.
It even makes sense from a utilitarian perspective, as we live in a global market economy.
Since when did people become so nationalistic again? We're humans, first and foremost.
However this is not about how many vaccines have been bought, but how many are being delivered via current production. The US, EU, UK, etc have indeed bought more than they needed, but they won't (by definition) be using more than they needed - the extra purchases were due to spreading the production and vaccine approval risk to ensure that enough were available.
You could reasonably argue they shouldn't be vaccinating whole populations, by which I mean including low-risk elements, whilst poorer countries cannot vaccinate even high-risk ones. That's a different question though.
That being said, none of the short term measures curently being discussed, will help getting any doses earlier. And the total amount ordered is more than enough.
"it is not under any obligation, contractual or otherwise, to any Person or third party in respect of the Initial Europe Doses or that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the complete fulfillment of its obligations under this Agreement;"
This ended up not being true, which was not totally unexpected.
AstraZeneca ends up in the bad position of choosing on which of their contracts their will fail, and they evidently chose to fail the EU's in its near totality for the next few months.
It pains me to see the cynicism in shielding behind "best effort" clauses (standard in any procurement under R&D) or in "who came first". It's a serious matter that warrants a cooler and more balanced solution that this.
There is text blacked out in the definition of Initial Europe Doses after "within the EU" that I'm curious about.
Also, the clause reads "AstraZeneca has committed to use Best Reasonable Efforts...to build capacity to manufacture 300 million Doses of the Vaccine...for distribution within the EU..." That's ambiguous with respect to distribution.
AstraZeneca are using Best Reasonable Efforts to build this manufacturing capacity. But they aren't under Best Reasonable Efforts obligations to use this capacity for the EU. (The definition of Best Reasonable Efforts overlooks distribution entirely.)
It's a shitty situation. Pain has to be allocated. But based on contract, versus loose notions of fairness, AstraZeneca is under no obligation to export British-made doses to the EU.
"5. Manufacturing and Supply.
5.1. Initial Europe Doses. AstraZeneca shall use its Best Reasonable Efforts to manufacture the Initial Europe Doses within the EU for distribution, and to deliver to the Distribution Hubs, following EU marketing authorisation, as set forth more fully in Section 7.1. approximately [censored] 2020 [censored] Q1 2021, and (iii) the remainder of the Initial Europe Doses by the end of [censored]"
It looks like the EU expected to have the vaccine approved by the end of 2020 and delivered soon after that. Based on media reporting, it would appear that AZ notified the EU that it would not meet the first deadline, but did so with only a short notice (15 days according to some outlets?).
Without getting into speculation, one date that isn't censored is that which specifies when the "Additional Doses" would stop being offered at the agreed price: 1 July 2021:
"9.3.Additional Doses. AstraZeneca shall provide any agreed Additional Doses at Cost of Goods until 1 July 2021, unless AstraZeneca determines in good faith that the COVID-19 Pandemic has not ceased as of 1 July 2021, in which case AstraZeneca shall [censored]"
So, if the initial doses are delayed, then the optional doses are delayed after that, and then the additional doses are delayed after that, it would seem that the agreed prices would only apply for a small fraction of the additional doses that would've been expected, whatever seemed reasonable. It seems that any delays in the "Initial Doses" could have an effect on the rest of the contract agreement.
EU was months late and they move much slower than other parties in the whole process and on top of that they signed agreements with "best effort" clauses instead of hard obligation of vaccine delivery. How is this UK's fault?
Section 6.2 of the contract:
"To the extent that Astra Zeneca's performance under this Agreement is impeded by any such competing agreements, AstraZeneca shall not be deemed in breach of this Agreement as a result of any such delay due to the aforementioned competing agreement(s). https://www.dailymail.co.uk/news/article-9201267/EU-vaccine-...
The rest of your comment makes OP's point: this is a contract dispute. Why is it relevant when the UK signed their contract, or that the EU hadn't approved the virus yet? Such comments only serve to make UK citizens angry at the EU.
Best Reasonable Efforts are defined on page 3 of this post.
"The activities and degree of effort that a company of a similar size and with similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a Vaccine..."
Couple problems:
- "Development and manufacture" doesn't include distribution.
- AstraZeneca has practically zero track record in vaccines. "Similar resources" is a potential out.
We are working on that!
There's no doubt the UK has been nimble and reasonably effective on the vaccine front (as we all know, the EU is a very mixed bag by construction); just as well since it has been dreadful on the mortality front. The UK commentariat is a little bit shocked, but it is to be expected - it's out of the club. There will be more consequences later.
I, for one, am leaving the UK with my family.
The problem, in my opinion, is with the way the report it, the time they spend on it and the demonization of the EU.
Even if EU is 100% in the wrong, do they need to spend half their air-time covering a dispute between AstraZeneca and the EU, arguing how the EU is unreasonable and pretty much the monster that tries to steal the vaccines from the UK people?
My disappointment is the with the division, polarization and demonization of the EU they are promoting.
After listening to that rhetoric with my (British) wife for 10 minutes straight, I heard heard saying "yeah, fuck these EU assholes".
Sounds reasonable. The EU are threatening to block exports of vaccines. It's a huge story over here because people are rightly concerned, especially given the huge number of deaths we've bad, and it's incredibly relevant because it's our first major of contention with the EU after the transition period.
If you want to place the blame for increasing divisions, maybe try starting with the organisation who are threatening a trade war during a global pandemic.
Meanwhile the EU acted bureaucratically and treated this like a procurement exercise, squabbling about spending and placing orders in December. It is now scapegoating andsuing a company that is producing the vaccine at cost.
GSK has every inventive to scale up capacity and produce as many doses as possible, and has no profit motive to divert doses. It is simply abiding by its agreement with the UK to use UK funded capacity to supply the country first, whilst making best efforts to iron out kinks for European orders.
https://www.politico.eu/article/europe-coronavirus-vaccine-s...
They, factually, objectively, _were_ later in signing an agreement, and have taken longer to approve a vaccine in use elsewhere in the world. Why should they not share some blame from their citizens like any other politician should? The UK government deserves scorn for their handling of the pandemic in the UK. The EU should be criticised for this. It is not a football match. We do not need to 'support' one 'side' against the other.
Now it is all water under the bridge because countries are desperate to have enough vaccines.
6 months from now, all countries are going to pretend to be nice nice and when there will be oversupply and new variant of the COVID, they will be dumping the old vaccines on other countries.
- The UK signed months before
- The EU has been slow to vaccinate independent of that AZ dispute
- The EMA did only approve this vaccine (which the UK is already using) a few hours ago
This dispute has sadly been made into a hugely sensitive national dispute as a distraction from the poor performance of the EU's vaccination programme. Even if nothing had gone wrong with the AZ vaccine production, the EU still would have much poorer rollout than the UK. It's just a cover of jingoism.
They did screw up distrbution so, royaly. And with distribution being the responsbility of the member states, well go figure. This contract has its defiencies, I really hate it that there are n consequences when delivery schedules aren't met. And how delivery schedules will be defined.
Or pretended to be. None of those people believe anything at all.
But that's the story of Brexit and its 40 years of media support. Even the BBC has often been on the technically correct side happily reporting welcome change as "UK change" and blaming unwelcome on the EU, even if the UK voted for it.
Now the Swiss and Brits are not part of EU and their own interest supersedes their alliance with EU obviously.
Shit hitting the ceiling wouldn't be that dramatic in comparison :)
You try and imply the BBC has been pro brexit - but seriously, this is by far the most hostile the liberal UK media has been to the EU in a long time.
Edit: Also spreading fake news about the efficacy of the drug.
I suspect if the EU were to invade the UK, you would still be attacking the UK press for outrage.
I frankly dislike the EU and am thoroughly enjoying them make such an ass of themselves.
The BBC can't win. When they editorialise to try to dig into a subject, it's left wing pandering, and when they just listen to official sources, they're right wing mouthpieces.
But if reallocating UK doses to the EU, would Astra Zeneca then be in a predicament of not fulfilling their contract to the UK? I have no idea, but presumably this would depend on knowing the UK contract.
So from my perspective, it's tough to know what Astra Zeneca ought to be doing without knowing all of their contractual obligations. That sounds tough.
So I'm glad that I'm not a lawyer.
Whether AZ is breaching the contract with the EU seems to be debatable, but the EU are certainly expecting AZ to explicitly break their contract with the UK.
Does it matter? From my perspective, that contractual problem is between AZ and the UK, not between the EU and the UK.
If I buy 100 doses from AZ and you buy 100 doses, and AZ only has 125, one of the contracts will have to breached.
The UK and AZ already had an agreement in place, with the UK taking main place manufacturing the product.
AZ signed a contract with EU way afterwards. That is the one which would be breached, and the center of the dispute.
So to stir towards more positive aspects:
AstraZeneca, which are between a rock and a hard place here, has agreed to supply the EU at cost. I don't know if it's their global policy, I hope it is, but they should be commended for that. That's not what all suppliers of Covid vaccines do.
More generally regarding the Covid vaccines: I find quite extraordinary that less than 12 months after Covid-19 was first analysed we have several vaccines available and we also have the capacity to produce hundreds of millions of doses. Science + technology + capitalism is a hugely potent combination (ok, sorry that last sentence may seem political but this is what drove the development of these large scale production technologies).
Edit:
It looks like I may need to clarify my mentioning capitalism. I was referring to production capability.
Private companies (not only in biotech, in every industry) have developed extremely effective and efficient ways to produce huge quantities of whatever they produce because driving down costs and increasing efficiency and quantities is how you increase profit. This is why we can now produce so many doses of Covid vaccines quickly and at relatively low cost.
For the sake of completeness AstraZeneca have agreed to supply all markets at cost, not just EU.
This was part of their contractual obligation with Oxford University.
The vaccine was developed with Oxford Uni funding, AstraZeneca signed an agreement to mass manufacture under the condition that it would be sold worldwide without a profit margin.
We would all have been better off of Oxford had partnered with someone with more experience that hadn’t already messed up: 1) The scientific trials 2) Manufacturing the vaccine 3) The legal agreements they signed with various governments.
Moderna, for example, has also fallen behind on their supplies but they signed sensible contracts (and followed sensible policies) and don’t have governments hounding them for more supplies.
Fun fact, epidemics are included as force majeur events. And the Force Majeur paragraph is a carbon copy from the last fulfillment contract I read.
Wait till you see what science + technology - capitalism can achieve!
But more seriously, we're also seeing the problems of capitalism here. Apart from the problems with its price, especially for the third world, I also think it's important to realize that the main motivation for vaccine skepticism is capitalism and the bad incentives it creates for companies. People understand that it's in any of these companies' best interest to lie about effectiveness and safety of these vaccines, and that they have more than enough money to hide any potential wrong doing for a long time.
I am NOT an anti-vaxxer. I take flu shots every year, and I will get this vaccine as well as soon as I am offered the chance (I'm neither at risk nor working in a crucial industry). But the pharmaceutical industry deserves its reputation to some extent, and it is mostly capitalism's fault that we have these huge behemoths that can act with impunity.
Vaccination right now is completely political, governments took over control instead of just regulating safety and efficiency of the vaccines.
The situation has improved since the beginning of the year, and some companies are better than others at supporting public health.
It's going to require resources no matter what, and the $5 to $10 that the AstraZeneca and J&J vaccines are estimated at is a pretty good value.
(for instance, the US could buy vaccine for the entire globe and not worry about the cost)
The Pasteur Institute in France is a major source of non-corporate medical research, at least historically. There are similar institutes in many countries which produce both research and actually manufacture drugs to be used in public health campaigns directly.
This argument reminds me of someone who I once tried to work with, I said, I'll just charge you my costs instead of full rate (this is like a 3x difference in price). So many arguments around cost, so many demands on quick delivery. Meanwhile, the folks paying 3x kept on reasonably agreed program and took 1/10th the time.
Anyone else have this experience?
Rumor had it astra wasn't going to mark up a huge amount.
My most difficult clients are always smaller design studios and artists who invariably have small budgets and tight deadlines, obviously don't bother to read contracts and are often late with payment.
It basically boils down to how much the customer values your work. In this case I think the bureaucrats egos have got the better of them.
And then there are folks who have their own problems - they may be disorganized? Have internal conflicts? Have other financial issues. So they come in saying - hey give us a break on cost. you do. And then you are in for it, because they can't agree internally, complain about everything.
This EU situation reminds me of that. Instead of saying how can we help increase production its endless blaming etc. Isn't the company an EU company? Why wouldn't they make wht they can?
The Guardian, a few days ago:
"Analysis: technical problem at Belgium plant failed to produce enough vaccine but EU demanding fulfilment of contract"
https://www.theguardian.com/world/2021/jan/26/why-has-astraz...
Really terrible timing to make a decision like this, too - makes it so much worse.
So far, I found this:
- Paragraph 5.2: The delivery schedule in the main contract is quite short ( I assume based on quarters) and blacked out. I don't like that lack of transparence.
- Paragraph 6.2: I read that paragraph concerning capacit limitations, that of any additional EU orders result in capacity shortfalls, AZ has to increase capacity. And in case AZ is not able to adhere to the schedule agreed in 5.2, AZ is not in breach of contract. If the Pfizer contract is the same, that would mean the EU really shot itself in the foot with the additional orders, that forced a temporary / partial shitdown of Pfizers Belgian plant.
- 6.3: Regular reporting intevalls are not specified, neither is any appendix referenced. That could be an issue.
- 8.1, Delivery: Coordination of deliveries is supposed to happen between the central AZ rep and the reps o the EU member states. Again no details, no mention of working groups, no detailed time tables, eg AZ has to inform "in good time" before doses will be available. I'd say very hard o implement once deliveries are supposed to start, and a clear indication that nobody thought of how the whole purchasing and delivery to member state hubs is supposed to work in real life.
- 8.4 and 8.5: Now the contract specifies "in good time" to be 5 working days. Distribution is up to member states. And in case the hub cannot take the delivery within these 5 days, any storage is on the member state. The period behind this is blacked out. The focus here is purely cost, again I'd say the cintract is falling short on the logistcs side of things.
- 18.7, Force Majeur: Sure, pandemics are usually included as Force Majeur incidents. But really, for a COVID-19 vaccine as well? Come on. The means either the pandemic is delcared over (which it won't be), or AZ has a constant option to just declare Force Majeur if they run into issues. Why not explicitly exclude the ongoing pandemic from being a Force Majeur event?
- Order Form (pages 35 through 38): This is honestly the first contract I saw in my whole life, that spends fou complete pages on cntractually specifying the purchase order. Honestly, I don't see reason why.
- Delivery Schedule (page 40): Now we have a table with monthly quantities. All blacked out. Again, the contract references payment terms, but not a single word on what happens if AZ canno adhere to the schedule. Not good.
I have to say, from a supply chain perspective, this contract is dangerously lacking. Based on my experience with government sourcing, they tend to include everything in the cntract they think about, I assume nobody spared a thought at how the deliveries wil bemanaged,how the schedule will look like, or what will happen if there are delays. That almost borders negligence.
Again, asuming the contracts with the other suppliers are similar, I'm almost sure that there is no organization put in place on EU level, at the suppliers or member states to manage the actual deliveries. None. There is no word in that contract about thecoordination between local vaccination efforts and deliveries. I have the impression, that as with masks, the governments think that you sign a contract, place an order and then have the goods are delivered without issues. It didn't work out like that with masks, it won't with vaccines.
Delivery into any specified single NDC seems sensible.
More specifics around delivery requirements and regulations will differ on a by-country basis regardless.
A single DC is sensible, Germany has a total of 16 for the Pfizer vaccine. As states have a lot of independence in Germany, I fear that every state has its own DC for AZ as well. How that middle mile will be organised, I have no idea.
Middle mile will be organised via transhipment / trunking. Transshipment from an NDC via a regional hub is a very common practice and I would be surprised if anyone has a network with 16 regional hubs without an NDC to support them.
The answer I got from the bavarian Ministry of Interior, the Ministry of Health and the Ministry of Economics was, I paraphrase, "distribution is easy, we can handle that". 3 months later the same people said they underestimated distribution.
Ideally, I would say that vaccination centers should never run out of doses. So there should be more doses in these centers than appointments. Appointments is a mess, even for elderly and risk patients. One could also piggy back on the existing vaccine supply chains, using doctors practices. I am not aware of any plans to do so.
In case appointment management would work, one could allign these appointments with push deliveries from AZ and others. Manufacturers would have a forecast, push deliveries based on forecast would end up in the national hubs and supply of local centers would work using something like Knban loops. Easy, robust and scalable. Not that we will see any of this, or other solutions that would actually work, antime soon in Germany. So I expect it go down something like this:
1. manufacturer informs that a batch is available.
2. Bacth is delivered to central hub, in quite some cases tha hub cannot take the delivery resulting in a mess to get the doses at a later point
3. Once the doses are in the hub, authorities will (try) to reach out to eligible people that they can get vaccinations
4. two weeks after the batch is delivered, the first appointments will be available
5. Vaccination centers will not be able to vaccinate everyone with an appointment beause the supply with doses isn't working
6. Three weeks after the batch was delivered, it will partially be used
7. Repeat with the next batch
Joker: Political blame game and glory hunting, we have quite a lot of elections, including the federal one, this year. To be inserted at any point of the above chain, likely multiple times.
So what are those black out parts?
Maybe just partly "uncensored"
1.9 “Best Reasonable Efforts” means (a) in the case of AstraZeneca, the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a Vaccine at the relevant stage of development or commercialization having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world but taking into account efficacy and safety; and
1.15 Indicates what costs the EU will cover. Essentially EU will pay for AZ to build capacity, pays all materials, staff (incl. overtime), facility operating and AZ's admin costs (incl. legal, finance, executive, ..), regulatory filing costs, ....). So AZ comes out of the deal with no formal "profit" but new machinery, lots of staff costs paid, lots of studies paid, and all the IP.
4.2(b): Commission has the right to request all data on the production - so they will surely request this to see where doses are actually going.
5.2 and 5.4: Explicitly specified that AZ shall use its "Best Reasonable Efforts" to manufacture the Vaccine within EU - and the UK. So explicitly UK sites are included. Commission or EU countries may prod AZ to license other manufacturers to also produce further doses.
7.2 The Commission sent EUR 336 Mio when signing the contract, and (7.1) before production sends more funding to cover the cost of materials (number blacked out but 7.4 suggests that it might be up to EUR 870 Mio)
13.1(e) AZ warrants that "(e) it is not under any obligation, contractual or otherwise, to any Person or third party in respect of the Initial Europe Doses or that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the complete fulfillment of its obligations under this Agreement". Essentially it has no conflicting obligations for delivering those same doses. It might be difficult to identify what are the exact doses, but given that the EU transferred at least EUR 300 Mio, which in 1.15 and 7 is specified explicitly as covering all the development, capacity building, materials and production costs, it would be hard to argue that that is not a float to manufacture the first doses. This seems a difficult clause and could hang AZ if it comes out that they prioritised UK doses. See above - UK manufacturing sites were explicitly included as manufacturing sites in 5.4.
14. The EU countries indemnify AZ from any damage claims from harm caused by the vaccine's use. 15.1 also says as long as EMA has authorised the vaccine no EU country can claim damages due to safety or efficacy issues.
18.5(b) Any legal case will go before the courts in Brussels, Belgium (that's in the first instance a local court, not the Luxembourg or Hague-based ones handling EU law).
18.7 gives a force majeure clause, but explicitly excludes "defaults of service, defects in equipment or material or delays in making them available".
page 34 - signatures were made on 27 August! The beginning of the contract gives some possible delays though, if EU countries are slow to sign up.
page 40 - sadly the schedule is blacked out.
tl;dr: My takeaway from this is that AZ signed a contract that obliges them to deliver. While there's a best effort clause it's very wide. They explicitly included UK facilities as production facilities (contradicting their public claims that they only promised to use EU facilities) and committed there's no competing claim, so either signed a false warrant or the UK has no prior purchase right.
AstraZeneca: Yes.
EU: We wouldn't want anything to happen to it.
AstraZeneca: What?
Germany: No, what EU means is it would be a shame if...
Also, where are the people who laughed about Brexit now?
The idea that this one event makes up for the colossal mess of Brexit is... interesting.
The exact same arrangement would have been possible and likely before Brexit as well.
I highly suspect this is going to cost AstraZeneca big.
UK pro-brexit reporting I have seen has been focusing not on other countries (such as Germany) being upset at the EU's treatment of the UK, but the fact that the EU prevented them from negotiating individually and securing vaccines earlier, and instead imposing additional bureaucracy that delayed the ordering of the vaccine by multiple months.
With the EU introducing export controls against existing (and actually binding) vaccine contracts and now threatening war time-esque controls over production and intellectual property rights of private pharma companies, it is not AstraZeneca that this will cost big, actions like these are much much bigger than uk vs EU
Oxford uni and the production plant just happen to be on the other side of the fence right now, there is very little to claim it as a British triumph. They need something to hold onto I guess.
> it is not under any obligation, contractual or otherwise, to any Person or third party in respect of the Initial Europe Doses or that conflicts with or is inconsistent in any material respect with the terms of this Agreement or that would impede the complete fulfillment of its obligations under this Agreement;
GB is by far one of the worst performers in the region in handling covid: https://www.reddit.com/r/europe/comments/l7meq9/covid_deaths...
Now try to imagine a world where the development of the Oxford vaccine had failed. And EU based companies had had the success in their place, would you still be having a laugh, given that GB would be on the end of the unfulfilled contract?
Astra Zeneca has contractual obligations with the UK too, and human decency applies to UK people too.
Yet the EU is not only trying to do exactly what you say you dislike, they are also attempting to interfere with totally unrelated contractual obligations (EU-AZ issues leading to "monitoring" of UK-Pfizer contractual deliveries, which has nothing to do with the EU-AZ contract).
And I'm not sure what this has to do with Brexit.
Allowing everyone else to see the contract would give other countries stronger leveraging positions against AstraZeneca.
Perhaps AstraZeneca asked for it and the member states didn't think it was worth fighting over?
Please don't throw grenades.
manufacturing sites. AstraZeneca shall use its Best Reasonable Efforts to manufacture the Vaccine at manufacturing sites located within EU(which, for the purpose of this Section 5.4 only shall include the United Kingodm) and may manufacture the Vaccine in non-EU facilities if appropriate, to accelerate supply of the Vaccine in Europe; provided, that AstraZeneca shall provide prior written notice of such non-EU manufacturing facilities to the Commission which shall include an explanation for such determination to use non-EU manufacturing facilities. If AstraZeneca is unable to deliver on its intention to manufacture the Initial Europe Doses and/or Optional Doses under this Agreement in the EU, the Commission or the Participating Member States may present to AstraZeneca, CMOs within the EU capable of manufacturing the Vaccine Doses, and AstraZeneca shall use its Best Reasonable Efforts to contract with such proposed CMOs to increase the available manufacturing capacity within the EU. The manufacturing site planning is set out in Schedule A.
Probably needs a lawyer specialised in this stuff and the jurisdiction where the contract is signed, but it seems like this is the part that EU says the contract included the UK facilities.
Anyway, whatever happens people of Europe wont forget this, even if it was purely EU's fault. You don't say you belong to a team, omit the vaccines of China and Russia and then be let to die off because the rest of the team says you should have signed better contract. Next time something important comes up, EU should think beyond the UK/USA.
Anything can be construed as “best reasonable effort” - or is this specific legalese I’m unaware off?
Also, just by definition, whatever the lawyers agreed on is likely appropriate in a legal context and a layman's criticism of the language is almost invariably because they're missing the knowledge. Imagine said lawyer reading your code and challenging you on your API design.
Anyway, if challenged in court, AZ would have to demonstrate that they actually made genuine efforts before going down a different path.
The addition of the word "reasonable" is because they need an out in case they feel they've spent a decent amount of efforts. Whether that amount was actually decent or not is for the judge to decide.
1.9. “Best Reasonable Efforts” means
(a) in the case of AstraZeneca, the activities and degree of effort that a company of similar size with a similarly-sized infrastructure and similar resources as AstraZeneca would undertake or use in the development and manufacture of a Vaccine at the relevant stage of development or commercialization having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world but taking into account efficacy and safety; and
(b) in the case of the Commission and the Participating Member States, the activities and degree of effort that governments would undertake or use in supporting their contractor in the development of the Vaccine having regard to the urgent need for a Vaccine to end a global pandemic which is resulting in serious public health issues, restrictions on personal freedoms and economic impact, across the world.
From his explanation the EU signed their contract with a 3 month delay from the UK contract. Arguing that he is being accused of EU production issues on sites that have not had the 3 month lead time that the UK sites had to resolve any production issues.
You can argue that the UK production output could potentially be distributed proportionally for worldwide demand but to me the real question is why isn't anyone in the media or in the European Commission asking questions on why did it take 3 months to draft such a bland generic urgent supply contract?
I am sure the truth is probably somewhere in between but to me it seems the EC is playing the media game and trying to through AstraZeneca under a bus to cover for their own ineptitude in such a clutch time.
AstraZeneca, which apparently has no experience with maki vaccines, has messed up every part of their job. Starting with the trials (which is why the EU delayed the emergency authorization and the US hasn’t given it yet) continuing with manufacturing, and apparently now it’s becoming evident their legal department has screwed up as well.
I think first it remains to be seen if AstraZeneca did something problematic. But if that is the case, one can be sure there will be political repercussions. Though I think that they are now just using the threat of repercussions to force AstraZeneca to change their policies. If they do so, this will be the first big test for the new relation between the EU and Brittain and AstraZeneca will be in the middle of it.
[1] https://www.politico.eu/article/charles-michel-says-eu-could...
In my opinion they should, This is no time to play silly games regarding contract law. Vaccines should be produced as quickly as possible by as many capable facilities as possible.
Let's also not forget that most of the developing world is dead last in receiving vaccines, and greatly increasing production could prevent the death of countless lives.
talk about a unifying force
It's AstraZeneca. They are frauds.