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AstraZeneca/EU contract
- DangerousPie 6y agoNothing particularly interesting or shocking about the parts that got un-censored. The important part seems to be 5.4, which was already readable before. 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.
- mytailorisrich 6y agoFrom what I gather from the media here in the UK one problem is that AstraZeneca's contract with the UK government is that they will not export vaccines produced in the UK until the British government's order is fulfilled. Pretty smart stipulation by the UK government but it may be putting AstraZeneca, which agreed to it, in an awkward position...
- DangerousPie 6y agoAh, that's an interesting aspect I didn't know about. 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...
- mytailorisrich 6y agoOf course. As I said in my other comment, there is a lot of politics involved, not least because of Brexit and, frankly because the EU did not do very well (they may be looking for a diversion...) here while the UK did.
- thow-01187 6y agoTo be fair, despite the heavy criticisms, it's not clear whether the EU objectively made any major mistake. The countries ahead of them in the vaccination effort did so by writing a blank check to the pharma companies - definitely not an ideal outcome either. 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.
- libertine 6y agoHow would EU be painted if they demanded all vacines produced in Europe to stay in Europe before all their orders are fulfilled? 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.
- 6y ago
- notimetorelax 6y agoWouldn’t be the first time a politician behaved hypocritically, would it?
- freeone3000 6y agoIt's not hypocritical at all. Keeping vaccine in the borders of the UK gives more vaccine to the UK, and importing vaccine from Europe gives more to the UK.
- alastor2020 6y agoIt's different though surely? UK had an exclusivity agreement with a private company (AZ). EU had their own agreement. There is now a contractual dispute between EU and AZ. In retaliation, EU wants to use export controls to prevent another EU company (Pfizer) honouring its legal civil contract with the UK. This is trade war sort of stuff. EU should go to court with AZ to settle the dispute. The UK isn't a party here.
- Scarblac 6y agoNo, the EU wants to stop exporting to the UK from Belgium, as they have already done,as long as they are behind on the agreed EU schedule.
- makomk 6y agoAn exclusivity agreement for, as I understand it, a production line that the UK basically paid to set up in exchange for that exclusivity. Which seems like a pretty normal commercial arrangement.
- cs02rm0 6y agoThere's a quite a difference between a contract signed by a company who could walk away without the money and imposed law that restricts trade!
- deleted 6y ago[deleted]
- usrusr 6y agoIt seems like the gloves have come off wrt the idea of fair(ish) vaccine access across the board recently. 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.
- Bombthecat 6y agoSo basically, two exclusive contracts? Lol..
- JumpCrisscross 6y ago> two exclusive contracts? 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.
- DangerousPie 6y agoAccording to AZ they are selling the vaccine at cost to all customers, so the price should have nothing to do with it. Unless they're lying I guess.
- hef19898 6y agoI think profits will come from page 5, paragraph a (the second a on that page): "(a) costs related to the operation of the facility incurred while using the facility to manufacture other products;" are included in the vaccine costs.
- makomk 6y agoIncluding similar language in their agreement would probably have made the EU's already terrible case even worse anyway, since it would almost certainly have only covered AstraZeneca's non-UK European facilities, and the whole problem seems to be that those can't produce nearly enough vaccine to cover EU demand. Note that the current clause about the initial supply of doses only covers manufacturing them within the EU; the part about the EU including the UK explicitly does not apply to that clause. (Indeed, the only mention of UK manufacturing seems to be exempting it from a clause banning the use of non-EU manufacturing sites.)
- zwaps 6y agoOp meant having the same clause for the Pfizer/BionTech vaccine, which was developed and is mostly produced in the EU. If the EU had done that, things would look quite different today. Even for the UK. We can all be glad that the EU was quite a bit more naive than the UK.
- rsynnott 6y agoAstraZeneca's real problem seems to be that they, on the face of it, promised contradictory things to different customers.
- krona 6y agoExcept the wording in the EU contract is too vague and loose, and isn't a commitment beyond best reasonable efforts. Obviously the Commission (publically) disagrees and is using AstraZeneca as a scapegoat for its incompetence.
- 7952 6y agoMy hunch is that the EU knew this all along and were vague on purpose to kick the issue down the road.
- hardlianotion 6y agoLoosely worded? What contract lawyer has suggested this? The lawyer comments I have seen say that it is quite clear the Commission has no case.
- riedel 6y agoThe other part is the definition of Best Reasonable Effort . I wonder if the behaviour of Pfizer has an impact here.
- ldng 6y agoYes it does. They used it to announce that they deliver 20% bottle because they are not billing 6 doses per bottle while at the same time arguing publicly that they contains 5. They are then hiding behind that contract the talks about doses, not bottles and best effort not hard delivery. They all have the same contract and are following Pfizer example. BigPharma is screwing up UE big time and that is unacceptable. Source for downvoters : https://www.mediapart.fr/journal/france/290121/retards-de-vaccins-comment-les-etats-europeens-se-sont-fait-avoir-par-les-laboratoires https://www.mediapart.fr/journal/france/290121/retards-de-va... (FR)
- hef19898 6y agoOh, there is also a paragraph in the AZ contract, that frees AZ from breach of contract if additional orders from the EU result in capacity shortfalls. Not that dditional orders would have been necessary, but hey, the press called for it.
- cs02rm0 6y agoCertainly one Belgian lawyer has already stated that he thinks the EU Commission don't have a leg to stand on here. Not that I expect that to slow them down. https://twitter.com/JeremyC64/status/1355156181753475073?s=19 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. https://thumbsnap.com/sc/JtrAXvhv.jpg https://thumbsnap.com/sc/JtrAXvhv.jpg
- DangerousPie 6y agoCan we have a zoomed out version of that map please? I suspect it's been framed for maximum controversy. And I'd also like to hear from more reliable lawyers than "a guy on Twitter".
- smnrchrds 6y agoYeah. Canada is not exempted either. And we have no domestic production of COVID-19 vaccine. All our vaccines are coming from Europe.
- hardlianotion 6y agoQuite.
- berdario 6y agoThe UK should be the same color as Russia and Turkey. Either they're all red, or they're all grey
- hardlianotion 6y agoNo, the important section is 5.1. 5.4 includes UK only to say that production centres outside the EU need to be explained to and approved by the EU. UK factories are counted as EU for this point only.
- NiceWayToDoIT 6y ago> "Uncensored" So what are those black out parts? Maybe just partly "uncensored"
- arendtio 6y agohttps://news.ycombinator.com/item?id=25960718 https://news.ycombinator.com/item?id=25960718
- zoobab 6y agoSee https://twitter.com/VrlPlt/status/1355219237745405954 https://twitter.com/VrlPlt/status/1355219237745405954
- ape4 6y ago"AstraZeneca has committed to use its Best Reasonable Efforts (as defined below) to build capacity to manufacture 300 million Doses of the Vaccine, at no profit and no loss to AstraZeneca, at the total cost currently estimated to be ** Euros for distribution within the EU"
- hannon4 6y agoSeems much more convoluted than the pzifer contract with Israel.
- deleted 6y ago[deleted]
- cinntaile 6y agoApparently it was mistakenly uploaded uncensored before this was changed? Where can we find the uncensored version?
- DangerousPie 6y agoThis is the "uncensored" version. Parts in red were originally censored but have been revealed.
- mytailorisrich 6y agoThere's a lot of controversy and arguments on this at the moment, a lot of it is political with a good dose of Brexit added in. 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.
- DoingIsLearning 6y ago> AstraZeneca, which are between a rock and a hard place here, has agreed to supply the EU at 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.
- mytailorisrich 6y agoThanks for giving details and to make clear that this is their global policy. They should indeed be commended for that.
- addicted 6y agoOxford University should be commended for that. 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.
- ajvarparadise_ 6y agoSorry for asking, is there a tldr: ?
- hannob 6y agoTo explain what this is: The EU mistakenly uploaded a censored version of the contract earlier today where some blacked out parts could be reconstructed using PDF metadata. This version has those included in red.
- raverbashing 6y agoNot sure if it was the EU or AZ that did the (failed) redaction. (Yes, despite the fact that it was published on an EU website) Anyway it seems that orgs keep falling for the "PDF redaction" caveats
- vinay427 6y agoTo be fair, I've grown paranoid about PDF metadata and redactions, so I prefer taking screenshots and making a new PDF out of those as long as the document is only a few pages in length, or using imagemagick or similar to flatten it. I haven't found an easier way to be absolutely sure that my annotations are permanent, and this metadata issue is perhaps even trickier.
- toast0 6y agoPrint, review, and scan is probably easier than screenshotting, if you have the equipment.
- mrtksn 6y ago5.4. 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.
- dstick 6y agoIt’s mind boggling to me that “best reasonable effort” made it in there multiple times. That’s so vague and up to interpretation, who can blame them that they sold the supplies for 3x as much to another country? Anything can be construed as “best reasonable effort” - or is this specific legalese I’m unaware off?
- jorvi 6y agoEven if AstraZeneca gets away with it legally, they will be a leper to the EU and be crushed in whatever other medicine negotiations they end up having with the EU or its constituent national governments. Burning the goodwill that gets you access to a relatively rich 450 million consumers market is pretty boneheaded.
- eznzt 6y agoWhat is the excuse to have this contract censored? I understand what it's in the interest of security for example, but this...? Also, where are the people who laughed about Brexit now?
- maxerickson 6y agoThere's a confidentiality clause in the contract (page 26 of the link). Perhaps AstraZeneca asked for it and the member states didn't think it was worth fighting over?
- frombody 6y agoEU is massive and has a lot of negotiating power. Allowing everyone else to see the contract would give other countries stronger leveraging positions against AstraZeneca.
- addicted 6y agoI’m not sure what this has to do with Brexit. The exact same arrangement would have been possible and likely before Brexit as well.
- that_guy_iain 6y agoPeople who were pro-Brexit seem to think this one thing proves they were right. They seem to think other EU members will be angry with how the EU are treating the UK in this matter and will also want to leave. This point seems nuts since the EU is basically fighting for it's members vs a non-member, kind of shows why it's better to be with them than againist them. Considering this hasn't fully played out, their constant bragging on the matter seems foolish. Especially considering the EU clearly has more power. The UK is in an extremely vulnerable position overall and seem to be making their position unsafer by the day. The damage the UK goverment is doing to the EU relations will, I suspect, haunt the UK for decades. I suspect if this carries on for a year or so, the UK will end up in a trade war with their closet and largest trading partner during one of the largest recessions ever. I highly suspect this is going to cost AstraZeneca big.
- temp667 6y agoSo weird - and a good lesson for business. Generally the customer that gives you the most hassle on front end and is the cheapest will demand the most and hassle you the most for the entire period. 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.
- itronitron 6y agoA friend of mine who used to own a small Inn learned within a year to turn away customers who either asked too many questions before booking a room or that showed up complaining.
- temp667 6y agoYeah - there are folks I think interested in having things done. They pay, you do it, they are happy. 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?
- string 6y agoAbsolutely. My best paying clients are both the most reasonable and flexible. These are generally well established businesses or big cultural organisations (fintech and museums mostly), and the people I work with are professionals. 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.
- yread 6y agoIs there anything that goes right with this vaccine? First they mess up the trial giving it to only 18-55 year old, then the manufacturing of half doses instead of full, then the efficacy is not so great, then they manage to manufacture only 1/3 of the doses they promised, then it turns out efficacy in old people is basically nothing and now this. As Derek Lowe said: if there is one pharma company that comes out of pandemic looking worse it will be AZ.
- johnghanks 6y ago> then it turns out efficacy in old people is basically nothing didn't this turn out to be false
- snet0 6y ago> giving it to only 18-55 year old This is simply untrue, the mixed-dose regimen was limited to those under 55, but 4% of the study population were over 70. > the efficacy is not so great While the efficacy numbers indeed look lower than the mRNA vaccines, I'm lead to believe that at least part of this is due to methodology. As far as I am aware, neither the Moderna or the Pfizer mRNA vaccines tested for asymptomatic cases, and presented their efficacy against symptomatic cases only. > it turns out efficacy in old people is basically nothing I believe this claim is totally untrue, also.
- yread 6y agoDon't get me wrong I would still take if I got the chance (and I will according to the plan as I work in a hospital) but it was a sloppily done trial. > This is simply untrue, the mixed-dose regimen was limited to those under 55, but 4% of the study population were over 70. It was given only to 18-55 in the UK. 4% doesn't compare well to 20+% for all the other trials. Brilliant for a disease which kills people with median age of 82 years (in the UK). Why would you even design a protocol that looks only at young people?! They used a different protocol in Brazil and South Africa. Why did they use a different protocol in different places? Pfizer and other companies managed with one. Having different protocol is treated as different trials - so the trial in South Africa didn't have enough cases and wasn't even considered in the EMA authorization. EMA estimates 60% efficacy. https://www.ema.europa.eu/en/news/ema-recommends-covid-19-vaccine-astrazeneca-authorisation-eu https://www.ema.europa.eu/en/news/ema-recommends-covid-19-va... > methodology Ok so the efficacy looks worse but is not directly comparable. That doesn't really detract from my point that the trial(s) was not well designed, no? It just wasn't given to enough old people. EDIT: Also, the efficacy in preventing asymptomatic infection was only 27% (again with insanely wide confidence interval). So, they designed the trial to measure it, but it doesn't do really well at that. > I believe this claim is totally untrue, also. It could be true, could be untrue but it's not falsifiable from the data. The confidence interval for efficacy in 65+ is -140.5% (yes there is a minus) - 94.2%. We just don't know. https://twitter.com/olivernmoody/status/1354781400071860230 https://twitter.com/olivernmoody/status/1354781400071860230
- ucha 6y agoIn 7.1., when they say the EU will provide funding at an amount equal to the "cost of goods", does it mean that AZ doesn't make profits on the vaccine they sell to the EU? 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...
- JumpCrisscross 6y ago>does it mean that AZ doesn't make profits on the vaccine they sell to the EU? 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.)
- DangerousPie 6y agoPretty sure that's a standard part of any agreement AZ made, since Oxford University only licensed the vaccine to them if they provided it at cost.
- kitd 6y agoI believe the "no profit" clause comes from Oxford Uni who own the IP.
- trebligdivad 6y agoRight, AZ is doing all of this at cost for everyone, not just the EU (until the end of the Pandemic); I feel sorry for AZ having to take this hastle when they're not making anything out of it.
- thow-01187 6y agoDon't they get their manufacturing facilities upgraded for free?
- noncoml 6y agoIf you listen to UK BBC news, they spend half of their airtime saying how the UK government placed the order months before the EU, and that the EU is in the wrong, since they haven't even approved the vaccine yet(as of the last time I listened to the BBC news), so they shouldn't complain and so on. 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.
- pasabagi 6y agoIt's hard to overstate how tight the british establishment is, media included. It's a small country, and power is concentrated in a vanishingly small number of hands, many of whom are married, or went to school together, or are close friends. 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.
- isbvhodnvemrwvn 6y agoVery relevant "Yes, Minister"; https://www.youtube.com/watch?v=B9tzoGFszog https://www.youtube.com/watch?v=B9tzoGFszog
- subsubzero 6y ago> It's a small country, and power is concentrated in a vanishingly small number of hands 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.
- 6y ago
- cblconfederate 6y agoI'm for the EU and of course hope the vaccine problems are solved ASAP, but i'm troubled by the way this has become a political, lawyeristic issue. On the one hand UK media is deseperate to somehow prove brexit worked, on the other hand EU is , once again, trying to solve problems magically by legal means. Are we forgetting we are in an urgent pandemic that threatens the world economy with collapse? This requires a warlike level of mobilization of engineers, not lawyers.
- kazen44 6y agoI agree with your sentiment. Also, why not let other manufacturers produce vacciness aswell? Getting the vacinnes produced rapidly and in enough numbers seem to be the number one priority in this.
- stefano 6y agoSanofi will be producing the Pfizer-Biontech vaccine, but it takes a lot of time to set up a new production line. Last estimate I saw was saying July.
- thinkindie 6y agoapparently this is going to happen with Sanofi producing Pfizer vaccine after they closed their own trials without a successful candidate.
- martinald 6y agoYou sound like the "UK media" is one thing. The Guardian, FT, etc are staunchly pro EU and have been endlessly pointing out the problems.
- hef19898 6y agoIt isnot, at least not yet, a legal issue. As you said, it is an engineering (manufacturing) and supply / logistics (distribution) issue. None of which are even remotely discussed, not politially, not in the media, no where. So I suspect we won't see any changes on these two fronts. At least no coordinated ones, the manufacturers will have quite motivated engineers working on manufactring ramp ups, I asume.
- beefield 6y agoEU:You've... you've got a nice IP protection here, AstraZeneca 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...
- calpaterson 6y agoThe EU's approach to resolving this dispute makes absolutely no sense. 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.
- YeGoblynQueenne 6y ago>> 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: (...) 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.
- calpaterson 6y agoIt's a big step from agreeing to use UK sites as part of "Best Reasonable Efforts" to the EU having the right to recieve certain manufacture from UK sites. 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.
- omginternets 6y agoAm I unreasonable in thinking it scandalous that the EU’s contract with AstraZeneca is censored? Shouldn’t this kind of thing be public?
- jackweirdy 6y agoIf it makes you feel any better, their attempt at redaction was poor and the whole text is present in the bookmarks of the PDF: https://twitter.com/lijukic/status/1355164987212390402 https://twitter.com/lijukic/status/1355164987212390402
- omginternets 6y ago“Thankfully the stormtroopers are lousy shots” ;) 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.
- martin-t 6y agoI came here to say the same thing. Yet somehow people don't seem to question it. I think everything governments do should be public by default, unless there's strong justification why to keep something secret. Then that justification has to be public and periodically reviewed if it still applies, otherwise it goes public automatically.
- hef19898 6y agoI just started to read it, not finished yet, so I will update this post a needed. Also, I look at it from a purely supply chain / logistics erspective. I also asusme that the other contracts (Biontech/Pfizer, Moderna, Jihnsson&Johnsson,...) are similar. 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.
- lhnz 6y agoAstraZeneca is currently struggling to produce 2 million doses a week for the UK [0]. How does the EU expect to use UK production to shore up a shortfall of 49 million doses that they require in February/March? 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/ https://committees.parliament.uk/oralevidence/1505/html/
- YeGoblynQueenne 6y ago>> AstraZeneca is currently struggling to produce 2 million doses a week for the UK [0]. How does the EU expect to use UK production to shore up a shortfall of 49 million doses that they require in February/March? 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.
- damagednoob 6y agoI guess it comes down to the legal interpretation of "Best Reasonable Efforts".
- 6y ago
- phonebucket 6y agoI'm not a lawyer. 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.
- ChrisKnott 6y agoYes, the UK contract has an explicit clause that says doses manufactured from the UK plants can only be exported once the UK order is fulfilled. The UK government demanded this as a condition of partnering with Oxford, and vetoed Oxford partnering with Merck because they wanted a UK HQed company. 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.
- rvieira 6y ago(I'm also not a lawyer) 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.
- breakfastduck 6y agoNo, that's wrong. The contractual dispute is between AZ and the EU. 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.
- toyg 6y agoUnless it's acknowledged in the contract, order of signature has little or no relevance from a legal perspective.
- s_dev 6y agoThe fact that the EU and UK are already fighting illustrates how imporant the EU is. Imagine if the EU didn't intervene in the vaccine programme and it was 28 rich countries trying argue to 28 contracts with AZ instead of just two -- and all the complexity that emerged from just two contracts.
- PJDK 6y agoThe EU is fighting with Astrazenica. The UK has mostly kept out of it - only just commenting once the EU decided to change export rules and around the Northern Ireland agreement.
- UK-Al05 6y agoI'm thinking a lot of countries are regretting joining the EU vaccination scheme considering how slow it's been.
- tomohawk 6y agoThe knives are coming out. https://www.spiegel.de/international/europe/europe-s-vaccine-disaster-commission-president-ursula-von-der-leyen-seeking-to-duck-responsibility-a-1197547d-6219-4438-9d69-b76e64701802 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-raid-astrazeneca-vaccine-factory-brussels/ https://www.euroweeklynews.com/2021/01/28/eu-bosses-order-ra...
- klelatti 6y agoThis seems to me to best sum up the problem with the Commission's position: > 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 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).
- illuminati1911 6y agoNone of that is really relevant. Both AZ and EU agreed to this contract. If AZ has signed a contract that they cannot fulfill, then they have commited a fraud.
- klelatti 6y agoThere was clearly significant risk associated with an unprecedented ramp up of vaccine production and I expect that AZ, Pfizer, J&J etc are all working round the clock to try to deliver as soon as possible. Fraud implies bad faith which I expect is a long, long way from the truth.
- breakfastduck 6y agoThey agreed to a contract much later than the UK, and the UK is the main supplier. 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.
- zwaps 6y agoIt's not really a contracting issue. It's also not a legal one, because legal enforcement of anything is completely irrelevant for the time scales that matter. The EU is in a position where none of these things can be fixed now. 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.
- neximo64 6y agoThe EU was ready to invoke Article 16 of the NI protocol just to get AstraZeneca to send vaccine over. Someone in Brussels really doesn’t like AZ
- dependsontheq 6y agoLet's take a step back: - the EU has a binding contract with Astra Zeneca - the idea is to manufacture vaccine before the EMA decision - one week before the EMA decision AstraZeneca tells everybody that there are only 30% of the agreed doses 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.
- jpdus 6y agoWhat I don't understand: Most comments sound like the EU wants to take doses away from the UK. 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.
- mchusma 6y agoI don't know about the legality, but I can say that if you want to take forever to lift the ban on the vaccine, you lose moral justification for complaining about things being slow. If they approved in November, I'd feel differently.
- zwaps 6y agoThe UK is a small country. Their "Britain first" clause, in absolute terms, has little impact. 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.
- breakfastduck 6y agoEU have really shown themselves up here. Big time. Really terrible timing to make a decision like this, too - makes it so much worse.
- btbuilder 6y agoI have read a number of comments where folks state that AZ is accused of shipping doses out of EU to other markets (I assume the U.K.). However, I don’t believe any evidence of this has been presented and it is a suspicion of officials in Brussels. 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-vaccine-stumble-11611871968 https://www.wsj.com/articles/behind-astrazenecas-covid-19-va... I am interested in any other sources for this.
- pastapriest 6y agoA few highlights: 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.