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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

by lhnz 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? 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 ago
  I guess it comes down to the legal interpretation of "Best Reasonable Efforts".
  - flipbrad 6y ago
    I've been a lawyer for quite some time, and I can't recall the last time I saw this phrase used. I'm not sure I ever have.
    - kerneis 6y ago
      The term is capitalized, which means it is defined in the first section of the document, more precisely on p. 3 in that case: 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.
  - matthewheath 6y ago
    "Best Reasonable Efforts" is defined in clause 1.9 of the contract: > 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.
- deleted 6y ago
  [deleted]
- 7952 6y ago
  That does not say anything about exclusivity of doses. It just states that manufacturing has to occur in particular places. What the EU gets out of this is parity between different purchasers within the group. Also it doesn't seem reasonable to expect AZ to ignore other contracts.
  - kmonad 6y ago
    Not sure I understand your second sentence, it might be saying what I am about to write. From reading several articles on the issue, the EU seems to demand that the slow-down in production be shared equally across orders. This puts AZ in a pickle: it would then mean they are not only breach of contract with the EU but also UK. Hence, they publicly reiterate the "first come first serve" argument which resonates well in the UK media and rallies support (I think AZ is pitting EU against UK in all of this). I do not believe the "first come first serve" principle is how supply chains like this usually work though. Totally not my field of expertise, but hearsay from some friends working in supply chain management.
    - makomk 6y ago
      It's not actually a "first come first serve" argument as I understand it - it's that contractually the UK and EU supply chains are separate, each contract only requires them to supply the contracted vaccines from that supply chain, and the EU one is in much worse shape yields-wise because the EU dragged their feet on signing the contract for internal political reasons leaving AZ with less time to fix the problems. (There's a contractual provision in the EU contract allowing them to supply some vaccines from the UK which the EU is trying to stretch into them requiring it.) The whole claim that AZ is doing first come, first serve and it isn't fair seems to be EU spin, and pitting the EU against the UK seems to be an intentional EU tactic. In particular, as I recall EU officials started making evidence-free claims early on that AZ had been exporting doses from their European facilities to the UK and this caused the shortage, something they deny and that no evidence has been found for despite raids on their facilities.
      - makruiten 6y ago
- lhnz 6y ago
  > In short, AstraZeneca agreed to use UK facilities > to manufacture doses for the EU. Section 5.1 of the PDF seems to imply that the "Initial Europe Doses" are to be manufactured within Europe [0] "following EU marketing authorization". 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/1355137923411279878
  - Closi 6y ago
    Thanks - your explanation gives a lot of clarity. 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”
  - brmgb 6y ago
    > Section 5.1 of the PDF seems to imply that the "Initial Europe Doses" are to be manufactured within Europe [0] "following EU marketing authorization". 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.
InTheArena 6y ago
As an close observer, I’ve lost a lot of respect watching how the EU in general has handled the whole covid and vaccine mess. They got a away with a lot of shit because USA/Trump/India was a bigger and more obvious bogeyman/disaster. Multiple times there were stories that were just factually untrue that were parroted by leaders in Europe about covid or the vaccine effort. The same bogeyman stories came out about masks being hijacked, Drugs being boarded by Indians or respirators being seized and the USA “buying” all the vaccines and drugs and leaving Europeans to die. Meanwhile the USA and European covid rates pulled equal and Europe now has the dubious honor of leading total cases by 4 million. 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.
gdamjan1 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? open-source the vaccine, the recipes, processes, etc. everything needed so EU can look for a capable manufacturer on its own?
- FuckButtons 6y ago
  Because bill gates convinced them not to: https://khn.org/news/rather-than-give-away-its-covid-vaccine-oxford-makes-a-deal-with-drugmaker/ https://khn.org/news/rather-than-give-away-its-covid-vaccine...
  - bennyelv 6y ago
    There doesn’t seem to be a primary source for that, just the author’s statement that that is what happened. As such I’m skeptical...

by lhnz 6y ago

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 ago
I guess it comes down to the legal interpretation of "Best Reasonable Efforts".
- flipbrad 6y ago
  I've been a lawyer for quite some time, and I can't recall the last time I saw this phrase used. I'm not sure I ever have.
  - kerneis 6y ago
    The term is capitalized, which means it is defined in the first section of the document, more precisely on p. 3 in that case: 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.
- matthewheath 6y ago
  "Best Reasonable Efforts" is defined in clause 1.9 of the contract: > 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.
deleted 6y ago
[deleted]
7952 6y ago
That does not say anything about exclusivity of doses. It just states that manufacturing has to occur in particular places. What the EU gets out of this is parity between different purchasers within the group. Also it doesn't seem reasonable to expect AZ to ignore other contracts.
- kmonad 6y ago
  Not sure I understand your second sentence, it might be saying what I am about to write. From reading several articles on the issue, the EU seems to demand that the slow-down in production be shared equally across orders. This puts AZ in a pickle: it would then mean they are not only breach of contract with the EU but also UK. Hence, they publicly reiterate the "first come first serve" argument which resonates well in the UK media and rallies support (I think AZ is pitting EU against UK in all of this). I do not believe the "first come first serve" principle is how supply chains like this usually work though. Totally not my field of expertise, but hearsay from some friends working in supply chain management.
  - makomk 6y ago
    It's not actually a "first come first serve" argument as I understand it - it's that contractually the UK and EU supply chains are separate, each contract only requires them to supply the contracted vaccines from that supply chain, and the EU one is in much worse shape yields-wise because the EU dragged their feet on signing the contract for internal political reasons leaving AZ with less time to fix the problems. (There's a contractual provision in the EU contract allowing them to supply some vaccines from the UK which the EU is trying to stretch into them requiring it.) The whole claim that AZ is doing first come, first serve and it isn't fair seems to be EU spin, and pitting the EU against the UK seems to be an intentional EU tactic. In particular, as I recall EU officials started making evidence-free claims early on that AZ had been exporting doses from their European facilities to the UK and this caused the shortage, something they deny and that no evidence has been found for despite raids on their facilities.
    - makruiten 6y ago
lhnz 6y ago
> In short, AstraZeneca agreed to use UK facilities > to manufacture doses for the EU. Section 5.1 of the PDF seems to imply that the "Initial Europe Doses" are to be manufactured within Europe [0] "following EU marketing authorization". 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/1355137923411279878
- Closi 6y ago
  Thanks - your explanation gives a lot of clarity. 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”
- brmgb 6y ago
  > Section 5.1 of the PDF seems to imply that the "Initial Europe Doses" are to be manufactured within Europe [0] "following EU marketing authorization". 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.

InTheArena 6y ago

As an close observer, I’ve lost a lot of respect watching how the EU in general has handled the whole covid and vaccine mess. They got a away with a lot of shit because USA/Trump/India was a bigger and more obvious bogeyman/disaster. Multiple times there were stories that were just factually untrue that were parroted by leaders in Europe about covid or the vaccine effort. The same bogeyman stories came out about masks being hijacked, Drugs being boarded by Indians or respirators being seized and the USA “buying” all the vaccines and drugs and leaving Europeans to die. Meanwhile the USA and European covid rates pulled equal and Europe now has the dubious honor of leading total cases by 4 million. 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.

gdamjan1 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? open-source the vaccine, the recipes, processes, etc. everything needed so EU can look for a capable manufacturer on its own?

FuckButtons 6y ago
Because bill gates convinced them not to: https://khn.org/news/rather-than-give-away-its-covid-vaccine-oxford-makes-a-deal-with-drugmaker/ https://khn.org/news/rather-than-give-away-its-covid-vaccine...
- bennyelv 6y ago
  There doesn’t seem to be a primary source for that, just the author’s statement that that is what happened. As such I’m skeptical...