What exactly is happening with AstraZeneca?

oharach7 · 29-01-2021 10:58PM

Pete_Cavan wrote: »

Just to confirm, that is the point I am making. Some posters throw out "shur it was only Best Reasonable Efforts", it's not that simple. If it were up to me, that phrase would be banned as it doesn't mean what some want it to mean.

I'm agreeing with you. It's definitely short of the absolute obligation that van der Leyen was talking about yesterday (which makes her look a bit foolish for having said that) - but equally it is a high standard if you look at how they have defined the term - certainly no "get out of jail free card" for AZ.

Don't act so surprised that I might actually be agreeing with you

The_Brood · 29-01-2021 11:02PM

IRISHSPORTSGUY wrote: »

Not one bit happy if the EU create a border on OUR island. Not one bit.

It's ours, not something for some Belgian bureaucrat to decide.

Brexit did that, not the EU. Too much friendliness, cosines, and most importantly reliance on Britain. Corridors should have been build with other EU nations.

Wolf359f · 29-01-2021 11:03PM

brickster69 wrote: »

It is in the contract that they can. Just not make a profit from it.

Unless AZ signed a contract with a subsidiary company stating the subsidiary would get sole/exclusive rights to any vaccines sold by AZ to a 3rd party who intends on said vial to be administrated in a country other than the country of initial purchase.

We'll slap an NDA on that and we won't inform any new customers of that conflict of interest.

Edit: Is the UK & AZ contract public?

josip · 29-01-2021 11:08PM

Given that AZ and EU (legal teams) are still at loggerheads implies that both sides believe they have a case. These are legal teams with full visibility of the contracts and way more experience of Belgian contract law than anyone else here. So, apart from having an entrenched position, I can't understand why either side on this thread would be so confident who is right in this dispute.

Some things that I am curious about:

How did AZ and EU agree on such an ambiguous contract?
In what plants did AZ use the EU investment money? I'm assuming that they only used EU money in EU plants based on their stated interpretation of the contract.
Would AZ not have known earlier that supplies from Belgium would be significantly reduced and if so why didn't they communicate the delay and scale of it earlier?

Bit cynical · 29-01-2021 11:09PM

Pete_Cavan wrote: »

**** knows but you would have to think they were there from the beginning seeing as last week they said they would deliver less than a third of Q1 target delivery.

When the production issues arose would have a bearing on extent to which AZ are liable under Clause 13.1.

Wolf359f · 29-01-2021 11:11PM

Quick question, with Brexit, any contract signed before the UK left that referenced the EU, would for the purpose of the contract include the UK.
During the transition period, I assume that the term EU only means the EU and one would have to include the UK separate?

political analyst · 29-01-2021 11:11PM

European nations put Brussels in charge of the vaccination effort. James Mates said that central co-ordination, whatever cost benefits it had, slowed things down.

https://www.youtube.com/watch?v=qajwkcd9USs

Why didn't the European Medicines Agency (EMA) give emergency authorisation for the AZ vaccine, which is what the British regulator did?

I doubt that leaving the EU has changed Britain's pharmaceutical standards that quickly. So why did the EMA think that the British emergency authorisation of the AZ vaccine was good enough for the EU? After all, what's good for the goose .....

brickster69 · 29-01-2021 11:12PM

No i am on about if AZ sold x amount to the EU they ( EU ) could resell any excess they had to whoever they wanted as long as they never made a profit on what they purchased it for. I think it is quite standard in Pharma contracts.

Wolf359f · 29-01-2021 11:15PM

political analyst wrote: »

European nations put Brussels in charge of the vaccination effort. James Mates said that central co-ordination, whatever cost benefits it had, slowed things down.

https://www.youtube.com/watch?v=qajwkcd9USs

Why didn't the European Medicines Agency (EMA) give emergency authorisation for the AZ vaccine, which is what the British regulator did?

I doubt that leaving the EU has changed Britain's pharmaceutical standards that quickly. So why did the EMA think that the British emergency authorisation of the AZ vaccine was good enough for the EU? After all, what's good for the goose .....

Because the EMA does not have the power to give emergency approval, that's left within the control/power of member states.

political analyst · 29-01-2021 11:17PM

Wolf359f wrote: »

Because the EMA does not have the power to give emergency approval, that's left within the control/power of member states.

Why didn't member states do it?

volchitsa · 29-01-2021 11:17PM

political analyst wrote: »

European nations put Brussels in charge of the vaccination effort. James Mates said that central co-ordination, whatever cost benefits it had, slowed things down.

https://www.youtube.com/watch?v=qajwkcd9USs

Why didn't the European Medicines Agency (EMA) give emergency authorisation for the AZ vaccine, which is what the British regulator did?

I doubt that leaving the EU has changed Britain's pharmaceutical standards that quickly. So why did the EMA think that the British emergency authorisation of the AZ vaccine was good enough for the EU? After all, what's good for the goose .....

Emergency authorisation affects who takes responsibility for any patients suffering health issues as a result of the vaccine. The British and U.S. governments took on that risk so as to get the vaccine sooner. It was a reasonable gamble for them, with their disastrous infection rates. Not such an obvious choice for the European governments, who'd locked down much harder and kept the rates that much lower.

In hindsight of course...

Wolf359f · 29-01-2021 11:18PM

brickster69 wrote: »

No i am on about if AZ sold x amount to the EU they ( EU ) could resell any excess they had to whoever they wanted as long as they never made a profit on what they purchased it for. I think it is quite standard in Pharma contracts.

I can't see that. Some country comes in buys up all the stock, starts getting political with who gets what etc...
I'd say it more like stock options. Said country decides not to by any more so the manufacturer goes back to his list of customers etc...

29-01-2021 11:19PM

political analyst wrote: »

Why didn't member states do it?

Which E.U. Countries had full ICUs with COVID patients in summer 2020. The answer is none.

embraer170 · 29-01-2021 11:20PM

Something I have not picked up in the media coverage.

Why did AZ only inform the Commission so late? Given the huge reduction in foreseen deliveries, this could not suddenly appear as an issue from one day to the next? I'm sure somewhere in the contract there is a clause requiring AZ to keep the Commission informed about possible delays.

Wolf359f · 29-01-2021 11:22PM

political analyst wrote: »

Why didn't member states do it?

Some don't have the expertise, some may not have rubber stamped an application without checking. Some vaccine manufacturers may not have even bothered applying to authorization due to it being a small customer etc...
The fact also we were tied into the EU purchase agreement meant we would only get a delivery after the EU. So then it opens up the can or worms where you're competing with as a small country vs the rest of the world.

Still nothing stopping smaller countries approving and buying Chinese or Russian vaccines as shown by hungry. As Sputnik was not in the EU list of vaccines, they were free to buy as many as they wished.

Wolf359f · 29-01-2021 11:26PM

embraer170 wrote: »

Something I have not picked up in the media coverage.

Why did AZ only inform the Commission so late? Given the huge reduction in foreseen deliveries, this could not suddenly appear as an issue from one day to the next? I'm sure somewhere in the contract there is a clause requiring AZ to keep the Commission informed about possible delays.

It also follows the question why they applied so late for approval. Well over a month after the application to the UK.
The fact the EU raided the factory to check and soon after the EU want's export controls smells fishy. Also the fact the delivery has been brought forward a week and AZ found ~8mil doses in a few days also seem suspicious.

There's definitely more to the story than we're told.

brickster69 · 29-01-2021 11:34PM

Could be a Noble Peace Prize for the Eu with the DUP & Sinn Fein in agreement with something. Just waiting on Sturgeon now and we could have a full house.

29-01-2021 11:38PM

volchitsa wrote: »

Emergency authorisation affects who takes responsibility for any patients suffering health issues as a result of the vaccine. The British and U.S. governments took on that risk so as to get the vaccine sooner. It was a reasonable gamble for them, with their disastrous infection rates. Not such an obvious choice for the European governments, who'd locked down much harder and kept the rates that much lower.

In hindsight of course...

The Eu contract gives an indemnity to AZ against any action by individual people.

Wolf359f · 29-01-2021 11:39PM

brickster69 wrote: »

Could be a Noble Peace Prize for the Eu with the DUP & Sinn Fein in agreement with something. Just waiting on Sturgeon now and we could have a full house.

DUP, SF & Dublin!
I dunno, I think she would buckle the trend. I certainly wouldn't want her in the bet spread. Maybe after the fact she would condemn it. But bookies wouldn't pay out for that!

FileNotFound · 30-01-2021 12:00AM

Wolf359f wrote: »

It also follows the question why they applied so late for approval. Well over a month after the application to the UK.
The fact the EU raided the factory to check and soon after the EU want's export controls smells fishy. Also the fact the delivery has been brought forward a week and AZ found ~8mil doses in a few days also seem suspicious.

There's definitely more to the story than we're told.

The late application may not be such a shock.

EMA are pretty black and white on applications. Pretty non political.

MHRA is a shell of an old org in many ways. Its hyper political right now. Could be Boris told AZ "send what you have" and told MHRA "get that signed off no matter what".

Many things highlighted under EMA review were never mentioned before.

All conjecture alas.

Donald Trump · 30-01-2021 12:06AM

political analyst wrote: »

Why didn't member states do it?

It would be a fairly big call to try to roll out a vaccine which has not been subjected to the regular Could you please confirmfull testing standard.

There will be skepticism anyway. Imagine if they were pushing a vaccine with the warning "not fully tested".

What difference would it really have made anyway? They have only been able to make whatever they have been able to make anyway.

Donald Trump · 30-01-2021 12:09AM

political analyst wrote: »

European nations put Brussels in charge of the vaccination effort. James Mates said that central co-ordination, whatever cost benefits it had, slowed things down.

https://www.youtube.com/watch?v=qajwkcd9USs

Why didn't the European Medicines Agency (EMA) give emergency authorisation for the AZ vaccine, which is what the British regulator did?

I doubt that leaving the EU has changed Britain's pharmaceutical standards that quickly. So why did the EMA think that the British emergency authorisation of the AZ vaccine was good enough for the EU? After all, what's good for the goose .....

Where would the smaller countries like Ireland be in the queue for vaccines in an "every-man-for-himself" scenario?

I'd imagine that there'd be chaos and our date for having everyone vaccinated would be pushed out. Not only that, I'd imagine that there would be more of a market for private vaccinations.

Wolf359f · 30-01-2021 12:09AM

FileNotFound wrote: »

The late application may not be such a shock.

EMA are pretty black and white on applications. Pretty non political.

MHRA is a shell of an old org in many ways. Its hyper political right now. Could be Boris told AZ "send what you have" and told MHRA "get that signed off no matter what".

Many things highlighted under EMA review were never mentioned before.

All conjecture alas.

Well if they are behind in production, delaying their application for a few days/weeks could make up the shortfall.... but yeah, not like 40mil doses though lol.

Hopefully it will all blow over and they can ramp up production.
Have they even mentioned what their maximum weekly capacity is withing the EU?

mista11 · 30-01-2021 12:11AM

Flying Fox wrote: »

Section 5.4 clearly addresses manufacture of the vaccines from plants in the EU and the UK. You can't just claim it's not relevant because it doesn't support your opinion.

it does but apparently clause 5.1 takes precendence

Wolf359f · 30-01-2021 12:12AM

Donald Trump wrote: »

Where would the smaller countries like Ireland be in the queue for vaccines in an "every-man-for-himself" scenario?

I'd imagine that there'd be chaos and our date for having everyone vaccinated would be pushed out. Not only that, I'd imagine that there would be more of a market for private vaccinations.

I totally agree.
I think larger EU countries, like France, Germany, Spain & Italy would be more pissed off with how things have developed. But then again, France and Germany in a bidding war would be fun, apart from us all loosing out. Actually it could have been a France v Germany v UK bidding war, had they went solo!

IRISHSPORTSGUY · 30-01-2021 12:12AM

The_Brood wrote: »

Brexit did that, not the EU. Too much friendliness, cosines, and most importantly reliance on Britain. Corridors should have been build with other EU nations.

Sorry, but Brussel's reaction to Britain being ahead in the 'vaccination race' has been hysterical on their part. They need to tone it down. Come April there'll be enough vaccine to fill Lough Neagh anyway.

I care more about no land border on the island of Ireland than EU cock waving. Even the so-called 'best case scenario' of diverting supply from GB results in slowing Britain down rather than make substantial gains to the EU vaccination programme because of the vast population differences (68m vs 450m).

Wolf359f · 30-01-2021 12:16AM

mista11 wrote: »

it does but apparently clause 5.1 takes precendence

5.1 states "Initial Europe doses", what's that mean?

Wolf359f · 30-01-2021 12:20AM

IRISHSPORTSGUY wrote: »

Sorry, but Brussel's reaction to Britain being ahead in the 'vaccination race' has been hysterical on their part. They need to tone it down. Come April there'll be enough vaccine to fill Lough Neagh anyway.

I care more about no land border on the island of Ireland than EU cock waving. Even the so-called 'best case scenario' of diverting supply from GB results in slowing Britain down rather than make substantial gains to the EU vaccination programme because of the vast population differences (68m vs 450m).

Yeah I dunno, are the EU afraid that AZ factories in the EU will be supplying the UK first? If the EU believe AZ have acted in bad faith previously, maybe they believe they will keep acting in bad faith?

I don't subscribe to the vaccine race. It's not a sprint, it's a marathon.

mista11 · 30-01-2021 01:35AM

Wolf359f wrote: »

5.1 states "Initial Europe doses", what's that mean?

The original 100m doses that they cut to 30m

Wolf359f · 30-01-2021 01:41AM

Wolf359f wrote: »

5.1 states "Initial Europe doses", what's that mean?

mista11 wrote: »

The original 100m doses that they cut to 30m

So it states in the contact 'Initial Europe Doses' is the original 100mil?
There's so much redacted regarding delivery, I can't see how you deduced that.
Could we also deduce 'Initial Europe Dose' is the first delivery to Europe (regardless of volume)? Sounds reasonable. After the first dose delivered to Europe the rest come from mixed plants. I mean AZ signed the contract in good faith, they assumed the initial doses would come from European factories, which they are living up to. So the next doses will come from mixed plants!

What exactly is happening with AstraZeneca?

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