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> Astrazeneca would have may have made other supply chain decisions to build infrastructure outside the EU had they known this. They absolutely would not. Ther
by Tehnix 6y ago
> Astrazeneca would have may have made other supply chain decisions to build infrastructure outside the EU had they known this.
They absolutely would not. There is so much that goes into the regulations at play here (GxP specifically in Europe, similar to FDA in USA) and building out capacity takes years. They were struggling enough with restructuring their existing production towards this vaccine.
It's an incredibly complex system, for good reason, but it does mean it's extremely slow moving.
- s1artibartfast 6y agoI disagree. Manufacturing planning is slow and complex, but not on the scale of years for the covid vaccine. AZ has a complex internal and CMO supply chain with over 20 sites around the world, much of which has be brought online within the last 6 months [1]. For example, much of the European shortfall is tied to expected production at the Belgian CMO partner NOVASEP. AZ first partnered with them in June 2020 and product was expected to be shipping 6 months later in Q1 2021 Over the last 12 months AZ has made a number of similar decisions for retooling or expanding existing facilities, as well as partnering with CMOs based on their distribution plans, which are now disrupted. Had they known about an EU export ban upfront, they may have negotiated different quantiles with ex-EU partners, or engaged additional Ex-EU partners. https://bioprocessintl.com/bioprocess-insider/global-markets/astrazeneca-manufacturing-should-take-lions-share-of-credit-for-vaccine-success/ https://bioprocessintl.com/bioprocess-insider/global-markets...
- pgeorgi 6y ago> Had they known about an EU export ban upfront Had the EU known that AZ has a different understanding of the contract both had signed (to put it as neutral as possible), the EU-side signature might not have happened. In that case, the EU could have invested more in other vaccine providers instead of that dud.
- s1artibartfast 6y agoThe contract was very clear on the obligations and expectations. It defined a process for AZ to notify the EU of shortfall, which AZ followed. AZ was required to put forth it's best efforts to meet the targets, which it did. The EU did not negotiate any exclusivity for EU production or penalties for missed targets, and it is crazy to think this was an accidental oversight by the EU legal team. The EU is clearly very interested in this "dud" because their few other vaccine investments were unlucky, performed worse, and didn't make it through trials
- pgeorgi 6y ago> The EU is clearly very interested in this "dud" because their few other vaccine investments were unlucky, performed worse, and didn't make it through trials https://qap.ecdc.europa.eu/public/extensions/COVID-19/vaccine-tracker.html#distribution-tab https://qap.ecdc.europa.eu/public/extensions/COVID-19/vaccin... claims that 47M doses in total have been distributed across the EU. Of those, 8.7M are AZ. If that company continues to be such a high maintenance supplier (the others had production shortages as well, but _somehow_ they managed to not make a mess out of that that made EU bureaucrats consider it necessary to set up an export control instrument just for them) any effort to get AZ involved might have been better invested in supporting any of the others. For reference, the sums per product that I extracted from that data set (as of 2021-03-05): AstraZeneca 8.682.532 BBIBV-CorV 550.000 Moderna 3.069.953 Pfizer/BioNTech 34.366.485 Sputnik V 46.000 Unknown 604.275 -------------------------- Total 47.319.245
- kcartlidge 6y agoThe EU contract agreed in regard to other contracts (eg the UK one) that when being "impeded by any such competing agreements, AstraZeneca shall not be deemed in breach".
- s1artibartfast 6y agoWhile I generally think the AZ is free and clear of contract violations, but think this reading is incorrect. The "competing agreements" discussed in this section of the contract refers to conflict between the EU-AZ agreements and agreements between the EU and other vaccine manufacturers. That is to say, if the EU is asking two manufacturers for vaccines who are in turn competing for the same processing plant, they are not in breach. They do however have the responsibility to let the EU know about it. The contract is actually silent on competition/priority between the EU and other customers.
- kcartlidge 6y agoI'm not a lawyer so you may be correct. Clause 6.2 says: > In the event AstraZeneca's ability to fulfill its obligations under this Agreement is impeded by a competing agreement entered into by or on behalf of the Commission ... AstraZeneca shall not be deemed in breach of this Agreement as a result of any such delay due to the aforementioned competing agreement(s). It does, as you say, come from a different perspective. It seems to be saying that if the EU has other agreements, and those other agreements impact AZs ability to meet its obligations, then AZ isn't liable. So the competing agreements are not agreements between AZ and third parties, but further agreements either between AZ and the EU (most likely, perhaps to cover additional EU orders which may run in parallel for example) or other agreements between the EU and third parties (maybe if those agreements restrict AZ ability to obtain equipment or materials). Either way, thanks for leading me to look again. This stuff is so complex and interwoven it's almost like we need a specialised profession to help clarify the legal aspects.
- s1artibartfast 6y ago> This stuff is so complex and interwoven it's almost like we need a specialised profession to help clarify the legal aspects. Haha, Agreeed.