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The EU And Indian Made AstraZeneca Vaccines

Covid 19

This is not just about Brexit – although there’s almost certainly some of that in there – this is a wake up call to how the medical licencing system needs to be changed.

The European Union is recognising the AstraZeneca vaccine as being good if it comes from certain factories, not good if it comes from some others. This is absurd:

British holidaymakers are being barred from boarding flights after receiving an Indian-made version of the AstraZeneca vaccine that is not licensed in the EU.

The Telegraph revealed this month that up to five million Britons had received the version of the jab without being told.

There is nothing wrong with the vaccine, which has been authorised by the World Health Organisation, but it is yet to be approved by the European Medicines Agency and so is not accepted by the EU vaccine passport scheme.

Of course there’s an element of stick it to the Brits because some 5 million of those Indian doses have been given to Brits.

We’ve also an interesting and specific point here, which is that all those UN cries for abolishing patents etc won;t in fact work. The limitation isn’t on patents, nor even upon the necessary expertise to make the stuff if patents are folded away. It’s in the licencing authorities speed and capability at approving the vaccines. This is not something solved by a relaxation of IP rules.

But there’s a larger issue here as well. We’ve some selection of decent enough, First World, drug licencing authorities. The FDA in the US, the EMA for the EU, the UK has one, Japan, we might extend the list out to Canada and a few others.

OK. The current system is that each, individually, has to approve a licence. Drugs and vaccines become legally useful territory by territory as they do so. This clearly increases the costs of a medicine gaining approval and thus reduces the number that do so – humans do less of higher cost things, recall?

It’s also quite obvious that it’s not the licencing authorities which have covered themselves in glory during these troubled times. The FDA, for example, tried to insist that only the CDC test could be used in the early days. The CDC not having the capacity. And, amusingly, then managing to infect their own test reference kits. The FDA also banned a take at home test. Not for any reason other than that someone might take it without a doctors’ prescription.

Here we’ve the EMA not approving that Indian vaccine. Because they will insist that they must inspect the plant before approval can be given. But EMA officials aren’t going to travel to India right now. Dangerous, d’ye see? There’s a pandemic on, don’tcha know? So we can’t have the vaccine against a pandemic approved because there’s a pandemic on.

The answer is as Alex Tabarrok has been saying. If one – perhaps two, let’s be flexible here – of those rich world, good enough, agencies approves something then it is by definition approved by them all.

After all, the problem with this Indian version of AstraZeneca is nothing more than that the bureaucracy hasn’t got around to it yet. So, you know, bugger ’em.

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20 days ago

Before we reform a system of prior restraint to increase efficiency, we should mention in passing that its basis is the notion that Pharma wants to harm or kill its customers, and will do so unless each of its actions is subject to gov’t veto, and that we cannot develop/rent/buy the expertise to prevent it. If you disagree, one chorus of, “It’s this or thalidomide!” will shut you up. Meanwhile, pols rush out an Emergency Use vaccine without long-term testing coz “Covid changes everything!”

20 days ago

Cross-licensing of course runs into the problem of ensuring that all authorities are using the same standards. If they don’t, then you get forum shopping.

And of course it will be very easy to ensure this. Our experience with standards in electronics tells us this (where standardizing is reducing vendor lock-in and the stakes are not whether the product can be sold at all).

20 days ago

Immer the bureaucrats. Always.

Michael van der Riet
Michael van der Riet
18 days ago

Institutional racism at its finest.

15 days ago

I don’t think there’s much chance of getting mutual recognition between regulatory agencies. Take a look at an electronic device (e.g. a laptop power supply) an you’ll see quite a few symbols showing which approvals it has. For example, UL is underwriters laboratories, which is important for the American market, while CE indicates conformity to EU standards. While there has been a trend towards unifying standards and certifications, it is extremely slow except where driven by politics – such as the EU wanting an EU-wide standard.

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