Thread by @bengoldacre

The generics market has a lot of turnover, new products, tight margins. The NHS benefits from the low cost medicines this market produces.

The govt's no-deal Brexit plan looks to me like it will block approvals, and hit generics hard. This could get expensive for the NHS...

... Let me explain a little. A drug is basically owned by the originator company for the first decade (or so, no quibblers please) after it comes on the market. Then the drug goes "generic". Anyone can make it. Like paracetamol. So it gets cheap....

... because the manufacturing cost of most drugs is actually pretty low, you're paying for the idea, and the development of the product. Now, getting a generic approved is about demonstrating equivalence to something that's already approved, i.e. the originator brand...

.. so here's the problem. You can apply to the UK regulator, the MHRA, to prove equivalence of your new generic to an old drug that was approved by the MHRA before everything was unified under the EU regulator, the EMA...

... but as the government's own Brexit no-deal plans state, the MHRA cannot assess your claim that your new generic is equivalent to something approved by the EMA. Now, here's the big problem with that...

... the drugs approved by the EMA, not the MHRA, are those that came on the market most recently, over the past decade or so. These are the ones that are most expensive. Where generics represent the biggest cost savings, and the biggest new cost savings...

... we're talking about big HIV drugs (£billions) coming off patent, new cancer drugs, and so on. Replacing expensive branded drugs with cheaper generics as they come off patent is something we've all gotten used to, it's an important part of how we budget for the NHS...

..if we can't get generics approved for the newest drugs coming off patent (because the MHRA never approved the newer drugs, and so has no data to benchmark generics against) then we're just going to have an ever growing pile of expensive branded drugs to pay for...

... all the current expensive branded ones, and all the new expensive branded ones joining the market all the time. No safety valve of things going generic. The financial implications of this could be staggering. £100s of millions certainly, but in fact....

...(i'd have to check patent horizons and prescribing volumes) i think it's likely this could amount to extra £billions per year draining the NHS. in the context of a total NHS drugs bill of £14bn (depending on how you count)....

..so, once again, ladies and gentlemen, that is VERY BIG POTATOES INDEED, and another good example of how little forethought has gone into Brexit from the Brexiteers. Their simple, unrealistic, populist fantasies will prove very expensive for us all. Now if you'll excuse me...

... I'm going to go and mention this to some civil servants who I'm sure have already noticed it.

... In haste I didn't post the source for that quote. It was of course the government's own Brexit "no deal" planning document on medicines, issued today.

gov.uk/government/pub…

Ah, now. It has been suggested to me that the MHRA could simply ask the EMA to share their marketing authorisation applications and data with us, so we can benchmark new generics against those. That sounds like a nice idea, if you can sort the legals and goodwill, but (lol)...

.. one barrier might be this. The EMA have recently announced a load of things they won't be able to do because of the chaos introduced by moving the EMA out of London and over to Amsterdam. One of the work packages they're cancelling because of Brexit is...

.. oh go on see if you can guess....

... one of the work packages they are cancelling is exactly that: they're cancelling their plans to share data packages from marketing authorisation applications.

ema.europa.eu/ema/index.jsp?…

...

So, not only is that a catastrophic setback for trials transparency (thanks again Brexit morons) it's also potentially another barrier to the UK being able to approve new cheap generic medicines.

That £350m a week for the NHS (that we're not getting) is going to be spread thin!