Thread by @GeorgePeretzQC

A brief explanation of what appears to be going on here. telegraph.co.uk/politics/2021/…

(NB medicines regulation is complex: I am trying to summarise accurately but do not rely!)

The effect of the Protocol is to put NI into the EU medicines regime.

The basic principle of that regime is that any medicine that is placed on the market in the EU must have a marketing authorisation (MA).

For new medicines to treat these conditions, MAs are issued only by the EMA for the whole EU.

The EMA also deals with new medicines using these technologies.

(There are some other “EMA-only” categories.)

For all other new medicines, and for all generics (essentially, copies of existing authorised medicines), MAs are granted by the Member State where the product is to be sold.

(There are various procedures for coordinating and reaching a common view on multiple applications to different Member States and for carrying over an MA issued in one State into another.)

All this applies in NI. The U.K. MHRA (the medicines regulator) now wears two hats. It is the NI Member State regulator under EU law. And it is the GB regulator under GB medicines law (which is now, of course, a separate regime).

For generics, and for non-EMA-only new medicines, the MHRA (NI hat) can grant MAs for NI, following EU rules.

The difficulties with these products have largely concerned problems that arise where (as is common) NI is supplied with those medicines from GB and by companies based in GB. There has been a temporary fix to some of these problems.

The EU “non-paper” offered some permanent solutions: see ec.europa.eu/info/sites/def…. But, as the article points out, there are some further problems eg with having to produce separate patient information leaflets for NI, as the rules about those leaflets diverge.

However, there is a separate problem with EMA-only new medicines. Let’s say a new medicine in these categories comes along which is swiftly approved for GB by the MHRA (GB hat) under the GB regime. But the EMA doesn’t approve it (or hasn’t yet approved it) under the EU regime.

So in NI, the MHRA (NI hat) can’t generally* allow its use. (*NB there are some cases where it could: one - which shot to prominence last year - is where the new medicine is to be used in response to a pandemic. But eg new cancer treatments won’t benefit from that exception.)

So it could be that GB gets a new cancer treatment approved by the MHRA (GB hat) but the MHRA (NI hat) can’t allow it to be sold or prescribed in NI. This is unattractive.

The EU non-paper doesn’t deal with EMA-only medicines, and so says nothing about this problem. But it seems that there is now movement.

The sensitivity is that the EMA may have good regulatory reasons for a different view of eg whether safety or efficacy has been proved: these are very complex and sometimes controversial judgments where two very competent regulators just disagree.

The EU sensitivity is that if a medicine in the EMA-only category, which is not approved by the EMA but is approved by MHRA (GB hat), is circulating in NI, it will end up leaking over the Irish border into the EU.

This is a real fear: where lives and health are at stake, the incentives for leaks of that kind are potentially very high.

Hence the EU’s reported emphasis on “checks” to ensure that what is authorised for NI stays in NI.

(NB the current government’s line, in the July Command Paper, that medicines should just be removed from the Protocol entirely, seemed to me to be hopelessly over-optimistic on what it called the “extremely minimal” risk of leakage.

It was also, there as elsewhere in the paper, somewhat over-confident - particularly given its record - in the idea that the EU would readily go for mechanisms based on trust rather than law.)