Thread by @GeorgePeretzQC

Claim: the Ireland/NI Protocol is “starving NI of medicines”. A very serious claim, if true. But it isn’t. Thread: and trigger warning - contains nuance and detail.

https://twitter.com/danielmgmoylan/status/1491721033795219459

Start with some basics. Article 5.4 of and para 20 of Annex 2 to the NIP apply all EU legislation on medicines to NI. That provision overrides Article 7.1 NIP (U.K. law to govern what goes on market in NI) as Art 7.1 is subject to Annex 2.

Arts 7.3, 12 and 13 together have the result that the MHRA operates in NI in broadly the same way as the national competent authorities of EU member states do in theirs. Eg it can approve medicines in NI under EU law where national authorities can do so in the EU (most medicines)

It does so in accordance with EU law and subject to Commission and ECJ supervision.

The effect is also that (as a starting point) medicines flow freely into NI from the EU (in particular, obviously, 🇮🇪) but medicines coming in from GB are treated as coming from a third country.

Under the TCA, GB inspections and certificates of good manufacturing practice are acceptable in the EU and hence in NI. So that’s one barrier to GB-NI trade in medicines overcome. But there are others.

The problem here is that traditionally most medicines supplied to NI (even from elsewhere in the EU) have come through GB.

Post-Brexit, imports into the EU and NI from GB are third-country. That means (in particular) they have to be batch tested by a Qualified Person based in the EU or NI, and imported by someone holding the necessary permits (not many do in NI).

Problems are also caused by the EU regime of unique identifiers placed on medicines in the fight against falsified medicines.

In 2020 Commission issued a notice that made derogations from these requirements for products routed from the EU through, or coming from, GB. This dealt with many of these problems on a temporary basis - to end 2021.

There are also serious warehousing shortage issues in NI, which doesn’t help.

In late 2020 the Commission extended the 2020 notice. It also proposed further legislation, which is now proceeding through the EU system.

That legislation will allow the MHRA to authorise, in NI, those medicines (eg cancer treatments, biotech medicines, and antivirals including vaccines) that normally in the EU are reserved to the EMA.

So if a cancer drug or Covid vaccine is authorised in GB but not in the EU, NI can get it, for 6 months.
And ditto (though permanently in this case) if authorised in the EU but not GB: best of both worlds.

The “unique identifier” problem is also dealt with by a 3-year derogation.

That is the summary of a complex picture. GB-NI supply has been made harder and pricier. But many of the problems have been ameliorated/addressed.

The claim that the NIP is “starving” NI of medicines is therefore (at best) wildly overblown. It is also an irresponsible claim from any legislator who takes his responsibilities seriously.

Given the history, all politicians have a duty to use words carefully when talking about NI. And there is, after all, a real history of Ireland being starved by government policy - and it wasn’t the EU that was responsible.

(And - of course - all of these problems leapt out of the text of the NIP, as agreed by the current government as part of the deal that it then enthusiastically sold to voters. As anyone who knows about the regime could have, and doubtless did, tell Ministers at the time.)