In what specific way has the the EU "turned [its] rules upside down and inside out" on medicines in Northern Ireland?

Question

In response to UK government accusations that the EU has been inflexible on medicines under the Northern Ireland protocol (see e.g. Boris Johnson's charge on 30 cancer drugs) the EU ambassador to the UK has been quoted as saying:

“In some cases, notably on medicines, we have completely turned our rules upside down and inside out to find a solid solution to an outstanding challenge,” Mr Vale de Almeida writes in a column in The Daily Telegraph.

But the article lacks some concrete example of this supposed EU flexibility. Is there a concrete example of what the EU has done on this in terms of turning "upside down and inside out " its rules? (Another BBC article mentions that the EU plans to introduce some legislation on this... in August. It's not clear if that's what ambassador Almeida is talking about though...)

Answer 1

I think Ambassador Almeida was echoing Vice President Maroš Šefčovič in using the "upside down and inside out" soundbite - he used the same language in a press statement the day before (June 30th), where he unveiled a list of 'practical solutions' proposed to facilitate the implementation of the Protocol.

Turning to the second part of our package: we have put together a significant set of practical solutions, helping implement the Protocol and facilitating the everyday life of communities in Northern Ireland. On medicines – something I personally take very seriously in this time of pandemic – the Commission will table a legislative proposal in the early autumn that will secure their continued, long-term supply from Great Britain to Northern Ireland. This would allow for instance, for the continued availability of generic medicines in Northern Ireland – something of particular importance to the NHS. We have also identified a solution to ease the movement of guide dogs accompanying persons travelling from Great Britain to Northern Ireland. Similarly, we will simplify the movement of livestock, by removing the need for re-tagging when animals move multiple times between Great Britain and Northern Ireland. Lastly, drivers from the UK will no longer need to show the motor insurance Green Card when entering the EU, and this waiver will be particularly helpful for Northern Irish motorists crossing the border into Ireland. I am convinced that these forthcoming solutions are a true testament to our commitment to the people of Northern Ireland and to the Good Friday (Belfast) Agreement. They are also an unquestionable response to those in the UK suggesting that the EU is inflexible or too legalistic. Because in some cases, notably on medicines, we have completely turned our rules upside down and inside out to find a solid solution to an outstanding challenge.

These solutions are outlined in more detail here, and although the legislative proposals don't seem to have been published yet, the outline gives some indication of the EU's proposals.

In particular, on medicines:

The Commission has identified a creative solution to ensure the continued long-term supply of medicines from Great Britain to Northern Ireland. The solution involves the EU changing its own rules so that regulatory compliance functions for medicines authorised by the UK for the Northern Ireland market, in accordance with the Protocol, may be located in Great Britain, subject to specific conditions ensuring that the medicines concerned are not further distributed in the EU Internal Market. The Commission will put forward a legislative proposal in the early autumn in order to be able to finish the legislative process on time.