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I've read on the BBC that the UK is seeking to renegotiate the NI protocol with the EU (which is part of the Brexit deal). I can understand why the UK sees some of the provisions as burdensome, but I'm not sure I see why it seeks to "remove medicines entirely from the scope of the protocol". Medicines are among the most controlled things on earth in terms of imports/exports and general paperwork involved anywhere, even internally in a country. It's also not the case that they are manufactured by a mom-and-pop business that can't afford a compliance department. So I'm not sure why the UK thinks medicines in particular are extraordinarily burdened by NI protocol provisions. Can someone explain, preferably with the UK's own talking points?

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The government is concerned about the Protocol's requirements (Article 7) that manufactured goods placed on the market in Northern Ireland (including medicines) comply with both EU and UK regulations - even if they are only to be consumed within NI. In fact, it argues that because medicines are so tightly controlled and regulated, there would be little risk to the EU single market should an exception be made.

The two main arguments put forward in the government's command paper are that firstly, the link between medicines and the delivery of the national health service in Northern Ireland makes the risk of medicines destined for use in NI being transported to the Republic of Ireland minimal, and secondly, that the requirement that new medicines be approved by the EMA before they can be used in NI is disproportionate - it gives the example of new cancer drugs.

The paper also argues that there is a significant risk that businesses will not bother to export to Northern Ireland, given the extra regulation that is required, but this is more with regard to manufactured goods in general, rather than medicines.

To quote from the paper (emphasis mine):

  1. [...] Medicines are at risk of discontinuation because the hurdles to clear to reach the small Northern Ireland market make supply unviable.
  1. Under the Protocol, Northern Ireland aligns with all relevant EU rules relating to the placing on the market of manufactured goods. This requires products to meet EU rules if they are to be placed on the market in Northern Ireland, but goods approved to these rules by UK bodies are marked for sale only in Northern Ireland and Great Britain. The current arrangements have already caused difficulties for businesses trying to put goods from Great Britain onto the market. These will be exacerbated further once the UK moves fully onto the new UKCA product safety regime, leading to significant risks that many businesses in Great Britain simply give up trying to produce goods for the Northern Ireland market. The current system nevertheless enshrines the principle that there can be parallel arrangements for different goods in Northern Ireland, underpinned by risk-assessed regulatory checks performed by market surveillance authorities to limit the sale of goods beyond Northern Ireland.
  2. We suggest that the right way forward would be to extend this principle to provide for a full dual regulatory regime in Northern Ireland. Goods, whether manufactured or SPS goods, should be able to circulate within Northern Ireland if they meet either UK or EU rules, as determined by UK or EU regulators, and should be labelled accordingly. Of course, goods destined or produced for the EU Single Market would need to meet EU rules in full. Goods exported from Great Britain via Northern Ireland to Ireland or beyond would, under the arrangements set out above, need to meet full normal EU customs processes.
  3. It may be necessary to build into these arrangements specific provisions for medicines (and a small number of other key sectors). Arrangements for medicines, for example, are so closely linked to the delivery of national health services, an essential state function for a modern state, and the associated regulation and control arrangements are so substantial, that the risk of diversion into the Single Market is extremely minimal.
  4. Moreover the current arrangements are creating considerable challenges with medicine supply to patients in Northern Ireland being put at risk for a number of products from the end of 2021. The solution proposed by the EU in June was a welcome start, but is potentially complex to operate because of its need to work within the broader EU framework for regulating medicines; and furthermore it would not satisfactorily deal with certain medicines (such as new cancer drugs) which must be licensed by the European Medicines Agency. Given the range and depth of these challenges, the simplest way forward may be to remove all medicines from the scope of the Protocol entirely.
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I see Boris Johnson has been making a talking point out of cancer treatments:

Thirty medicines are no longer available in Northern Ireland because of rules enforced at the border with the Republic of Ireland following Brexit, the Prime Minister has said.

Speaking at the recent G7 summit, Boris Johnson reportedly said that the medicines and one innovative cancer treatment had been denied to patients because of the way regulations that were being phased in around the border were affecting the movement of goods, according to the Sunday Times.

“If the protocol continues to be applied in this way, then we will obviously not hesitate to invoke article 16,” he reportedly said during the summit.

A bit more searching finds a real example of a drug involved, Osimertinib (brand name: Tagrisso) from Astra Zeneca.

When asked about the issue, the MHRA confirmed that “any extension to the licence of Osimertinib (Tagrisso) in Northern Ireland must be authorised via the EMA’s centralised procedure which would automatically have effect in NI”.

However it's not too clear how real the barrier to access would be:

Stormont’s Department of Health told the newspaper that “patients in NI may still be able to access Tagrisso for this additional indication following a discussion with their clinician, in line with extant processes for access to new medicines.”

But it has become a political talking point locally as well:

But TUV leader Jim Allister said this was “a practical demonstration that in reality, the protocol is bad for your health”.

For what it's worth, I see from another BBC article that the EU response has been that: "The European Commission said its solution involves the EU changing its own rules so that regulatory compliance functions for medicines authorised by the UK for the Northern Ireland market may be located in Great Britain. The Commission will put forward a legislative proposal in the early autumn in order to be able to finish the legislative process on time."

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