Whatever you do, don’t get ill in the EU’s colony of Northern Ireland
If you live in the EU’s UK territory (N.I.) you may have to come to mainland UK for vital drugs
Montage Facts4EU.Org 2021
EU Commission issues “non papers” for new rules on availability of medicines for N.I. citizens
Yesterday in Brussels the EU issued a total of five ‘non papers’ which will affect the daily lives of United Kingdom citizens living in Northern Ireland. Presented as the EU being flexible in its approach to the N.I. Protocol, the reality is very different.
Here is what Lord Frost’s opposite number, EU Commission Vice-President Maroš Šefčovič, said yesterday:
“These solutions have an unambiguous common denominator – they were brought about with the core purpose of benefiting the people in Northern Ireland. Ultimately, our work is about ensuring that the hard-earned gains of the Good Friday (Belfast) Agreement – peace and stability in Northern Ireland – are protected, while avoiding a hard border on the island of Ireland and maintaining the integrity of the EU Single Market.”
It was the EU Commission that invoked Article 16 of the N.I. Protocol in January, creating a hard border between Northern Ireland and the Republic of Ireland, to prevent Covid vaccines from reaching N.I. citizens. The backlash from the UK and Irish governments forced it to recant, but the fact remains that it was the EU Commission that did this.
Need a new, life-saving, UK-approved cancer drug? EU says ‘Non, pas possible’
The EU’s new proposals for the availability of medicines in Northern Ireland after the current grace period lapses at the end of this year have major implications. Whilst the Commission claims that it has made major concessions, the reality is that Northern Ireland will be under the EU’s rules for medicines.
Brexit Facts4EU.Org Summary
There are two main issues with the EU's proposals
- Medicines approved in the UK but not yet approved in the EU will not be allowed for Northern Irish citizens.
All medicines sold in N.I. must conform to all EU regulations and be approved by the EU’s ‘European’ Medicines Agency (EMA). By way of illustration, in five months’ time (after 01 January 2022) a new life-saving cancer drug which has been approved in the UK will not be available to N.I. citizens unless and until it receives approval from the EMA.
- Over-the-counter generic medicines produced in mainland UK will not be allowed to be sold in Northern Ireland unless they meet highly onerous and costly conditions.
As such medicines are generic and therefore low-cost, it will not be economically viable in many cases for GB suppliers to conform to all the EU’s restrictions and labelling requirements for the N.I. market without losing money.
In short, a range of medicines currently available across the UK – including in N.I. – will no longer be available in pharmacies in Northern Ireland.
What are the conditions attached to the EU’s new ‘offer’?
Readers may wish to see some of the conditions attached to the EU Commission’s latest offer yesterday in respect of the developing Northern Ireland crisis caused by the N.I. Protocol on which they insisted.
Conditions attached to EU's medicines offer
- The UK fully applies the relevant Union [EU] legislation on medicines: on quality, safety, efficacy, pharmacovigilance and batch testing and release when issuing national marketing authorisations in respect to NI;
- The marketing authorisation contains a legal prohibition of sale (resale) outside its geographical scope: medicines with an authorisation for UK(NI) cannot be legally sold anywhere else in the EU and the specific authorisation code for NI is stamped on each pack;
- The safety features required under applicable Union [EU] law are placed on each pack ensuring that medicines can only be sold in conformity with a valid marketing authorisation in NI;
- The UK ensures and demonstrates the correct implementation/application of the Falsified Medicines Directive in respect of NI. The EU end-to-end verification system must generate an alert if a medicine specifically authorised for NI is scanned elsewhere in the EU Internal Market;
- Enforcement and supervision by the UK competent authorities on economic operators and regulatory compliance activities located in GB are carried out in accordance with applicable Union [EU] law.
It is therefore not surprising that a Government spokesman yesterday responded to the EU’s proposals, saying that:
“it would be complex to operate, onerous and would not deal at all with those medicines, such as new cancer drugs, which under current arrangements must be licensed by the European Medicines Agency in Northern Ireland.
“That is why we have proposed in our Command Paper that the simplest way forward in order to avoid these problems in future is to remove medicines from the scope of the protocol altogether.”
What are the EU’s other proposed new rules for a sovereign part of the United Kingdom?
Firstly, the EU Commission really does refer to the nine pages it issued yesterday as “non papers”. This is not a Facts4EU.Org description. There were five papers in total, but we have focused on the one relating to medicines, as this affects all N.I. citizens. The other four topics were:
- Assistance dogs (not pets)
- Identification and re-identification of cattle, sheep, and goats
- Re-entry into the EU of animals for exhibitions/events
- Products of animal origin that originate in the EU and are moved back to N.I. after being in GB
So what do the EU’s latest proposals on healthcare in Northern Ireland really amount to?
The main ‘concession’ granted by the EU Commission appears to be that UK regulators based in Great Britain can certify that a medicine is an EU-approved product that conforms to EU standards, instead of EU regulators in Northern Ireland doing so.
This is hardly progress. It does not change the fundamental fact that from the end of this year the citizens of Northern Ireland will be denied the same range, same quality, and same quantity of medicines which their fellow countrymen and women on the mainland of Great Britain are entitled to.
The EU will still decide what can and cannot be sold in Northern Ireland. In addition, manufacturers and suppliers in mainland GB will have to jump through all the EU’s legal hoops in order to continue supplying people in Northern Ireland. Even the new labelling requirements alone will add significant costs, as well as the need to have wholly separate stocks for GB and N.I. distribution.
It isn’t Brexit unless we all enjoy freedom, democracy, and independence
Are we really prepared to see a sovereign part of the United Kingdom suffer under EU rule like this? For more than five years Facts4EU.Org has argued consistently for a free, sovereign, and independent United Kingdom. We instantly attacked both versions of the Northern Ireland Protocol as soon as they were published.
What the EU is doing to UK citizens in Northern Ireland is outrageous. They have been disenfranchised and are living under the laws of a foreign power.
This Protocol must go and now is the time to act.
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[ Sources: EU Commission | UK Government ] Politicians and journalists can contact us for details, as ever.
Brexit Facts4EU.Org, Tues 27 Jul 2021
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