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Were it to make such a move, it might be that there is a “reduction of medicines for Northern Ireland patients”, a medicine supply chain chief has told Express.co.uk. However, “it’s not something either side wants.”
Last week, Maros Sefcovic, European Commission vice president, suggested that the EU could move on the issue of medicine without an agreement with the UK, and unilaterally impose EU regulations on medical goods entering Northern Ireland.
Speaking to a Northern Ireland Assembly committee on December 1, Mr Sefcovic said: “I would 100 percent prefer if we can present this good solution as a joint approach.
“But I’m fully conscious of time. I have to be very, very clear that we are ready to move on our own if it’s not possible at this stage to push on a joint approach.”
However, owing to the bureaucratic nature of the EU, the European Commission can only propose draft legislation.
This is then put to the European Parliament and the Council of the EU. It is then the job of the Commission to act on the will of the two decision-making organs.
Martin Sawer, chief executive of the Healthcare Distribution Association, commented that because of this bureaucracy “it wouldn’t be instantaneous.
“They have some legislation which they could start off moving through the European system in January, which would implement the EU’s version of the regulations that they want to have.
“But the consequences of that, depending on the start date, might be that we might see withdrawal of companies supplying Northern Ireland and the reduction of medicines for Northern Ireland patients.
“So it’s not something either side wants.”
Mr Sawer believes that Mr Sefcovic made his threat “to remind everybody that they also have unilateral capabilities, and Article 16 isn’t the only one on the table.”
He noted that triggering Article 16 would also be subject to a delay before any unilateral move could be made.
According to the Institute for Government, the Northern Ireland Protocol stipulates that once Article 16 is triggered, both the UK and the EU should enter negotiations to find a solution.
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No measures can be implemented during the initial one-month negotiating period. However, if negotiation fails, either party may adopt unilateral measures.
Mr Sawer commented: “I think both sides are saying these things to show they have autonomy, a bit, publicly […] but it’s not quite as straightforward as that.”
Last week, Mark Samuels, chief executive of the British Generic Manufacturers Association (BGMA), warned that the EU’s current proposals on revising the Protocol were “ultimately unworkable” for medicine suppliers.
He said that an “extremely low” number of new licenses being issued for the country meant there was “a force nine gale heading Northern Ireland’s way”.
He called for a UK-wide license as “the only way to avoid this storm”.
Mr Sefcovic reportedly told the Northern Irish Assembly that the Protocol is “not perfect but it is the best response to the UK’s decision to withdraw from EU and the form of Brexit the [UK] Government has chosen”.
Mr Sawer told the Express that in the immediate future, medicine supply to Northern Ireland would remain “business as usual” in an Article 16 scenario.
He commented: “If there’s regulatory simplicity, then it’ll make us have access to more medicines, you know, and more healthcare going forward.”
Mr Sawer said that “unilateral approaches” to the issue “might be okay, for medicine supply, but just in the short term.
“But in the longer term – I’m talking in six months or more – the repercussions for medicines access, for the whole of the UK would be affected.”
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