Brussels on Friday announced significant changes to post-Brexit regulations to allow medicines to continue to flow between Britain and Northern Ireland.
The move signals welcome progress in difficult and complex negotiations about the implications for Northern Ireland amid the UK’s departure from the EU.
As part of Brexit, Northern Ireland remains in the EU’s Single Market for goods, including pharmaceutical regulations.
This is to avoid a hard border between UK province Northern Ireland and the Republic of Ireland, which remains part of the EU.
Some fear the re-emergence of border infrastructure between the two would see a return to the sectarian violence that blighted the region for decades.
Why are the changes necessary?
The changes signalled by Brussels were not due to take place until next month when a 12-month grace period expires.
Yet problems were foreseen, prompting Brussels to act and change the Northern Ireland Protocol.
With Northern Ireland in Britain's medicines supply chain, there were fears that important medicines -- including cancer and COVID drugs -- would no longer get through.
However, some pharmaceutical firms had already confirmed they would end the supply of certain medicines to Northern Ireland due to the cost of having to comply with processes arising from being part of the EU system.
But the EU is now proposing to make fundamental changes to Single Market legislation as part of a bespoke arrangement for Northern Ireland.
It will allow Northern Ireland to continue to access medicines including generic drugs from the NHS.
"Today, the European Commission is delivering in the form of a legislative proposal, ensuring that everyone in Northern Ireland has access to the same medicines at the same time as in the rest of the United Kingdom," said European Commission Vice-President Maroš Šefčovič, in charge of relations with the UK.
"This will be possible because all regulatory functions of pharmaceutical companies supplying medicines from Great Britain to Northern Ireland can remain in the UK, while no additional batch testing, manufacturing and license authorisation or separate packaging is required," he explained.
The legislation also applies to anglophone member states including Cyprus, Ireland and Malta.
The UK cautiously welcomed the proposals as "constructive" but said it needed to look at the text more closely.
Commissioner for Health Stella Kyriakides said the proposals unveiled on Friday "make targeted amendments to the EU pharmaceutical legislation, as well as targeted changes to our clinical trials rules."
"They give exceptional administrative flexibility to the UK in respect to Northern Ireland so that certain regulatory functions for medicines for human use authorised by the United Kingdom for the Northern Ireland market under the Protocol may exceptionally be located in Great Britain," she told reporters
Additionally, the proposals allow for medicines approved by UK authorities but not yet authorised by their EU counterparts to to "temporarily supplied to patients in Northern Ireland pending authorisation in the EU".
"Those temporary authorisations should be time-limited and end as soon as the Commission has granted the authorisation to market the medicine," she stressed.
Cyprus, Malta and Ireland, will also be able to secure temporary derogations to continue to source medicines from the UK if needed.
Are relations improving between Brussels and London?
The legislative proposals come after several weeks of inflexible and at times fruitless talks.
Britain's Brexit Minister, David Frost, said in a statement that the EU's proposals "could constitute a constructive way forward, and we are willing to look at them positively, but as we have not been able to scrutinise the texts in the necessary detail we are not yet able to make that judgment with full confidence."
He said that the UK's position is to remove medicines from the Protocol altogether, "given that the provision of health services is an essential state function and that Northern Ireland medicines are overwhelmingly sourced from elsewhere in the UK."
"There has been much less progress in other areas," he continued.
He once more deplored "the burdensome customs and SPS arrangements for goods moving between Great Britain and Northern Ireland" which he said are having "a chilling effect on trade, increasing costs and discouraging firms from trading within their own country" and reiterated that London would prefer "to put in place substantively different processes for goods which all sides agree will stay in the UK and those which do not."
He also once more insisted that the European Court of Justice should be removed as the main arbiter of any dispute between London and Brussels.
It is a red line for the EU as the ECJ has the final word on all things related to EU law, including the EU’s Single Market.
The minister, who negotiated the Withdrawal Agreement and Northern Ireland Protocol with former EU negotiator Michel Barnier, said the UK's "preference would be to reach a comprehensive solution dealing with all the issues" but that they are prepared to look at an interim deal as a first step "to deal with the most acute problems, including trade frictions, subsidy control, and governance."
He said it was "disappointing" that such an interim deal had not been reached this year and once more threatened to trigger Article 16 — to unilaterally pull out of the deal — "if that is the only way to protect the prosperity and stability of Northern Ireland and its people."
Just weeks ago it was heavily anticipated in Brussels that the UK would effectively suspend indefinitely the protocol by triggering Article 16.
The EU warned of grave consequences for doing so including major trade sanctions across all sectors of the British economy.
”It feels like they [the UK] want to calm things for now, maybe because the risk is too great for Boris Johnson, and the UK is fully aware of the repercussions if they try to suspend the protocol,” said a source.
Brussels has so far staunchly rejected re-opening the Withdrawal Agreement or Northern Ireland Protocol insisting instead that solutions be found "within the framework" of the existing deals.
Šefčovič said on Friday that "I am convinced that the issue of medicines shows that the Protocol has the flexibility to work on the ground."
He added that "if political goodwill is maintained", the talks "could lead to timely agreements" on measures to facilitate customs procedures.
"Let me recall that the EU has proposed an extensive reduction of customs formalities unmatched for any other third country, while also protecting the integrity of the EU's Single Market through a number of pre-conditions and safeguards."
"In the SPS (Sanitary and phytosanitary) area, the UK government is yet to reciprocate the big move made by the EU, which could lead to a significant simplification of certification and around an 80% reduction in identity and physical checks for a wide range of retail goods moving from Great Britain to be consumed in Northern Ireland.
"I urge the UK government to reciprocate our efforts," he said.