By Philip Blenkinsop
BRUSSELS – The European Commission set out legal changes on Friday to ease the movement of medicines from Britain to the province of Northern Ireland and to avoid the disruption to supply the Brexit divorce agreement could have caused.
Britain, however, said many areas of dispute still existed between it and the European Union over the agreement’s protocol, which governs trade for Northern Ireland after the United Kingdom’s full departure from the bloc at the start of this year.
The protocol was intended to ensure that there was no hard border Northern Ireland and EU member Ireland, but has effectively placed one in the Irish Sea, angering pro-British unionists in the province.
The EU executive, which handles relations with the United Kingdom on behalf of the 27-member EU, said its easing of compliance and logistics rules for medicines showed the protocol had the flexibility to work on the ground.
“We must now carry this momentum into the other areas of discussion,” European Commission Vice President Maros Sefcovic said after talks with British Brexit Minister David Frost.
Frost negotiated the protocol, which was signed by Prime Minister Boris Johnson’s government before it had second thoughts about it. He said on Friday that, with the exception of medicines, negotiations were not close to solving problems the protocol had created.
Sefcovic said Britain needed to reciprocate Brussels’ efforts, highlighting a package of measures set out in October to ease transit of goods to Northern Ireland.
London has advocated renegotiating the protocol and removing medicines entirely from its scope.
The two sides will resume negotiations in January on issues ranging from customs checks and controls of agri-food products moving from Britain to its province, which is in the EU single market for goods and so subject to EU laws.
A set of grace periods have limited some checks and controls.
One was due to have expired at the end of the year for medicines, after which British operators would have needed to move regulatory compliance and testing facilities to the EU or to Northern Ireland.
The cost could have caused certain companies to stop supplying medicines to Northern Ireland, exacerbating trading problems the province is facing after Brexit.
The EU executive proposed an exception to allow compliance and testing to take place on the British mainland for generic medicines, such as paracetamol, and for the same packaging to be used for Northern Ireland.
A further change will allow marketing of new drugs, such as for cancer, in Northern Ireland after they have been authorised by the British medicines regulator, but before approval by the European Medicines Agency.
The changes, which will also affect medicine supply to Cyprus, Ireland and Malta, will require approval by the European Parliament and EU governments during 2022, but do not represent a formal agreement with Britain on the subject.
Frost also repeated his view that the European Court of Justice not be allowed to settle disputes and he reiterated Britain’s threat to use the Article 16 emergency safeguard mechanism.
Sefcovic said the EU’s highest court was “part and parcel” of the protocol.
“It was not disputed at all until the summer of this year. And therefore for us, this is the topic we are not ready to include in our discussions,” Sefcovic told a news conference.