The post-Brexit trade deal agreed on Christmas Eve has been overwhelmingly backed by the UK parliament, providing some degree of stability – but also plenty of disruption – for the coming months and years.
The UK is leaving the EU’s single market and customs union, but the deal means tariffs on goods won’t be imposed when the transition period ends at 23:00 GMT tonight.
In a marked divergence from the wrangling and acrimony that surrounded votes on the withdrawal agreement a couple of years ago, the EU (Future Relationship) Bill was backed by 521 votes to 73 last night.
Prime Minister Boris Johnson said the deal – which comes four-and-a-half years after the UK voted to leave the EU in a referendum – will “fulfil the sovereign wish of the British people to live under their own laws, made by their own elected Parliament.”
The new regime has been welcomed by pharma organisations on both sides of the English channel, although there are still a lot of unanswered questions about what it will mean in practice for the regulation and trade in medicinal products.
With the text of the 1,200-page document now available, it has been confirmed that there will be mutual recognition between the two parties, which means that inspections and certification of good manufacturing practice (GMP) facilities by the UK regulatory authority will be recognised by the EU, and vice versa.
What appears to be missing at first glance from the document however is mutual recognition of safety and quality testing, which might mean some duplicate tests are needed.
The appendix on medicines does however refer to “the exchange and acceptance of official GMP documents between the parties,” and includes an article covering “regulatory cooperation” on changes to technical regulations or inspection procedures.
To make that easier, a Working Group on Medicinal Products will be set up to monitor the impact of the deal on medicines in the UK and EU, for example to respond if there is a threat to medicines supply or public health, and organise future cooperation in areas like scientific or technical guidelines.
BioIndustry Association (BIA) chief executive Steve Bates said after the deal was agreed that it provides “much desired certainty for our sector” after four years of negotiation, although the trade body is still working through the details of the text.
BIA said that traders can self-certify the origin of goods sold and enjoy “full cumulation”, making it easier to comply with requirements and obtain zero-tariff access, adding that there will be specific facilitation arrangements for pharmaceuticals and chemicals.
The appendix on medicinal products is far from detailed – in fact, Labour Leader Keir Starmer has described the entire document as “thin”, whilst also instructing his party to back it in the parliamentary vote to prevent no deal.
There are other encouraging points for the life sciences, according to the BIA, including the UK continuing to have access to the Horizon Europe Research and Innovation programme as a paying third country.
“We look forward to working with the UK government on this positive agenda, mindful of the fact that our sector seeks, and benefits from, innovative global standards and regulatory collaboration and co-operation,” said Bates.
A joint statement released by the Association of the British Pharmaceutical Industry (ABPI) and European Federation of Pharmaceutical Industries and Associations (EFPIA) – representing the UK and EUK pharma industries – also said it would take time to examine the details of the agreement.
“We have always said that a deal is in the best interest of patients in the UK and the EU,” they said, adding: “regardless…the end of the transition means there will be a significant change in how border and customs arrangements work come Jan 1st and companies have been working on contingency plans to mitigate any disruption.”
Flurry of MHRA guidance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has already started publishing guidance on how things will change from Friday.
This week, for example, it confirmed it will set a 150-day assessment timeline for new medicines, whilst also providing details of its equivalent to the EMA’s “rolling review” designed process to speed up access to novel medicines.
It has also provided updates on the processes needed to submit changes to marketing dossiers for medicinal products, as well as for amendments to clinical trials.
Image by DANIEL DIAZ from Pixabay
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