LONDON – The U.K. life sciences sector has stepped into “a new reality” following publication of the government’s negotiating mandate on the future trading relationship with the EU.

“Plan A is no longer on the table,” said Steve Bates, chief executive of the Bioindustry Association, who has spent three long years lobbying for a favorable deal for the industry. “This is not what we were led to believe … and not where we expected to be at the end of last year,” he said in an update to members, as EU/U.K. negotiations got underway in Brussels this week.

Bates’ reading of the U.K. government’s stance is that industry will need to be ready for additional costs and the extra time taken to move goods, as a result of increased trade friction. In addition, there is potential for increased medicines regulatory processes from the beginning of 2021, when the transition period easing the U.K. out of the EU comes to an end.

The U.K. government negotiating mandate says any deal “has to respect our red lines of no commitments to follow EU law and no acceptance of the [rulings of] the European Court of Justice. There are very limited options for third country membership of EU bodies, and we’ve been clear we’ll be operating on the basis of existing precedents.”

For Bates, that is putting sovereignty before utility. It is unclear if there will be any room for cooperation with EU agencies, in particular the EMA, he said.

In a potent signal of intent, and in the face of the COVID-19 epidemic that is spreading across Europe, the U.K. announced it is withdrawing from the EU Early Warning and Response System, which links the European Commission, the European Center for Disease Control and national public health bodies responsible for measures to combat serious cross-border threats to health, including communicable diseases.

Also this week, the U.K. government said it will not participate in the Unified Patent, a long-awaited new system intended to streamline the process of applying for patents and making it cheaper to maintain and uphold them in multiple countries across Europe. London was due to host the new court being set up to adjudicate on pharmaceuticals and chemicals patents.

Bates’ dismay is all the greater because as recently as January all the signs were that the industry’s objective of securing a deep and close future relationship with the EU was in line with the government’s vision.

In October 2019 health minister Matt Hancock told the BIA’s autumn forum the U.K. government wanted to cooperate with EU agencies, including the EMA. In January, junior health minister Ian Duncan said agencies, including the EMA, “are clearly ones in which we would wish to see an active participation.”

The change in mood follows a reshuffle of Prime Minister Boris Johnson’s cabinet, which morphed the government “to a slightly more pro-Brexit crew,” said Michael Warren, BIA Brexit consultant. “That creates a slightly different slant for the whole agenda,” he said.

Duncan was out in the reshuffle, as was science minister Chris Skidmore, who had supported continued U.K. involvement in EU research funding programs. Another junior health minister, Nicola Blackwood, whose portfolio included life sciences, research and innovation, resigned.

Reduce non-tariff barriers

Bates said there is a bright spot in that the U.K. government is looking for specific provisions to reduce non-tariff barriers on drugs, calling for mutual recognition of GMP inspections and batch testing certificates, cooperation on pharmacovigilance, a confidentiality agreement on procedures relating to information sharing in the interests of patient safety, agreement on procedures relating to vaccines and biologics, and agreed procedures for clinical trials.

“I think this is important; it covers many of the things we care about,” said Bates.

The problem is that these provisions are in an annex to the U.K. negotiating mandate and the EU is fixed on having a single, overarching governance framework for the future relationship that would give the EU a route to seek redress if the U.K. is not in compliance.

The EU’s demand for a “level playing field” will be one of the most contentious aspects of the negotiations.

“We are ready to offer this highly ambitious trade deal, but the U.K. cannot expect high-quality access to the single market if it is not prepared to accept the guarantees the EU requires to ensure that competition remains open and fair,” the EU negotiating mandate says.

The U.K. said it is committed to maintaining high standards, but it rejects any role for the European Court of Justice, or any legally binding alignment with EU rules.

As a result, the annex on medicines will be “caught in the cross winds” of issues such as U.K. state aid rules remaining in line with those of the EU; the U.K. maintaining the same regulatory standards as the EU; and the argument over access to fishing grounds, Bates said.

No Comments