UK Govt Has ‘Made A Hash’ Of Managing Brexit For Life Sciences Sector
Executive Summary
A recent debate in the House of Lords saw some fiery words exchanged over the government’s plans for the life science sector in the event of a no-deal Brexit, with accusations that they would produce a “clunky” regulatory system and put industry’s future “at grave risk.”
The UK government has “made a hash of managing Brexit for the life sciences,” and the pharmaceutical industry and the medicines regulatory agency, the MHRA, have been given “ludicrously little time to master a massive amount of new detail and system change,” according to Lord Warner, a former Labour health minister.
Lord Warner, now a cross-bench peer, said that in its planning for a no-deal Brexit, the government was proposing a “clunky” regulatory system that would be costly, act as a disincentive to innovation, and put the future of the industry at “grave risk.”
His comments came during a March 7 House of Lords debate on three statutory instruments (SIs) drawn up by the government in an effort to ensure that the UK’s medicines regulatory system can continue to function effectively if the country leaves the EU without a withdrawal deal on March 29.
The SIs would introduce changes to the regulations on human medicines, clinical trials, and medical devices in a no-deal scenario, including establishing the MHRA as a stand-alone regulatory agency and setting out new national marketing authorization routes for the approval of drugs that currently go through the EU’s centralized procedure. The proposals have already come under fire from industry. (Also see "Industry Picks Holes In UK Plans For Post-Brexit Drug Regulation " - Pink Sheet, 2 Nov, 2018.)
Lord Warner said there were “416 pages of statutory instrument and 132 pages of explanatory memorandum, including impact assessments,” and that they would create “a great deal of additional red tape and running costs” and take funding and resources away from research and development of new drugs.
The Lords held its debate with only about three weeks to go until the Brexit date of March 29 when – barring a last-minute agreement on the withdrawal deal or an extension to the Article 50 process – the UK risks leaving the EU without a deal in place and falling back on World Trade Organization rules.
Parliament is due to vote again on the withdrawal deal on March 12, and the deal is widely expected to be rejected for a second time. If it is, members of parliament (MPs) will vote on March 13 on whether the UK should leave without a deal. If, as is likely, they reject the option of a no-deal Brexit, they will vote on March 14 on whether to seek a delay to Brexit by extending the Article 50 process.
Statutory Instruments Passed
In the event, the House of Lords passed all three SIs, but not without some acerbic observations from the peers present. “There are now just 22 days for those working in the life sciences industry to understand how they might be affected by these SIs if our beloved Prime Minister inadvertently drives the Brexit car over the cliff on 29 March,” said Lord Warner, who has previously raised concerns on behalf of the life sciences industry. (Also see "BIA ‘Reassured’ On Post-Brexit SPC Regime But Data Exclusivity Concerns Remain" - Pink Sheet, 13 Feb, 2019.)
“The one thing that I can congratulate the government on is that the MHRA has done its best to consult the industry on these SIs and has done a reasonably professional job on risk assessments,” he declared. He said he had “tried to understand the impact assessments” and had “had the benefit of some very helpful briefing from the industry, especially the BIA [BioIndustry Association].” The BIA has been very vocal about the impact of Brexit, and has called on the government to rule out a no-deal exit on March 29. (Also see "'Rule Out No-Deal Brexit,' BIA Tells Government" - Pink Sheet, 22 Jan, 2019.)
Labour’s Baroness Wheeler said it was “hard to see how even the most enthusiastic advocate of separating ourselves from the EU and going alone on such crucial medical treatment and patient safety issues and provisions on which we have worked for so long in partnership with the EU, to mutual benefit, can view these instruments with any enthusiasm, clarity and certainty about the efficacy and quality of what is to replace the current arrangements, particularly in the event of a no-deal Brexit.”
She pointed out that in a no-deal scenario the UK “would not have access to key EU-wide safety databases and checking systems, and the tougher rules to ensure that all medicines are safe and that trade is rigorously controlled will not apply to us.” Noting that the government had said in February that it was evaluating the options for a future framework, she asked: “How are the government going to ensure that the UK and the EU will cooperate on protecting citizens from counterfeit medicines and prevent fake or fraudulent medicines entering the legal supply chain?”
On the subject of clinical trials, she also wanted to know how the government would follow through on its promise to create “a separate legislative vehicle” to ensure “speedy alignment with the CTR [the EU Clinical Trial Regulation) in the UK,” and specifically what procedures and timescales were envisaged for doing so.
Checking IMP Imports
Lord Warner criticized some new measures proposed by the government on the certification of imported investigational medicinal products, which he said would introduce needless bureaucracy.
To illustrate his point, he quoted from a briefing given by the BIA regarding the clinical trials SI: “Industry does not understand the need for the requirement for an additional UK-based quality assurance system to verify QP [Qualified Person] certification of investigational medicinal products (IMPs) imported from EU/EEA countries on the approved country list given that the clinical trial sponsor is responsible for ensuring the integrity of the IMP supply chain.”
The government’s August 2018 technical notice on the batch release of medicines and IMPs had stated that the UK would unilaterally recognize EU batch release for IMPs, Lord Warner pointed out. However, the clinical trials SI had now added “a new layer of red tape that will reduce the benefit for the sector of that batch release recognition. This, in turn, will impact adversely on the attractiveness of the UK as a location for clinical trials.” He called on the government to “explain to us and to the industry why there has been this last-minute change of policy.”
Government Reply
Baroness Manzoor, replying on behalf of health minister Baroness Blackwood, suggested the MHRA was well able to handle its new regulatory responsibilities, noting that it has “over 30 years of knowledge as lead regulator on over 3,500 medicines on the EU market. The expertise of its licensing, devices, inspections, batch release and pharmacovigilance regime is globally recognized and respected. We want to ensure that this expertise and our shared experience continues to be of benefit to UK and to EU patients.”
On the falsified medicines question, she said that “the UK’s strict regulatory controls govern the sale, supply, manufacture, distribution and advertising of medicinal products,” and that the majority of the EU Falsified Medicines Directive was implemented in 2013 and would remain in UK law even after a no-deal Brexit.
And on IMPs she said these would “continue to be supplied direct from the EU to UK sites as they are today” and that the government was “actively working with organizations that run clinical trials to ensure continuity of supply of IMPs.” Contingency plans were being put in place, “including for access to the same prioritized shipping routes as are available for licensed medicines.”
Summing up, though, Lord Warner said that a “clunky regulatory system with extra costs and disincentives to innovation, which the government are busily devising, puts this sector’s future success at grave risk. It also damages patient access to new drugs and drives up NHS [national health service] costs.” The life sciences industry in the UK is “highly successful," he declared. “If it is seriously damaged by Brexit, I want people in the future to know where the blame rests: with this government.”
The clinical trials SI has now been approved by both houses of parliament, but those on human medicines and medical devices have to go back to the House of Commons, a spokesperson for the House of Lords said.
From the editors of Scrip Regulatory Affairs.