Scores of drugs just months away from approval for use by British patients – including breakthrough treatments for depression and cancer – could be delayed indefinitely by Brexit, The Independent can reveal.

Manufacturers who have pending European licences have been told they will have to reapply to the UK’s medicines watchdog if their products have not been approved at the time of Brexit unless a deal is struck on drugs regulation.

As of 28 September there were more than 70 drugs awaiting approval, including a cutting-edge skin cancer immunotherapy, a cannabis-based treatment for childhood epilepsy, and new antibiotics.

Jonathan Ashworth MP, Labour’s shadow health and social care secretary, said: “NHS bosses admitted this week they are having sleepless nights over what Brexit will mean for access to medicines. Now we find out that unless ministers get a grip, patients could wait longer and longer for life-saving treatments because of Brexit chaos. No one put that on the side of a bus.”

The UK’s Medicines and Healthcare products Regulatory Agency (MHRA) has said in the event of a no deal it hoped to be able to use the work already completed by the European agency.

However, it was unable to give guarantees that there would not be some delays or additional costs for companies which reapply, though it would try to “streamline the process”.

The Belgian pharmaceutical company Janssen – part of Johnson and Johnson – produces two of the drugs in the list that have the most excitement surrounding them.

One, a game-changing ketamine-derived “nasal spray”, has the potential to relieve severe depression and suicidal thoughts within hours, in patients who are resistant to first and second-choice treatments.

There were 2,944 patients admitted with recurrent depressive disorders in the UK in 2016, and this accounted for nearly 162,000 NHS bed days.

Clinical trials have shown the effects of the esketamine – part of the recreational drug’s molecule – spray,last much longer than conventional treatments, and act in hours rather than days.

Oxford University professor Rupert McShane, who has pioneered ketamine-assisted treatment and sits on Janssen’s advisory board, told The Independent: “We badly need better therapies for treatment resistant depression.

We badly need better therapies Professor Rupert McShane

“The number of people who could benefit is large. Exactly how large will depend on where it is positioned in the care pathway, if it is routine third-line therapy then the number could potentially be very large.”

Janssen is also seeking a European license for the prostate cancer drug apalutamide.

Trial results earlier this year showed apalutamide was able to stop the disease from spreading for three years in men whose tumours had stopped responding to treatment, double the current standard treatment.

Prostate cancer kills more than 11,000 men in the UK every year, and around 10,000 are thought to be living with advanced forms of the disease.

Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Show all 14 1 /14 Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Internal divisions in the Conservative Party have exploded into a bitter public row over Boris Johnson‘s “disgusting” criticism of Theresa May. Some senior Tories furiously denounced the former foreign secretary after he accused the prime minister of having ”wrapped a suicide vest” around Britain Reuters Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Sajid Javid, Home secretary Sajid Javid, the home secretary, rebuked his former cabinet colleague and said: “I think there are much better ways to articulate your differences.” He told the BBC’s Andrew Marr Show that the public wanted politicians to use “measured language” BBC/PA Boris Johnson 'suicide vest' Brexit jibe causes Tory divide But other MPs leapt to Mr Johnson’s defence, as dividing lines ahead of a possible leadership contest begin to take shape. The Uxbridge MP has repeatedly criticised Ms May’s Chequers plan and used a newspaper article on Sunday to suggest it amounted to “wrapping a suicide vest around the British constitution”. His latest salvo at the prime minister prompted immediate condemnation, with one minister publicly vowing to end Mr Johnson’s career over the matter PA Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Alan Duncan, Foreign minister Alan Duncan, a foreign minister who worked in Mr Johnson’s team for two years, wrote on Twitter: “For Boris to say the PM’s view is like that of a suicide bomber is too much. This marks one of the most disgusting moments in modern British politics. “I’m sorry, but this is the political end of Boris Johnson. If it isn’t now, I will make sure it is later.” Getty Boris Johnson 'suicide vest' Brexit jibe causes Tory divide James Brokenshire, Housing secretary Housing secretary James Brokenshire added his voice to the criticism, calling Mr Johnson’s comments ”wrong” He said: “I think he is wrong on this...I think the tone that he has used isn’t right and I think that we just need to be very focused on actually moving forward with the Chequers plan.” AFP/Getty Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Zac Goldsmith But as Tory hostilities spilled over into open public warfare, Richmond Park MP Zac Goldsmith, an ally of Mr Johnson, hit back at Mr Duncan. 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He delivered the Leave vote, Remainers and wannabe future PMs hate him.” If Mr Johnson became leader and prime minister he would deliver a “clean and prosperous” Brexit, she said Rex Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Andrew Bridgen Andrew Bridgen said Ms May was to blame for her leadership problems. Asked if Mr Johnson had put a bomb under her leadership, Mr Bridgen said: “I think that Theresa May did that herself when she put forward the Chequers proposals without consulting widely prior to that.” Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Steve Baker, former Brexit minister Steve Baker, the former Brexit minister, warned Ms May the Conservatives faced a "catastrophic split" if she did not jettison her Chequers plan. Mr Baker, who quit the government in July over the scheme, said: “When negotiating, the prime minister needs to demonstrate her intent and also her power to deliver. "If we come out of conference with her hoping to get Chequers through on the back of Labour votes, I think the EU negotiators would probably understand that if that were done, the Tory party would suffer the catastrophic split which thus far we have managed to avoid.” But he insisted he did not want a change in the Conservative leadership, saying Brexiteers did “not want to be in a position of conflict with our own prime minister” Reuters Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Tom Tugendhat The deep divisions on the Tory benches were laid bare as Tom Tugendhat, who chairs the Commons foreign affairs committee and is a possible leadership rival to Mr Johnson, also hit out at the former foreign secretary. Recalling how he encountered a suicide bomber in Afghanistan during his time in the army, Mr Tugendhat told Mr Johnson to “grow up”. He said: “A suicide bomber murdered many in the courtyard of my office in Helmand. 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Downing Street and Conservative Campaign Headquaters (CCHQ) both denied having leaked the 4,000 word memo after it was circulated around Westminster AFP/Getty Boris Johnson 'suicide vest' Brexit jibe causes Tory divide Mr Johnson confirmed that his 25-year marriage to wife Marina had ended AP

At the time of apalutamide’s final trial results, Professor Malcolm Mason from Cancer Research UK said the findings “very welcome” as there are limited options for these men and delaying the disease spreading may also increase survival.

Janssen told The Independent the MHRA has suggested it will be able to use some of the work done by the EMA if the company reapplies. “For ongoing licence applications, where the decision phase has not been reached by the EMA, we would need to resubmit our application to the MHRA,” a spokesperson said.

“The MHRA’s intention is to complete any assessment that they take over mid-process, aligning with the EMA’s assessment to date.”

However, there are no guarantees that data will automatically be handed over.

Speaking to the House of Commons on Exiting the European Union Committee earlier in October, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, said:

He told MPs: “In a no deal we do not have the agreements that we have in the withdrawal agreement with the regulator, and therefore the transfer of information between the two regulators is at some risk.”

Orphaned drugs The problems are particularly stark for small manufacturers or those making so-called “orphan drugs” for rare conditions where there isn’t a large market to offset the costs of licensing and developing drugs. British based GW Pharmaceuticals has been doing “extensive planning” with the MHRA and other government bodies to minimise disruption for its cannabis-derived childhood epilepsy treatment, epidiolex. The drug is currently pending a European license but the cut off for its decision falls close to the 29 March date set for Britain to quit the EU, though it’s hopeful of getting it confirmed before April. “The assessment of the company’s new pharmaceutical, plant-derived and highly purified formulation of cannabidiol oral solution (CBD) by the EMA is ongoing and recently passed ‘day 120’ in the EMA’s review,” Chris Tovey, chief operating office at the company said. “Engagement with these bodies has been productive and we are carefully exploring with them what would happen in the event of a no-deal scenario and GW’s CBD not already having received its European approval decision. “We are also awaiting a discussion with the EMA on this scenario.”

Even if there is a smooth handover, it is likely there could easily be delays to the process as the MHRA tries to get to grips with its new responsibilities.

Some manufacturers may also not immediately reapply to have their medicines approved by the UK – a significantly smaller market than the EU.

The application process costs hundreds of thousands of pounds and can nearly a year from the process once the evidence review begins – with up to 18 months in the pre-submission process.

Matt Hancock talks about stockpiling of blood products in the event of a no deal Brexit

Evidence reviews can take up to 210 days for the Committee for Medicinal Products for Human Use to review the scientific evidence and give a recommendation, after which the European Commission has 67 days to approve it.

Currently licensing a single medication costs a minimum of €286,900 (£251,855) and spending a similar amount for the UK’s population is likely to put off some manufacturers.

This is compounded by the fact that there is no guarantee a drug will be offered by the NHS, which assesses medicines based on cost-effectiveness instead of just safety and performance grounds.

An MHRA spokesperson said the government “remains confident” it will strike a deal with the EU to “help ensure patients continue to have timely access to safe medicines”.

The agency told The Independent that where medicines have passed the evidence review stage, it will be able to give an opinion in lieu of the European Commission; where the evidence review is not finished, it will try to use the work already done.

“We do not want or expect a no deal. However, it is the duty of a responsible government to continue to prepare for a range of potential outcomes including the unlikely event of no deal,” it added.