Breakthrough cancer and depression treatments just months away from approval could be delayed by Brexit

Exclusive: Drug companies with drugs awaiting European approval told to reapply to UK's medicines watchdog in the event of a no-deal Brexit

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.

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.

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.

“Whatever the outcome of the negotiations, we will continue to ensure that UK patients are able to access the best and most innovative medicines and be assured that their safety is protected.”