The UK’s Ethical Medicines Industry Group (EMIG) has written to the health secretary in England, Matt Hancock, urging the minister to "make financial support available to suppliers to support them to fulfil the government’s request to stockpile 6 weeks’ supply of medicines on top of their usual stocks". Out-Law.com reports that EMIG surveyed 61 of its members in September and found that 35% of respondents said they either do not intend to, or aren’t sure whether they will, stockpile medicines in contingency planning for a no-deal Brexit. The survey also found that more than half of small companies in the sector believe they will experience increased costs or cash flow problems due to additional stockpiling.
EMIG said funding from the government is therefore "urgently required" to ensure industry can "take steps to secure the UK’s medicines supply in the event of a no-deal Brexit outcome".
"Without this support we believe that some companies will not be able to fulfil the government’s request, which could jeopardise the future security of medicines supply," EMIG said.
According to EMIG's survey, fewer than half of the respondents said they have received guidance from the government about stockpiling medicines, but almost two-thirds of the companies said they plan to increase the amount of stock they hold in the event of reduced market access after Brexit.
EMIG's September 'Brexit barometer' survey followed two similar surveys the body carried out earlier this year, including one in June.
The latest survey found that more than a quarter respondents believe the UK will "crash out" of the EU in a 'no deal' scenario. More than two-thirds of the companies said they have "little or no confidence that the government will obtain a ‘good’ deal for the UK pharmaceutical industry".
The survey also revealed that more than a quarter of EMIG members estimate that they have already spent more than £100,000 preparing for Brexit, while approximately half of the respondents said they expect to spend at least that amount preparing for Brexit over the next 12 months.
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 reports that 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.
The report says 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, the report says, 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.
The report says 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, is quoted in the report as saying: “We badly need better therapies for treatment resistant depression. 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.”
The report says 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.
The report says, according to Janssen, 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, the report says, 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, CEO of the Association of the British Pharmaceutical Industry, said: “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.” 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.
The report says 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.
According to the report, a 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 said 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.”
[link url="https://www.out-law.com/en/articles/2018/october/government-urged-fund-brexit-stockpiling-medicines/?utm_source=Emerge&utm_medium=Email&utm_content=31d86093-d499-4717-9cf7-7874135ffea8"]Out-Law.com report[/link]
[link url="https://www.independent.co.uk/news/health/brexit-medicine-drugs-eu-uk-cancer-depression-epilepsy-cannabis-ketamine-mhra-ema-a8590896.html"]The Independent report[/link]