Brexit could have ‘catastrophic’ effect on access to new life-saving drugs for decades, warns expert – The Independent
Drug companies currently must apply to health regulators such as the European Medicines Agency (EMA) before their products can be used and they tend to target the largest, most profitable markets first.
Britain represents just three per cent of the global drug market and so it would be behind the likes of the US, EU and Japan in terms of pharmaceutical companies’ priorities.
In an article in the journal ecancermedicalscience, health economics consultant Anthony Hatswell, of BresMed Health Solutions and University College London, said quitting the EMA would be “nothing short of madness”.
But he also suggested a way in which the UK could actually jump ahead of the EU – although this involves remaining part of the EMA, which hard-line Brexiteers are likely to oppose.
Mr Hatswell said if the UK left the EMA, it would then have a choice: significantly expand its domestic regulator and slide down towards the bottom of the queue for new drugs or simply “rubber stamp” decisions made by the EMA without having any input into them.
“The claim of UK patients having to wait for two to three years for access to novel treatments does not sound unreasonable,” Mr Hatswell said.
And he added some drugs might never become available.
“With additional regulatory hurdles to sell pharmaceuticals in the UK, some drugs simply won’t get launched,” he said.
“In many cases this will be because the commercial calculation does not make sense for the UK alone.
“The impact of pharmaceuticals not launching would deprive patients of expensive (but effective) medicines in the medium term, but would have a catastrophic follow-on impact for decades.
“The high-priced medicines of today become generic, and often then become the backbone of cheap and effective therapy for the majority of patients.
“Without the original license, the UK would get neither. Alternatively once a medicine is generic elsewhere, companies may exploit the system to launch a product as ‘new’ with a substantial profit margin – as has been seen recently in the US with a decades-old steroid, deflazacort.”
The warning echoes remarks by Sir Alasdair Breckenridge, a former chair of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA), and the current chair, Professor Sir Michael Rawlins.
Speaking to BBC Radio 4’s Today programme in February, Sir Alasdair said: “The UK market compared to the European market of course is small and they may decide not to come to the United Kingdom.
“So, therefore, there will be delay in getting new drugs – important new drugs, anti-cancer drugs, anti-infective drugs – for patients in the UK.”
In January, Professor Rawlins said: “One of the biggest worries I have about Brexit and standing alone as a regulator is that we are only three per cent of the world market for new drugs and if we are not careful we are going to be at the back of the queue.”
However Mr Hatswell laid out what he described as a “have cake and eat it” scenario for the post-Brexit UK.
“In terms of the regulation of novel pharmaceuticals, exiting the EMA mechanism entirely would harm patients in both the short and long term, and thus needs to be avoided,” he said.
“The ideal mechanism would therefore be the MHRA participating fully in the EMA process as at present – having input to decisions, and ensuring UK patients are not disadvantaged.”
EMA decisions must be approved by the European Commission before coming into force in the EU, even though it has “little scientific knowledge”, whereas a post-Brexit UK could adopt them “immediately”.
The UK could also allow the MHRA to adopt decisions made by other regulators, such as the US Food and Drug Administration.
This, Mr Hatswell argued, “would speed access to medicines and keep the UK at the forefront of medical technology”.
“Rather than falling behind the EU (as would happen with a complete exit), close collaboration with additional powers for the MHRA to act in the interest of patents in the UK could lead to a more advantageous system,” he said.
The MHRA suggested its priorities were to safeguard access to new drugs.
“Understandably, it is too early to be able to comment fully. However, as the Prime Minister said in her letter triggering Article 50, ‘we want to be able to agree a deep and special partnership’ with the European Union,” a spokesperson for the agency said.
“We are working closely with industry, stakeholders and other parts of government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK – working to ensure that there will be no regulatory delay in the approval of new medicines is central to this analysis.”