The EU Home Affairs Sub-Committee was today warned that the UK will face a significant drugs shortage in the event of a hard Brexit unless its medicines regulator takes responsibility for the licensing of products that are centrally authorised with the European Medicines Agency (EMA).
Julian Maitland-Walker, a senior partner at Maitland Walker LLP, told the committee that time was running out to avert a shortage, especially of new products the “vast majority” of which are centrally authorised with the EMA.
More than 400 drug molecules currently centrally approved in Europe may no longer be available for distribution to patients in the UK from midnight on March 29 next year.
Earlier this year Richard Freudenberg, the secretary general of the British Association of European Pharmaceutical Distributors who also gave evidence to the inquiry, accused the MHRA of passing responsibility for avoiding a potentially devastating shortage to the EMA and urged the UK’s regulator to register products to allow patients in the country to continue accessing them.
Maitland-Walker took on that theme and, suggesting the MHRA’s role will “increase exponentially” post-Brexit, said it would have to take on responsibility for licensing centrally-approved drugs.
“Post-hard Brexit scenario, the role of the MHRA is going to increase exponentially because they will have to take over responsibility for the licensing of, not only the current products for which they license under the MHRA rules, but also the centrally authorised products,” he said.
“The vast majority of new products are centrally authorised with the EMA, so we have an immediate issue post-Brexit that those EMA products which are currently authorised for sale in the UK and elsewhere in the European Union will not be authorised either in the UK or in Europe.
“So something needs to be done immediately by the MHRA to deal with that. Now how they are going to deal with that, we don’t know. They haven’t indicated what their plans are which is a real difficulty for industry because industry has got to cope with the possibility that in the next four or five months, this is going to happen.
“The likelihood is that the MHRA will simply give blanket authorisation overnight, nationalise it in effect the EMA licensing position and that’s perhaps alright from a transitioning point of view, but in the long-term the regulatory authority has got to regulate.
“It can’t simply rubber-stamp something carried out by another regulatory authority. The MHRA is going to have that enhanced role and I think that’s going to be a major difficulty for it.”
Maitland-Walker also warned that 600,000 cancer patients in the UK may not be able to get hold of drugs from within the European Union if the issue is not resolved before Brexit.
“In relation to radiotherapy products, 60% of the UK requirements of cancer drugs, radiotherapy drugs, are imported from the EU. That involves 600,000 UK patients dependant upon cancer drugs imported from within the EU 27 (members),” he said.
“The short shelf life (of those drugs) puts a tremendous amount of pressure and risk to patients which needs to be addressed before we get to Brexit.”
He added: “The UK market will, not so much be less interesting because it’s an important market obviously for pharmaceuticals, but in terms of priority, if you’ve got a choice between accessing a market that’s got 250 million people compared with a market of 60 million people, you’re likely to go for the 250 million first.
“I remember reading a couple of days ago the time new drugs are introduced into the drugs market, if you look at the performance of Switzerland even where they have a high presentation of major international drug companies, the lead time for the introduction of new drugs into those markets is 154 days later I think I read than is the case for the EU and the US.
“Similar experiences are represented in other countries, Australia, Canada, much later than the major markets. That demonstrates that we can expect a slower introduction of new products into a UK market outside the EU.”
When asked if he expected a major disruption in the supply of medicines to UK patients post-Brexit, Maitland-Walker said: “The basic statistics speak for themselves. We talking about importing 45 million packs from the EU and exporting 37 million packs to the EU each month which represents 2.73 million packs per day is being transited through the channel ports.
“The issue of customs…how much friction is going to be generated as a result of a post-Brexit hard Brexit scenario? It’s quite possible the government will wave everything through, in which case we wouldn’t have a problem in relation to imports.
“We would have a problem however in relation to exports. The logistics and the geography of both sides of the Channel, even if the problems are with exports, it would have a knock-on effect on imports into the UK.
“That’s a major issue that has to be addressed and there’s precious little sign of it being addressed.”
Mark Dayan, policy and public affairs analyst at the Nuffield Trust, said the UK imports £21 billion worth of medicines from the EU which accounts for 62% of all the UK’s imports.