Richard Freudenberg, the chief executive of the European Association of Euro-Pharmaceutical Companies (EAEPC), has warned that a significant number of drugs may no longer be available to patients in Britain from midnight on March 29 next year unless its medicines regulator registers those products for use in the UK.
The long-running medicines shortage within community pharmacy which has jeopardised the safety of patients and placed great strain on pharmacies could get much worse as soon as the UK leaves the European Union (EU) in 10 months’ time, with over 400 drug molecules currently centrally approved in Europe no longer available for distribution to patients in the UK post-Brexit.
All medicines manufactured in the UK after March 29, 2019 will be regarded as imports from a ‘third country,’ however it is thought that manufacturers that set up entities in the EU could continue operating under EMA regulations. Otherwise all products which are authorised in Europe and manufactured in the UK will no longer be valid for use in the latter.
Freudenberg urged the Medicines and Healthcare products Regulatory Agency (MHRA), who he said was passing responsibility for avoiding a potentially devastating shortage to the European Medicines Agency (EMA) amid an impasse between the two agencies, to register the products to allow patients in the UK to continue accessing them.
Speaking to Pharmacy Business at the British Association of European Pharmaceutical Distributors (BAEPD) conference in London yesterday, Freudenberg said: “Yes, (there is genuine cause for alarm). But I don’t think it’s been expressed in as stark terms as the EMA is now presenting it. They are saying ‘you’re a third country from midnight on the 29th March next year and therefore these products will go out of our jurisdiction’ as far as they are concerned.
“It’s up to the two national agencies to deal with that and the MHRA are not in that position. They are saying it’s the EMA. So we are in this political football situation.”
When asked what he thought can be done to avoid the shortage, he said: “Look, we are in May and this is going to happen in March, so it’s 10 months away. Something needs to happen soon. The MHRA, if they are going to act, then they need to register those products for use in the UK.
“There are only two routes by which a medicine can be authorised. There’s a national route which the MHRA handle and there’s a pan-European route which the European Medicines Agency handles. The products can’t be authorised by both routes, it’s one or the other.
“It’s normally in the discretion of the manufacturer himself, which route he does that. But in this case we’re looking at such a big issue that I think it’s up to the agencies to get (the medicines) out there and that human story about availability of product is key.”
Freudenberg added: “Four hundred molecules which the EMA authorise and manage, roughly that number, and we just have no sight at the moment about what’s going to happen.”
He revealed that a supply of drugs is in place to offset the impact of a major shortage, with manufacturers already looking to secure “excess warehousing provision,” although he warned that those were short-term measures only.
“What I can tell you is this, and I don’t want to reveal my source, but I know that excess warehousing provision is being sought by manufacturers in advance of next March so there’s sufficient supply already in place. Any product which has already been QP-released, released to the market by the qualified person and the manufacturers, prior to the deadline date can still be distributed in the UK,” Freudenberg said.
“So there is provision being made for some interim measures but it won’t last forever. And don’t forget either that we’ve got a PPRS (pharmaceutical price regulation scheme) coming up on January 1, so that’s going to affect the price of the medicines, so balancing the volume price matrix is going to be key at distributors’ considerations.”
When asked if community pharmacists should be concerned, he said: “Of course they should. I know Raj Patel from the (National Pharmacy Association who was elected president of the Pharmaceutical Group of the European Union in 2016), I know the CCA (Company Chemists’ Association), I’m in contact with those guys through the FMD (Falsified Medicines Directive) stuff and they are as aware of this as I am and are as concerned about it.”
When contacted by Pharmacy Business an MHRA spokesperson said: “The European Council formally agreed on December 15 that sufficient progress has been made to move on to the second stage of the negotiations and adopted guidelines for that second phase.
“This followed the publication of a joint report on progress during the first phase by the government and the European Commission on December 8. In the context of ensuring continuity in the availability of goods placed on the market under Union law before withdrawal, the joint report on progress during the first phase makes clear that ‘goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law and that the goods concerned should be subject to continued oversight.’”
“MHRA is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019.
“We have reached agreement on the terms of an implementation period from March 30 2019 to December 31 2020. During this time, the UK will no longer be a member state, but market access will continue on current terms.
“We will continue to advise businesses on the basis of the UK position and will continue to work with the European Medicines Agency in planning for the UK’s withdrawal from the EU and future relationship.”
The spokesperson added: “Companies have been asking for detail about UK legislative requirements in different scenarios. We have been working closely with industry associations and other stakeholders and further details on all these issues will be provided when appropriate and more. Both our day one and longer-term proposals will be published when appropriate.”