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HDA UK Media And Political Bulletin – 18 May 2018

Media and Political Bulletin

18 May 2018

Media Summary

Medicines won’t be available in the UK post-Brexit unless MHRA-EMA deadlock ends

Pharmacy Business, Neil Trainis, 17 May 2018

 

Pharmacy Business reports that 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.

 

Hard Brexit could ‘injure’ UK pharma, MPs warn

Pharmaphorum, Richard Staines, 17 May 2018

 

Pharmaphorum highlights the warning from MPs that a hard Brexit could ‘injure’ UK pharma. The Business, Energy and Industrial Strategy Committee in an in-depth report into the impact of Brexit on the pharmaceutical sector, made a series of recommendations that aim to minimise the impact of leaving the EU in March next year.

These influential MPs have warned a hard Brexit could “injure” the UK’s pharma industry, and the government must take action to remove barriers such as tariffs and burdensome regulation to ensure its continued success.

MPs from the committee said they had concerns about the impact of Brexit in several areas affecting the industry – tariffs and customs arrangements, regulatory alignment, transitional arrangements, and trade opportunities after leaving the EU.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

Medicines won’t be available in the UK post-Brexit unless MHRA-EMA deadlock ends

Pharmacy Business, Neil Trainis, 17 May 2018

 

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 (pictured) 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.”

 

Pharmacy Business has contacted the MHRA for a response.

 

 

Hard Brexit could ‘injure’ UK pharma, MPs warn

Pharmaphorum, Richard Staines, 17 May 2018

 

Influential MPs have warned a hard Brexit could “injure” the UK’s pharma industry, and the government must take action to remove barriers such as tariffs and burdensome regulation to ensure its continued success.

The Business, Energy and Industrial Strategy Committee in an in-depth report into the impact of Brexit on the pharmaceutical sector, made a series of recommendations that aim to minimise the impact of leaving the EU in March next year.

MPs from the committee said they had concerns about the impact of Brexit in several areas affecting the industry – tariffs and customs arrangements, regulatory alignment, transitional arrangements, and trade opportunities after leaving the EU.

There are worries as negotiators have made little significant progress around detailed arrangements for Brexit since March, and pharma is preparing for a situation where the UK leaves without an agreement in place.

On tariffs, the committee said that evidence it had gathered suggests that arrangements post-Brexit will not affect pharma as much as other industries.

Nevertheless the committee said it has “significant concerns that (Brexit) could injure the UK’s position as a manufacturing base, a global supply hub and as a manufacturer and a recipient of new and innovative medicines.”

The government must therefore draw up a trade agreement with the EU and other countries, covering all finished and component pharma products, which is not limited to those currently listed under World Trade Organisation (WTO) rules.

Also of concern are customs arrangements – MPs on the committee called for the EU border to be as “frictionless” as possible, and wants arrangements so short-life pharma products for emergency treatments and public health needs can be transferred across the border.

“Form of membership” with EMA

The committee was most concerned about how Brexit will affect drug regulation, saying that “what little benefits there may be of regulatory divergence would be greatly overshadowed by the costs and loss of markets and influence the UK would face”.

MPs said it makes “commercial sense” for the UK to remain aligned with standards in the EU, because of the significant amount of trade between the UK and EU and access it gives to drugs.

They called for a “form of membership” with the European Medicines Agency that maintains cooperation and does not require replication of manufacturing sites, testing or roles.

There should also be a small number of EMA staff retained in the UK after its headquarters leaves London for its new home in Amsterdam, to support cooperation with the national regulator, the Medicines and Healthcare products Regulatory Agency (MHRA).

Other worries are trade opportunities post-Brexit – the committee wants the UK to remain aligned with EU intellectual property standards to allow easy trade, and ensuring skills shortages that already exist in the sector are not worsened by allowing effective circulation of staff from around the world.

Finally the committee called for the government to clarify its approach to R&D after Brexit, and whether it will be part of a successor to the Horizon 2020 research collaboration project.

HDA UK Media And Political Bulletin – 18 May 2018

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