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Media And Political Bulletin – 04 October 2018

Media and Political Bulletin

04 October 2018

Media Summary

MHRA to consult on EU exit no-deal legislative proposals

Medicines and Healthcare products Regulatory Agency, Press Release, 04 October 2018

The MHRA is to consult on ‘all potential outcomes’ of the Brexit negotiations between the UK and the EU. In a press release, it stated that as part of its contingency planning, ‘it is necessary to make sure the UK’s regulatory processes for medicines, clinical trials and medical devices are legally coherent on exit day.’

It also stated that the ‘overall approach in the unlikely event of a no-deal scenario is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.’

The consultation closes on November 1 2018.

Brexit uncertainty sees UK patients cut from heart attack drug trial

Independent, Alex Matthews-King, 03 October 2018

The Independent reports that UK patients have been cut from an international clinical trial to test a new heart attack drug because of uncertainties about registering new medicines after Brexit.

The drug, dutogliptin, is being tested to see if it can help regenerate cardiac muscle after a heart attack and patients in Exeter, Leeds and Clydebank in Scotland were due to take part.

However, the article states that Recardio, the US-based company developing the drug, has shelved the UK arm of the trial over fears that data in Britain will no longer be acceptable to the European Medicines Agency (EMA) – which licenses drugs for EU use – after Britain quits the bloc.

Health secretary wants pharmacy to follow ‘French model’, he tells C+D

Chemist and Druggist, Isabel Finch

Chemist and Druggist reports that the UK Health Secretary, Matt Hancock, has said that he wants community pharmacy to move towards the ‘French model.’ The article states that the Health Secretary told the publication that he wants to focus on ‘prevention rather than cure,’ stating that ‘pharmacy is incredibly important in the whole prevention agenda.’

‘I want to move towards the French model for pharmacies, where they do more, and I think [pharmacies] are absolutely vital to community health,’ he said. He also stated that he wanted to spend ‘as much as possible’ of the £20 billion-a-year extra funding for the NHS – announced by Prime Minister Theresa May in June – on prevention.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

MHRA to consult on EU exit no-deal legislative proposals

Medicines and Healthcare products Regulatory Agency, Press Release, 04 October 2018

The UK is exiting the EU on 29 March 2019. The UK and EU negotiating teams have reached agreement on the terms of an Implementation Period that will start on 30 March 2019 and last until 31 December 2020. With talks ongoing, we remain committed to reaching agreement on the Withdrawal Agreement and Future Framework in the Autumn.

However, a responsible government should prepare for all potential outcomes, including the unlikely scenario in which no mutually satisfactory agreement can be reached and that is exactly what we are doing, with this consultation forming part of these preparations.

As part of this contingency planning it is necessary to make sure the UK’s regulatory processes for medicines, clinical trials and medical devices are legally coherent on exit day.

This consultation covers changes to four different Statutory Instruments (SIs): the Medicines for Human Use (Clinical Trials) Regulations 2004, the Medical Devices Regulations 2002 and the Human Medicines Regulations 2012 (HMRs) and the Medicines (Products for Human Use) (Fees) Regulations 2016. The changes to the latter two instruments are combined in a single SI.

The overall approach in the unlikely event of a no-deal scenario is for the MHRA to be a stand-alone medicines and medical devices regulator, taking any decisions and carrying out any functions which are currently taken or carried out at EU-level.

Many of the changes to these SIs are of a technical nature which will remove relevant references to the EU, insert references to the UK and other similar changes. The legislation is still being drafted and we are not consulting on the exact legal texts. Rather, this consultation gives narrative on any amendments being considered, with the following principles having been applied:

a pragmatic and proportionate approach in establishing UK regulatory requirements

the UK regulator’s ability to take regulatory action to protect public safety

minimum disruption and burden on companies as the UK exits the EU

Dr Ian Hudson, Chief Executive Officer at the MHRA said:

Our position on medicines and medical devices regulation remains clear. We want to retain a close working partnership with the EU to make sure patients continue to have timely access to safe medicines and medical devices. However, it is important for the UK to prepare for all scenarios and this consultation is a key part of that.

I therefore strongly encourage anyone that has an interest to share their comments.

The MHRA’s vision for the future of medicines and medical devices regulations is underpinned by three clear principles, that patients should not be disadvantaged, that innovators should be able to get products to the UK market as quickly and simply as possible, and that the UK continues to play a leading role promoting public health.

In the unlikely event of a no-deal scenario, the UK will strive to be at the forefront of regulatory innovation and processes. For example, looking at ways to reduce the length of time required to approve new medicines.

The consultation, available online, will close at 23:45 on 1 November 2019 and its outcomes will be communicated.

Brexit uncertainty sees UK patients cut from heart attack drug trial

Independent, Alex Matthews-King, 03 October 2018

UK patients have been cut from an international clinical trial to test a new heart attack drug because of uncertainties about registering new medicines after Brexit.

The drug, dutogliptin, is being tested to see if it can help regenerate cardiac muscle after a heart attack and patients in Exeter, Leeds and Clydebank in Scotland were due to take part.

However, Recardio, the US-based company developing the drug, has shelved the UK arm of the trial over fears that data in Britain will no longer be acceptable to the European Medicines Agency (EMA) – which licenses drugs for EU use – after Britain quits the bloc.

Experts have repeatedly warned that leaving the EU means the UK will be put to the “back of the queue” for new drugs as manufacturers prioritise the large EU market, and half a million patients in clinical trials will be put at risk.

The lack of progress in addressing these issues ahead of the 29 March 2019 deadline is creating a “very difficult” situation for companies such as Recardio, its founder and president, Dr Roman Schenk, told the BBC.

But the government said it was “confident” the UK would still be a good base for trials after the March deadline.

The Independent’s own Final Say campaign is calling on Theresa May to guarantee a second referendum before the UK quits for voters to have their say on the deal.

The dutogliptin trial is running in hospitals in Poland, Austria, Belgium, Bulgaria, Hungary, the Netherlands and the US.

The Golden Jubilee Research Institute, near Glasgow, had been due to take part as well but was informed by Recardio by email on 17 September that this had been put on hold.

“According to the company, uncertainty due to EU withdrawal, particularly drug and data release to the EMA, are completely unresolved and represent a significant risk,” a spokesman for the institute said.

“However, this may change when the regulatory situation has clarity.”

While it was “disappointing” the trial would not go ahead as planned, they added that patients would still receive the same safe, effective, innovative care.

A Scottish government spokesman said: “This is the first clinical study we are aware of to be suspended in Scotland as a result of Brexit – and a very concerning sign of what could happen.

“We are working hard to protect Scotland’s interests in spite of a lack of clarity and meaningful engagement from the UK government over our future.

“With Brexit only six months away, we are doing all we can to plan and mitigate against as many of the significant uncertainties that exist for our health service.”

A spokeswoman for the Department of Health said: “We are confident of reaching a deal with the EU that benefits patients and continues to deliver the best possible environment in which to support clinical trials.

“We want to ensure that patients in the UK and across the EU are still able to access the most innovative and effective medicines.”

Health secretary wants pharmacy to follow ‘French model’, he tells C+D

Chemist and Druggist, Isabel Finch, 03 October 2018  

Health secretary Matt Hancock wants community pharmacy to move towards the “French model”, he has exclusively told C+D.

Mr Hancock – who replaced Jeremy Hunt as health secretary in July – made the comments to C+D following a fringe event at the Conservative party conference yesterday (October 2), where he said he wants to focus on “prevention rather than cure”.

“Pharmacy is incredibly important in the whole prevention agenda,” he told C+D.

“I want to move towards the French model for pharmacies, where they do more, and I think [pharmacies] are absolutely vital to community health.”

C+D has asked the Department of Health and Social Care to expand on what Mr Hancock’s vision for a “French model” would involve.

He also told C+D: “I didn’t have enough time on the platform, because if I had one more minute I would have spent one more minute talking about the importance of pharmacies.”

As much of £20bn as possible to go on prevention

Speaking to The Times’ Matt Chorley during a podcast recording at the conference, Mr Hancock said he wants to spend “as much as possible” of the £20 billion-a-year extra funding for the NHS – announced by Prime Minister Theresa May in June – on prevention.

“There will be more support needed to stabilise the hospital sector, but ultimately I want to get as much as possible out into prevention – and that’s GPs, pharmacies [and] out into the community services and health services.”

“Care always has to be available face-to-face”

The health secretary spoke to Mr Chorley following his speech to delegates at the party conference, in which he called for “more treatment closer to home” and cemented his plans for “bringing new technology across the health and care system”.

“We should be using technology to make lives easier for people, for patients, and also to reduce the burdens and the pressures on the professionals so that they can spend more time with people who need it.”

However, “care always has to be available face-to-face, human-to human”, he added.

Media And Political Bulletin – 04 October 2018

From Factory to Pharmacy

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