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HDA UK Media And Political Bulletin – 21 December 2017

Media and Political Bulletin

21 December 2017

Media Summary

EMA draws up plans to move MHRA work

The Pharmaceutical Journal, 20 December 2017

 

The Pharmaceutical Journal reports that plans are being drawn up to redistribute the European work of the UK’s medicines safety watchdog in the run up to Brexit.

European Union business currently carried out by the UK’s Medicines and Healthcare products Regulatory Agency and the Veterinary Medicines Directorate will be shared among the EU’s national drug regulatory agencies, it has been announced.

Which national agencies take on which elements of the work will be revealed early next year, the European Medicines Agency (EMA) decided at its meeting on 13 and 14 December 2017.

 

 

Pharma companies may be less likely to invest in the UK post-Brexit, MPs told

The Pharmaceutical Journal, 20 December 2017

 

The Pharmaceutical Journal highlights that UK patient involvement in clinical trials will diminish post-Brexit making manufacturers less likely to want to invest in the UK, MPs on the House of Commons Health Select Committee were told on Tuesday, 19 December 2017.

MPs also heard that unlocking the potential of patient data held by the NHS may be enough to persuade the pharmaceutical industry to continue to look to the UK for its involvement in developing new drugs and mitigate any disadvantages from leaving the European Union (EU).

Emma Greenwood, director of policy at Cancer Research UK said: “We need to unlock the data in the NHS…so they [drug companies] want to use the UK as its laboratory. And there is a real drive to push and make that happen.”

Greenwood was speaking at the committee’s ongoing inquiry into the impact of Brexit on the UK’s drugs supply chain and the regulation of medicines after Brexit.

 

 

Parliamentary Coverage

House of Commons Liaison Committee – Evidence from the Prime Minister, 20 December 2017

Rachel Reeves, MP: To ask the Prime Minister if the Government would consider remaining in institutions like the European Medicines Agency, the European Aviation Safety Agency (EASA) or EURATOM?

Theresa May, Prime Minister: The Government would consider continued participation in EASA, but EURATOM had a unique legal position. Mrs May also pointed to the role of the Nuclear Safeguards Bill in relation to the latter body, explaining that the UK would continue to apply international nuclear safety standards, and thus continuing to operate on a basis where other nations could have confidence in its activities.

 

House of Commons – Tabled Written Question, 20 December 2017

Jim Shannon, MP: To ask the Secretary of State for Health, what steps he plans to take to ensure that UK Drug Licensing continues to be linked to the European Medicines Agency after the UK leaves the EU to ensure that decisions by the two organisations are made to the same timetable.

Steve Brine, MP: We recognise the important role that the European Medicines Agency plays in the protection of human and animal health.

In the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation in the best interests of both the United Kingdom and the EU.

The UK is fully committed to continuing the close working relationship with our European partners. Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data. As my Rt. hon. Friend the Prime Minister has stated, we want deep, broad and dynamic co-operation and in this context, the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety.

 

House of Commons – Tabled Written Question, 20 December 2017

Ronnie Cowan, MP: To ask the Secretary of State for Health, what discussions his Department has had on ensuring that decisions on the timetable for UK drug licensing remain linked to the timetable for decisions to be made the European Medicines Agency after the UK leaves the EU.

Steve Brine, MP: We recognise the important role that the European Medicines Agency plays in the protection of human and animal health.

In the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation in the best interests of both the United Kingdom and the EU.

The UK is fully committed to continuing the close working relationship with our European partners. Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data. As my Rt. hon. Friend the Prime Minister has stated, we want deep, broad and dynamic co-operation and in this context, the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety.

Full Coverage

EMA draws up plans to move MHRA work

The Pharmaceutical Journal, 20 December 2017

 

Plans are being drawn up to redistribute the European work of the UK’s medicines safety watchdog in the run up to Brexit.

European Union (EU) business currently carried out by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate will be shared among the EU’s national drug regulatory agencies, it has been announced.

Which national agencies take on which elements of the work will be revealed early next year, the European Medicines Agency (EMA) decided at its meeting on 13 and 14 December 2017.

A spokesperson for the EMA described the EU network of medicines regulatory agencies as “a very strong and flexible system that is able to adapt to changes as necessary without putting at risk the quality of its work”.

Also following its December meeting, the EMA said that preparing for the withdrawal of the UK from the EU will impact on its work in the coming year. It expects to maintain its core activities in 2018 —which includes deciding drug marketing authorisations — but predicts some other work will have to be “temporarily reduced” or “suspended.”

The EMA will move into temporary offices when it vacates its current home in London’s Canary Wharf and relocates to Amsterdam as its new purpose built headquarters is not expected to be completed until November 2019.

Meanwhile the agency is moving forward with the development of its EU-wide clinical trial portal and data base — which will support the needs of EU clinical research, and which it describes as “the most ambitious IT development project…required by the EU pharmaceutical legislation”.

It has tested a partially completed version of the system and, following feedback, has fixed bugs and is working on suggested improvements.

 

 

Pharma companies may be less likely to invest in the UK post-Brexit, MPs told

The Pharmaceutical Journal, 20 December 2017

 

UK patient involvement in clinical trials will diminish post-Brexit making manufactures less likely to want to invest here, MPs on the House of Commons Health Select Committee were told on Tuesday, 19 December 2017.

But MPs also heard that unlocking the potential of patient data held by the NHS may be enough to persuade the pharmaceutical industry to continue to look to the UK for its involvement in developing new drugs and mitigate any disadvantages from leaving the European Union (EU).

Emma Greenwood, director of policy at Cancer Research UK said: “We need to unlock the data in the NHS…so they [drug companies] want to use the UK as its laboratory. And there is a real drive to push and make that happen.”

Greenwood was speaking at the committee’s ongoing inquiry into the impact of Brexit on the UK’s drugs supply chain and the regulation of medicines after Brexit.

Her comments about the potential of NHS data to protect the UK’s contribution to clinical trials, were endorsed by senior drug company figures who also gave evidence to the committee on 19 December.

Hugo Fry, UK general manager of Sanofi suggested that finding itself outside the EU could create a “potential opportunity” if the UK could “lighten the burden of administration” around clinical trials.

He told MPs: “Any country that is good at science and can rapidly enrol patients and can get them through…then companies like us… would look to countries like that and they would get a bigger allocation of patients in a clinical development programme.”

Phil Thomson, president, global affairs at GlaxoSmithKline, said if it was possible to make the UK “the best lab in the world”, it would give it a competitive edge.

Implementing the government’s current life sciences strategy in partnership with industry and “capitalising” on the potential of the NHS was “really important”, he said.

Earlier, Alan Boyd, president of Faculty of Pharmaceutical Medicine, warned MPs that leaving the EU would damage research.

“It will certainly have an impact on the high quality research that we get involved in,” he said.

From the clinician’s perspective, it means they would miss out on being kept up to date around the potential advantage or disadvantages of a new drug, he told MPs.

He said the UK was not the “largest market in the world” for drugs sales, so it ran the risk post-Brexit of becoming less attractive to drug companies looking to test their drugs and invest.

The issue, he said, was how to make most use of the NHS to create more clinical research.

MPs heard that it was crucial to continue collaborating in research and development after the UK leaves the EU.

Greenwood said that 25% of cancer UK research projects relied on collaboration with other EU countries. Boyd revealed that while the UK could support phase one trials on its own as well as early investigations, it relied on collaboration from outside its own borders for phase II and phase III drug trials.

Hugh Taylor, co-chair of the Brexit Health Alliance — a campaigning organisation that brings together the NHS, medical research, industry, patients and public health organisations — said that currently, there was commitment from the UK and the EU to continue collaboration.

He said the contribution the UK had made in the past to public health and patient safety was “a statement of fact”, but he added “it would be a real loss to lose that sense of collaboration.”

HDA UK Media And Political Bulletin – 21 December 2017

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