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Media And Political Bulletin – 11 December 2018

Media and Political Bulletin

11 December 2018

Media Summary

ABPI response to Brexit vote delay

ABPI, Press Release, 10 December 2018

The ABPI issued a response yesterday to Theresa May’s announcement that the parliamentary vote on Brexit has been delayed.

Responding, the ABPI emphasised the need to avoid a ‘no-deal’ situation. Mike Thompson, Chief Executive of the ABPI said that the ABPI was ‘working as closely as possible with Government on ‘no-deal’ planning and continue to look for further guidance on how medicines will be prioritised as new supply routes are put in place.’

Pharma calls for more detail on plan for post Brexit meds access

Pharma Times, Selina McKee, 10 December 2018

The Pharma Times reports that the pharmaceutical industry is call on the government to urgently provide more detail on how it plans to ensure a continued supply of medicines should the UK leave the EU under a ‘no-deal’ scenario.

The move follows the publication of an open letter by Health Secretary, Matt Hancock, touching on the government’s preparations in the event that an agreement is not finalised.

Warwick Smith, Director General of the British Generic Manufacturers Association, said that: ‘while an update from the Secretary of State is helpful, it contains less detailed information than leaks from other Government Departments. It is vitally important that the Government shares with us and others all their current information so that we can plan accordingly.’

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 10 December 2018

Paul Farrelly, MP: To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 03 December 2018 to Question 196736 on Medicines and Healthcare Products Regulatory Agency (MHRA), and with reference to the transition period set out in the Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union, if the MHRA will be recognised as an EU competent authority under the EU (a) Medical Devices Directive, (b) in-vitro diagnostic medical devices, and (c) Medical Devices Regulation during the period covered by the Agreement.

Answered by Jackie Doyle-Price: The agreement of an implementation period will mean that the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to be recognised as a European Union competent authority designated under the EU Directives for medical devices, in vitro diagnostic medical devices and active implantable medical devices, during this period.

This is also the case for the new EU Regulations for medical devices and in vitro diagnostic medical devices, which both entered into force in May 2017.

It is possible for a single organisation to have individual notified bodies designated in more than one Member State. The authority within each Member State is responsible for notified bodies based in its own country.

The MHRA is responsible for the designation and monitoring of notified bodies in the United Kingdom, which the response to Question 196736 refers to.

Grahame Morris, MP: To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 10 September 2018 to Question 170794 on Allergies: Medical Treatments, what steps have been taken to increase the supply of Epipens to the NHS.

Answered by Steve Brine: Supplies of EpiPen and other adrenaline auto-injectors are currently available with further deliveries expected in the coming weeks. All patients who require an adrenaline auto-injector should now be able to obtain a device. The Department is continuing to work very closely with all the manufacturers of adrenaline auto-injectors and the supply situation is rapidly improving. We have been working very closely with the Medicines and Healthcare products Regulatory Agency and NHS England over the past few months to manage this supply issue and we have issued clear guidance to patients, and their parents or caregivers, to explain the issue and what they should do, if they are having difficulties in accessing a new auto-injector device.

Paul Farrelly, MP: To ask the Secretary of State for Exiting the European Union, pursuant to the Answer of 03 December 2018 to Question 196736 on Medicines and Healthcare Products Regulatory Agency (MHRA) and with reference to the transition period set out in the Agreement on the Withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union, if the MHRA will be recognised as an EU competent authority under EU Regulations (a) Medical Devices Directive, (b) in-vitro diagnostic medical devices, and (c) Medical Devices Regulation during that period.

Answered by Chris Heaton-Harris: The agreement of an implementation period will mean that the Medicines and Healthcare products Regulatory Agency (MHRA) will continue to be recognised as an EU competent authority designated under the EU Directives for medical devices, in vitro diagnostic medical devices and active implantable medical devices, during this period.

This is also the case for the new EU Regulations for medical devices and in vitro diagnostic medical devices, which both entered into force in May 2017.

Full Coverage

ABPI response to Brexit vote delay

ABPI, Press Release, 10 December 2018

The Prime Minister has today announced that the parliamentary vote on Brexit has been delayed. In response, the ABPI has emphasised the need to avoid a ‘no-deal’ situation.

Mike Thompson, Chief Executive of the ABPI said:

“The focus of pharmaceutical companies is on making sure that medicines and vaccines get to patients whatever the Brexit outcome. We are working as closely as possible with Government on ‘no deal’ planning and continue to look for further guidance on how medicines will be prioritised as new supply routes are put in place.

But we reiterate that a ‘no deal’ Brexit would present very serious challenges and this must be avoided.  Politicians need to find a way through the current impasse and reassure patients that medicines will not be delayed or disrupted come March 2019.”

Pharma calls for more detail on plan for post Brexit meds access

Pharma Times, Selina McKee, 10 December 2018

The pharmaceutical industry is calling on the government to urgently provide more detail on how it plans to ensure a continued supply of medicines should the UK leave the EU under a ‘no-deal’ scenario.

The move follows publication of an open letter by Health Secretary Matt Hancock touching on the government’s preparations in the event that an agreement is not finalised.

According to Hancock, the European Commission has made it clear that under a ‘no deal’ scenario it will impose ‘full third country controls’ on people and goods entering the EU from the UK, the impact of which would likely be felt most on the short straits crossings into Dover and Folkestone, potentially affecting medicines supply.

“The revised cross-Government planning assumptions show that there will be significantly reduced access across the short straits, for up to six months,” he said.

The government has already asked that pharma companies stockpile medicines as part of a UK-wide ‘no deal’ contingency plan, but “it is clear that in light of the changed border assumptions…this will now need to be supplemented with additional actions,” Hancock noted, adding: “I am writing in parallel to pharmaceutical companies, and my officials will continue to work closely with these companies to develop our plans”.

Mike Thompson, chief executive of the ABPI, said pharmaceutical companies “continue to do everything in their power to make sure that patients get access to medicines whatever the Brexit scenario,” includingduplicating processes, changing supply routes and stockpiling medicines in line with the Government’s guidance. “However, we have been clear that there are things which are out of our control,” he stressed.

Hancock’s update on potential border delays for six months in a ‘No deal’ scenario is “stark,” he said, and argued that stockpiling more medicines “is not the solution to this problem”.

“While we welcome the Secretary of State’s intention to prioritise the flow of medicines and vaccines, we need the detail. With just 16 weeks until the UK leaves the EU, we need the Government to take immediate action to open up alternative supply routes between the UK and Europe and tell companies so that they can make plans.”

Warwick Smith, director general of the British Generic Manufacturers Association (BGMA), welcomed the government’s work with industry, but noted: “Whilst the outcome of Brexit clearly remains uncertain, it is now the time to accelerate this work and putting mitigating measures in place takes time.

“Therefore, while an update from the Secretary of State is helpful, it contains less detailed information than leaks from other Government Departments. It is vitally important that the Government shares with us and others all their current information so that we can plan accordingly.”

Media And Political Bulletin – 11 December 2018

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