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Media and Political Bulletin – 02 September 2020

Media and Political Bulletin

02 September 2020

Media Summary

ABPI response to MHRA guidance for the end of the transition period

ABPI Press Office, 01 September 2020

Following the publication of MHRA guidance for industry and organisations preparing for the end of the Brexit transition period, the ABPI has published its response.

Richard Torbett, Chief Executive of the ABPI, said: “Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the NHS from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and on other areas of regulation.

“However, we have always said that the best way to avoid disruption in the long term is for both sides to consider the impact on patients in the UK and the EU and agree a deal.”

The ABPI stressed that more guidance and detail would be needed, and that it will continue to seek more engagement with the Government in areas including the Northern Ireland protocol.

Parliamentary Coverage

MHRA post-transition period information

Medicines and Healthcare products Regulatory Agency, 01 September 2020

Following the email circulated to HDA members yesterday, we wanted to re-share the MHRA’s guidance published yesterday on the regulation of medicines and medical devices at the end of the Transition Period, in both a negotiated and non-negotiated outcome with the EU.

To help ensure the continuity of supply of medicines and medical devices from 1st January 2021, especially in a non-negotiated outcome with the EU, the UK will unilaterally recognise certain EU regulatory processes for a time limited period. This recognition is known as ‘Standstill’.  You can find more detail on the guidance here.

In addition to the guidance, the DHSC and the MHRA will be hosting a webinar from 9:30 to 10:30am on Thursday 3rd September to talk through the guidance and answer any questions. Click here to register to attend the webinar: https://www.workcast.com/register?cpak=3123752941732861.

Stephen Lightfoot to become Chair

Medicines and Healthcare products Regulatory Agency, 24 August 2020

As of 1st September 2020, Stephen Lightfoot has become Chair of the Medicines and Healthcare products Regulatory Agency (MHRA). Stephen has been a Non-Executive Director of the Agency since September 2015 and is also Deputy Chair of Sussex Community NHS Foundation Trust and Non-Executive Chair of Sussex Primary Care Limited.

Before joining the Board, Stephen had a 30-year career in the life sciences industry working on the development and commercialisation of a wide range of medicines and medical devices in UK and global healthcare companies. His most recent executive roles were General Manager of the global pharmaceutical diagnostics business of GE Healthcare, Managing Director of the UK pharmaceutical business of Daiichi Sankyo and Commercial Director of the UK pharmaceutical and medical device business of Schering Healthcare.

House of Commons, Oral Question – 01 September 2020

Kirsten Oswald (East Renfrewshire): In just four months’ time, new customs bureaucracy will lead to increased drug costs for the NHS, including for insulin, which the UK does not produce. Pharmaceutical and medical supply firms report that they are struggling to rebuild last year’s stockpiles because of global shortages due to covid. How does the Minister plan to ensure that patients will not face shortages next year?

Health Minister Edward Argar: The Department is putting in place a multi-layered approach to help to ensure continuity of supply of medicines and medical products in any case ​that might fall out of the negotiations and the end of the transition period. We are confident that we will maintain continuity of supply.

House of Commons, Written Questions Tabled – 28 August 2020

Martyn Day (Linlithgow and East Falkirk):

  • To ask the Secretary of State for Health and Social Care, what steps he is taking to support the Medicines and Healthcare products Regulatory Agency to uphold quality and safety standards after the end of the transition period.
  • To ask the Secretary of State for Health and Social Care, what steps he is taking to support the Medicines and Healthcare products Regulatory Agency (MHRA) to uphold quality and safety standards following the UK’s withdrawal from the EU.

Full Coverage

ABPI response to MHRA guidance for the end of the transition period

ABPI Press Office, 01 September 2020

The guidance provides some information on how to operate from 1 January 2021, including on licensing of medicines and devices, clinical trials, exporting active substances for medicines, importing medicines and investigational medicinal products, pharmacovigilance procedures and new IT systems.

Companies will welcome the important detail included in this guidance which will support them in planning for the end of the transition period.

Whilst the guidance is largely similar to the Brexit ‘no deal’ guidance published in 2019 (which was withdrawn as a deal was secured), there are some additions relating to the added complexity of the Northern Ireland protocol and a more time-restricted acceptance of EU batch testing and release. The ABPI will continue to seek more engagement with the Government in these areas.

In response, Richard Torbett, Chief Executive of the ABPI, said:

“Our members will be reassured that Government has provided some critical information to help them continue preparations for the end of the transition.

“Companies face significant changes in how the complex environment for medicines regulations will operate in 2021. If we are to ensure uninterrupted supply for the NHS from January, the MHRA must continue to work closely with them on details related to individual medicines as well as on issues related to the Northern Ireland Protocol and on other areas of regulation.

“However, we have always said that the best way to avoid disruption in the long term is for both sides to consider the impact on patients in the UK and the EU and agree a deal.”

What is needed

More guidance

Pharmaceutical companies are still waiting for the MHRA to provide additional technical information on other issues such as the handling of Decentralised [DCP] and Mutual Recognition Procedures [MRP], how variations to Marketing Authorisations (MAs) will be handled and new assessment routes from 1 January 2021.

Companies are also still waiting for detailed guidance on the regulation of medicines in Northern Ireland.

More detail

Even with the guidance published today pharmaceutical companies are going to face a significant change in the way they need to operate and will have to work through the practicalities of implementing the guidance. The MHRA will need to be available to work through the detail on an individual company basis, given the complexity of medicines regulation.

In the future

Alongside planning for the end of transition, industry is working with the MHRA to ensure that the UK remains at the forefront of medicines regulation.

By expanding the work it does with other regulators around the world to quickly adopt new breakthroughs, exploring new routes for approving medicines and aligning standards with the best in the world, the UK would be an attractive destination for pharmaceutical companies to submit their research.

Media and Political Bulletin – 02 September 2020

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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