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Media And Political Bulletin – 02 November 2018

Media and Political Bulletin

02 November 2018

Media Summary

Re-sending a working link to full transcript of oral evidence received by the Health and Social Care Select Committee on Tuesday 23 October, from Pharmaceutical Chiefs, including HDA’s Executive Director, Martin Sawer, on the Impact of a ‘no-deal’ Brexit. Read the full transcript of the evidence session here.

ABPI and BIA input to MHRA consultation on EU Exit ‘no deal’ contingency legislation for the regulation of medicines and medical devices

ABPI, Press Release, 01 November 2018

The ABPI and BIA have submitted a joint submission in response to the MHRA and DHSC consultation on ‘no-deal’ contingency legislation for medicines and devices regulation for the UK.

The ABPI and BIA stated that industry is ‘aligned in believing that a ‘no deal’ Brexit would significantly damage public health and the UK life sciences sector and that this must be avoided at all costs.’

Mike Thompson, Chief Executive of the ABPI said that ‘this consultation brings home the reality of forty years of close cooperation breaking apart…Putting patients first in the Brexit negotiations must remain a top priority for politicians in the UK and across Europe’

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

ABPI and BIA input to MHRA consultation on EU Exit ‘no deal’ contingency legislation for the regulation of medicines and medical devices

ABPI, Press Release, 01 November 2018

The ABPI and BIA have submitted a joint submission in response to the MHRA and DHSC consultation on ‘no deal’ contingency legislation for medicines and devices regulation for the UK.

The MHRA and DHSC consultation seeks views on how the MHRA’s legislation and regulatory processes would have to be modified in the event of the UK not securing a deal with the EU after the UK’s exit, with no Implementation Period. It covers ‘no deal’ proposals on medicines, clinical trials and medical devices and the BIA and ABPI believe this is a pragmatic response to a ‘no deal’ scenario.

However, the ABPI and BIA position is and remains that close cooperation with the EU in the regulation of medicines, including mutual recognition of regulatory activities and quality testing, is essential in ensuring that patients in the EU and the UK can continue to access safe and effective medicines.

Industry is aligned in believing that a ‘no deal’ Brexit would significantly damage public health and the UK life sciences sector and that this must be avoided at all costs. We continue to advocate that position.

Key concerns in the consultation response include:

The potential impact on public safety of removing certain legal obligations under the Falsified Medicines Directive;

The lack of incentives linked to research and development of orphan medicines;

The proposal for UK paediatric investigation plans;

The practical details of the proposed new targeted assessment route;

The proposed requirements for data provision for grandfathered centrally-authorised products;

The challenges of the proposed approach on packaging.

Mike Thompson, chief executive of the ABPI, said:

“A ‘no deal’ Brexit would have a very serious impact on the ability for pharmaceutical companies to get medicines to patients. Companies are doing everything in their power to prepare, but there are too many things outside of our control.

“It is absolutely right that the MHRA are putting their own plans in place, and we support many of these sensible measures.

“But this consultation brings home the reality of forty years of close cooperation breaking apart.  It’s clear that the combined protection they have delivered to public health, the control of infectious diseases and managing the safety of medicines for patients will be compromised without ongoing, close cooperation. Putting patients first in the Brexit negotiations must remain a top priority for politicians in the UK and across Europe.”

Steve Bates, CEO of the BioIndustry Association UK said:

“A ‘no deal’ Brexit would lead to double red tape for life sciences companies wanting to operate in the UK and EU. Although the measures outlined in this consultation would help to deal with the practicalities of a ‘no deal’ Brexit. Industry is concerned that there are only 150 days for the statutory instruments to go through both houses of the UK parliament. Time is tight and any delay could leave companies in legal limbo”

“There are no measures in the consultation to replace existing incentives for innovative biotech companies currently in EU legislation – this would make the UK less attractive than the EU for companies wanting to launch orphan drugs.”

The BIA and the ABPI continue to have a constructive dialogue with the MHRA and government on those issues. We will progress the issues of concern highlighted in this consultation document alongside our broader advocacy and engagement work on impacts on the sector from the UK’s exit from the EU.

Media And Political Bulletin – 02 November 2018

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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