BIA and ABPI input to MHRA consultation on EU Exit no deal contingency legislation for the regulation of medicines and medical devices
The UK BioIndustry Association (BIA) and the Association of the British Pharmaceutical Industry (ABPI) 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; and
- The challenges of the proposed approach on packaging.
ABPI CEO, Mike Thompson, 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.”
BIA CEO, Steve Bates, 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.
Notes to editors
Contact: Ed Sexton, BIA Communications and Media Relations Manager – firstname.lastname@example.org 0207 630 2196
To download the full response, go to the BIA website: https://www.bioindustry.org/resource-listing/abpi-bia-responses-mhra-consultation-eu-exit-no-deal-contingency-legislation.html
To get up to speed on the latest developments, the next briefing points from the BIA/ABPI are as follows:
- Brexit Lead Network event, run in collaboration between the ABPI and BIA, taking place on Monday 5 November 2018, further information at: https://www.bioindustry.org/event-listing/abpibia-brexit-lead-network.html
- BIA Brexit briefing webinar, 16.00-16.45 on Friday 30 November, please register at: https://www.bioindustry.org/event-listing/brexit-briefing-webinar-november-1.html
Key themes and questions included in the consultation document
The scope of this consultation includes proposals from the MHRA on how it would handle various issues in the scenario of the UK not securing a deal with the EU after the UK’s exit from the EU. Topics covered by the consultation questions include:
- Legal presence
- New Marketing Authorisation assessment routes
- Converting Centrally Authorised Products to UK Marketing Authorisations
- Paediatrics Investigations Plans and studies
- Orphan designation
- Abridged applications
- Increased requirements for needing a manufacturer’s licence for import or a wholesaler dealer’s licence
- Recognition of prescriptions
- Clinical trials – legal presence, transparency, use of designated country lists and costs
- Medical devices – registration and costs
- Fees – waivers for orphan products, MHRA fees for processes previously provided by the EC/EMA and costs
- Future operation of NIBSC