Regulation & IP

The 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 UK and the EU can continue to access safe and effective medicines. We believe 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 this position working closely with the Medicines and Healthcare products Regulatory Agency (MHRA) and UK Government.

 

We acknowledge the MHRA’s commitment to ensuring continuity in medicines regulation despite the uncertainty surrounding Brexit and would like to thank the Agency for its engagement with us to date.

 

The BIA alongside EuropaBio and other European trade associations participated in the European Medicines Agency (EMA) and Industry Stakeholder meetings regarding the preparations for the UK’s withdrawal from the EU.

 

Maintaining a strong intellectual property framework is essential if the UK wishes to have long-term sustained investment in R&D and remain a globally-attractive location for international investment. Any signals that the UK may not offer the same patent protection after Brexit will adversely impact the global reputation of the UK as a location for the life sciences industry.

 

Following agreement by the EU27 leaders with the UK on 21 March, the date for the UK’s withdrawal from the EU has been extended to 22 May 2019, provided the Withdrawal Agreement is approved by the House of Commons. If the Withdrawal Agreement is not approved by 29 March 2019, the extension will be until 12 April and the UK is expected to indicate a way forward for consideration by the European Council at a special meeting on 10 April 2019. This means the deadline of 29 March 2019 referred to in Brexit-related guidance should be understood to be replaced by 12 April 2019 until further notice.

 

 

 

LATEST UPDATES 28 March – 4 April 2019

 

Communication from Steve Oldfield, Chief Commercial Office, Department of Health and Social Care, regarding the latest HMRC guidance to help navigate changes in customs and borders processes in the event of a no-deal Brexit – 4 April

 

Exporting active substance manufactured in the UK if we leave the EU without a deal – 4 April

Updated Register of Written Confirmations for UK Active Substance Manufacturers added to the page.

 

Apply to release a vaccine or a blood product to market – 3 April

Guidance added for the OCABR (Official Control Authority Batch Release) Release and Marketing Information Form processes in a no deal scenario.

 

Guidance on substantial amendments to a clinical trial if the UK leaves the EU with no deal – 3 April

This covers changes to the trial sponsor/legal representative, IMP certification and importation and amendments relevant to the Research Ethics Committee (REC).

 

Webinars related to making submissions to the MHRA if the UK leaves the EU with no deal – 3 April

Details added about recent webinar which cover how stakeholders can make informed IT plans and preparations in the event of leaving the EU with no deal.

 

Guidance Updates to packaging components and instructions on submissions if the UK leaves the EU without a deal for those marketing authorisations (MA) issued following conversion of EU MA – 2 April

Amended to provide further clarity on the steps companies need to take in order to register new artwork for medicines packaging.

 

Guidance Conditional Marketing Authorisations, exceptional circumstances Marketing Authorisations and national scientific advice in a no deal scenario – 28 March

 

Contact MHRA for EU exit no deal enquiries – 28 March

 

 

Key Documents

 

BIA briefings and consultation responses

 

BIA Briefing to the House of Lords – March 2019  

Briefing for the House of Lords debate on the draft Human Medicines (Amendment etc.) (EU Exit) Regulations 2019 and the draft Medicines for Human Use (Clinical Trials) (Amendment) (EU Exit) Regulations 2019

 

BIA Briefing to the House of Lords – January 2019
Briefing for the House of Lords Grand Committee debate on the draft Patents (Amendment) (EU Exit) Regulations 2018 

 

BIA Briefing to the Department of Health and Social Care and MHRA – November 2018

The BIA carried out a survey among its member companies – UK-based SMEs and start-up companies involved in the discovery and development of new and innovative medicines – on R&D incentives for orphan medicines in a no-deal Brexit.

 

BIA submission to MHRA consultation on EU exit no-deal legislative proposals – November 2018 

The BIA has, through a joint submission developed in collaboration with the ABPI, inputted to this MHRA consultation which sought views on how the UK’s legislation and MHRA 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. Our discussions with regulators over the last year around contingency planning for the regulation of medicines, clinical trials and medical devices fed into the consultation documents.

 

Press Release.  - November 2018

 

 

Guidance and Q&As from UK and EU regulators

 

Making a success of Brexit – June 2016-now 

The MHRA's response to exiting the EU

 

MHRA guidance and publications on a possible no deal scenario 

The MHRA is publishing a series of guidance documents for industry and other stakeholders covering proposed arrangements for the regulation of medicines, clinical trials and medical devices if the UK leave the EU with no deal.

 

  1. Marketing authorisations, variations and licensing guidance
  2. Importing and exporting
  3. Medicines for children
  4. Medical devices
  5. Legislation concerning a no deal scenario
  6. Regulatory submissions and vigilance activities
  7. Technical notices
  8. MHRA consultation on EU exit no-deal legislative proposals

 

Information from NIBSC :

 

European Commission/EMA guidance and Q&A for companies 

The EMA and the European Commission have provided guidance to help pharmaceutical and biotech companies prepare for Brexit. This aims to ensure that companies take the necessary steps to enable undisrupted supply of centrally authorised medicines in the EU for the benefit of patients, based on the assumption that the UK will become a third country.

 

Questions & answers: EU actions to prevent medicine shortages due to Brexit 

On 26 March 2019 the EMA published a Q&A document to address potential questions from stakeholders on the supply of medicines in the EU after Brexit and what the Agency, the European Commission and national competent authorities in the Member States are doing to minimise the impact on the supply of medicines in a no-deal Brexit.

 

For more on EMA preparedness and business continuity planning 

 

EU Heads of Medicines Agencies (HMA) guidance

The European Commission and CMDh have issued guidance and Q&A in the event the UK becomes a third country without a withdrawal agreement and hence without a transition period. MAHs of products authorised in decentralised or mutual recognition procedures need to ensure that the necessary changes are made by the withdrawal date.

 

Human Tissue Authority guidance for 'no deal' preparations

The HTA has provided information on the changes to make if the UK will become a third country with regards to the EU Tissues and Cells Directive.

 

Intellectual Property Office (IPO) guidance on changes to SPC and patent law if the UK leaves the EU without a deal – March 2019

 

This guidance complements the technical notice on patents and SPCs published on 24 September 2018.