Although the UK Government anticipates leaving the EU with a deal in place, in order to cover any scenario which may occur, the Medicines & Healthcare Products Regulatory Agency (MHRA) has published contingency legislation to assist the pharmaceutical industry in the event of a no-deal Brexit.
In the latter part of 2018, the government warned of a no-deal Brexit as a consequence of time running thin between now and 29 March 2019, raising further concerns amid the pharmaceutical industry. Experts have advised that Brexit could result in “the biggest disintegration of the complex regulated medicines market in Europe” due to the UK’s significant involvement and contribution towards the life sciences sector in Europe. Furthermore, the European Medicines Agency (EMA) relocating their headquarters to Amsterdam has been an additional consequence of Brexit, causing the loss of 900 pharmaceutical jobs in London alone.
The aim of such legislation is to give those involved in the UK’s pharmaceutical business a “Plan B” in terms of how medicines, medical devices and clinical trials will be regulated post-Brexit. Three separate pieces of legislation have been drafted to cover all three of the aforementioned areas; in terms of any manufacturing, importation, labelling, sale, distribution, advertising and pharmacovigilance which will be relevant to them.
The three pieces of legislation mentioned above have been proposed as follows:
- Human Medicines Regulations 2012, as amended by the Human Medicines (Amendment etc) (EU Exit) Regulations 2019
- The Medical Devices (amendment) (EU exit) Regulations 2019
- The Medicines for Human Use (Clinical Trials) (amendment) (EU exit) Regulations 2019
All of the above pieces of legislation are in draft at present and have been prepared ‘just in case.’
For more information on the MHRA’s contingency plan and the impact that Brexit may have on the pharmaceutical industry, please visit the Government website.Share this News item: