What 2020 means for the life sciences
2020 has been a tumultuous year in many respects and the conflation of a pandemic and the impact of the UK’s departure from the EU has profound implications for the life sciences and medical devices industries in the UK and the EU. In this article, we consider how and why these events will have such an effect and how affected businesses may need to prepare for these.
Brexit implications
At 11pm on December 31, 2020, the Brexit transition period will come to an end. At this point, the UK will no longer be required to comply with EU rules and regulations and will no longer be part of the single market and the customs union. In due course, divergence from EU regulations is anticipated, although the extent of such divergence has yet to be seen and continues to be a source of controversy.
Some would like the UK to continue to align itself to the EU standards to facilitate trade with the EU, while others see opportunities to differentiate the UK from the EU. One area where we are already witnessing the beginning of this divergence is in the field of medical devices and medicines.
In 2021, and the UK and the EU will be operating sperate product approval and regulation systems. In September earlier this year, the UK Medicine and Healthcare products Regulatory Agency (MHRA) published guidelines on what businesses operating in these fields can expect. To provide a flavour, here are some of the highlights which will take effect from January 1, 2021.
Medicines
The MHRA will, for the UK, take responsibility for all decisions and functions which were previously handled by the European Medicines Agency (EMA). There is one main exception to this—the EMA will continue to take responsibility for decisions over applications for marketing authorisations (MA) made via the EMA procedure for the purpose of marketing medicines in Northern Ireland.
All centrally authorised EMA MAs which exist at January 1, 2021, for the purposes of supply of medicines to Great Britain (excluding Northern Ireland), will automatically convert to UK MAs. Existing EU MAs which have been centrally authorised will remain valid for the marketing of medicinal products to Northern Ireland.
Medical devices
Once the transition period comes to an end, the UK Medical Devices Regulations 2002, as amended and in the form in which they exist on January 1, 2021 (UK MDR 2002), will remain the key legislation applicable to medical devices in Great Britain (Northern Ireland will have closer links to the regulations).
The UK MDR 2002 will not include the amendments that would have been introduced by the EU Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), which will be fully implemented only in May 2021, post the end of the transition period. For the purposes of medical devices in Great Britain, the UK MDR 2002 will be supplemented by the Medicines and Medical Devices Bill which is currently being debated in the UK parliament.
Manufacturers wishing to place a medical device on the UK market will need to register with the MHRA. Manufacturers based outside the UK will need to designate a ‘responsible person’ based in the UK to register and act on its behalf; hitherto only one responsible person would have been required for the whole of the EU, including the UK.
