Brexit - plus ça change, plus c'est la même chose or angst?
What does the flurry of the last minute Brexit deal mean for intellectual property (IP) and related regulatory protection for medicinal products and medical devices? How far is it more of the same, and how far do we have to wrestle with the new rules in our lives?
The Brexit transition period ended on 31 December 2020 (Completion Day). Existing EU legislation has broadly been retained in UK law, subject to the over 100,000 amendments which came into force on 31 December 2020, including for IP amendments. (Note that Northern Ireland remains under EU rules as a result of the Northern Ireland Protocol (Protocol).
IP
Supplementary protection certificates (SPCs) were always national rights and continue in the UK much as before. After Completion Day you will need a national UK marketing authorisation (MA) to apply for an SPC through the Medicines & Healthcare products Regulatory Agency (MHRA). (European Medicines Agency (EMA) MAs have been cloned automatically into UK MAs). The difference is that you can apply for an SPC for the UK, Great Britain or Northern Ireland. The manufacturing waiver remains. So, despite the SPC, UK manufacturers can manufacture and stockpile products outside of both the UK and EU. The 6 month paediatric extension also remains available (but not for orphan products).
Regulatory
We cannot think about IP protection in the sector without considering the relevant regulatory protections. MHRA has issued guidance.
The new orphan designation will just be for Great Britain (England, Scotland and Wales) and the criteria for it are tied to Great Britain (with no pre-marketing authorisation orphan designation). The 10 year market exclusivity for new applications to MHRA will be set from the date of first approval of the product in Great Britain. There is also still the possibility of an additional 2 years of market exclusivity for paediatric indications.
The new UK equivalent marking to CE is UK CA (or CE UKNI for Northern Ireland). UK-based manufacturers supplying medical devices to the EU will need an Authorized Representative and importer located in the EU. Manufacturers based outside the UK will similarly have to designate a UK Responsible Person (UK REP).
The EU Medical Devices Regulation and EU in vitro Diagnostic Medical Devices Regulation do not apply fully in the EU until 26 May 2021 and 26 May 2022 respectively. So they will not be implemented in Great Britain. There are suggestions that there will be some future strengthening of the legislation in the UK.
Conclusion
The agreement between the UK and the EU has helped. We should be grateful that we already have as much detail about the changes as we have, and many things will continue as before. However, UK based businesses selling into the EU now require the necessary EU MAH and QPPV or EU Authorized Representative and importer and EU-recognised Notified Body assessment. The added complexity of the Northern Ireland Protocol will also keep us on our toes for some time yet.
By Janet Knowles
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