Life Sciences– Key Issues (January 2021)

  1. Regulatory Regimes - While the EU-UK Trade and Cooperation Agreement of December 2020 (Agreement) contains a number of general provisions which are relevant to pharmaceutical and medical device companies, rather disappointingly, it does not significantly alter the impact of Brexit on the life sciences sector. Both the EU and UK now have independent regulatory regimes, resulting in dual regulatory obligations for manufacturers of medicinal products and medical devices who intend to place their products on both markets.

    The Agreement does however promote co-operation and transparency between the EU and UK regulatory regimes. For example, international regulatory standards must be used as a starting point for proposed technical regulatory changes and, when deviating from international standards, the parties must provide reasons for so doing.
  2. Medicinal Products - The EU and UK will conduct independent assessments of marketing authorisation (MA) applications for medicinal products. While the Agreement does not ease this regulatory burden for manufacturers of medicinal products, it offers some protection for existing MAs. Part Two, Title V (Intellectual Property) provides for the protection of commercially confidential data submitted to obtain MAs in the EU or UK markets, therefore preventing sensitive clinical trial data, for example, which was used by the original MA applicant from being relied on in a subsequent MA application.

    Annex TBT-2 of the Agreement is specific to medicinal products. In ease of pharmaceutical companies, it provides for the mutual recognition of Good Manufacturing Practice (GMP) inspections of manufacturing facilities between the EU and UK. Further, the EU and UK are obliged to consult with one another before effecting any changes to GMP requirements.

    Quality control and pharmacovigilance are not specifically covered by the Agreement. However, the UK Medicines and Healthcare Products Regulatory Authority (MHRA) has confirmed that it will accept batch testing conducted in the European Economic Area (EEA) until 1 January 2023 and QPPV certification can continue to be conducted by persons located in the EEA (provided that a national UK contact person is registered with the MHRA by 1 January 2022). Conversely, the EU will not recognise UK batch release, and each batch of finished product must be certified by a Qualified Person in the EEA before being marketed in the EEA.
  3. Medical Devices - Medical devices are not specifically mentioned in the Agreement and there is no scope for any mutual recognition of medical device regulations between the EU and UK.

    Of note, the UK has allowed for a transitional period until the end of June 2023 within which the UK will accept CE marked medical devices (provided that they are registered with the MHRA). Conversely, the EU makes no such allowance and all EU regulatory requirements in respect of medical devices must be met from 1 January 2021.
  4. Supply Chains - From 1 January 2021 the EU and UK are now separate customs areas and therefore certain customs formalities, such as written declarations, apply to the export and import of medicinal products and medical devices between the two markets.

    Of critical importance, the Agreement provides for no tariffs or quotas on trade in all goods between the EU and UK. So, there will be no customs duties or charges on medicinal products and medical devices which originate in the EU or UK and which are traded for consumption within both markets. Manufacturers should be aware however, that products with component parts from outside the EU or UK will be required to meet complex rules of origin and provide certifications as to their "Statement of Origin". In addition, where goods are being imported between the UK and EU for the purpose of onward sale outside the jurisdiction, either EU or UK import duties will be applicable. 


Charleen O'Keeffe
Charleen O'Keeffe

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