This report reviews the impact of various Brexit deal scenarios on healthcare in the UK

Summary:

Scenario 1: The Medicines and Healthcare products Regulatory Authority (MHRA) remains fully involved in EU27/EEA public health activities; the UK negotiates free trade agreements (FTAs) with the EU

  • Public health and economic consequences are minimal for the EU27/EEA and the UK due to full cooperation in public health activities and free trade agreements
  • The cost of Brexit for both a large UK-based pharmaceutical company and a large US-based pharmaceutical company in year 1 is assumed to be negligible

Scenario 2: The MHRA implements a standalone regulatory system and negotiates agreements with the EU that cover inspections of quality and manufacturing processes (not the releases of batches); the UK negotiates FTAs with the EU.

  • There could be a reduction in the number of submissions and/or delays in submissions of marketing authorisation applications in the UK for new medicinal products:
  • 45% of marketing authorisation applications submitted to the EMA during 2013- 2015 had not been submitted to all three third countries (Australia, Canada, and Switzerland) by the end of 2016
  • Applications that were submitted to the third countries faced delays in submission of two-three months (median), and in 5-15% of cases the delay was greater than one year
  • The cost of Brexit for a large UK-based pharmaceutical company in year 1 is estimated to be £45.3 million (£42.4 million implementation; £2.9 million annual maintenance) in this scenario
  • The cost of Brexit for a large US-based pharmaceutical company in year 1 is estimated to be £64.63 million (£54.9 million implementation; £9.73 million annual maintenance) in this scenario.

Scenario 3: The MHRA implements a standalone regulatory system and negotiates agreements with the EU that cover inspections of quality and manufacturing processes (not the releases of batches); trade cooperation is regulated by WTO most favoured nation (MFN) agreements.

  • In addition to the consequences outlined above, there could be shortages of medicines due to changes in trade and parallel trade between the UK and the EU27/EEA
  • The cost of Brexit for a large UK-based pharmaceutical company in year 1 is estimated to be £72.8 million (£42.4 million implementation; £30.4 million annual maintenance) in this scenario
  • The cost of Brexit for a large US-based pharmaceutical company in year 1 is estimated to be £72.43 million (£54.9 million implementation; £17.53 million annual maintenance) in this scenario

Scenario 4: No public health cooperation between the MHRA and the EU27/EEA; trade cooperation regulated by WTO MFN agreements.

  • In addition to the consequences outlined above, the absence of an MRA may complicate the certification of manufacturing, importation and distribution sites (e.g. the MHRA would face a sudden additional inspection workload, and different GMP inspection regimes could result in different findings)
  • The cost of Brexit for a large UK-based pharmaceutical company in year 1 is estimated to be £86 million (£49.6 million implementation; £36.4 million annual maintenance) in this scenario
  • The cost of Brexit for a large US-based pharmaceutical company in year 2 is estimated to be £101.03 million (£62.9 million implementation; £38.13 million annual maintenance) in this scenario.

To read more from OHE, visit their website.