18 December 2018 247

The implications of Brexit for pharmaceutical companies

Since UK voted to leave the European Union (EU) at the referendum two years ago, Brexit has been a constant subject of conversation. There is no doubt that this British exit will have severe implications on both the UK and the EU economy, among which also the pharmaceutical industry.

UK and EU have recently reached a draft withdrawal agreement on the future UK-EU relationship mentioning a transition period. This period would enable pharmaceutical companies to gradually adjust to the new legislation and to guarantee a constant supply of medicines. Eventually, this draft agreement would need to be voted by the UK parliament:

Deal Brexit: In the event of a “Deal Brexit”, the transition period would be approved lasting until the 31th December 2020 and would have following, less severe, consequences:

  • EU law would still apply in the UK during the transition period.
  • A continued circulation of pharmaceutical products could be guaranteed.
  • The marketing authorization documents of pharmaceutical products held by the British MHRA would still be shared with EMA and vice versa.

No-deal Brexit: If the UK parliament rejects the draft agreement, there would be a “no-deal Brexit” (or so-called “hard Brexit”). This would mean that there would be no transition period and companies would need to set up dual corporate structures in order to supply in both EU and UK:

  • There would be no regulation on the exchange of information between MHRA and EMA.
  • A transfer of market authorization holders currently held by UK to a registered office in one of the 27 EU Member States would be needed.
  • A new set of market authorizations would be created to apply in UK.

With only about 100 days remaining before the end of March 2019 (official date for UK to leave EU), the pharmaceutical industry remains to be faced with additional uncertainties to the already complex regulatory environment. Therefore, as any unexpected change could cause disruption of stocks, pharmaceutical companies must embrace themselves to prepare for all possible Brexit scenarios until the crucial vote by the parliament has been reached.


How can we at CMAST help?

To stay ahead of your Brexit challenges, CMAST can assist you in the preparation and implementation of the different regulatory Brexit scenarios. As our regulatory expertise stretches from process optimization to project/portfolio management in the end to end labeling processes, our experts could be able to help you in setting realistic deliverables in terms of how Brexit will affect regulatory affairs. Moreover, with the Center of Excellence Regulatory, Quality and Compliance, CMAST is sharing their knowledge and is staying up-to-date in the latest requirements for Brexit. Therefore, we will keep you posted and provide you with more details in follow-up articles once additional developments become available.

Marlies Oorts, Project Manager

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