Advanced Operating Models
Mar 20, 2018

Brexit — deal or no deal

While there is no confirmation of a transition period, life sciences companies must plan and act to safeguard patients.

In little more than a year, the United Kingdom will exit from the European Union. As Brexit approaches, operating procedures will change, but the number-one priority in the life sciences industry is to ensure that patients don't suffer any disruption to their medicine supply. Uncertainties in trade agreements might cause pharmaceuticals to be detained at national borders and subject to further rounds of testing. To ensure minimal disruption to the drug supply chain — and reduce impact on patient health — companies have considerable work to do.

But they also need to know if there is a transition arrangement for Brexit after the exit date. Without details of this or the government's contingency plan to protect patient health, it's going to be extremely difficult for life sciences companies to adequately prepare. MP and Chair of the Commons Select Health Committee Dr. Sarah Wollaston emphasized this in a letter to Jeremy Hunt on February 15. She noted that businesses and healthcare services need certainty as soon as possible, adding that if confirmation of a transition period is delayed beyond March 2018, life sciences companies will be forced to plan for the worst-case scenario: They'll have to redirect R&D funds to pay for the cost of contingency planning.

In the current circumstances, companies should consider industry proposals to ease the impact on those affected. According to the Life Science Industry Coalition, the government should establish a transition period beyond March 2019 and up to two years after that date. The industry needs this transition period so regulators can ensure procedures, licensing activities, life cycle maintenance and other activities can be delivered without disruption. The table below outlines the implications for the industry, and corresponding recommendations to ease the impact.

Implications of Brexit on the pharma industry

Planning amid uncertainty

In this unique situation, regulators and the industry must agree on a flexible and logical approach to ensure compliance to Brexit-related changes and minimal impact on patient health and safety. However, many companies are already preparing for a worst-case scenario of “no deal" and executing these changes.

For those who haven't yet started, it's imperative to start planning immediately. Life sciences companies need to assess the potential impact, create a plan, and develop a roadmap to understand what they must do for minimal disruption to business as usual.

The roadmap should include an assessment of the following:

  • For all products where the UK is MAH, start planning labeling updates
  • For UK-sponsored orphan medicines, determine if changing the sponsor or establishment address is most appropriate
  • Where the UK is RMS or CMS, find alternative RMS
  • Manufacturing sites based in the UK that act as batch release need to plan labeling updates
  • Where the batch control site is based in the UK, firms must implement new batch control sites in EEA and start the technology transfer process
  • UK companies must rethink and reassess their supply chains. With multiple import/export requirements for manufacturing, the supply chain function will become more expensive, face greater bureaucracy and consume more time
  • UK companies must determine if it's viable to move or reassign QP and QPPV to EEA market

About the author

Claire Colville

Claire Colville

Assistant Vice President, Genpact Pharmalink

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