This document discusses Brexit and its implications for pharmaceutical and medical device regulation. It summarizes the Brexit timeline and process so far. It notes concerns that the UK establishing its own regulatory framework distinct from the EU's could lead to a lengthy approval process for drugs and increased administrative burden. It advises companies in the industry to identify risks from Brexit like funding, competition policy, contracts, taxation, and supply chains. It also says companies should consider opportunities in both the UK and EU27 from issues like customs, tariffs, regulation, and access to markets after Brexit. It quotes sources noting costs to business from new market barriers or divergent rules between the UK and EU. The document concludes by advising industry to stay informed on Brexit developments

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8th Annual Pharmaceutical and
Medical Device Conference:
Brexit Update
Patrick De Ridder, McGuireWoods LLP
London/Richmond
pderidder@mcguirewoods.com
Matthew Hall, McGuireWoods LLP
Brussels
mhall@mcguirewoods.com

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Why are we here and where are we going?
• The run-up: Jan. 2013 – Feb. 2016
• The result: June 23, 2016
• Supreme Court Article 50 hearing:
Dec. 5-8, 2016
• The future: March 2017? - ?
• The six deals
• The problems

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The EU and pharmaceutical/medical device regulation
• EU regulation and pharmaceuticals
• EU regulation and medical devices
• Potential issues
• The Great Repeal Bill
“There are concerns over the possible
occurrence of a cumbersome or
lengthy process for pharmaceutical
approvals and an increase in the
clerical burden once the UK
establishes its own framework distinct
from the EU’s, in a move away from
international efforts at the
harmonisation of pharmaceutical
regulations, the framework of mutual
recognition of GMPs and the approval
scheme operated by the European
Medicines Agency.” *
* Source: Japan’s Message to the United Kingdom and the European Union, September 2016, available at
http://www.mofa.go.jp/files/000185466.pdf

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Preparing for the unknown: practical steps
Risk identification and assessment:
• funding
• company policies
• competition/antitrust
• corporate and commercial contracts
• taxation
• data protection
• employees and staff
• supply chain
• IP
• government contracts/public procurement
• etc.

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Business opportunities in the UK and EU27
• Consider your competitors, customers, suppliers, staff
• Pre and post-Brexit, gain a competitive advantage in the UK and
the other 27 EU states (EU27) from concerns about:
 Supply chains
 Freedom to provide services/establishment
 Staffing
 Customs/origin issues even with FTA
 Tariffs
 Regulation
 etc.

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Business opportunities in the UK and EU27
“If the UK were not to retain its current level of access, the risks of new
market access barriers and divergent regulatory regimes would increase
the cost of doing business both in the UK and when exporting to EU
member states. Ultimately, these costs are likely to be borne by British
workers and consumers. Already some U.S. businesses have indicated that,
without continued seamless free market access to Europe, investment and
hiring decisions likely would favor other locations.” *
* Source: U.S. Chamber of Commerce, The Future of UK-EU Relations: Priorities of the U.S. Business Community, October
2016, available at https://www.uschamber.com/sites/default/files/documents/files/the_future_of_uk-eu_relations_-
_priorities_of_the_u.s._business_community.pdf

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What else do I do now?
• Stay aware
• Find allies/mobilise
• Transitional arrangements
• What do you want?
- UK EU Life Sciences Transition Programme
- Liam Fox’s trade deals
- same in the EU27 and Brussels

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Questions or Comments?
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