OR WAIT 15 SECS
Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.
Editor's Note: This article was published in Pharmaceutical Technology Europe's April 2019 print issue.
The United Kingdom put its left leg in Europe, is now trying to pull its left leg out, and as the well-known song goes, is seemingly ‘shaking it all about’ with a lack of clear direction and much confusion over potential future relationships. But what impact will this Brexit ‘hokey cokey’, that is presently underway, ultimately have on the bio/pharma industry?
According to the original timeline, the UK should have already left the European Union-initially scheduled to happen on 29 March 2019. However, with the UK Parliament at an impasse, there is uncertainty over whether the UK will leave the EU with any deal whatsoever.
So, if the UK leaves the EU without a deal in place, what does that mean for the bio/pharma industry? As Lynn Byers, executive director for NSF International, explained back in November 2018, if the outcome is ‘no-deal’ then the UK becomes a third country, which will impact many aspects of the bio/pharma market for both the UK and Europe (1).
Some of the areas that will be affected in a ‘no-deal’ scenario include batch release and testing, imports and exports, regulatory issues, packaging, and clinical trials. Byers highlighted packaging as the aspect that will probably incur the most significant impact and as the one facet that may not have been considered by many companies in their Brexit preparations. “If you change a batch release site, your qualified person, and your marketing authorization number, the packaging will be affected,” Byers confirmed. “All the artwork will need to change, and everything will need to be repackaged, which is a substantial issue.”
Add to this the anticipation that the value of the British pound will fall in the event of a ‘no-deal’ Brexit and, as the Association of the British Pharmaceutical Industry (ABPI) noted, there may be knock-on effects for patient access to medicines due to preferential exporting. In light of this potential issue, the ABPI has called on the government to place a temporary ban on drug exports by wholesalers to protect the National Health Service from prospective drug shortages (2).
Both sides, the UK and Europe, have issued documents listing important steps companies should be considering in order to prepare for every potential Brexit outcome, particularly a ‘no-deal’ scenario. For example, the European Medicines Agency (EMA) recently published a questions and answers document assuring that drug safety will not be impacted by Brexit (3), and the UK’s Medicines and Health products Agency (MHRA) has laid out a new process for regulatory submissions in a ‘no-deal’ Brexit scenario (4).
Despite the planning made by industry, however, there are many issues that fall out of its control that will still significantly impact the flow of medicines between Europe and the UK. As reported in The Financial Times, factors such as congestion at ports and regulations cannot be predicted until there is clarity over the way in which the UK will leave the EU (5).
Furthermore, investment in the bio/pharma sector is expected to be impacted, which itself could affect access to medicines. The Guardian reported that AstraZeneca, which is not alone in its actions, has frozen manufacturing investments, and Eisai has confirmed it will not make any new investments in the UK until there is clarification on the Brexit situation (6).
The UK’s Prime Minister, Theresa May, herself stressed the importance of the pharma sector in her national campaign launch speech back in July 2016 (7) when she said, “It is hard to think of an industry of greater strategic importance to Britain than its pharmaceutical industry.” Yet, despite these sentiments, and repeated calls from industry to avoid a ‘no-deal’ scenario at all costs, the sector is still facing an anxious wait on the eventual outcome of Brexit.
On a final note, there may even still be a second referendum or complete reversal to Brexit, with a significant number of people (six million) calling for Article 50 to be revoked (2). So, if the finale of this long-drawn out process is Brexit being turned around, as the ‘hokey cokey’ suggests, is that what it’s all about?
1. PharmTech, “Prioritizing Pragmatism in Face of a ‘No-Deal’ Brexit,” PharmTech.com, 20 Nov. 2018.
2. PharmTech, “Difficult to Swallow? ABPI Requests Temporary Ban on Drug Exports Amid Fears of a ‘No-Deal’ Brexit,” PharmTech.com, 29 March 2019.
3. PharmTech, “EMA Answers Brexit Questions,” PharmTech.com, 26 March 2019.
4. MHRA, “Making Submissions to the MHRA in a No-Deal Scenario,” gov.uk, 4 March 2019.
5. Financial Times, “Pharma Industry Steels Itself for No-Deal Brexit,” ft.com, 26 Feb. 2019.
6. The Guardian, “What are Brexit Contingency Plans for Pharmaceutical Industry?”,
theguardian.com, 19 Feb. 2019.
7. The Conservative Party, “We Can Make Britain a Country that Works for Everyone,” conservatives.com, 11 July 2016.
Pharmaceutical Technology Europe
Vol. 31, No. 4
When referring to this article, please cite it as F. Thomas, “Doing the Brexit Hokey Cokey,” Pharmaceutical Technology Europe 31 (4) 2019.