Felicity Thomas is the former Associate Editorial Director of Pharmaceutical Technology, Pharmaceutical Technology Europe, BioPharm International.

Felicity Thomas

: This article appears in the November 2018 issue of 

	As the industry reflects on the latest CPhI Worldwide event, which this year had an impressive international contingency, it is also bracing itself for the imminent fallout and ramifications of Brexit. So, in these uncertain times, where globally the pharma industry appears to be going from strength-to-strength, and more locally, within Europe, it is preparing for turbulence, what are the provisions and advice that should be considered?

	So, what do we currently know about Brexit and the pharma industry? There are wide ranging complications that may potentially affect not only pharma companies but also the general public. For example, if the Brexit deal results in hard borders between Europe and the United Kingdom (UK), there could be disastrous interruptions to the supply of medicine. The Healthcare Distribution Association (HDA UK) warned that a ‘no-deal’ Brexit could give rise to medicine shortages and price increases (1).

	On 23 October, 2018 it published, "If crossing borders is not made easy for medicines, then HDA is concerned about the impact on patients requiring critical treatments."

	Regulatory issues rank high on the Brexit agenda for pharma. The Association of the British Pharmaceutical Industry (ABPI) has stressed, "For the mutual benefit of patients and industry in the UK and the European Union (EU), the UK should seek to negotiate alignment and commonality with the EU for the regulation of medicines." According to the association, this should be achieved by a mutually recognised agreement being put in place between the UK and the European Medicines Agency (EMA), continuation in the alignment of both current and future regulations in both regions, and maintenance of the UK’s participation in EU regulatory and medicines safety processes (2).

	Furthermore, manufacturing, considered to form a vital part of the UK’s economy, will be hindered as a result of Brexit. The impact on this sector has already begun in the UK with manufacturers experiencing recruitment challenges and stressing the likelihood of a ‘skills gap’ post-Brexit, as reported by the manufacturers’ organization in May (3).

	And these are just the tip of the iceberg! So, as there is still a lot of uncertainty surrounding the Brexit deal that will be agreed upon, how can companies prepare?

 (4), some companies, such as GlaxoSmithKline and AstraZeneca, have addressed potential quality control issues by setting up facilities across Europe, although this duplication of work comes with a huge price tag, meaning smaller companies will unlikely be able to afford this option.

	Another preparative measure that both the UK government and EMA have recommended is for companies to stockpile medicines to counter any potential disruptions to supply. Companies such as AstraZeneca in the UK, Novartis in Switzerland, and Sanofi in France have all confirmed they are taking this action (5).

	As the new European editor for the PharmTech Group, I will be doing my utmost to help guide you through the ups and downs of Brexit. Expect an increase in our European-specific content over the coming months, where I will aim to provide you with as much up-to-date information on Brexit, European regulatory issues, and breaking news from the region.

	I would also like to open the floor to expert opinions and contributions on European-related issues within the bio/pharmaceutical field. If you are interested in contributing you can find the most recent submission guidelines on 

, where you can also view the editorial calendar for 2019.

	I shall look forward to hearing from you and collaborating with you on the critical and thought-provoking topics from the industry.

	1. HDA, "'No-Deal Brexit' Risks Supply of Medicines to Patients, Warns Healthcare Distribution Association," Press Release, Oct. 23, 2018.
	2. ABPI, "What We Do: Brexit," abpi.org.uk, 

https://www.abpi.org.uk/what-we-do/policy-and-parliament/brexit/


	3. EEF, "Number of EU workers Leaving UK Eases but Industry Still Faces Recruitment Crunch as Brexit Exodus Continues," Press Release, May 21, 2018.
	4. The Financial Times, "UK Pharmaceutical Sector Prepares for Hard Brexit as Regulator Exits," Nov. 21, 2017, ft.com, 

https://www.ft.com/content/85c0152e-ce96-11e7-b781-794ce08b24dc


	5. BBC News, "Drug Makers Sanofi and Novartis Stockpiling for Brexit," Aug. 1, 2018, bbc.co.uk, 

https://www.bbc.co.uk/news/business-45028842


	Vol. 30, No. 11
	November 2018
	Page: 5

	When referring to this article, please cite it as F. Thomas, "Fasten Your Seatbelts …," 

	Felicity Thomas is European editor of 

Articles

… Brexit may be a bumpy ride. Here, the new European editor of the PharmTech Group, Felicity Thomas, discusses Brexit and its implications for the pharma industry.