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Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.
Editor's Note: This article was published in Pharmaceutical Technology Europe's February 2019 print issue.
Just like a ‘bad penny’, Brexit keeps returning and is leading headlines once again. The European region as a whole is still in the midst of uncertainty-with no clear outcome of whether or not a deal will be struck between the United Kingdom and the European Union-inevitably leading to a rising sense of urgency by the pharma industry to batten down the hatches and prepare for the worst.
However, political disturbances are not solely affecting Europe-the United States, for example, is currently struggling to deal with the backlog of work left in the wake of the recent government shutdown.
With all the political happenings and continuing uncertainty of any agreement being made on a deal before Brexit deadline day-29 March 2019-it is looking more and more probable that the UK will leave the EU with ‘no-deal’. As a result of this scenario being more likely, many news stories are emerging about contingency plans being put into place.
One such contingency plan is that medicines are set to be prioritized over food, which was specified by the health secretary, Matt Hancock, when he answered questions at the health and social care select committee (1). Hancock stated, “Medicines of course will be prioritized … in order to ensure that there is a plan for continuity of supply for all medicines in the event of a no-deal Brexit. The pharmaceutical industry has risen to the challenge and done its duty thus far … I am giving you the absolute assurance that, if everybody does what they need to do, the continuity of supply of medicines will be in place no matter what the Brexit scenario.”
Pharma companies are following suit with contingency planning. Novartis released a statement explaining it is putting plans in place to ensure continuity of supply to patients of its products, which includes stockpiling (2). Additionally, there are numerous other drug companies and trade associations working with the government on contingency plans in the case of a ‘no-deal’ scenario; however, non-disclosure agreements have been signed preventing any information being revealed, according to a report in The Guardian (3).
And while the political furore was happening in the UK’s houses of Parliament, the European Medicines Agency (EMA) promptly left its London base (4) and is readying to complete its move to Amsterdam despite significant losses of employees. Through the move and with the reduction in staff, EMA is continuing to focus on its highest priority activities and has reported that in April 2019 it will review other activities that may be continued later on in the year (5).
As Colin Newbould revealed to Pharmaceutical Technology Europe in the January issue, through the relocation and resultant loss of staff there will inevitably be a knock-on effect on the available resources and ultimately a slowdown in the development of new regulations, at least in the short-term (6).
In the US, there has been the longest government shutdown in history, which as Jill Wechsler discussed in her recent commentary (7), is set to wreak havoc for its regulatory body, the US Food and Drug Administration (FDA). After the government closure, which lasted 35 days, the agency is faced with a wave of new submissions that some anticipate will take months to process.
Added to these woes is the potential threat of a further closure from President Trump should Congress and the White House be unable to negotiate a longer-term budget for 2019, which would only exacerbate any issues FDA is currently trying to tackle.
Of course, political change and disruptions inevitably impact economics. The British pound is fluctuating with Brexit news and updates, still not managing to regain its pre-Brexit rates (8). Economic fluctuations have a knock-on effect for any market, but for the bio/pharma industry investment, manufacturing costs, research and development spending, and merger and acquisition activity could all be negatively affected.
However, the changing political landscape is fluid for the moment and only time will tell how the decisions of various elected officials will impact the bio/pharma industry on a global scale. As Harold Wilson (former UK Prime Minister) famously said “a week is a long time in politics.”
1. House of Commons, Health and Social Care Committee, “Oral Evidence: Budget and NHS Long-Term Plan, HC1712,” 28 Jan. 2019.
2. Novartis, “Novartis UK Brexit Statement,” 25 Jan. 2019, Novartis.co.uk
3. The Guardian, “Drug Firms Preparing for No-Deal Brexit Told to Sign ‘Gagging Orders’,” theguardian.com, 23 Dec. 2018.
4. The Guardian, “Key EU Medicines Regulator Closes London Office with Loss of 900 Jobs,” theguardian.com, 26 Jan. 2019.
5. PharmTech, “EMA Implements the Next Phase in its Relocation Plan,” PharmTech.com, 25 Jan. 2019.
6. F. Thomas, Pharm. Tech. Eur., 31 (1) 44–45 (2019).
7. J. Wechsler, “Government Shutdown too Have Repercussions for Months to Come,” PharmTech.com, 31 Jan. 2019.
8. IG, “The Value of the Pound Since Brexit,” ig.com
Pharmaceutical Technology Europe
Vol. 31, No. 2
When referring to this article, please cite it as F. Thomas, “A Week is a Long Time," Pharmaceutical Technology Europe 31 (2) 2019.