Brexit – Maintaining Pharma Supplies & Support

Edition 2 / December 2018

---

Brexit: Support for Pharma in Uncertain Times

EU & UK Flags working together for Brexit.

Uncertainty Remains

With less than 4 months remaining before the UK is scheduled to leave the EU in what is commonly referred to as “Brexit”, concerns are increasing within the pharmaceutical industry about the consequences of the UK and EU failing to agree on terms of departure. This so-called hard exit or no-deal scenario, which would come into effect on March 29, 2019, would place patients and the pharmaceutical industry in the UK and across Europe in an unenviable state of uncertainty.

CordenPharma, with an integrated network of 7 GMP sites in mainland Europe and 2 in the US organized around 5 Technology Platforms, is geographically well placed to deal with this uncertainty and to help customers throughout Europe with continuity of supply.

Potential Pitfalls

EMA – In November 2017 the European Medicines Agency (EMA), which regulates the access of medicines to EU member states, made the decision to move its London Headquarters to Amsterdam (NL), with the potential loss of ~900 UK jobs. Despite this set back, the UK government’s preferred option is to remain part of the EMA, with Prime Minister Theresa May wishing that products only undergo one set of approvals. If this doesn’t happen, getting new medicines to patients will become more costly and slow. This has resulted in several of our UK customers asking for increased production and stockpiling medicines to negate this eventuality.

Labour Market – The UK pharmaceutical industry directly employs 73,000 people, with about 10% of them coming from the mainland EU. If the UK changes its immigration policy, it would become a less attractive place to secure top talent in this highly competitive sector. Reciprocal changes in EU policy could cause similar problems for British nationals working in the EU. This would obviously have unwanted ramifications throughout the Pharmaceutical and CDMO industry.

Free Trade – According to the UK Government’s analysis in 2016, £24.9 billion of pharmaceutical products were exported from the UK, almost half of which went to EU, benefitting 446 million potential patients. In the same period the UK imported £24.8 billion of pharmaceutical products, of which almost 75% came from the EU. Maintenance of frictionless borders and tariff free barriers are high on the wish list for most European businesses. The import and export of pharmaceutical products need to be tested and certified by qualified staff working for licensed companies that are recognised by the relevant national health authorities. Currently, a test in the UK is valid in the EU and vice versa due to a Mutual Recognition Agreement (MRA). The concern, at least up until September 2018, was a reversal of this process, with widespread consequences in the industry. The UK government recently, however, issued guidelines which will give UK Pharmaceutical companies at least some breathing space. They have agreed to accept batch testing of marketed products and Investigational Medicinal Products (IMPs) that are manufactured in EU and EEA (Norway, Lichtenstein & Iceland) states, essentially prolonging the MRA until “further change is necessary.” CordenPharma welcomes this development and hopes that the MRA, in some shape or form, remains in place come April, 2019.

CordenPharma has 9 GMP sites across Europe and the US, and although none of these are in the UK, it does have customers who must import and export to and from the UK. CordenPharma remains willing and able to help UK and other European countries during this challenging period. This could include supporting increased inventory of APIs, finished Drug Products, Pharma Packaging & Logistic services, and enhanced Analytical /QP Release, as well as aid in navigating the complexities of ever-changing regulatory authorities, if this need should arise.

---