Like a good sporting event, the process of the United Kingdom leaving the European Union (“Brexit”) is full of uncertainty over the final outcome, and even as we enter the late stages we do not know if extra time will be required. However, it is not fans awaiting the result but millions of patients across Europe, as well as pharmaceutical manufacturers globally, who will be greatly affected by the outcome.
As of July 2018, the situation can be summarized as follows:
- The UK will leave the European Union on 29 March 2019. This is a fact.
- A transition agreement has been reached between the two parties’ negotiators that would extend the breakup process until 31 December 2020. However, this agreement has not yet been ratified by the European Parliament. This is an aspiration.
- The European Medicines Agency has stated the UK will become “a third country” on 29 March 2019, meaning importation testing will be required for any pharmaceutical product either manufactured in or imported through the UK for use on the EU-27’s (the remaining, post-Brexit EU countries) soil. This statement is a fact.
- The UK government has issued a proposal (white paper) outlining how post-Brexit trade should look. The proposal specifically mentions UK participation in the EMA and mutual recognition of GMP between the UK and the EU-27 allowing the present arrangements on importation and testing of pharmaceutical products to continue. Again, this is an aspiration.
Where does this leave patients, pharmaceutical manufacturers, and testing companies such as Charles River?
Currently, 96 pharmaceutical products on the EU market are released through the UK only, 754 are tested in the EU-27 only, and 128 have aspects of testing conducted in both the UK and EU-27.1 If the UK becomes a third country on 29 March 2019, 96 products cannot be released directly from the UK and importation and testing will have to be established in the EU-27. Testing methods will have to be transferred to a new laboratory, validation performed, and the EU marketing license amended. Can this be done in eight months? If transfers start now, there is probably enough overall laboratory capacity for this testing in the EU-27.
How is Charles River preparing to support these products? Prior to the Brexit vote, Charles River conducted most of our clients’ European importation testing through our facility in Edinburgh, UK. Since the announcement of the Brexit result, we have established additional testing facilities in Ballina, Ireland and expanded capabilities in Erkrath, Germany. We have also worked with our clients to transfer methods to cover the eventuality of a 29 March 2019 deadline and are making sure that they have an option to perform their testing on EU-27 soil.
But what about the 754 products where testing would need to be set up in the UK?
Looking the other way, many pharmaceutical companies are now considering UK-based testing to support the UK market. Charles River is working to support these requirements through its facility in Edinburgh, UK. It is important to note that the volume of testing required to support the 754 products currently only tested in the EU-27 will place an immense strain on UK-based laboratories and eight months will not be enough time to achieve the transfers and gain approval from the Medicines and Healthcare products Regulatory Agency (MHRA) for all amended licenses. In order to accomplish this, the transition period mentioned above must either be agreed on or, preferably, mutual recognition of testing between the UK and EU-27 should be established. If neither of these happens there is a fear that patients will lose access to the medicines necessary to save or improve their lives.
1Public Health and Economic Implications of the United Kingdom Exiting the EY and the Single Market, UK Office of Health and Economics, November 2017.