HDA Welcomes Pharmaceutical Industry’s Brexit Letter

The Healthcare Distribution Association (HDA UK) welcomes a joint letter to the EU's Chief Brexit Negotiator and Brexit Secretary David Davis MP by the European pharmaceutical industry calling upon the UK and European Union (EU) to come to a rapid agreement on ensuring patient access to medicines is maintained post-Brexit.

In an open letter on the risks associated with the UK leaving the EU in October 2016, the Association set out its concerns that the failure to maintain close cooperation with the EU’s pharmaceutical regulatory regime could lead to medicine shortages, increased costs to the NHS and lead to delays in the launch of new treatments. Perhaps most importantly, and as the letter clearly highlights:

In the case of an unorderly withdrawal there is a risk that all goods due to be moved between the UK and EU could be held either at border checks, in warehouses or manufacturing and/or subject to extensive retesting requirements. In fact, this would lead to a severe disruption of most companies’ supply chains, which would lead to potential supply disruptions of life-saving medicines.

The HDA supports the letter’s signatories and their call for swift negotiations to ensure there are no adverse impacts on patient safety as a result of the UK leaving the EU. It is imperative that the UK aligns its approach to medicines regulation as much as feasibly possible to mitigate the substantial risks associated with leaving the current European regulatory regime, which ensures patient safety across 28 countries. In the case of our sector, the EU Good Distribution Practice Guidelines (GDP) are vital for public health, because medicines, and their many constituent parts, cross many country borders before finally reaching patients.

A further point raised by the letter is the future role of the Medicines and Healthcare products Regulatory Agency (MHRA). The MHRA performs a proportionately larger role in European medicines regulation and there is a distinct risk that this expertise is neutered by the UK leaving the EU. Our members rely on a close working relationship with the MHRA and the Government must do all it can to maintain its reputation for excellence.

As an Association, the HDA looks forward to continuing to work with the Government and officials to ensure that the impact on patient access to medicines is as limited as possible when the UK leaves the EU in March 2019.