Editorial | Open Access | Published 27th September 2020

EDITORIAL - Brexit and the Pharmaceutical Industry

Never talk about religion or politics is the rule – I have to break the rule now!

The Brexit Trade agreements were published 31st December and included the Medicinal Products agreements.

The wording of the UK-EU TRADE AND COOPERATION AGREEMENTS Document was:

“Annex on medicinal products

22.This Annex aims to facilitate availability of medicines, promote public health and protect high levels of consumer and environmental protection in respect of medicinal products. It provides for mutual recognition of Good Manufacturing Practice (GMP) inspections and certificates, meaning that manufacturing facilities do not need to undergo separate UK and EU inspections, as well as ongoing co-operation.”

This, at first, sounded to me that all aspects of GMP were within the Mutual Recognition Agreement (MRA) UK/Europe. Excellent news – mutual recognition for EU/UK GMP is longstanding. I immediately thought that GMP included inspections, facilities and laboratories. But this does not seem to be the case as QC laboratories are excluded from the UK/EU MRA.

From the UK Bioindustry Association (BIA)

Mutual recognition of batch testing: There is no mention of mutual recognition of batch testing in the final annex. For some reason this was a red line for the EU. We understand this may be because the EU believed that forcing batch testing to take place in the EU will encourage greater medicinal products manufacturing in the EU. There is still an opportunity to push for a mutual recognition agreement outside of the FTA.

Within the Medicinal Products and the EU-UK Trade Agreement 24/12/2020 it looks like only Cyprus, Malta and Ireland will accept UK testing and that is only for common packs until the end of 2021. There is no MRA that covers acceptance of batch testing. It also seems to be a requirement for NIBSC biological testing, if applicable, to be tested again in the EU.

I am yet to understand the benefits of leaving Europe for the Pharmaceutical Industry. We have spent nearly 40 years harmonising the rules and now in just a few years we have pulled them apart. All I am seeing from my company is a truck load of new requirements that add cost and no value.

For my company these include:

• Setting up a virtual office in the EU

• MAH transferred to virtual EU Office

• Setting up a QPPV in Europe

• Setting up QP release sites in Europe

• Setting up an “Exploitant” in France

The licence variations for the above

But now, the worst of all, there appears to be no mutual recognition between GMP laboratories in Europe and the UK. How can this be when there has been mutual recognition within Europe since the concept one European community was first established? Did the quality of UK QC testing become unacceptable overnight? My company will now have to transfer our finished product testing to a laboratory in Europe.

We are a small company and our product portfolio is unusual and small. The cost of the actions above was significant – but the cost of transfer of the product to European laboratories will be even greater and this additional cost will have to be passed on to the customers, most of which are based in EU countries. Retesting in an EU laboratory is of no value – we have equivalent systems which overnight are no longer recognised as such.

Where can we go from here? That there is no GMP equivalence between Europe and the UK is blatantly false. While I expect little from politicians, I do expect common sense from the medicine competent authorities world-wide. While these new rules were not made by the competent authorities within Europe, I do hope that these competent authorities can get us out of this mess.