Brexit could pose risk to patients, ABHI states

New data from the Association of British Healthcare Industries (ABHI) has shown that the majority of imported health technologies used by the NHS come from the EU.

By analysing HMRC’s UK Trade Info database, the ABHI were able to see that of the £5 billion worth of health technology used in the NHS in 2016, £3.2 billion came directly from the EU. In recent years, reliance of this source has also increased by 20%.

International supply chains mean that products can currently move across the UK and EU border many times in their lifecycle for sourcing, assembly, packaging and sterilisation. Any delays and disruption to this process could pose a significant risk to patients if not correctly managed.

About the data, ABHI CEO Peter Ellingworth said: “The nature of supply chains for healthtech is such that even goods manufactured in the UK are often, ultimately supplied to the NHS from distribution centres in the EU. It is vital, therefore, that we have sensible trading agreements in place the moment we leave the EU.”

The UK also exports around £2 billion of health technologies to the EU, a market that ABHI members identified in a recent business survey as a major target for growth in 2018. The same delays and disruptions pose a threat to the health of patients throughout Europe.

The industry body is calling for all products used in healthcare to be exempt from any new customs, tariff or VAT arrangements, and afforded pre-shipping clearance and fast track access across any new EU/UK borders.

In her announcement on Friday (2 March), the prime minister said that the government would explore ‘terms on which the UK could remain part of EU agencies’ including the European Medicines Agency.

During the announcement, May said: “For example, membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations. But it would also be good for the EU because the UK regulator assesses more new medicines than any other member state. And the EU would continue to access the expertise of the UK’s world-leading universities.”

The UK has the highest number of phase I clinical trials and the second highest of phase II/III clinical trials taking place across the EU, according to a recent European industry coalition report.

With newly adopted regulations for in vitro diagnostic medical devices (IVDs) and medical devices, any divergence in regulation would be of great concern to the medical technology sector, according to the report.

The report states that ‘EU-wide IVDs and MDs legislations have played a key role in delivering high-quality care to patients for over 25 years, allowing them timely access to safe and effective medical technologies. In the event that there are two divergent regulatory systems as a result of Brexit, patient access to medical technologies risks being hindered. As a consequence, both parties need to ensure the full availability of medical technologies for patients once the negotiations have come to an end.’

More so, the Brexit Health Alliance has recently highlighted the dangers of losing access to European data, stating that it would “clearly impact the UK’s ability to map trends in safety of devices and medicines.”

Speaking about the prime minister’s announcement, UK BioIndustry Association CEO Steve Bates, welcomed the news, saying: “It’s good to see the PM articulating the practical dynamics of our industry of the future, when she said in her speech that ‘membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations."

“Her language reflects the work that the BIA has undertaken on regulatory cooperation since before the referendum, as well as the desire of patient, NHS Confederation and European coalitions. The PM also stated that it would also be good for the EU because the UK regulator assesses more new medicines than any other member state.”

“There is much work to be done but this is a positive step forward on the future of medicines regulation.” Bates concluded.