News

Health Committee – Healthcare Distribution Association, University of Nottingham, Royal College of Radiologists, British Association of European Pharmaceutical Distributors – Brexit and regulation of medicines, medical devices and substances of human origin
Date: Wednesday, 06 December 2017

Type: DeHavilland Report – Parliamentary Committee

Overview

During a session of the Health Committee on Brexit and regulation of medicines, medical devices and substances of human origin, MPs heard from:

• Martin Sawer, Executive Director of the Healthcare Distribution Association
• Professor Andrew Grainger, University of Nottingham
• Dr Jeanette Dickson, Vice President, Faculty of Clinical Oncology, Royal College of Radiologists
• Richard Freudenberg, Secretary-General of the British Association of European Pharmaceutical Distributors

Summary

The shape of a “worst case” Brexit scenario

Beginning, Conservative Committee Chair Dr Sarah Wollaston asked about what a “worst case scenario” would look like after Brexit.

In response, Mr Sawer suggested a scenario where there were no guidelines and rules by which his members could operate. If there was no common regulation with other countries, he suggested medicines could become less safe for UK patients in the long run.

Further, he highlighted the lack of tariffs as an advantage to trade, and that a lack of trade agreement could cause “great problems” in the supply and import of medicines.

Dr Dickson pointed to the sheer level of imports of radioisotopes and the lack of ability for them to currently be produced in Britain. She also highlighted a potential slow down in diagnostics processes. There were also risks associated with the ability to treat thyroid and cervical cancers due to interruptions to sustained therapy pathways.

On research, Dr Dickson expressed concern about the lack of supply and about how UK patients’ future access to new clinical trials could be impeded.

Professor Grainger highlighted the possibility of backed up supply chains and labour market supply issues.

Following this, Mr Freudenberg said that his members depended on free movement of goods to import into the UK and the affect that changes could have on competitive pricing.

Resilience planning for post-Brexit

Pressed by the Chair on improving resilience, Mr Sawer stressed the need to “carry on” beyond 30 March 2019 and avoid a cliff edge. He advocated a transition phase of at least two years.

Dr Dickson said supply chain operations needed to continue as it did now, while Professor Grainger stressed the difficulty in predicting what would happen.

Mr Freudenberg said resilience was inherently difficult to plan for, not least because organisations were delaying their investment decisions.

Supply chain issues

Conservative MP Maggie Throup asked about the risks Brexit could pose for the supply chain of medicines and medical devices.

In response, Mr Sawer said that there could be risks about stocking of medicines, and that being in the EU meant that short supplies could be easily and quickly dealt with. A hard Brexit would affect this, he affirmed.

Professor Grainger again described the sheer complexity of supply chains, warning that disruptions could affect entire processes.

Dr Dickson again drew attention to patients’ access to diagnostics, while Mr Freudenberg questioned how medicines would be regulated in future. He doubted that there would be enough time to resolve the issue before Exit Day.

Pressed by Ms Throup asked about what a future trade deal should seek in order to minimise disruption to supply chains and minimise the impact on patients.

In response, Mr Sawer said that regulations needed to mirror the current regulatory regime. He also highlighted elements like the Medical Devices Directive which were hoped to be implemented in full. Moreover, if a zero tariffs regime on medicines were not achieved, this would necessarily increase costs to consumers.

Pressed by Labour MP Luciana Berger on the supply of isotopes, Dr Dickson affirmed that 80 per cent of the supply was imported and that the drugs were time limited.

Medical equipment supplies

Conservative MP Johnny Mercer pressed on the impact of Brexit on UK medical equipment supplies.

In response, Professor Grainger described how trade monitoring across supply chains were part of a deeply complex set of operations. He doubted whether the required expertise was available to deal with the complexities of the issue.

Asked about how customs arrangements could be adapted to support medical equipment imports, Professor Grainger suggested a need to avoid additional customs duties if value was added in other EU countries.

Regulatory divergence

SNP MP Dr Lisa Cameron asked about the impact if the UK diverged from EU regulation on manufacturing, batch testing and distribution.

In reply, Mr Sawer said that, in this scenario, distribution costs and costs of medicines would “definitely” increase. Following this, Mr Freudenberg highlighted the position of Qualified Persons (QPs), explaining that if the rules changed in future, retraining individuals would take a considerable period time.

Mr Sawer said his organisation was engaged with Brexit working parties within Government, but that the political negotiations were a matter for them. The fundamental issue was one of giving certainty and confidence, which was not possible to deliver while negotiations were still ongoing.

The Chair clarified at QPs were not being asked to relocate elsewhere in the EU.

Falling back on WTO rules

Conservative MP Andrew Selous asked about the impact of the UK moving to WTO rules and the trade in life sciences.

In response, Mr Freudenberg said that exports from the UK would cease, but in certain circumstances imports could continue.

Mr Sawer said that if products were able to be moved under WTO rules, costs would increase.

On whether comparisons had been made of countries trading outside the EU, he added that there had been some discussion about whether the MHRA could partner with countries such as Australia. However, there was also a need to be careful with doing trade deals with other “well off” countries because this could lead to significant exports away from Britain.

Mr Freudenberg also detailed how parallel trade had benefited the country and said this risked being undone in future.

Smoothing the transition

Labour MP Rosie Cooper asked how the Government could ensure a smooth transition for the life sciences sector.

In response, Mr Sawer said that there should be a transition period of two years from March 2019 so as to provide for a better understanding of the basis Brexit had been predicated on. However, a political settlement was needed to decide how Britain would relate to the EU in future.

Asked whether two years was a long enough transition period, Mr Sawer believed it to be “realistic” and could allow distribution industries to adapt. More widely, there would be issues with the interaction of the new regulatory regime.

Dr Dickson said that other issues for the industry included the workforce and Britain being a net benefactor from research funding. Therefore, the effects of Brexit would be much more profound than trade. Mr Sawer again warned about trying to make assumptions about policies which were currently theoretical.

Regulatory alignment

Labour MP Ben Bradshaw pressed on arguments about “continued regulatory alignment”. He asked if the witnesses advocated staying in the Single Market and the Customs Union.

In reply, Mr Sawer said his members would welcome this. The witnesses said that this point was being made to the Government.

In response to Labour MP Dr Paul Williams about the UK’s ability to shape future EU regulatory policy-making, Mr Sawer said that some of his member organisations were having to consider their budget planning proposals by early next year, and that this could have an impact in the future.

Lastly, Professor Grainger concluded by affirming the complexity of the supply chain and the wider implications for businesses associated with the industry. He warned that ministers needed to be prepared for the unexpected, particularly on issues regarding a lack of capacity for logistics firms.

Dr Dickson said that the nimbleness to change would be “very difficult”, particularly in the length of time it took to train medical practitioners.

“I would hope common sense is going to prevail”, Mr Sawar warned. A reversion to WTO could pose a serious risk of medicines shortages.