BREXIT
EEA; the government is seeking to preserve this position if there’s no deal. While the legal representative will only need to be based in the EU or EEA, the government anticipates it will be necessary to have an individual based in the UK who has overall responsibility for the trial, and can be contacted to discuss urgent issues arising in connection with a trial, for example urgent safety matters or trial suspensions.
Transparency
The government says its intention is to align UK transparency provisions with those currently operating in the EU. Information on how a UK system would be developed will be the subject of consultation.
Steps to take in preparation
The Medical Protection Society (MPS) is a specialist protection organisation for doctors, dentists and healthcare professionals. In preparation for Brexit, Medical Protection has advised doctors on a number of steps to take, should the supply of treatments or devices be limited or delayed. Medical Protection has taken a small number of queries from members asking for advice in relation to concerns about access to drugs and medical devices should the UK leave with no deal.
In July 2019, Stephen Barclay MP, the Brexit secretary, expressed that maintaining the flow of medicines between the UK and EU will be a top priority in the case of a no-deal Brexit. It is still not clear under what arrangements the UK will leave the EU. Although it is hoped that Brexit will not affect the provision of healthcare in the UK, he said it is important that doctors are aware of what steps to take should patients face delays in treatment or limited access to drugs and medical devices.
In a clinical scenario in which the access to treatments or devices is limited or delayed, Medical Protection suggests that doctors take the following steps: l Explain the position fully to the patient l Explain the treatment and investigation options fully to the patient (including the risks, benefits and burdens of each) and seek the patient’s consent as to which option they wish to pursue
l Arrange any relevant follow-up that may be required
l Make a comprehensive contemporaneous record of your discussions and rationale for the approach. Escalate your concerns in accordance with the GMC Good Medical Practice guidance.
Dr Rob Hendry, Medical Director at MPS, said: “Healthcare professionals and patients would, of course, be concerned if they were to face a disruption in the supply of treatments and devices. If doctors follow official guidance and act in accordance with responsible colleagues faced with the same circumstances, it is unlikely that they will be legitimately criticised. “Doctors are understandably concerned about the potential for interruption to the supply chain of drugs and medical devices, which may then lead to delays in the provision of treatment as well as inferior treatment being given.
“If this situation were to occur, our advice is to fully explain the situation to the patient, as well as what treatment and investigations options are available – including risks and benefits – and seek the patient’s consent regarding the option they wish to pursue. Doctors may also wish to arrange any relevant follow-up that may be required, while recording all the discussions and rationale for the approach.
“Clinicians should familiarise themselves with local and national guidance which may be issued on the subject from time to time as the situation evolves.”
Concerns for protecting patients
Earlier in the year, The Royal College of Physicians took the unusual step of writing to all MPs asking them to vote against the UK leaving the EU without an agreement, to protect patients. The letter, from RCP president Professor Andrew Goddard, to MPs, carried a stark warning, which asked MPs to keep foremost in their minds: “If the UK leaves the EU
In the event of a ‘no deal’, there will be a UK system for regulation of paediatric medicines in which the UK will ensure incentives remain to encourage such medicines onto the UK market.
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without an agreement, there will almost certainly be a negative impact on the health of your constituents and the NHS.” Professor Goddard also wrote:
“Throughout the negotiations, the RCP has been clear that patients and patient safety must be a priority. That is why we have worked closely with the Department for Health and Social Care, NHS England and colleagues in the devolved nations to support preparations. “We are confident that officials are working hard to protect patients, whatever the outcome. Yet the public rightly expects candour from health professionals, and we have ultimately been unable to reassure our patients that their care won’t be negatively impacted by the UK exit from the EU.” The letter referred to concerns frequently raised by members and fellows over access to medicines and medical devices, the workforce supply from the EU and beyond, the funding of medical research, and the particular risks to patients in Northern Ireland.
Early in 2019, the House of Lords EU Home Affairs Sub-Committee called on the government to provide clarity on whether access to medicines and medical products can be guaranteed after Brexit in the event of no deal.
The Committee had initially written to then Secretary of State Matt Hancock MP, following an evidence session on no-deal preparations for medicine provision in November 2018, asking for clarity and further detail. While the answers received were welcomed by the committee, the minister’s response did not alleviate all of the members’ concerns. In particular, the minister is said to have failed in his response to state what action is being taken to address the uncertainty that data from clinical trials conducted in the UK will be accepted by the EMA. The Minister’s response referred to information published months ago and, in its letter, the committee asked for assurances to drug companies that
SEPTEMBER 2019
© Shaun Wilkinson 2017
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