Patient safety must be top of the agenda in Brexit negotiations says women’s health campaign
PUBLISHED: 00:01 21 March 2018
Women’s health campaigners are urging the Government to put patient safety at the top of their agenda in the next round of Brexit negotiations.
Sling The Mesh is one of scores of interest groups urging the UK’s health and social care committee to make sure medical devices and medicines are properly regulated when Britain leaves the EU.
Dr Sarah Wollaston, chairman of the committee, said: “In order to minimise harm to their citizens, both the UK and the EU-27 should look to secure the closest possible regulatory alignment in the next round of the Brexit negotiations.
“Failure to do so would signal a triumph of ideology over the best interests of patients.”
But Sling The Mesh, which has almost 5,800 members. fears the committee does not have a true understanding of the already weak regulation system.
And women fear that surgical mesh, due to be raised to a high risk device by 2020, may get missed out.
A Sling The Mesh spokesman said: “Under the EU, all surgical mesh, pelvic and hernia, is due to be raised to a Class III high risk medical implant by 2020. That means it will need more trials before and after it is launched.
“We fear this may not happen under Brexit.”
Linda Millband, national practice lead for clinical negligence at Thompsons Solicitors, said: “We share the concerns of the Health and Social Care Committee that Brexit will lead to an erosion of patient safety standards, particularly in the private health care sector which we know is governed by less stringent regulations when compared to the NHS.
“As it currently stands, Europe is due to be classing mesh implants as high risk in 2020 and we would urge that this happens in the UK, regardless of Brexit.
“That is the only way to ensure that there is a rigorous testing process and any patients offered mesh surgery are carefully monitored post-operatively.”
The Health and Social Care Committee says it welcomes the Government’s stated intention to maintain regulatory alignment with the European Medicines Agency (EMA).
The entire supply chain of pharmaceuticals, from research and development through to the product on a pharmacy shelf, will be seriously affected by regulatory divergence in the event of a ‘no deal’ Brexit, it says.
For the benefit of patients, it is vital that the UK life sciences sector is able to continue to take part in Europe-wide clinical trials, the committee adds.
A statement by the committee said: “The UK should seek mutual recognition of pharmacovigilance mechanisms by the MHRA and the EMA as a priority in the next round of negotiations, as the failure to do so could affect patient safety.
“It is also in the best interests of patients for the UK to continue membership of all of the major EU pharmacovigilance systems and databases, including the European Database on Medical Devices (EUDAMED) and Eudravigilance.”
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