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EU medicines testing to remain recognised in the event of a no-deal Brexit, Government says


By Gemma Collins
23 August 2018

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The Government will continue to recognise batch testing of medicine carried out in an EU member state even after a potential no-deal Brexit, announced Brexit secretary Dominic Raab today.

Raab was speaking ahead of today’s release of the first in a series of technical notices – offering guidance to public and private sector businesses within a number of different fields, including healthcare –  on what to except in the event that the UK exits the European Union without a deal on March 29 next year.

The Brexit secretary explained that: ‘In the unlikely event that we do not reach a negotiated deal with the European Union,’ the UK would no longer be a member of the European regulatory network for the testing of medicine.

However,  to prevent any ‘delays or distribution of supplies from the EU’ when it comes to medicines in such a situation, the Government ‘propose accepting the testing and safety approvals of existing medicines, if they’ve been carried out by a member state regulator,’ Raab said.

He added: ‘Firstly, it simplifies the planning for those businesses that are exporting from the EU, by avoiding the need, at short notice, to adapt to new regulations.

‘Secondly, it minimises any potential disruption for UK businesses or consumers relying on that particular source of supply, in this case medicines from the EU.’

In guidance on the preparations for a no-deal scenario, the Government added that this approach would ‘avoid the ned for these medicines to be retested in the UK’.

In an open letter to NHS staff today, health and social care secretary Matt Hancock said:

‘In the unlikely event we leave the EU without a deal in March 2019, based on the current cross-Government planning scenario, we will ensure the UK has an additional six weeks supply of medicines in case imports from the EU through certain routes are affected.

However, he added that: ‘Hospitals, GPs and community pharmacies throughout the UK do not need to take any steps to stockpile additional medicines, beyond their business as usual stock levels. There is also no need for clinicians to write longer NHS prescriptions.’

The UK’s removal from the European regulatory medicines network in the event that there is no deal would also mean the Medicines and Healthcare Products Regulatory Agency (MHRA) assumes the regularly function currently shouldered by the EU.

This would entail amendments to UK law, a topic on which the MHRA is planning a public consultation in early autumn – looking at the most vital of the proposed legislative amendments.

Commenting on today’s no-deal guidance, Niall Dickson, co-chair of the Brexit Health Alliance, said:

‘What we need is a categorical assurance that patients will continue to get the medicines and treatment they need, no matter what happens in the negotiations. This guidance is […] only a first step, towards that.

‘The NHS will now want to see more comprehensive operational advice on issues such as the stockpiling of medicines and equipment, medical research and public health, in time for them to take robust action locally well before the UK leaves the EU.

‘We will continue to work with the UK Government to make sure these issues are addressed in future guidance and that the NHS is able to care for its patients without disruption of any kind.’

A technical notice on the quality and safety of organs, tissues and cells was also published today.

It confirmed that, in the event of no deal, the EU Organs Directives and EU Tissues and Cells Directives, which regulate, the move of tissues, organs and cells between member states would no longer apply to the UK.

The notice advised that, as UK law already ‘implements the EU directives’, safety standards would remain intact.

However, UK establishments such as hospitals, tissue banks, fertility clinics and stem cell laboratories, would in some cases need new written agreements with EU establishments they work with, the notice explained.

The Government said:

‘UK licensed establishments that import or export tissues or cells from EEA establishments would need to make written agreements with those EEA establishments to continue importing or exporting these products post-exit.’

It added that UK organisations that exchange organs with establishments in EU countries can also ‘make written arrangements to ensure organs can still move between the UK and EU countries.’

Today saw the publication of the first bath of technical notices for a no-deal Brexit scenario, on topics ranging from farming, workplace rights and money and tax, to state aid, studying in the UK or EU, and applying for EU-funded programmes.

Additional technical notices will be published in September and form, the Government said, part of ‘increased public preparation’ for the UK potentially leaving the EU without a deal.

Commenting on a possible no-deal situation, Raab said in his speech: ‘This is not what we want and it’s not what we expect, but we must be ready. We have a duty, as a responsible government, to plan for every eventuality.’

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