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EMA: Wollaston warns UK risks becoming ‘rule-taker rather than rule-maker’

The chair of the Health and Social Care Committee has written to the health secretary demanding clarity on the transitional arrangements for medicines set out in the Draft Agreement on Brexit.

The Draft Agreement appears to state that during the transition, UK agencies and industry will continue to abide by European Medicines Agency (EMA) laws and regulations, but the committee says that there appears to be no formal method of engaging with the decision-making process of the EMA.

In her letter to Jeremy Hunt, committee chair, Dr Sarah Wollaston, asks: “Does this limit the UK to becoming a ‘rule-taker’ rather than a ‘rule-maker’ with regards to the EMA during the transitional period?

“What degree of transparency will be afforded by the government regarding those EMA meetings which the UK continues to be invited to during transition, to allow for parliamentary, stakeholder and public scrutiny?”

The Draft Agreement appears to outline a “more restrictive relationship with the EMA” than was set out by the prime minister for associate membership, and Wollaston questioned Hunt about how the government will negotiate associate membership after the transition period “if, for the 21 months previously, the UK has accepted a significantly ‘worse’ deal from the EU?”

In her letter, she warned that the conditions of the Draft Agreement appear to suggest that from the onset of the transitional period, the UK will be excluded from the EMA and other EU agencies, without permission to attend EMA meetings or contribute to decision-making – despite retaining membership of the bodies during the period.

The committee has previously argued that “the worst outcome [post-Brexit] would be for the UK to become an isolated rule-taker,” and Wollaston again argued that this may be what the transitional period holds for the UK.

The new data briefing on NHS winter pressures makes it clear what a difficult winter this has been, the Nuffield Trust has said.

Over a fifth of patients (23%) spent more than four hours in A&E, compared with 21% last winter and just 6% in 2010-11.

One in eight ambulance handovers were delayed by more than 20 minutes, peaking at one in four on 2 January, and 3% of handovers were delayed by over an hour – this also peaked on 2 January at 9%.

General and acute bed occupancy was at a whopping 94.4%, and exceeded 90% for all but four days this winter, with an average of 20 trusts having over 99% occupancy each day.

On average the number of available beds dropped by 1,100 from last winter, although there were also 1,500 fewer bed days lost due to delayed discharges this winter.

In response to the report, the Nuffield Trust said: “Hospitals have been operating at alarmingly high occupancy levels, opening an average of five-and-a-half extra hospitals’ worth of beds every day this winter, and some trusts seeing 99 in every 100 beds full.

“At the same time ambulances have been queuing outside hospitals for worryingly long periods of time, with over one in eight ambulances delayed by more than half an hour in handing patients over to hospital.”

The think tank warned that behind these figures are stories of patients in pain and distress, as well as NHS staff members working in stressful and pressured conditions.

“We know that the NHS has been pulling out all the stops to keep the health service on the straight and narrow this winter,” it added.

“But with staff shortages widespread and funding tight, it has been doing this with the odds stacked against it.”

An NHS England spokesperson said: “As we have said before, in the face of a ‘perfect storm’ of prolonged bad weather, persistently high flu hospitalisation and spikes in norovirus, the NHS treated 160,000 more A&E patients within four hours during a challenging winter, compared with the previous year.

“The NHS also treated a record number of cancer patients over the most pressured months of the year.”

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