Brexit preparedness: EMA to further temporarily scale back and suspend activities.
The European Medicines Agency (EMA), presently based in London, will be relocating to Amsterdam in March 2019 - a direct result of the UK leaving the European Union.
It has announced in a press statement that the next phase of its Brexit business continuity plan needs to begin on 1 October 2018 - at the latest.
The Agency is required to safeguard its ‘core activities’. It is accountable for the evaluation and supervision and licensing of all medicines – whether meant for humans or animals – that may be used across the 28 EU States.
The next phase of the plan sees it: intensify its preparations for the physical move and a ‘significant’ staff loss.
Temporary cuts in activities are needed as it becomes clear that the Agency will lose more staff than initially anticipated. Staff who have chosen not relocate to Amsterdam have already started to leave the Agency - and this trend is expected to accelerate. There are different Dutch employment rules to contend with – meaning that 135 short-term contract staff will no longer be able to work for EMA.
Overall, EMA: “expects a staff loss of about 30%, with a high degree of uncertainty regarding mid-term staff retention.”
EMA is supporting staff relocating to Amsterdam – with some additional support provided by the Dutch government. There is also a: “comprehensive staff recruitment programme” underway.
Activities initially impacted by phase 3
International collaboration: temporarily scaled back to focus primarily on product-related requests, supply-chain integrity and procedures under Article 58; activities such as the harmonisation of global medicine regulation - EMA will only take a reactive role; EMA’s engagement in other global public health issues such as antimicrobial resistance or vaccines – to be maintained as long as possible, but reviewed on a case-by-case basis.
Development and revision of guidelines: temporarily limited to those guidelines that address an urgent public/animal health need, or are necessary to support and facilitate preparations for Brexit.
Non-product-related working parties: temporarily reduced as a consequence of the scaling back of guideline development or revision.
Programmes and projects: activities in relation to project governance will be reduced in line with the reduction/suspension of projects.
Organisation and attendance at stakeholder meetings: limited to Brexit-related interactions.
Clinical data publication: the launch of new procedures are temporarily suspended as of 1 August 2018; data packages submitted for medicines before 31 July 2018 will be processed and finalised.
AstraZeneca has warned that failure to get a seamless transition to the post-Brexit World brings risks of medicines shortages. There statement included a suggestion that they would need to ‘dual-license’ drugs in the UK and EU to protect customers and patients.
Ad Antonisse, of AstraZeneca in The Netherlands set out his “three Brexit tips”.
1. “We have to transfer the admission registration to the EU - otherwise the medicines can no longer be imported into the EU…we also have to adjust the admission registrations in the UK so that we can import there.”
2. “We have begun working with our suppliers to ensure that they are prepared as well as possible for Brexit. We need them to make our products.”
3. “Science is simply an international playing field” - scientists must be able to work freely where they are needed – in the UK or EU.
As the UK has not announced, much less established, its future regulatory framework – and EMA will only guarantee completion of the approvals processes for applications received before July 2018 – it is unclear what the short-term response for medicine providers should be.
Meanwhile, UK Government is stepping up planning for a 'no deal' Brexit. The NHS in England is preparing to stockpile medicines and blood products in case of a 'no deal' Brexit, Health Secretary Matt Hancock has said. He told the Health Select Committee in July that he had met medical industry leaders to "accelerate" preparations since taking over as health secretary two weeks ago.
"We are working with industry for the potential need for stockpiling in the event of a no-deal Brexit."
Hancock added that: "We are also focusing on the importance of a continuous supply of medicines that have a short shelf life - so some of the medicines most difficult to provide in a no-deal scenario where there is difficult access through ports will need to be flown in.
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