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July 27, 2018updated 19 Jan 2022 1:28am

EMA and Brexit: alarm bells for the healthcare industry

This disparity between the EMA’s and the UK government’s expectations of medicines regulations post-Brexit adds more uncertainty for healthcare stakeholders.

By GlobalData Healthcare

On 11 July, the European Medicines Agency (EMA) published its ‘Brexit Preparedness Report’, summarizing the results of a survey it conducted with UK-affiliated medicines marketing authorization holders (MAHs). The report found that the supply of over 100 medicinal products could be disrupted upon the withdrawal of the UK from the EU on 29 March 2019, due to marketing authorizations (MAs), personnel, and manufacturing sites requiring transferals out of the UK.

On 12 July, the UK government released its highly anticipated ‘Brexit White Paper’, stating that the UK will pursue a deal that ensures MAs remain valid in both the UK and the EU. This disparity between the EMA’s and the UK government’s expectations of medicines regulations post-Brexit adds more uncertainty for healthcare stakeholders ahead of the UK’s withdrawal from the EU.

EU law, which requires MAHs of centrally authorized medicinal products to be established in the EU or European Economic Area (EEA) and for activities such as pharmacovigilance to be performed in the EU or EEA, will no longer apply to the UK post-Brexit. The EMA has therefore been urging companies to transfer, for example, a medicine’s MAH and quality control sites from the UK to the EU or EEA, which would need to be processed via the EMA before the withdrawal date. Failure to do so would result in MAs being invalidated and patients being denied access to those medicines.

The EMA’s survey of over 180 companies with 694 centrally authorized medicinal products for which transferals will need to be made showed that most companies are taking steps to ensure their products are unaffected by Brexit. However, most change requests are expected to be submitted to the EMA during Q4 2018 and Q1 2019. With the coinciding relocation of the EMA’s headquarters from London to Amsterdam, it could be challenging for the EMA to process all of these requests in time.

In addition, some MAHs have decided not to change their UK-only sites. Taken together, survey results have shown that 108 medicinal products—16% of those covered in the survey—are at risk of critically low supply due to regulatory issues. This echoes GlobalData’s own findings that regulatory issues are the greatest concern of professionals in the healthcare industry.

EMA and Westminster diverge over membership

While the EMA strongly advised companies to submit requests before the end of Q4 2018, under the assumption that the UK will cut ties with the EMA, the UK government stated in its Brexit White Paper that the UK would seek participation in the EMA—albeit with a financial contribution and forfeiting voting rights—to retain access to the centralized approval system.

It also proposed that MAs remain valid in both the UK and EU. While this is the best-case scenario in the interest of public health, the EU has indicated that it is an unlikely one, and rejected a similar proposal by the UK government in March this year. Furthermore, if the UK government was to obtain these terms, significant resources of both medicines regulators and pharmaceutical companies will have been wasted on making the required changes to retain MAs.

It seems that while the EMA is gearing up for a Brexit where UK ties are lost, and is taking measures to minimise supply disruptions by strongly urging companies to make preparations, the UK—hoping to maintain close alignment—is doing quite the opposite. The UK’s Medicines and Healthcare Products Regulatory Agency (MHRA) has simply stated that it is “aware” of the EMA’s notifications, and have advised MAHs to refer to these “if [they] do want to consider preparation for any potential changes”.

Furthermore, the MHRA’s plan in the event of separation from EMA networks so far consists of only four bullet points, stating “we would ensure the minimum disruption and burden on companies as the UK exits the EU”, with no further details on how this would be achieved.

In an already turbulent time, with a wave of government resignations over possible Brexit deals, including those of the Foreign Secretary and the Brexit Secretary, and skepticism from EU leaders and the US President over the UK Prime Minister’s Brexit plan, it seems that for now, the healthcare industry must accept the lingering uncertainty over the UK’s future relationship with the EMA and must closely monitor how the EU responds to the Brexit White Paper.

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