‘High risk’ of drug supply issues with 'no deal' Brexit despite best efforts, says EMA

Country : UK

Keywords :
LONDON, 22 Mar (APM) - There remains a “high risk” of supply issues for medicines in the case of a ‘no-deal’ Brexit despite major efforts from all stakeholders, the European Medicines Agency (EMA) said on Friday.
The UK is still to agree terms for leaving the EU, although the departure date has been extended by at least two weeks from the original deadline of 29 March. If Prime Minister Theresa May can get her withdrawal deal through Parliament next week, that date will be pushed back to 22 May to give time to pass the necessary legislation.
If she can't get the deal through, the UK will have to propose a way forward by 12 April for EU leaders to consider.
Continued supply of medicines has been a major concern for all healthcare stakeholders during the negotiating period, with regulators, industry and healthcare systems emphasising the impact on patient safety if no deal is agreed.
The EMA said in the highlights of its latest management board meeting that regarding the supply of centrally authorised products (CAPs), the number of medicines at risk of shortages continues to decrease as more companies take the necessary steps to ensure that their medicines can remain on the market.
It also commented on the European Commission’s publication of a document last month that suggest possible exemptions to the rules for batch testing, saying this “may also lower the number of products currently considered as critical and at risk of supply shortages, provided that eligible companies make use of the new available measure and the exemption is granted.” (APMHE 62048)
However, it still warned that: “Despite the proactive approach by the European medicines regulatory network, there is still a high risk of supply issues with some medicines if the UK were to leave the EU without a withdrawal agreement.”
The regulator said it will publish shortly a questions-and-answers document for patients and healthcare professionals on the work that EU authorities are doing to prevent medicines shortages due to Brexit.

‘Lack of focus’ on medicines

The EMA’s comments came a day after Stefan Oschmann, president of European pharma’s trade body EFPIA, said he is “concerned by a certain lack of focus, outside of our industry, on protecting medicines supply”.
“We have witnessed positive action in areas such as fisheries, transport and financial services but more needs to be done to protect public health and the supply of medicines to patients,” he said in a blog post on EFPIA's website.
Oschmann, who is also chief executive of Merck KGaA, called for several key actions to be taken, including further clarity on batch resting and the availably of medical devices that hold UK certified CE marks.
He added: “While the situation at the EU-UK border remains unclear, two-thirds of the pharma companies indicated that border disruption remained their biggest concern. As a consequence steps should be taken to prioritise medicines, active pharmaceutical ingredients, raw and clinical trial materials.”

EMA move to Amsterdam

The EMA’s management board highlights also updated on the progress of the regulator since moving from London to Amsterdam this month (APMHE 62326).
It said that committee meetings in the new building have run smoothly so far but that it will need several months to rebuild its workforce due to staff leaving as part of the move from London.
This means the EMA will continue to operate under business continuity conditions until at least the end of 2019, focusing on core activities.
“This may impact on the implementation of important pieces of legislation such as the medical devices legislation, the veterinary legislation and the General Data Protection Regulation (GDPR),” said the EMA. “At its next meeting in June 2019 the board will discuss a list of temporarily suspended or reduced activities which could be gradually restored as a priority.”



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