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Brexit Anticipation Forces Away Medicine Assessment Contracts From UK

Brexit Anticipation Forces Away Medicine Assessment Contracts From UK
According to reports, there has been a collapse of the leadership role of the United Kingdom in evaluating new medicines that for sale in the rest of Europe as now more new work is coming its way.
The British pharma companies have been dealt a severe blow because of the decision of the European Medicines Agency to exclude the UK from its contracts seven months before he actual date of the setting of the Brexit. The British pharma companies had already been suffering from the shifting of the headquarters of EMA from London along with 900 jobs.
A lengthy EMS process has to be undertaken by all new drugs that are sold in the European Union before they can be sold commercially and used in health services. And in this respect a leading role had been played by the Medicines & Healthcare products Regulatory Agency (MHRA). This body used to conduct about 20-30% of all assessments in the EU.
There have been only two contracts that the MHRA has got so far this year and the EMA has made it clear that no further contracts would be given to the organization. “We couldn’t even allocate the work now for new drugs because the expert has to be available throughout the evaluation period and sometimes that can take a year,” said a spokeswoman to the media.
Additionally, other members of the EU are being reallocated the existing contracts lying with the MHRA.
This has spelled doom for the MHRA which generated about £14m a year from the EMA, said Martin McKee, the professor of European health at the London School of Hygiene and Tropical Medicine.
This is like watching the breaking up a British success story, says the head of the Association of British Pharmaceutical Industry.
“Clearly we’ve all been incredibly proud of the MHRA’s role over the last few years. They’d established themselves as one of the most respected regulators across all of Europe and industry. It’s been a British success story,” said Mike Thompson, the chief executive of the association.
According to the EMA, there a long length of time is required for assessing new medicines and therefore such contracts could not be further awarded to the UK because it is unsure whether the UK would remain a part of the single customs of the EU following the March 2019 deadline of Brexit.
According to reports, only two of the 36 EMA contracts that the MHRA had bid had been given to it. and the two contracts were for those drugs that for which assessment had already started.
Thompson believes that the EU would be at a loss by the removal of the MHRA from the approvals system. Mike Thompson, the chief executive of the association, said: “This is a pre-eminent regulator. As part of the withdrawal agreement the UK regulator ... they will just be an observer in that system,” he said.
“The MHRA has benefited enormously from its close links with the EMA. The fracturing of those links will impact severely. on its budget, much now from the EMA, and its ability to attract and retain skilled staff,” McKee said.

Christopher J. Mitchell

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