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HDA UK Media And Political Bulletin – 9 April 2018

Media and Political Bulletin

9 April 2018

Media Summary

Prognosis needed for UK’s pharma future

Financial Times, Sarah Neville, 5 April 2018

 

The Financial Times highlights that it is just over a month since Theresa May formally spelled out her desire to maintain a close, post-Brexit bond with the European Medicines Agency.

But, four weeks on, the mechanics involved in achieving “associate membership” of the agency, her declared aim, remain unclear. So too does the attitude of the other member states to her vision of a world in which the UK can remain part of the pan-European system for evaluating and approving medicines, even after it formally quits the union.

In her long-awaited speech at the Mansion House in the City of London in March, Mrs May said the status she now sought “would mean abiding by the rules” of the EMA and “making an appropriate financial contribution”.

Associate membership, not only of the EMA, but of the agencies governing chemicals and airlines, was “the only way to meet our objective of ensuring that these products only need to undergo one series of approvals, in one country”.

 

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Prognosis needed for UK’s pharma future

Financial Times, Sarah Neville, 5 April 2018

 

It is just over a month since Theresa May gladdened pharmaceutical industry hearts by formally spelling out her desire to maintain a close, post-Brexit bond with the European Medicines Agency.

But, four weeks on, the mechanics involved in achieving “associate membership” of the agency, her declared aim, remain unclear. So too does the attitude of the other member states to her vision of a world in which the UK can remain part of the pan-European system for evaluating and approving medicines, even after it formally quits the union.

In her long-awaited speech at the Mansion House in the City of London in March, Mrs May said the status she now sought “would mean abiding by the rules” of the EMA and “making an appropriate financial contribution”.

Associate membership, not only of the EMA, but of the agencies governing chemicals and airlines, was “the only way to meet our objective of ensuring that these products only need to undergo one series of approvals, in one country”.

The EMA’s “products” are potentially life-saving or -preserving medicines, underlining the stakes if she cannot pull off this tricky balancing act.

Given the UK’s relatively small share of the global market for pharmaceuticals, there is a real risk that companies will choose to delay the launch of medicines on this side of the channel if they have to seek and secure a separate approval to sell medicines in Britain via the country’s own drugs regulator, the Medicines and Healthcare Products Regulatory Agency. Were that to happen, the venerable geopolitical metaphor could become reality: Britons could find themselves the sick men (and women) of Europe.

According to participants at a Downing Street meeting earlier this year with Japanese companies that undertake significant inward investment in the UK, ministers at the summit spoke of the government’s determination that the MHRA should not become “a fourth agency”, after the EMA, the Food and Drug Administration in the US and the Japanese regulator: in other words, a body by which medicines would have to be separately approved because no form of mutual recognition had been agreed between the UK and the other agencies.

Some within the pharma industry have privately warned that in those circumstances, the MHRA would be likely to be “deprioritised” by many companies.

MPs, however, are getting restive about the continuing lack of clarity over how exactly the proposed new relationship will work. The Commons health and social care committee last week raised concerns about the draft agreement hammered out between the UK and member states as part of agreeing a 21-month transition deal.

In a letter to Jeremy Hunt, health and social care secretary, they suggested that the deal had left the UK in a worse position than now, because it would have to continue to abide by EMA laws and regulations while no longer having any “formal method of engaging with the decision-making process of the EMA”.

Did this limit the UK to becoming entirely a “rule taker” rather than having any meaningful input during the transition period, they asked.

As the MPs outlined, the overarching issue is how the UK would negotiate associate membership from a position, during the transition, that appears likely to be far less favourable than that to which they aspire post-Brexit.

They have asked Mr Hunt to say how the government will attempt to negotiate associate membership after the transition period “if, for the 21 months previously, the UK has accepted a significantly ‘worse’ deal from the EU?”

Such questions will only become more pressing in the coming weeks. For the industry, as it seeks to calculate how much it must invest in preparations for “third party” status, by replicating safety and quality functions on mainland Europe, the uncertainty is becoming increasingly irksome — and costly.

HDA UK Media And Political Bulletin – 9 April 2018

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