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As ‘No Deal’ fears grow, pharma can’t rely on transition period

UK could still remain part of EMA 'club' until 2020 - but time is running out

The UK government has outlined how a transition deal would allow the life sciences sector to keep operating in the same way for 21 months after ‘Brexit day’ 29 March next year – but the industry can’t be sure this transition will ever be agreed.

The transition deal – or ‘implementation period’ as the government calls it – would extend up to December 2020, and would allow the UK to participate in all existing EMA and EU medicines regulations, across human and animal medicines and medical devices.

This would give companies a significantly longer lead time to make new arrangements – however the transition period is not definitively agreed, as it remains contingent on the draft withdrawal deal. In EU parlance, the phrase is 'nothing is agreed until everything is agreed' and that is why a no deal scenario is still a real possibility.

The growing threat of this for life sciences has been illustrated in recent days, with Sanofi the latest big pharma company letting it be known that it is stockpiling medicines in preparation for a no deal scenario from next March.

The UK industry association is maintaining a calm response to the ongoing uncertainty, but frustration in the sector is growing. This is not least because having to plan for two separate scenarios is diverting considerable time and resources from UK and European operations.

Sheuli Porkess

“Pharmaceutical companies need as much clarity as possible so they can continue to supply medicines to patients as the UK leaves the EU,"  said Dr Sheuli Porkess, Deputy Chief Scientific Officer for the ABPI.

She said the guidance from government was welcome, as was the reiteration of the UK’s preference for close co-operation with the EU across all aspects of medicines regulation.

She added: "There are still some unanswered questions. We are clear that there needs to be an implementation period but whether there will be one is still subject to negotiation. The document also states that the future role of the MHRA, whose expertise is vital, is also still being discussed.

Dr Porkess said the sector therefore had to plan “for all scenarios” including no deal, and reiterated the ABPI’s support close co-operation with the EU on medicines regulation.

However even if a transition period is agreed, the UK’s status with the EMA group will not be entirely the same:  it will be a ‘rule taker’ rather than a ‘rule maker’ as it will not have voting rights in EMA and EU committees.

What’s more, the UK’s agencies the MHRA and the VMD will not act as a ‘leading authority’ to conduct assessments, meaning their current position as central contributors to European regulation will end whatever the outcome.

Read the full UK government document here:  The Implementation Period: What It Means for the Life Sciences Sector

Article by
Andrew McConaghie

7th August 2018

From: Regulatory

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