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HDA UK Media And Political Bulletin – 19 April 2018

Media and Political Bulletin

19 April 2018

Media Summary

Our view: Redistribution of UK’s portfolio of centrally authorised products

ABPI, 18 April 2018

 

The ABPI has responded to the European Medicines Agency (EMA) announcement that it has completed the reallocation of the medicines for which the UK’s national regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – is currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.

In response, Mike Thompson, chief executive of the ABPI, said:

“Given that the MHRA assesses up to 20 per cent of EU medicines, it is clearly in the EMA’s interest to continue to draw on its expertise.

“It would also be disadvantageous for the EU to be unaligned with the UK as the largest biopharmaceutical cluster outside of the US.

“The UK Government has been clear that cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health.”

 

 

Parliamentary Coverage

House of Commons – Tabled Written Questions: Health and Social Care, 18 April 2018

 

Tom Brake MP: To ask the Secretary of State for Health and Social Care, when he plans to publish the Government’s commissioned analysis by Ernst and Young of the effect of the UK leaving the EU on the medicines supply chain.

Tim Farron MP: To ask the Secretary of State for Health and Social Care, what steps his Department is taking to ensure that patients can promptly access drugs if the UK is no longer a member of the European Medicines Agency during any transition period after the UK leaves the EU.

Paul Blomfield MP: To ask the Secretary of State for Health and Social Care, what assessment he has made of the implications of the Medicines and Healthcare products Regulatory Agency being excluded from the European Medicines Agency during the implementation period after the UK leaves the EU.

Answered by Jackie Doyle- Price: During the implementation period, the United Kingdom will no longer be a Member State of the European Union, but market access will continue on current terms.

It will be in the interests of both sides for the UK to participate in some EU bodies and agencies, including the European Medicines Agency, during the implementation period – and the agreement we have reached allows for this.

The UK is fully committed to continuing the close working relationship with our European partners. As my Rt. hon. Friend the Prime Minister outlined in her Mansion House speech, we will want to make sure our regulators continue to work together and the UK is keen to explore with the EU the terms on which the UK could remain part of EU agencies that are critical for medicines and other industries after the implementation period.

Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.

Paul Blomfield MP: To ask the Secretary of State for Health and Social Care, whether the UK will remain a member of the European Medicines Agency during the implementation period after the UK leaves the EU.

Answered by Jackie Doyle- Price: During the implementation period, the United Kingdom will no longer be a Member State of the European Union, but market access will continue on current terms.

It will be in the interests of both sides for the UK to participate in some EU bodies and agencies, including the European Medicines Agency, during the implementation period – and the agreement we have reached allows for this.

The UK is fully committed to continuing the close working relationship with our European partners. As my Rt. hon. Friend the Prime Minister outlined in her Mansion House speech, we will want to make sure our regulators continue to work together and the UK is keen to explore with the EU the terms on which the UK could remain part of EU agencies that are critical for medicines and other industries after the implementation period.

Our aim is to ensure that patients in the UK and across the EU continue to be able to access the best and most innovative medicines and be assured that their safety is protected through the strongest regulatory framework and sharing of data.

 

Full Coverage

Our view: Redistribution of UK’s portfolio of centrally authorised products

ABPI, 18 April 2018

 

Last week, the European Medicines Agency (EMA) announced it has completed the reallocation of the medicines for which the UK’s national regulator – the Medicines and Healthcare products Regulatory Agency (MHRA) – is currently rapporteur or co-rapporteur appointed by the scientific committees to coordinate the evaluation of a medicine.

In response, Mike Thompson, chief executive of the ABPI, said:

“Given that the MHRA assesses up to 20 per cent of EU medicines, it is clearly in the EMA’s interest to continue to draw on its expertise.

“It would also be disadvantageous for the EU to be unaligned with the UK as the largest biopharmaceutical cluster outside of the US.

“The UK Government has been clear that cooperation on medicines is a priority and we urge both sides to come to an early agreement in the interest of patients and public health.”

The pharmaceutical industry’s priorities for the second phase of Brexit negotiations are:

Regulation: For the mutual benefit of patients and industry in the UK and the EU, the UK should seek to negotiate alignment and continued collaboration with the EU for the regulation of medicines

Trade: Due to the existing integrated nature of pan-European supply chains and to ensure continuity in medicines supply, the UK should seek to negotiate free and frictionless ​trade with the EU for pharmaceuticals and medical supplies

Science and innovation: The UK should seek to negotiate continued access to long-term European funding and collaboration programmes for science, such as Horizon 2020 and its successor

Access to talent: The UK should seek to negotiate an agreement with the EU that guarantees the rights of EU citizens already in the UK and facilitates the ease of movement for highly-skilled talent

HDA UK Media And Political Bulletin – 19 April 2018

From Factory to Pharmacy

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