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HDA UK Media And Political Bulletin – 17 January 2018

Media and Political Bulletin

17 January 2018

Media Summary

MHRA update to pharmaceutical companies on exit preparations

MHRA, 16 January 2018

 

The Medicines and Healthcare products regulatory agency has published an update for pharmaceutical companies on the status of preparations for exiting the European Union. This follows the formal agreement of the European Council on 15 January that sufficient progress has been made to move to the second stage of Brexit negotiations.

Companies have been asking the MHRA for details about UK legislative requirements in the event of different regulatory scenarios. The agency has highlighted that they have been working closely with industry associations and other stakeholders and further details on these issues will be published in due course.

The MHRA has reiterated that it is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019 and as such will continue to advise businesses on the basis of the UK position and will continue to work with the European Medicines Agency in planning for the UK’s withdrawal from the EU and future relationship.

 

Preparing for Brexit: ABPI’s reaction to MHRA update for pharma

ABPI, 17 January 2018

 

The ABPI has responded to the MHRA update to pharmaceutical companies on preparing for Brexit. In a statement, the ABPI has reaffirmed the importance of patient and public health in negotiations.

“Today’s statement from the MHRA is a welcome update for companies who are already actively making plans and taking decisions in advance of the UK’s departure from the EU.

We share the MHRA and the Government’s ambition for patients in the UK and EU to have continued access to best and most innovative medicines through a close working relationship with Europe, underpinned by the strongest regulatory framework and the sharing of data. This is an outcome we shall continue to work towards –  yet, if such cooperation is unable to be agreed we welcome the MHRA’s intent to take a pragmatic approach. Planning for this scenario does, however, require further detail, and further highlights why a realistic implementation period needs to be urgently agreed.

For patients and the public there are very real consequences of failing to get this right, and we will continue to work with our members, regulators, governments and the Commission to mitigate these risks. The complex issues surrounding medicines regulation and supply chain need to be front and centre in the second phase of talks.”

 

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

MHRA update to pharmaceutical companies on exit preparations

MHRA, 16 January 2018

 

Update on negotiations

The European Council formally agreed on 15 December that sufficient progress has been made to move on to the second stage of the negotiations, and adopted guidelines for that second phase.

This followed the publication of a Joint Report on progress during the first phase by the Government and the European Commission on 8 December.

These are important steps forward for both sides and demonstrate the shared interest in managing our exit smoothly, and in moving on with our negotiations.

In the context of ensuring continuity in the availability of goods placed on the market under Union law before withdrawal, the Joint Report makes clear that “goods placed on the market under Union law before the withdrawal date may freely circulate on the markets of the UK and the Union with no need for product modifications or re-labelling; be put into service where provided in Union law, and that the goods concerned should be subject to continued oversight.”

The guidelines set out the need for the EU and the UK to complete work on all withdrawal issues and to start drafting the Withdrawal Agreement. The UK looks forward to continuing these discussions.

The EU guidelines also acknowledge the proposal put forward by the UK for a time-limited implementation period, based on the existing structure of EU rules and regulations. The aim is for access to one another’s markets to continue on current terms throughout this period, and for it to be based on the existing structure of EU rules and regulations.

Both parties have recognised the importance of such a period in the interests of providing certainty and continuity to businesses and individuals, and the EU is expected to adopt additional negotiating directives on transitional arrangements in January 2018. The UK expects to be able to rapidly agree the detail with the EU in 2018.

Finally, the guidelines reconfirm the EU’s desire to establish a close future partnership with the UK. As the UK enters the second phase of negotiations, its position on medicines regulation remains clear. The UK is fully committed to continuing the close working relationship with its European partners, in the interests of public health and safety. Its 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.

Preparing for all outcomes

MHRA is aware that companies who market pharmaceuticals in the EU and UK will need to plan and make decisions in advance of the UK’s departure from the EU in March 2019.

As noted above, the UK’s intention remains to secure an implementation period based on the existing structure of EU rules and regulations as quickly as possible, and to agree a deep and special future partnership.

We will continue to advise businesses on the basis of the UK position and will continue to work with the European Medicines Agency in planning for the UK’s withdrawal from the EU and future relationship.

Current regulatory relationship between UK and European network

It is also important to note that the UK’s current regulatory relationship with the European network remains unchanged. The UK has underlined to Member States and to the EMA on several occasions that at present:

  • the UK continues to be a full member of the EU: we will fulfil our responsibilities, and, in turn expect to be treated as such.

  • the UK continues to bid for EMA work and expects its bids to be respected and considered on merit. There are simple, pragmatic solutions to manage the possibility of various outcomes in March 2019: we are, for example, putting forward UK bids in conjunction with other Member States, in the centralised procedure, to ensure business continuity where procedures are likely to run beyond this date.

MHRA have committed to complete all assessments under evaluation at the time that the UK departs from the EU and will make assessment reports available to the network.

  • the UK continues to carry out its Official Control Authority Batch Release (OCABR) responsibilities as part of the Official Medicines Control Laboratory (OMCL) network for human biologicals.

  • the UK will continue to put candidates forward for leadership roles where appropriate and expects the committees with responsibility for electing chairs to do so on merit.

UK regulatory requirements after March 2019 in the event of no ongoing relationship with EMA networks

Companies have been asking for detail about UK legislative requirements in different scenarios. We have been working closely with industry associations and other stakeholders and further details on all these issues and more – both our Day One and longer-term proposals – will be published when appropriate.

As stated above, the UK intends to agree a time-limited implementation period with the EU, and both parties have recognised its importance. Should however there be no implementation period, MHRA’s approach would be in line with the following principles:

the European Union (Withdrawal) Bill will convert the existing EU legislative framework into UK law at the moment of exit, so there would be no sudden changes to the UK regulatory framework.

We would be pragmatic in establishing UK regulatory requirements. We would give adequate notice and ensure that companies had sufficient time to implement any changed requirements.

Where possible, we would be making use of the information we already have to complete administrative tasks for continuity of work and licences.

We would ensure the minimum disruption and burden on companies as the UK exits the EU, while building on the existing relationship between MHRA and firms.

We will continue to engage with business, patient groups and other stakeholders to help plan ahead with certainty, and will look to publish more technical detail if appropriate.

Preparing for Brexit: ABPI’s reaction to MHRA update for pharma

ABPI, 17 January 2018

In December 2017 the European Council formally agreed sufficient progress had been made in the UK’s withdrawal from the European Union to move onto the second stage of negotiations. As our industry prepares for Brexit, the Medicines and Healthcare products Regulatory Agency (MHRA) has today published an update to pharmaceutical companies on exit preparations.

The ABPI – the trade group representing the pharmaceutical industry in the UK – has responded to the MHRA’s statement reiterating the importance of getting Brexit right:

“Today’s statement from the MHRA is a welcome update for companies who are already actively making plans and taking decisions in advance of the UK’s departure from the EU.

“We share the MHRA and the Government’s ambition for patients in the UK and EU to have continued access to best and most innovative medicines through a close working relationship with Europe, underpinned by the strongest regulatory framework and the sharing of data. This is an outcome we shall continue to work towards –  yet, if such cooperation is unable to be agreed we welcome the MHRA’s intent to take a pragmatic approach. Planning for this scenario does, however, require further detail, and further highlights why a realistic implementation period needs to be urgently agreed.

“For patients and the public there are very real consequences of failing to get this right, and we will continue to work with our members, regulators, governments and the Commission to mitigate these risks. The complex issues surrounding medicines regulation and supply chain need to be front and centre in the second phase of talks.”

HDA UK Media And Political Bulletin – 17 January 2018

From Factory to Pharmacy

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