Media And Political Bulletin – 18 July 2018

Media and Political Bulletin

18 July 2018

Media Summary

Brexit vote: Government defeats EU customs union bid

BBC News, 17 July 2018

The BBC reports on the fact that yesterday, the government lost a Commons vote on its Trade Bill on the regulation of medicines after Brexit.

MPs backed an amendment by 305 votes to 301 that would keep the UK in the European medicines regulatory network.

The 12 MPs that voted against the government on trade were: Heidi Allan, Guto Bebb, Ken Clarke, Jonathan Djanogly, Dominic Grieve, Stephen Hammond, Philip Lee, Nicky Morgan, Bob Neill, Antoinette Sandbach, Anna Soubry and Sarah Wollaston.

It was Dr Phillip Lee, who quit the government to speak out on Brexit, that put forward his own amendment to protect the links between the UK and the European Medicines Agency to ensure the smooth flow of medicines and new drugs for British patients after Brexit.

The vote on medicine regulation was only the government’s second defeat on Brexit in the House of Commons.

MPs voted for the UK to take “all necessary steps” to participate in the regulatory network operated by the European Medicines Agency after it leaves the EU.

Responding to the defeat, the government said: “We will now reflect on this amendment and seek to revisit in the Lords.”

Read the full debate here

Pharmaceutical industry responds to Trade Bill amendment on medicines

ABPI, Press Release, 17 July 2018

The ABPI has responded to a parliamentary vote yesterday which favoured an amendment to clause 17 to the Trade Bill that will make it a negotiating objective for the UK Government to seek the UK’s participation in the European medicines regulatory network.

In a joint statement on behalf of the pharmaceutical industry in the UK, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, said:

“Today, Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations. Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. Therefore, it is essential that the UK continues to participate in the EMA after Brexit, as set out in the Brexit White Paper and in the Prime Minister’s Mansion House speech.”

Parliamentary Coverage

House of Commons Tabled and Written Questions, 17 July 2018

Derek Thomas, MP: To ask the Secretary of State for Health and Social Care, pursuant to the Answer of 8 March 2018 to Question 130691, whether formal negotiations have begun on the next Pharmaceutical Price Regulation Scheme.

Answered by Steve Brine: The Government is committed to supporting the United Kingdom life sciences industry and ensuring that patients can access cost-effective innovative medicines and technologies at a price the National Health Service can afford. We have been listening to industry feedback and discussing how the medicines market is likely to evolve over the next five years. These discussions have now moved into a more formal phase and are commercially sensitive. The Government will update Parliament if and when agreement is reached. NHS England is involved in these negotiations.

Derek Thomas, MP: To ask the Secretary of State for Health and Social Care, what role will be played by NHS England in the re-negotiation of the Pharmaceutical Price Regulation Scheme.

Answered by Steve Brine: The Government is committed to supporting the United Kingdom life sciences industry and ensuring that patients can access cost-effective innovative medicines and technologies at a price the National Health Service can afford. We have been listening to industry feedback and discussing how the medicines market is likely to evolve over the next five years. These discussions have now moved into a more formal phase and are commercially sensitive. The Government will update Parliament if and when agreement is reached. NHS England is involved in these negotiations.

Derek Thomas, MP: To ask the Secretary of State for Health and Social Care, what broad topics are being considered for negotiation with industry on the successor to the current Pharmaceutical Price Regulation Scheme.

Answered by Steve Brine: The Government is committed to supporting the United Kingdom life sciences industry and ensuring that patients can access cost-effective innovative medicines and technologies at a price the National Health Service can afford. We have been listening to industry feedback and discussing how the medicines market is likely to evolve over the next five years. These discussions have now moved into a more formal phase and are commercially sensitive. The Government will update Parliament if and when agreement is reached. NHS England is involved in these negotiations.

Full Coverage

Brexit vote: Government defeats EU customs union bid

BBC News, 17 July 2018

The government has survived an attempt by pro-EU Conservative MPs to change its post-Brexit trade strategy.

The MPs wanted the UK to join a customs union if it does not agree a free-trade deal with the EU.

But the government, which says a customs union would stop it striking new trade deals, won by 307 to 301.

Ahead of the vote, Tory MPs were told a defeat would lead to a vote of no confidence in the government, sources told the BBC’s John Pienaar.

The government did, however, lose a separate vote on its Trade Bill on the regulation of medicines after Brexit.

MPs backed an amendment by 305 votes to 301 that would keep the UK in the European medicines regulatory network.

There were 12 Tory rebels in both the customs and medicines votes – but the government’s total was boosted by four Labour MPs in the customs vote.

The customs union allows for tariff-free trading between members with a common tariff set for imports from the rest of the world.

The UK is due to leave the EU on 29 March 2019 but the two sides have yet to agree how their final trading relationship will work.

The Commons has been debating two pieces of legislation – on customs and trade – and there have been several attempts to change them by both pro-Brexit and pro-EU MPs.

The latest key vote was on customs, with a debate sparked by Tory MP Stephen Hammond’s amendment to the Trade Bill.

It stated that if a free trade area had not been negotiated by 21 January, ministers must change tack and start discussions on joining a customs union.

Labour backs the idea of a customs union with the EU after Brexit – but the government says this would mean the UK is unable to strike its own international trade deals.

During the debate on the Trade Bill, a minister tried to persuade Mr Hammond and his supporters to back down, promising to deal with the “essence” of their concerns when the bill goes to the House of Lords.

Although this was rejected by Mr Hammond, the government won the vote and the bill was later approved by the House of Commons.

The 12 MPs that voted against the government on customs and trade were: Heidi Allan, Guto Bebb, Ken Clarke, Jonathan Djanogly, Dominic Grieve, Stephen Hammond, Philip Lee, Nicky Morgan, Bob Neill, Antoinette Sandbach, Anna Soubry and Sarah Wollaston.

On the other side, four Labour MPs voted with the government: Frank Field, Kate Hoey, John Mann, and Graham Stringer.

Lib Dem leader Sir Vince Cable and his predecessor Tim Farron – who were criticised after missing Monday night’s knife-edge Brexit votes – were back at Westminster and voted against the government.

But a former Lib Dem minister, Jo Swinson, complained that Tory MP Brandon Lewis participated in the votes despite having agreed to abstain.

Ms Swinson, a Remain supporter who has recently given birth and was unable to vote, tweeted Mr Lewis did not keep to their arrangement to balance out her effective abstention – known as “pairing” – and accused the government of “desperate stuff”.

Laura Kuenssberg’s analysis

They didn’t escape defeat for long.

Having squeaked through last night the government was beaten for only the second time ever in the Commons on key Brexit legislation.

And guess what, it was on a vote they didn’t expect to lose – Dr Phillip Lee, who quit the government to speak out on Brexit, put forward his own amendment to protect the links between the UK and the European Medicines Agency to ensure the smooth flow of medicines and new drugs for British patients after Brexit.

And he had enough to support to win it, just. An embarrassment for the government certainly.

It is another reminder of how difficult it is for Theresa May to get her way in the House of Commons where she doesn’t have her own majority.

It is serious. A defeat is a problem. But it wasn’t a complete disaster tonight for two reasons.

First, the amendment isn’t a million miles away from the government’s own policy. While not straightforward, the vote hasn’t forced a screeching U-turn.

The more important reason is that the vote that followed, on keeping the UK in a customs union, went the other way.

The medicines vote explained

The vote on medicine regulation was only the government’s second defeat on Brexit in the House of Commons.

MPs voted for the UK to take “all necessary steps” to participate in the regulatory network operated by the European Medicines Agency after it leaves the EU.

The agency, which evaluates and supervises medicines and helps national authorities authorise the sale of drugs across the EU, is currently based in London but is moving to Amsterdam after Brexit.

There have been warnings that Brexit may cause delays in UK patients getting new drugs.

The government says it is “seeking participation” in the agency after Brexit and would make an “appropriate financial contribution” in return.

But it has not agreed to take “all necessary steps” to secure this.

Responding to the defeat, the government said: “We will now reflect on this amendment and seek to revisit in the Lords.”

Pharmaceutical industry responds to Trade Bill amendment on medicines

ABPI, Press Release, 17 July 2018

Parliament has voted in favour of amendment NC17 to the Trade Bill that will make it a negotiating objective for the UK Government to seek the UK’s participation in the European medicines regulatory network.

n a joint statement on behalf of the pharmaceutical industry in the UK, Mike Thompson, chief executive of the Association of the British Pharmaceutical Industry, and Steve Bates, chief executive of the BioIndustry Association, said:

“Today, Parliament has sent a clear message that patients and public health should be a top priority for the Government in these negotiations. Every month, 37 million packs of medicine arrive in the UK from the EU and 45 million move the other way. Therefore, it is essential that the UK continues to participate in the EMA after Brexit, as set out in the Brexit White Paper and in the Prime Minister’s Mansion House speech.”

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”.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

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.

Media and Political Bulletin

4 April 2018

Media Summary

Health and Social Care Committee seek clarity on Brexit

26 March 2018  

 

Dr Sarah Wollaston, Chair of the Health and Social Care Committee has written to Jeremy Hunt seeking further clarity following the publication on 19th March of the Draft Agreement on the withdrawal of the UK from the EU and the European Atomic Energy Community.

This letter follows a letter sent by the Committee to the Health and Social Care Secretary on 15th February regarding Brexit transitional arrangements and also the publication of the Fourth Report of the Health and Social Care committee on Brexit: medicines, medical devices and substances of human origin.

The letter concentrates on three core issues:

  • Whether the UK will continue to have a meaningful role in shaping future policy within the EMA
  • If ‘associate membership’ of EU agencies is a realistic ambition
  • Assurances of stakeholder scrutiny and Government transparency post-Brexit

To read the letter in full, please follow this link.

 

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

 Health and Social Care Committee seek clarity on Brexit

26 March 2018  

 

Dr Sarah Wollaston, Chair of the Health and Social Care Committee has written to Jeremy Hunt seeking further clarity following the publication on 19th March of the Draft Agreement on the withdrawal of the UK from the EU and the European Atomic Energy Community.

This letter follows a letter sent by the Committee to the Health and Social Care Secretary on 15th February regarding Brexit transitional arrangements and also the publication of the Fourth Report of the Health and Social Care committee on Brexit: medicines, medical devices and substances of human origin.

The letter concentrates on three core issues:

  • Whether the UK will have a meaningful role in shaping future policy within the EMA
  • If ‘associate membership’ of EU agencies is a realistic ambition
  • Assurances of stakeholder scrutiny and Government transparency post-Brexit

To read the letter in full, please follow this link.

Media and Political Bulletin

7 March 2018

Media Summary

PM says UK should try to remain a member of the EMA after Brexit

The Pharmaceutical Journal, 6 March 2018

 

The Pharmaceutical Journal reports on the Prime Minister’s Brexit speech on 2 March. In Theresa May’s speech on 2 March 2018, billed as her vision for the future economic partnership between the UK and the European Union, she spoke of her commitment to seeking for the UK to remain part of “critical” EU agencies, including the EMA.

“Membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations,” she said.

“But it would also be good for the EU because the UK regulator assesses more new medicines than any other member state. And the EU would continue to access the expertise of the UK’s world-leading universities.”

May said the government would “explore with the EU, the terms on which the UK could remain part of EU agencies” including the EMA.

And she said: “We would, of course, accept that this would mean abiding by the rules of those agencies and making an appropriate financial contribution.”

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

PM says UK should try to remain a member of the EMA after Brexit

The Pharmaceutical Journal, 6 March 2018

The UK should seek to remain a member of the European Medicines Agency (EMA), the Prime Minster has said.

In her speech on 2 March 2018, billed as her vision for the future economic partnership between the UK and the European Union (EU), Theresa May spoke of her commitment to seeking for the UK to remain part of “critical” EU agencies, including the EMA.

“Membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations,” she said.

“But it would also be good for the EU because the UK regulator assesses more new medicines than any other member state. And the EU would continue to access the expertise of the UK’s world-leading universities.”

May said the government would “explore with the EU, the terms on which the UK could remain part of EU agencies” including the EMA.

And she said: “We would, of course, accept that this would mean abiding by the rules of those agencies and making an appropriate financial contribution.”

Government ministers had previously stated that they wanted a post-Brexit UK to “work closely” with the EMA.

Niall Dickson, co-chair of the Brexit Health Alliance, which represents many UK healthcare organisations, including the NHS Confederation, the Academy of Medical Royal Colleges, and the Association of the British Pharmaceutical Industry, said it was “good to hear the desire to remain part of the European Medicines Agency, to abide by its rules, and make appropriate financial commitments”.

“That is the best way to make sure patients have quick access to the drugs and treatments they need,” he said.

British Medical Association treasurer, Andrew Dearden commented that he was “pleased” to see that the government wanted to explore associate membership of the EMA.

“We want to see the government work closely with the EMA through a formal agreement to continue to support and participate in their assessments for medicines approvals,” he said.

Steve Bates, chief executive of the BioIndustry Association, which represents the UK bioscience industry, remarked: “It’s good to see the PM articulating the practical dynamics of our industry of the future, when she said in her speech that membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK, and it would mean these medicines getting to patients faster as firms prioritise larger markets when they start the lengthy process of seeking authorisations.”

Media and Political Bulletin

5 March 2018

Media Summary

The pharmaceutical industry response to the Prime Minister’s ‘Road to Brexit’ speech

ABPI, 2 March 2018

 

The ABPI has responded to the ‘Road to Brexit’ speech by Prime Minister Theresa May on 2 March. In the speech the Prime Minister outlined that “UK and EU regulatory standards will remain substantially similar in the future” and that “membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK”.

Reacting to the speech, Chief Executive of the ABPI, Mike Thompson said:

“Every month, 45 million packs of medicines move from the UK to the EU – and 37 million come the other way. That is why the Prime Minister’s commitment to seek cooperation on medicines regulation would be the best outcome for patients, not just in the UK but across Europe.

“It’s now critical that both sides prioritise patient safety in phase two of the negotiations. Delivering close cooperation on the regulation of medicines is only one part of the challenge. Making sure the supply of medicines is uninterrupted is essential to ensure patients in the UK and EU can get the medicines they need from day one of Brexit.”

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

The pharmaceutical industry response to the Prime Minister’s ‘Road to Brexit’ speech

ABPI, 2 March 2018

In today’s speech, the Prime Minister outlined that “UK and EU regulatory standards will remain substantially similar in the future” and that “membership of the European Medicines Agency would mean investment in new innovative medicines continuing in the UK”.

Reacting to the speech, Chief Executive of the ABPI, Mike Thompson said:

“Every month, 45 million packs of medicines move from the UK to the EU – and 37 million come the other way. That is why the Prime Minister’s commitment to seek cooperation on medicines regulation would be the best outcome for patients, not just in the UK but across Europe.

“It’s now critical that both sides prioritise patient safety in phase two of the negotiations. Delivering close cooperation on the regulation of medicines is only one part of the challenge. Making sure the supply of medicines is uninterrupted is essential to ensure patients in the UK and EU can get the medicines they need from day one of Brexit.”

The pharmaceutical industry’s policy priorities for Brexit are:

Securing a transition period. This should be a single-step transition that adequately reflects the time needed by pharmaceutical companies to transition to a new framework.

Securing co-operation with the EU on the regulation of medicines. This should achieve alignment between the UK and EU regulatory framework, to deliver proportionate, robust and effective regulation of medicines in the UK.

Securing the ability to freely trade and move medicines and pharmaceutical supplies across borders. This should be ‘frictionless’ and include access to free trade agreements already in place between third countries and the EU.

Securing access to the best talent. This should achieve an immigration system which allows global pharmaceutical companies to attract and transfer talented and skilled students, scientists and other professionals from around the world.

Securing predictable access to funding and collaboration for scientific research. This should achieve agreements on existing and future funding and collaboration opportunities such as Horizon 2020 (and its successor), including the Innovative Medicines Initiative. UK life science entrepreneurs should also be able to access the European Investment Bank and European Investment Fund.

Media and Political Bulletin

8 February 2018

Media Summary

Swift deal on EU transition is vital, says Glaxo chief

The Times, Alexandra Frean, 8 February 2018

 

The Times reports that the Head of Glaxosmithkline has urged the government to sign a two-year Brexit transition deal within two months to minimise disruption to medicine supplies.

Emma Walmsley also called for zero tariffs and minimal customs procedures after Britain leaves the European Union so that drug makers could be sure of “getting the right medicines to the patients”.

“The most important thing is that we get a transition period of at least two years, starting from March 2019, but . . . secured by April 2018, and we need to make sure that the negotiations that are ongoing are very clearly focused on patient safety and the continued supply of medicines to patients,” Ms Walmsley said yesterday.

 

Parliamentary Coverage

House of Commons Tabled Written Question – NHS: Drugs, 7 February 2018

Jonathan Edwards: To ask the Secretary of State for Health and Social Care, what assessment he has made of the effect of leaving the EU on access to existing medicines in the NHS.

Jackie Doyle-Price: The United Kingdom is fully committed to continuing the close working relationship with our European partners, and as part of the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation (including with the European Medicines Agency).

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. Whatever the outcome of Brexit negotiations, we are clear that our regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

We are in regular contact with the pharmaceutical industry through the Ministerial and industry co-chaired UK-European Union Life Sciences Steering Group. Outside of this group we have consistent contact with industry and research charities.

As a member of the Cabinet, the Secretary of State has regular discussions with all Cabinet colleagues, including on Brexit.

House of Commons Tabled Written Question – NHS: Drugs, 7 February 2018

Jonathan Edwards: To ask the Secretary of State for Health and Social Care, what discussions he has had with the Secretary of State for Exiting the European Union on access to medicines (a) in the event of a no deal Brexit and (b) during a transitionary period.

Jackie Doyle-Price: The United Kingdom is fully committed to continuing the close working relationship with our European partners, and as part of the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation (including with the European Medicines Agency).

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. Whatever the outcome of Brexit negotiations, we are clear that our regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

We are in regular contact with the pharmaceutical industry through the Ministerial and industry co-chaired UK-European Union Life Sciences Steering Group. Outside of this group we have consistent contact with industry and research charities.

As a member of the Cabinet, the Secretary of State has regular discussions with all Cabinet colleagues, including on Brexit.

House of Commons Tabled Written Question – European Medicines Agency, 7 February 2018

Jonathan Edwards: To ask the Secretary of State for Health and Social Care, what assessment he has made of the benefits to the UK of remaining in the EU Medicines Agency after the UK has left the EU.

Jackie Doyle-Price: The United Kingdom is fully committed to continuing the close working relationship with our European partners, and as part of the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation (including with the European Medicines Agency).

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. Whatever the outcome of Brexit negotiations, we are clear that our regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

We are in regular contact with the pharmaceutical industry through the Ministerial and industry co-chaired UK-European Union Life Sciences Steering Group. Outside of this group we have consistent contact with industry and research charities.

As a member of the Cabinet, the Secretary of State has regular discussions with all Cabinet colleagues, including on Brexit.

House of Commons Tabled Written Question – Drugs: EU Law, 7 February 2018

Jonathan Edwards: To ask the Secretary of State for Health and Social Care, what discussions he has had with the Secretary of State for Exiting the European Union on the UK remaining in the EU Medicines Agency and complying with EU regulations for medicines after the UK leaves the EU.

Jackie Doyle-Price: The United Kingdom is fully committed to continuing the close working relationship with our European partners, and as part of the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation (including with the European Medicines Agency).

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. Whatever the outcome of Brexit negotiations, we are clear that our regulatory system that protects the best interests of patients and supports the UK life science industry to go from strength to strength.

We are in regular contact with the pharmaceutical industry through the Ministerial and industry co-chaired UK-European Union Life Sciences Steering Group. Outside of this group we have consistent contact with industry and research charities.

As a member of the Cabinet, the Secretary of State has regular discussions with all Cabinet colleagues, including on Brexit.

Full Coverage

Swift deal on EU transition is vital, says Glaxo chief

The Times, Alexandra Frean, 8 February 2018

 

The head of Glaxosmithkline has urged the government to sign a two-year Brexit transition deal within two months to minimise disruption to medicine supplies.

Emma Walmsley also called for zero tariffs and minimal customs procedures after Britain leaves the European Union so that drug makers could be sure of “getting the right medicines to the patients”.

“The most important thing is that we get a transition period of at least two years, starting from March 2019, but . . . secured by April 2018, and we need to make sure that the negotiations that are ongoing are very clearly focused on patient safety and the continued supply of medicines to patients,” Glaxo’s chief executive said yesterday.

Glaxo is Britain’s biggest drugs manufacturer, employing almost 100,000 people worldwide, and is an important contributor to the domestic economy and research and medicine.

Ms Walmsley, a former L’Oréal manager who joined as chief executive last April, has emphasised that the company’s pharmaceuticals business and research and development should be its top priority under her leadership.

She has attended the prime minister’s business advisory council and has been outspoken on Brexit, repeatedly talking of the importance of a transition period to help Britain to adjust after it officially leaves the EU in March 2019 but before the permanent arrangements for UK-EU relations kick in.

Although the impact of Brexit on Glaxo’s overall business will not be material, as Britain accounts for only 4 per cent of sales, drugs companies are particularly affected by Brexit because their business is highly regulated. Ms Walmsley called for mutual agreements between the UK and the EU to avoid duplication of regulatory procedures and full co-operation with the European Medicines Agency.

In its first annual results since Ms Walmsley took over, Glaxo reported an 8 per cent rise in revenue to more than £30 billion, for the first time and better than expected. Pre-tax profits rose by 82 per cent to £3.5 billion in the 12 months to December 31.

Glaxo warned that its earnings could slip this year in the face of increased competition in its core respiratory and HIV businesses, particularly if generic copies of its Advair inhaler, which accounts for 10 per cent of group sales, are launched in the American market by mid-year, as many analysts expect.

However, Ms Walmsley said she was optimistic that Glaxo would deliver on a promise of mid to high-single-digit earnings growth in the five years to 2020.

“Given the momentum we are seeing in our new products and recent launches, the performance improvements we are driving and the benefit of US tax reform, we are increasingly confident in our ability to drive growth over the next few years,” she said.

She added that the company would pay a dividend of 80p for the full year and expected the same figure for 2018.

Nicholas Hyett, an analyst at Hargreaves Lansdown, the broker, said that although Advair sales were holding up better than expected, the looming increase in competition remained a ticking time bomb under the group. “If a generic makes it to market early next year, it will blow a hole in the Glaxo income statement,” he said.

Glaxo’s shares, which have fallen by nearly 18 per cent in the past 12 months, rose 3.4 per cent to close at £12.85½.

Media and Political Bulletin

2 February 2018

Media Summary

EMA admits temporary Amsterdam home ‘not optimal solution’

The Pharmaceutical Journal, 1 February 2018

 

The Pharmaceutical Journal reports that initial plans for a temporary building to house the European Medicines Agency (EMA) after it moves to Amsterdam have been shelved after it was concluded that the intended accommodation was not “fully fit for purpose”, EMA executive director, Guido Rasi, has said.

Rasi said Dutch authorities had been asked to find an alternative to the EMA’s proposed temporary home and while a decision on new premises had taken “longer than expected” new short-term accommodation had now been found.

But he admitted that the temporary premises were still “not an optimal solution” as they would only provide half the space currently available in the EMA’s London location. As a result, external facilities will need to be used for anything other than “core scientific meetings”.

 

Parliamentary Coverage

Department of Health and Social Care – European Medicines Agency, 1 February 2018

Virendra Sharma: To ask the Secretary of State for Health and Social Care, what assessment his Department has made of the effect of the UK’s withdrawal from the European Medicines Agency on the UK health sector.

Jackie Doyle-Price: We recognise the important role that the European Medicines Agency plays in the protection of human and animal health.

In negotiations, the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation in the best interests of both the United Kingdom and the EU.

The UK is fully committed to continuing the close working relationship with our European partners. 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. As the Prime Minister has stated, we want deep, broad and dynamic co-operation and in this context, the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety.

Full Coverage

EMA admits temporary Amsterdam home ‘not optimal solution’

The Pharmaceutical Journal, 1 February 2018

 

Initial plans for a temporary building to house the European Medicines Agency (EMA) after it moves to Amsterdam have been shelved after it was concluded that the intended accommodation was not “fully fit for purpose”, EMA executive director, Guido Rasi, has said.

Rasi said Dutch authorities had been asked to find an alternative to the EMA’s proposed temporary home and while a decision on new premises had taken “longer than expected” new short-term accommodation had now been found.

But he admitted that the temporary premises were still “not an optimal solution” as they would only provide half the space currently available in the EMA’s London location. As a result, external facilities will need to be used for anything other than “core scientific meetings”.

“We are working against extremely tight deadlines,” said Rasi.

“On 1 January 2019 we need a fully operational building in order to move our staff gradually from London to Amsterdam before 30 March 2019, when the UK withdraws from the EU. That means that even if these temporary premises are not ideal, they are the best option under the current time restrictions.”

In his statement, Rasi explained that the double transfer will force the EMA to invest more resources and means it will take the organisation longer to get back to “normal operations”.

However he assured that the EMA would do its utmost to make the double move work.

The planned move to Amsterdam from the EMA’s current Canary Wharf headquarters had always included temporary accommodation while the organisation’s new permanent home, the Vivaldi Building, was completed.

An internal survey carried out in 2017 showed that 81% of EMA staff would be willing to move to Amsterdam. Among the 19 EMA candidate cities Amsterdam scored highest in terms of staff retention.

However, a spokesperson for the EMA said it was still too early to determine exactly how many staff would relocate.

“Staff are encouraged to reflect on whether they would relocate with the Agency and one-on-one meetings will be held to get a clearer picture of people’s plans by the end of February,” they said.

Media and Political Bulletin

29 January 2018

Media Summary

EMA surveys pharma companies on their preparedness for Brexit

European Pharmaceutical Review, Zara Kassam, 26 January 2018

 

The European Pharmaceutical Review reports that the EMA is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

The EMA is consulting marketing authorisation holders of centrally authorised medicines that are located in the UK, or who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilance(QPPV) or pharmacovigilance system master file (PSMF) in the UK, on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of the UK’s withdrawal from the European Union (EU).

The aim of the survey is to identify those companies where there is a need for concerted action to address medicines supply concerns due to Brexit in order to protect human and animal health, and secondly to help the Agency and the European Commission plan resources in the areas where these submissions will be processed.

 

Last year ‘worst ever’ for NHS medicines shortages – expert

Pharmaphorum, Richard Staines, 25 January 2018

 

Pharmaphorum highlights that last year was one of the worst years for medicines shortages for NHS patients, and that the situation is unlikely to improve, according to senior health service figure.

The Medicines for Europe conference heard that shortages of previously abundant generic drugs is an issue throughout the continent. A perfect storm of pricing pressures, increasing costs, and procurement policy is causing issues across the EU, with countries such as Portugal, Romania and Estonia being the worst hit.

Maggie Dolan, regional pharmacy procurement specialist at NHS Commercial Solutions, said the UK issues had been caused by an industry-led legal challenge to the health service’s procurement of drugs.

Dolan told the conference in London: “In the UK 2017 was the worst year we have ever had in terms of generic medicines shortages.”

 

 

Government has commissioned external analysis of Brexit impact on UK medicines supply chain, MPs told

The Pharmaceutical Journal, Debbie Andalo, 25 January 2018

 

The Pharmaceutical Journal reports that the government has commissioned an analysis by professional services consultants Ernst and Young (EY) into the impact of Brexit on the UK medicines supply chain. The results of the investigation, which will include talks with drug manufacturers who have already revealed they are spending millions of pounds preparing for the UK leaving the European Union (EU), may however, remain secret because the information could be commercially sensitive.

Details of the external scrutiny were revealed to the House of Commons health select committee at its continuing inquiry into the impact of Brexit on the UK’s medicines supply chain. Health and social care secretary Jeremy Hunt, appearing before the committee, impressed on MPs the importance of protecting the supply chain during the current Brexit negotiations.

 

Parliamentary Coverage

 

There is no parliamentary coverage today.

 

Full Coverage

EMA surveys pharma companies on their preparedness for Brexit

European Pharmaceutical Review, Zara Kassam, 26 January 2018

 

The EMA is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health…

EMA surveys

The European Medicines Agency (EMA) is launching a survey to gather information from companies on their Brexit preparedness plans and identify any particular concerns with regard to medicines supply that may impact public or animal health.

EMA is consulting marketing authorisation holders of centrally authorised medicines that are located in the United Kingdom (UK), or who have quality control, batch release, and/or import manufacturing sites or a qualified person for pharmacovigilance(QPPV) or pharmacovigilance system master file (PSMF) in the UK, on their plans to submit transfers, notifications or variations to their marketing authorisations in the context of the UK’s withdrawal from the European Union (EU).

The aim of this survey is twofold. Firstly, to identify those companies where there is a need for concerted action to address medicines supply concerns due to Brexit in order to protect human and animal health, and secondly to help the Agency and the European Commission plan resources in the areas where these submissions will be processed. Information from the survey will also be used to inform next steps in Brexit preparedness for EMA, the European Commissions and the European medicines regulatory network.

The survey is being sent directly to holders of a centralised marketing authorisation for human and veterinary medicines who are located in the UK, or who have an important part of their site operations in the country. The deadline for completion of the questionnaire is 9 February 2018.

The survey will also serve to stimulate those companies who have not yet taken any action to start planning for any regulatory steps required for their centrally authorised products to remain on the EU market post-Brexit in order to minimise disruption to medicines supply and avoid shortages.

Findings and recommendations from the survey will be shared with the European Commission and presented to EMA’s Management Board. A high-level summary of the overall results of the survey will be published on the EMA website.

Further surveys may be carried out by the EU national competent authorities in relation to nationally authorised products. Companies should check EMA’s dedicated webpage regularly for guidance on the consequences of Brexit.

Last year ‘worst ever’ for NHS medicines shortages – expert

Pharmaphorum, Richard Staines, 25 January 2018

Last year was one of the worst years for medicines shortages for NHS patients, and the situation is unlikely to improve, a senior health service figure has said.

The Medicines for Europe conference heard that shortages of previously abundant generic drugs is an issue throughout the continent.

A perfect storm of pricing pressures, increasing costs, and procurement policy is causing issues across the EU, with countries such as Portugal, Romania and Estonia the worst hit.

Maggie Dolan, regional pharmacy procurement specialist at NHS Commercial Solutions, said the UK issues had been caused by an industry-led legal challenge to the health service’s procurement of drugs.

The shortages are affecting products such as analgesics, anaesthetics and antibiotics which have been available for years.

Dolan told the conference in London: “In the UK 2017 was the worst year we have ever had in terms of generic medicines shortages.”

Dolan was unable to provide figures about the problem because the NHS is so busy fire-fighting the problem, but she said the shortages are occurring across different drug types.

Procurement had previously based around ensuring that at least three companies were included on tenders for drugs, a system that ensured that there are at least two other suppliers who could step in should shortages occur.

But since the legal challenge around two years ago, Dolan said NHS legal experts said the arrangements were not legal, giving rise to an increasing number of tenders with a single supplier.

She warned that there is no end in sight, as procurement laws prevent the NHS from managing supply of drugs across different contracts.

Dolan said: “What we have seen in 2017 and 2018 is we have more and more single responses to tenders for molecules in the generic space. That is proving very challenging.”

But it is not just procuring drugs that is causing problems – in some cases there are issues with supplies of ingredients that are having a knock-on effect on the supply of certain products.

These range from the unpredictable issues such as factories burning down, to an industry’s approach to manufacturing which is increasingly based around contracting out production to external suppliers.

Representatives of the generics and biosimilars industry at the conference said that the only way to solve the problems was through joint working to resolve the many issues that are causing the patchy supply of drugs.

Marc-Alexander Mahl, president of Medicines for Europe, which represents biosimilars and generics manufacturers, said regulations such as the falsified medicines directive and expensive anti-tamper safety features are driving up costs.

At the same time the rock-bottom prices demanded by government tenders in some countries mean it is not economical to supply drugs in those areas.

One of the most shocking examples is Romania, where according to Mahl generics firms have pulled around 2,000 drug products from the market because of the government’s aggressive pricing demands in tenders.

And Kristin Raudsepp, chair of a task force from European regulators created to tackle the issue, also called for joint working from regulators, industry and government to solve the problem.

Government has commissioned external analysis of Brexit impact on UK medicines supply chain, MPs told

The Pharmaceutical Journal, Debbie Andalo, 25 January 2018

The government has commissioned an analysis by professional services consultants Ernst and Young (EY) into the impact of Brexit on the UK medicines supply chain, MPs on the Health Select Committee were told on 23 January 2018.

The results of the investigation, which will include talks with drug manufacturers who have already revealed they are spending millions of pounds preparing for the UK leaving the European Union (EU), may however, remain secret because the information could be commercially sensitive, MPs were told.

Details of the external scrutiny were revealed to the House of Commons health select committee at its continuing inquiry into the impact of Brexit on the UK’s medicines supply chain.

Health and social care secretary Jeremy Hunt, appearing before the committee, impressed on MPs the importance of protecting the supply chain during the current Brexit negotiations.

He said: “We need to make sure that there is continuity for the supply chain … that will all be part of the different scenarios that we are preparing for.”

Hunt said he was confident about reaching a successful transition agreement with the EU, which would protect both the supply chain and UK patients’ access to drugs.

“It is uniquely damaging to both parties if we don’t come to an agreement … that gives me a lot of confidence that we will ultimately agree what needs to be agreed,” he said.

“It is an absolute priority to make sure that access to new drugs does not slow down as a result of Brexit,” he said.

“We are confident that we can avoid that. When it comes to importing drugs from overseas we are the customers. It would be against our national interest to make it harder to import life-saving drugs.”

Hunt was responding to concerns from MPs who were keen to discover whether the government had carried out any analysis into the risks that Brexit posed for the life sciences industry and for patients, and what measures had been put in place to minimise those risks.

They also asked about any government contingency plans for the possibility of a no-deal — especially if it happened at the last minute.

They wanted Hunt to spell out the impact of Brexit on the government’s life science strategy, the medicines supply chain and what it expected its future relationship to be with the European medicines safety watchdog, the European Medicines Agency.

Hunt reiterated the government’s position statement on medicines regulation post-Brexit.

He told MPs that negotiators were seeking a deal that offered regulatory alignment but “with a different legal structure under it.” He said: “That is the case that we will be making to the EU; that would be our most preferred outcome.”

He said that there was no “intellectual problem or incompatibility” to having “close regulatory alignment” in the long term post-Brexit: “The issue is the legal underpinning to that.”

But, he said, staying in the single market and in the customs union was not an option: “I don’t think that is compatible with what the British people voted for … But I think we can have close regulatory alignment and still be outside the single market. It’s entirely possible.”

Dr Ian Hudson, chief executive of the UK’s medicines safety watchdog the Medicines and Healthcare products Regulatory Agency (MHRA) told MPs he was confident that the UK’s contribution to potentially ground-breaking clinical trials would continue post-Brexit.

Hudson explained that the country could still be involved in multi-national clinical trials regardless of the outcome of Brexit talks, provided it continued to observe agreed protocols and went through the necessary approval process.

“Our ability to run a multinational trial involving the UK doesn’t change,” he said.

“The mechanism for that approval may change but the ability to do it does not change.”

Media and Political Bulletin

8 January 2018

Media Summary

UK in push to remain part of EU medicines agency after Brexit

Financial Times, George Parker, Sarah Neville, Jim Pickard, 8 January 2018

The Financial Times reports that Britain is pushing to remain under EU regulation for medicines after Brexit. The publication highlights that this is the latest sign that ministers want to stay close to Europe in some sectors despite the bloc warning the UK that it cannot “cherry-pick” parts of the single market.

Three senior government figures have told the Financial Times that the UK hopes to be regulated by the European Medicines Agency, even as the body moves from London’s Canary Wharf to a new post-Brexit home in Amsterdam.

Pharma industry leaders have warned of the consequences for patients in both the UK and Europe if some form of regulatory harmonisation cannot be achieved. Around 45 million packs of medicines are supplied from the UK to other European countries each month, while more than 37 million packs come from Europe to the UK.

Commons Science and Technology Committee to hold summit on Brexit and scientific innovation

The Pharmaceutical Journal, 5 January 2018

The Pharmaceutical Journal underlines that the House of Commons Science and Technology Committee is to host a summit on how Brexit will affect the future of scientific innovation in the UK.

The summit will focus on the risks Brexit could produce for the sector, as well as possible opportunities. The committee is currently asking for written submissions and inviting interested parties to take part in the summit itself.

The committee wants to hear views on the advantages, disadvantages and uncertainties for science, research and innovation following the outcome of initial Brexit discussions; the government’s future partnership paper ‘Collaboration on science and innovation’; the UK’s future participation in EU research programme, Horizon 2020; and whether recently agreed science co-operation deals with non-EU countries represent a good model for collaboration with other countries post-Brexit.

Parliamentary Coverage

There is no parliamentary coverage today.

Full Coverage

UK in push to remain part of EU medicines agency after Brexit

Financial Times, George Parker, Sarah Neville, Jim Pickard, 8 January 2018

Britain is pushing to remain under EU regulation for medicines after Brexit in the latest sign that ministers want to stay close to Europe in some sectors despite the bloc warning the UK cannot “cherry-pick” parts of the single market.

The move follows calls for the UK’s chemicals and aviation industries to continue to be regulated by EU agencies, keeping them within Europe’s standards and safety regime and under the auspices of the European Court of Justice.

Three senior government figures have told the Financial Times that the UK hopes to be regulated by the European Medicines Agency, even as the body moves from London’s Canary Wharf to a new post-Brexit home in Amsterdam.

Greg Clark, business secretary, is also backing demands from Britain’s chemicals sector to stay within the EU’s Chemicals Agency, while Chris Grayling, transport secretary, last month told the aviation industry Britain would continue to be regulated by the EU after Brexit.

The proposals would put parts of the British economy under the indirect jurisdiction of the ECJ, threatening to breach “red lines” set out by Theresa May in her October 2016 Tory conference speech.

But one government official said the ECJ “red line” had been blurred since the departure of Nick Timothy, Mrs May’s pro-Brexit former co-chief of staff, from Downing Street last June. “It’s not quite so rigid now,” the official said.

Pharma industry leaders have warned of the consequences for patients in both the UK and Europe if some form of regulatory harmonisation cannot be achieved. Around 45m packs of medicines are supplied from the UK to other European countries each month, while more than 37m packs come from Europe to the UK.

Jeremy Hunt, health secretary, and Mr Clark signalled their support for Britain having an ongoing relationship with the EMA in a joint letter to the FT last July.

Their position has hardened in recent months as the pharmaceutical sector has stepped up its lobbying on the issue. The Department of Health declined to comment but referred to the July letter.

Steve Bates, head of the BioIndustry Association, told the health select committee last month that the complex issues surrounding the regulation of medicines and their supply chain “need to be front and centre in the second phase of talks”.

Michel Barnier, the EU’s chief negotiator, has warned Britain it cannot “cherry pick” parts of the single market but Sarah Wollaston, Tory chair of the Commons health committee, said she hoped that “common sense” would prevail.

Speaking in a personal capacity, she said: “There is a very strong case for allowing flexibility for sector deals, especially when it’s in the best interests of patients both here and in Europe.”

Mrs May’s cabinet will this year have to decide where different parts of the British economy should be assigned as negotiations begin on a future trade deal with the EU.

Cabinet “divergers” such as Boris Johnson and Michael Gove want as much of the economy put into a category that would see Britain free to set its own rules, even if it pursued similar regulatory outcomes to the EU.

But other sectors heavily regulated and closely integrated with the EU are likely to be placed closer to the union. Mrs May hinted at this in her Florence speech last year when she said “we want to achieve the same goals in the same ways”.

Ministers accept that breaking with the EU in areas such as aviation, medicines and chemicals would cause serious disruption. The price could be accepting a role for the ECJ in settling disputes and payments to Brussels for the right to participate.

David Prior, life sciences minister until October, said that it would be “fantastic” if the UK stayed in the EMA, warning of a negative impact on inward investment if it did not.

“It would be a very good idea, because having one regulatory system for drug approvals is very important for UK patients — otherwise we will be behind everyone else and not have as good access to new drugs as other people in Europe,” he said.

“Pharmaceutical companies tend to go to the US, then the EU, it’s very important we are not left behind. If you’re a drug company, you tend to look for approval from the FDA, then the EMA, then everyone else.”

Commons Science and Technology Committee to hold summit on Brexit and scientific innovation

The Pharmaceutical Journal, 5 January 2018

The House of Commons Science and Technology Committee is to host a summit on how Brexit will affect the future of scientific innovation in the UK.

It will focus on the risks Brexit could produce for the sector, as well as possible opportunities. The committee is asking for written submissions and inviting interested parties to take part in the summit itself.

The summit will be held in February, on a date to be decided, with the intention to present its findings as the UK government begins its second stage of negotiations with the EU on Brexit.

The committee wants to hear views on the advantages, disadvantages and uncertainties for science, research and innovation following the outcome of initial Brexit discussions; the government’s future partnership paper ‘Collaboration on science and innovation’; the UK’s future participation in EU research programme, Horizon 2020; and whether recently agreed science co-operation deals with non-EU countries represent a good model for collaboration with other countries post-Brexit.

The committee’s chair, Norman Lamb, said: “The UK’s decision to leave the EU has presented the science and innovation sector with its greatest challenge in generations. If we are to confront this challenge effectively so that we protect and enhance science in the UK, it is crucial that the science community’s voice is heard now.

“We stand at a vital crossroads in the Brexit negotiations. By holding this summit before the next stage of negotiations commence, we can ensure that our priorities are clear and our demands are delivered right to the heart of government.”

Written evidence can be submitted via the committee’s inquiry page by 5 February 2018. Anyone interested in taking part in the summit can contact the committee at scitechcom@parliament.uk by 31 January 2018 using “Nomination for summit” in the title box.

Media and Political Bulletin

21 December 2017

Media Summary

EMA draws up plans to move MHRA work

The Pharmaceutical Journal, 20 December 2017

 

The Pharmaceutical Journal reports that plans are being drawn up to redistribute the European work of the UK’s medicines safety watchdog in the run up to Brexit.

European Union business currently carried out by the UK’s Medicines and Healthcare products Regulatory Agency and the Veterinary Medicines Directorate will be shared among the EU’s national drug regulatory agencies, it has been announced.

Which national agencies take on which elements of the work will be revealed early next year, the European Medicines Agency (EMA) decided at its meeting on 13 and 14 December 2017.

 

 

Pharma companies may be less likely to invest in the UK post-Brexit, MPs told

The Pharmaceutical Journal, 20 December 2017

 

The Pharmaceutical Journal highlights that UK patient involvement in clinical trials will diminish post-Brexit making manufacturers less likely to want to invest in the UK, MPs on the House of Commons Health Select Committee were told on Tuesday, 19 December 2017.

MPs also heard that unlocking the potential of patient data held by the NHS may be enough to persuade the pharmaceutical industry to continue to look to the UK for its involvement in developing new drugs and mitigate any disadvantages from leaving the European Union (EU).

Emma Greenwood, director of policy at Cancer Research UK said: “We need to unlock the data in the NHS…so they [drug companies] want to use the UK as its laboratory. And there is a real drive to push and make that happen.”

Greenwood was speaking at the committee’s ongoing inquiry into the impact of Brexit on the UK’s drugs supply chain and the regulation of medicines after Brexit.

 

 

Parliamentary Coverage

House of Commons Liaison Committee – Evidence from the Prime Minister, 20 December 2017

Rachel Reeves, MP: To ask the Prime Minister if the Government would consider remaining in institutions like the European Medicines Agency, the European Aviation Safety Agency (EASA) or EURATOM?

Theresa May, Prime Minister: The Government would consider continued participation in EASA, but EURATOM had a unique legal position. Mrs May also pointed to the role of the Nuclear Safeguards Bill in relation to the latter body, explaining that the UK would continue to apply international nuclear safety standards, and thus continuing to operate on a basis where other nations could have confidence in its activities.

 

House of Commons – Tabled Written Question, 20 December 2017

Jim Shannon, MP: To ask the Secretary of State for Health, what steps he plans to take to ensure that UK Drug Licensing continues to be linked to the European Medicines Agency after the UK leaves the EU to ensure that decisions by the two organisations are made to the same timetable.

Steve Brine, MP: We recognise the important role that the European Medicines Agency plays in the protection of human and animal health.

In the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation in the best interests of both the United Kingdom and the EU.

The UK is fully committed to continuing the close working relationship with our European partners. 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. As my Rt. hon. Friend the Prime Minister has stated, we want deep, broad and dynamic co-operation and in this context, the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety.

 

House of Commons – Tabled Written Question, 20 December 2017

Ronnie Cowan, MP: To ask the Secretary of State for Health, what discussions his Department has had on ensuring that decisions on the timetable for UK drug licensing remain linked to the timetable for decisions to be made the European Medicines Agency after the UK leaves the EU.

Steve Brine, MP: We recognise the important role that the European Medicines Agency plays in the protection of human and animal health.

In the negotiations the Government will discuss with the European Union and Member States how best to continue cooperation in the field of medicines regulation in the best interests of both the United Kingdom and the EU.

The UK is fully committed to continuing the close working relationship with our European partners. 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. As my Rt. hon. Friend the Prime Minister has stated, we want deep, broad and dynamic co-operation and in this context, the UK would like to find a way to continue to collaborate with the EU, in the interests of public health and safety.

Full Coverage

EMA draws up plans to move MHRA work

The Pharmaceutical Journal, 20 December 2017

 

Plans are being drawn up to redistribute the European work of the UK’s medicines safety watchdog in the run up to Brexit.

European Union (EU) business currently carried out by the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) and the Veterinary Medicines Directorate will be shared among the EU’s national drug regulatory agencies, it has been announced.

Which national agencies take on which elements of the work will be revealed early next year, the European Medicines Agency (EMA) decided at its meeting on 13 and 14 December 2017.

A spokesperson for the EMA described the EU network of medicines regulatory agencies as “a very strong and flexible system that is able to adapt to changes as necessary without putting at risk the quality of its work”.

Also following its December meeting, the EMA said that preparing for the withdrawal of the UK from the EU will impact on its work in the coming year. It expects to maintain its core activities in 2018 —which includes deciding drug marketing authorisations — but predicts some other work will have to be “temporarily reduced” or “suspended.”

The EMA will move into temporary offices when it vacates its current home in London’s Canary Wharf and relocates to Amsterdam as its new purpose built headquarters is not expected to be completed until November 2019.

Meanwhile the agency is moving forward with the development of its EU-wide clinical trial portal and data base — which will support the needs of EU clinical research, and which it describes as “the most ambitious IT development project…required by the EU pharmaceutical legislation”.

It has tested a partially completed version of the system and, following feedback, has fixed bugs and is working on suggested improvements.

 

 

Pharma companies may be less likely to invest in the UK post-Brexit, MPs told

The Pharmaceutical Journal, 20 December 2017

 

UK patient involvement in clinical trials will diminish post-Brexit making manufactures less likely to want to invest here, MPs on the House of Commons Health Select Committee were told on Tuesday, 19 December 2017.

But MPs also heard that unlocking the potential of patient data held by the NHS may be enough to persuade the pharmaceutical industry to continue to look to the UK for its involvement in developing new drugs and mitigate any disadvantages from leaving the European Union (EU).

Emma Greenwood, director of policy at Cancer Research UK said: “We need to unlock the data in the NHS…so they [drug companies] want to use the UK as its laboratory. And there is a real drive to push and make that happen.”

Greenwood was speaking at the committee’s ongoing inquiry into the impact of Brexit on the UK’s drugs supply chain and the regulation of medicines after Brexit.

Her comments about the potential of NHS data to protect the UK’s contribution to clinical trials, were endorsed by senior drug company figures who also gave evidence to the committee on 19 December.

Hugo Fry, UK general manager of Sanofi suggested that finding itself outside the EU could create a “potential opportunity” if the UK could “lighten the burden of administration” around clinical trials.

He told MPs: “Any country that is good at science and can rapidly enrol patients and can get them through…then companies like us… would look to countries like that and they would get a bigger allocation of patients in a clinical development programme.”

Phil Thomson, president, global affairs at GlaxoSmithKline, said if it was possible to make the UK “the best lab in the world”, it would give it a competitive edge.

Implementing the government’s current life sciences strategy in partnership with industry and “capitalising” on the potential of the NHS was “really important”, he said.

Earlier, Alan Boyd, president of Faculty of Pharmaceutical Medicine, warned MPs that leaving the EU would damage research.

“It will certainly have an impact on the high quality research that we get involved in,” he said.

From the clinician’s perspective, it means they would miss out on being kept up to date around the potential advantage or disadvantages of a new drug, he told MPs.

He said the UK was not the “largest market in the world” for drugs sales, so it ran the risk post-Brexit of becoming less attractive to drug companies looking to test their drugs and invest.

The issue, he said, was how to make most use of the NHS to create more clinical research.

MPs heard that it was crucial to continue collaborating in research and development after the UK leaves the EU.

Greenwood said that 25% of cancer UK research projects relied on collaboration with other EU countries. Boyd revealed that while the UK could support phase one trials on its own as well as early investigations, it relied on collaboration from outside its own borders for phase II and phase III drug trials.

Hugh Taylor, co-chair of the Brexit Health Alliance — a campaigning organisation that brings together the NHS, medical research, industry, patients and public health organisations — said that currently, there was commitment from the UK and the EU to continue collaboration.

He said the contribution the UK had made in the past to public health and patient safety was “a statement of fact”, but he added “it would be a real loss to lose that sense of collaboration.”

From Factory to Pharmacy

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