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Media And Political Bulletin – 13 November 2018

Media and Political Bulletin

05 November 2018

Media Summary

UK asks drug companies to sign no-deal Brexit gag clause

Politico, Charlie Cooper, 3 November 2018

 

Politico reports that drug companies advising the UK Government on how to maintain medicine supplies after a no-deal Brexit have signed strict non-disclosure agreements barring them from revealing information on planned border arrangements and supply routes.

 

The article states that the government has been in close contact with the pharmaceutical industry which is stockpiling drugs to ensure British citizens still have access to vital medicines if supply routes are disrupted by delays at the border. Politico also highlights that firms consulted on no-deal arrangements are threatened with injunction if they breach the terms of the agreements.

 

The article includes a quotation from Mike Thompson, Chief Executive of the ABPI, who said that ‘given the complexity of planning – including commercially sensitive information shared between government and industry – an NDA was agreed to support effective planning for continued medicines supply in ‘no-deal’ Brexit.’

 

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

UK asks drug companies to sign no-deal Brexit gag clause

Politico, Charlie Cooper, 3 November 2018

 

Drug companies advising the U.K. government on how to maintain medicine supplies after a no-deal Brexit have signed strict non-disclosure agreements (NDAs) barring them from revealing information on planned border arrangements and supply routes.

 

The government is being so secretive that information is only being provided to firms orally, or via hard copies of documents that must be returned at the end of meetings, according to a draft NDA document published by Department of Health and Social Care.

 

Firms consulted on no-deal arrangements are threatened with injunction if they breach the terms of the agreements.

 

The government has been in close contact with the pharmaceutical industry, which is stockpiling drugs to ensure British citizens still have access to vital medicines if supply routes are disrupted by delays at the border.

 

The template NDA, published by the department in response to a written parliamentary question from the opposition Labour party, states that the government “will need to share confidential and sensitive information about customs and border arrangements and supply routes.”

 

Attendees at meetings are required not to divulge what they have heard, “not to take or make a copy of any papers provided for a meeting,” and “to return at the end of each meeting where requested any papers or material provided by the Department.”

 

Mike Thompson, CEO of industry body the Association of the British Pharmaceutical Industry (ABPI), told POLITICO: “Given the complexity of planning — including commercially sensitive information shared between government and industry — an NDA was agreed to support effective planning for continued medicines supply in a ‘no deal’ Brexit.

 

“The ABPI is clear and continues to advise government that ‘no deal’ is not in the interest of patients in the U.K. or the EU.”

 

Health and Social Care Secretary Matt Hancock told the House of Commons’ health committee last week that he was “confident … so long as everybody does what they need to do” that the U.K. would have an “unhindered supply of medicines,” even if there is no deal.

 

“We are getting on with making sure that we have the plans in place, and we are taking the actions that we need to take now in order to have the mitigations in place,” he said.

 

The Department of Health and Social Care had not responded to a request for comment at the time of publication.

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Media and Political Bulletin

13 November 2018

Media Summary

HDA appoints Jeremy Main as First Independent Chair

HDA, Press Release, 13 November 2018  

The HDA issued a press release yesterday announcing the fact that it has appointed Jeremy Main as its first independent chair. The appointment will help the association build and broaden its leadership role in the UK’s medicines distribution and wholesale sector at a time of immense change in the medicines supply chain.

Based on his 30 years’ business experience, including 12 years at Alliance Healthcare, eight of those as Managing Director, Jeremy will be working closely with the HDA Council and Executive Director to identify future strategic challenges to the sector, whilst addressing immediate issues such as Brexit and the implementation of the Falsified Medicines Directive.

Jeremy main appointed HDA’s first independent chair

Pharmacy Business, Kiran Paul, 13 November 2018

Pharmacy Business reports on the fact that the HDA has appointed Jeremy Main as its first Independent Chair.

The article includes a quotation from Jeremy Main who said: “I am delighted to join the HDA at a time when the association is working extremely hard to address the ever-increasing number of challenges facing its members and supply chain partners. Constant collaboration and cooperation across the supply chain will be crucial if we are to continue to ensure patients get the right medicines, in the right place, at the right time.”

Brexit — Commission’s contingency plans

Politico, 14 November 2018

Politico reports that the Commission to the European Parliament issued its latest advice on preparations across the block for a cliff-edge, no-deal Brexit on Tuesday.

The article states that “surprisingly,” that didn’t include health care, despite concerns raised by industry that medicines supply shortages are a very real threat.

Regarding medicines, the guidance noted: “The European Medicines Agency (EMA) has conducted several surveys and, where necessary, has contacted holders of EU marketing authorizations to recall the need to take the necessary preparedness measures.” Together with the European Chemicals Agency (ECHA), and others, the EMA has re-attributed regulatory functions from the U.K. to other member countries, it added.

Read the Commission’s document here

Parliamentary Coverage

House of Commons, Tabled and Written Questions, 12 November 2018

Dr David Drew, MP: To ask the Secretary of State for Health and Social Care, whether he plans to extend the expiration date of medicines to reduce waste; and if he will make a statement.

Answered by Jackie Doyle-Price: Any change to the expiry date of a medicine requires an independent review of the stability study by the Medicines and Healthcare products Regulatory Agency (MHRA) or the European Medicine Agency in consultation with the MHRA. The MHRA is the Government agency responsible for ensuring that medicines and medical devices work and are acceptably safe.

Companies can and often do extend the shelf life of their medicines once the product is on the market and additional stability data become available. The MHRA is not able to insist on lengthy shelf lives considering the time needed to complete stability studies as to do so would create additional delays with bringing new medicines to the market. It is not possible however to extend the expiry date of all medicines unilaterally in the absence of supporting stability data.

House of Commons, Tabled and Written Questions, 13 November 2018

Jim Shannon, MP: To ask the Secretary of State for Health and Social Care, what steps his Department is taking to reduce the number of medication errors that result in serious harm to patients; and if he will make a statement.

Answered by Caroline Dinenage: The Department works with NHS Improvement, NHS England, the Medicines and Healthcare products Regulatory Agency (MHRA), Public Health England, and the Medication Safety Officer Network to improve the safety of medicine use across the National Health Service in England.

The Medication Safety Programme, covering the NHS in England, has been established to take up the World Health Organization’s (WHO) global challenge to reduce the incidence of severe and avoidable harm in relation to medication globally by 50% over five years. Progress to date includes the publication of the Short Life Working Group into Reducing Medication Harm and the publication of an evidence-based review on the Prevalence and Economic Burden of Medication Errors in the NHS in England, which has helped the programme to understand the scale of the issue and identify key areas for improvement.

Full Coverage

HDA appoints Jeremy Main as First Independent Chair

HDA, Press Release, 13 November 2018  

The Healthcare Distribution Association (HDA UK) has appointed Jeremy Main as its first independent Chair. The appointment will help the Association build and broaden its leadership role in the UK’s medicines distribution and wholesale sector at a time of immense change in the medicines supply chain.

Based on his 30 years’ business experience, including 12 years at Alliance Healthcare, eight of those as Managing Director, Jeremy will be working closely with the HDA Council and Executive Director to identify future strategic challenges to the sector, whilst addressing immediate issues such as Brexit and the implementation of the Falsified Medicines Directive.

Jeremy Main, HDA Chair noted:

I am delighted to join the HDA at a time when the Association is working extremely hard to address the ever-increasing number of challenges facing its members and supply chain partners. Constant collaboration and cooperation across the supply chain will be crucial if we are to continue to ensure patients get the right medicines, in the right place, at the right time.

Martin Sawer, HDA Executive Director added:

Jeremy’s appointment will energise the Association’s aim to be a respected opinion leader that is responsive to the needs of its medicines supply chain partners. I and the HDA team look forward to working with him to both identify the opportunities and address the strategic challenges facing our members now and in the future.

About the Healthcare Distribution Association

The Healthcare Distribution Association (HDA UK) represents those businesses who supply medicines, medical devices and healthcare services to patients, pharmacies, hospitals, doctors and the pharmaceutical industry. HDA UK members operate across the 4 nations of the United Kingdom enabling a safe, efficient and high-quality supply chain for the healthcare sector.  They are responsible for distributing over 92% of NHS medicines and provide wholesaling services including working capital, stock management and IT systems to their supply chain partners. The HDA and its members are at the forefront of the constantly evolving healthcare supply chain, which is seeing innovative practices and technologies make new services possible for manufacturers and to those who dispense medicines, reflecting the needs and choices of individual patients.

Jeremy main appointed HDA’s first independent chair

Pharmacy Business, Kiran Paul, 13 November 2018

The Healthcare Distribution Association (HDA UK) has appointed Jeremy Main, former managing director of Alliance Healthcare, as its first independent Chair.

Main, who has 30 years of experience in the business, will lead the suppliers’ association  at a time of immense change in the medicines supply chain such as Brexit and the implementation of the Falsified Medicines Directive.

Responding to the news, Main said: “I am delighted to join the HDA at a time when the association is working extremely hard to address the ever-increasing number of challenges facing its members and supply chain partners. Constant collaboration and cooperation across the supply chain will be crucial if we are to continue to ensure patients get the right medicines, in the right place, at the right time.”

HDA said Main’s appointment will help the association build and broaden its leadership role in the UK’s medicines distribution and wholesale sector.

“Jeremy’s appointment will energise the association’s aim to be a respected opinion leader that is responsive to the needs of its medicines supply chain partners. I and the HDA team look forward to working with him to both identify the opportunities and address the strategic challenges facing our members now and in the future,” said Martin Sawer, Executive Director of HDA.

Main has earlier served as the Chair of the HDA during his tenure at Alliance Healthcare, a member of the association.

Brexit — Commission’s contingency plans

Politico, 14 November 2018

The Commission late Tuesday issued its latest (could it be final?) advice on preparations across the block for a cliff-edge, no-deal Brexit. The Commission set out several key industries deemed necessary for special, temporary contingency plans to avoid major turmoil at borders, at airports and elsewhere. Surprisingly that didn’t include health care, despite concerns raised by industry that medicines supply shortages are a very real threat.

Instead, the Commission reminded businesses the buck stops with them to prepare for the worst-case scenario. “Contingency measures taken by national or EU authorities cannot replace the preparations that each citizen and business must take to prepare for the United Kingdom’s withdrawal,” the guidance said. “Where new authorizations, licences or certificates will be required, each party has the responsibility to apply in good time,” it added.

Regarding medicines, the guidance noted: “The European Medicines Agency (EMA) has conducted several surveys and, where necessary, has contacted holders of EU marketing authorizations to recall the need to take the necessary preparedness measures.” Together with the European Chemicals Agency (ECHA), and others, the EMA has re-attributed regulatory functions from the U.K. to other member countries, it added.

Drug pricing — get ready for WTO tariffs: All relevant EU legislation on imported goods and exported goods will apply, “including the levy of certain duties and taxes (such as customs duties, value added tax and excise on importation), in accordance with the commitments of the European Union under the rules of the World Trade Organisation,” the Commission states. Time to get to grips with the various definitions and rates for medicines, biological materials, devices, active ingredients and various stages and combinations of these things.

Research: In an annex document, the Commission said it was preparing an implementing act to “amend the decisions setting up the European Research Infrastructure Consortia (ERICs) to relate headquarters currently in the United Kingdom.”

Health professionals — get validated: Are you a British health care professional working in the EU? A separate Commission document reminds that you have until March 29 to get your U.K. qualifications recognized in the country you are working in.

Media And Political Bulletin – 13 November 2018

From Factory to Pharmacy

As part of our mission to build awareness, understanding and appreciation of the vital importance of the healthcare distribution sector, we developed an infographic explaining the availability of medicines. It identifies the factors that can impact drug supply, as well as the measures that HDA members undertake day in, day out to help mitigate the risks of patients not receiving their medicines.

See the Infographic

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