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HDA UK Media And Political Bulletin – 21 March 2018

Media and Political Bulletin

21 March 2018

Media Summary

Scottish parliament told of Brexit fears by pharmacy owners

The Pharmaceutical Journal, 19 March 2018

 

The Pharmaceutical Journal reports that the UK could become a dumping ground for counterfeit medicines after Brexit if it fails to continue to sign up to the European Union (EU) falsified medicines directive, Scottish community pharmacy owners have warned members of the Scottish parliament.

Matt Barclay, director of operations at Community Pharmacy Scotland (CPS) — which represents pharmacy owners — said he was hopeful that the new EU regulation, due to be introduced next February to tighten control over the medicines supply chain against counterfeit medicines, would still be applied across the UK after Brexit.

 

Industry backs findings of new Health and Social Care Committee report into Brexit

ABPI, 21 March 2018

 

Responding to a new House of Commons Health and Social Care Select Committee report ‘Brexit – Medicines, Medical Devices and Substances of Human Origin’, the trade associations representing the UK’s pharmaceutical and biotech industries have issued a joint response backing the Committee’s recommendations.

Issuing a joint response, Mike Thompson, ABPI CEO and Steve Bates, CEO of the BioIndustry Association (BIA), commented: “This thoughtful Select Committee report makes a compelling case to Brexit negotiators why public health and patient safety must be prioritised in Brexit talks.

For medicines the detail of Brexit matters. To ensure uninterrupted continued supply we need rapid clarity on the legal position of medicines during the transition period from the EU and UK. In addition, we need progress from both sides on how the desired close co-operation for the future will work in practice.”

 

 

Parliamentary Coverage

Health Select Committee publishes its report following inquiry into ‘Brexit: medicines, medical devices and substances of human origin’21 March 2018

 

The Health and Social Care Committee report urges UK and EU negotiators to prioritise patient safety in the next round of Brexit negotiations. The report, published today, is fully supportive of all the Healthcare Distribution Association’s positions and references the Association throughout the document.

The HDA has led the way in influencing the final report with the Committee now calling on negotiators on both sides to heed the call of industry and patient groups in securing the closest possible regulatory alignment in the next round of Brexit talks.

Chair of the Committee, Dr Sarah Wollaston MP, says: “In order to minimise harm to their citizens, both the UK and the EU-27 should look to secure the closest possible regulatory alignment in the next round of the Brexit negotiations. Failure to do so would signal a triumph of ideology over the best interests of patients.”

 

Draft Agreement on the withdrawal of the United Kingdom of Great Britain and Northern Ireland from the European Union published20 March 2018

 

Professional qualifications and health care rights for EU and U.K. citizens will continue to be recognized during the Brexit transition period, according to the agreement between the two sides announced yesterday in Brussels.

This means EU health care workers in the U.K. and British health care workers in the EU will continue to have the right to practice until the transition period ends on 31 December 2020. Plus, a British national who starts treatment in an EU27 country during the transition period will have it reimbursed by the U.K. and vice versa, even if the treatment ends after the transition period, the agreement said.

 

 

Full Coverage

Scottish parliament told of Brexit fears by pharmacy owners

The Pharmaceutical Journal, 19 March 2018

Matt Barclay, director of operations at Community Pharmacy Scotland, said he was hopeful that the new EU regulation would still be applied across the UK after Brexit.

The UK could become a dumping ground for counterfeit medicines after Brexit if it fails to continue to sign up to the European Union (EU) falsified medicines directive, Scottish community pharmacy owners have warned members of the Scottish parliament.

Matt Barclay, director of operations at Community Pharmacy Scotland (CPS) — which represents pharmacy owners — said he was hopeful that the new EU regulation, due to be introduced next February to tighten control over the medicines supply chain against counterfeit medicines, would still be applied across the UK after Brexit.

He told members of the Scottish parliament’s health and sport committee: “If we have reversal of the Falsified Medicines Directive, and it is fair to say that there is no indication that it will not be part of the system [post Brexit], … but if it were to fall, it would mean the UK could become the dumping ground for counterfeit medicines, because we would not have the same safeguards that the other EU states have. The whole system then becomes a patient safety issue.”

His warning came during his evidence to the committee that is looking at the impact of leaving the EU on health and social care in Scotland.

The CPS is also concerned about the impact on access to new drugs post-Brexit— even if, as Prime Minister Theresa May hopes, the UK successfully negotiates associate membership of the European Medicines Agency (EMA), the drug’s safety watchdog.

Barclay said he hoped that, post-Brexit, access to drugs would remain as “seamless” as it is under the present system.

He told the committee that at the moment, 90% of drugs used in the UK are imported and 50% come from the EU.

Negotiating a mutual recognition agreement between the UK and the EU around the import and export of medicines – which would avoid the need to double-test drugs and batches of drugs — is crucial if that seamless supply is to continue.

He said: “There are potential increased costs if that mutual recognition isn’t there. For the current system to be maintained and supported, it [post Brexit] has to be as aligned or as mutually reciprocal as possible.”

Michael Clancy, director of law reform at Law Society of Scotland, spelt out the scale of the problem if there was no mutual recognition agreement post-Brexit.

He told the committee that 82 million packs of drugs cross the EU into the UK every month. And without a mutually recognised system post Brexit, these drugs and batches of drugs will all have to be double-tested, slowing down access of drugs to patients, with a potential impact on patient safety.

John Brown, director of policy at the Scottish Lifesciences Association, agreed about the potential impact and revealed what its members were seeking.

He said: “The UK government position is that it will ask for associate membership of the EMA but the industry view is that the UK should have a mutual recognition agreement of health regulation…that avoids the need for double-testing. That issue is vitally important and we are pressing the government on that.

“The industry is alive to the threat of double-testing and double everything. It would be foolish to say what will happen, but there is still a degree of optimism.”

However, he revealed that the introduction of double-testing could actually have a silver lining and bring business opportunities for Scotland.

He said: “If double-testing and double-batch testing were imposed, there would be an impact on the costs of medicines but it may not be as large as some people might fear.

“We have also seen inward investment by a drug-testing company’s move to Scotland. I can’t say why they have, but it’s interesting that it has moved in at the moment.

Industry backs findings of new Health and Social Care Committee report into Brexit

ABPI, 21 March 2018

Publishing the report, the Committee said “negotiators on both sides must heed the call of industry and patient groups in securing the closest possible regulatory alignment in the next round of Brexit talks”, highlighting that the “supply chain of pharmaceuticals, from research and development through to the product being available on a pharmacy shelf, would be adversely affected by regulatory divergence.”

Other recommendations called for by the Committee include:

  • continued UK participation in Europe-wide clinical trials and adoption of the new EU clinical trials regulations
  • continued UK membership of all of the major EU pharmacovigilance systems and databases
  • the negotiation of “free and frictionless trade” with the EU
  • a Government assessment of the impact of the loss of parallel imports

Issuing a joint response, Mike Thompson, ABPI CEO and Steve Bates, CEO of the BioIndustry Association (BIA), commented:

“This thoughtful Select Committee report makes a compelling case to Brexit negotiators why public health and patient safety must be prioritised in Brexit talks.

For medicines the detail of Brexit matters. To ensure uninterrupted continued supply we need rapid clarity on the legal position of medicines during the transition period from the EU and UK. In addition, we need progress from both sides on how the desired close co-operation for the future will work in practice.”

HDA UK Media And Political Bulletin – 21 March 2018

From Factory to Pharmacy

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