News

HDA UK Media And Political Bulletin – 11 January 2017

Jeremy Hunt slams subsidies for ‘clustered’ pharmacies

Chemist and Druggist, Annabelle Collins, 10 January 2017

Jeremy Hunt has claimed that “40% of pharmacies are clustered in groups of three or more”, asserting that the NHS should discontinue subsidizing pharmacies that are within such close proximity. Mr Hunt underscored: “Our reforms are designed to ensure that where there is only one local pharmacy that people can access, that pharmacy is protected”. Mr Hunt’s comments were issued at a parliamentary debate, during which Mr Hunt stressed the importance of community pharmacy making “efficient savings”, as with “all parts of the NHS”.

Global Firms ‘Could Follow European Medicines Agency out of UK’

Press Association, Josie Clarke, 10 January 2017

Concerns have been raised that international companies could follow the European Medicines Agency (EMA) out of the UK if it chooses to move away after the Brexit furore. The political difficulties for the European Commission to have one of its primary agencies outside the EU was highlighted by Sir Michael Rawlins, chairman of the UK’s Medicines and Healthcare Regulatory Agency (MHRA). Previously, Sir Michael has said the MHRA is “certainly not” prepared to take responsibility for many roles currently provided by the EMA.

Parliamentary Coverage

Scottish Parliament, Written Answers, 9 January 2017

Anas Sarwar (Glasgow, Scottish Labour,): To ask the Scottish Government what safeguards are in place to ensure that the security measures specified by the UK Government for the transportation of controlled drugs are adhered to by (a) NHS boards and (b) private and independent pharmacies. [S5W-05312]

Shona Robison: The Scottish Government issued guidance to NHS Scotland following the introduction of the Health Act 2006 by the UK Parliament and the governance arrangements for controlled drugs which the Act and subsequent relevant Regulations put in place:- www.sehd.scot.nhs.uk/mels/CEL2007_14.pdf www.sehd.scot.nhs.uk/mels/CEL2008_07.pdfThe legislation requires all healthcare organisations holding stocks of controlled drugs to appoint Accountable Officers responsible for the safe, appropriate and effective management and use of controlled drugs. In NHS Scotland, Controlled Drugs Accountable Officers (CDAOs) are responsible for ensuring the safe management and use of controlled drugs within their organisation. CDAOs should ensure that their own organisation, and those providing services to their organisation, have adequate and up-to-date Standard Operating Procedures (SOPs) in relation to controlled drugs. The CDAO Network publishes and updates guidance on good practice in the management of controlled drugs in primary care, including monitoring, auditing and reporting:- www.knowledge.scot.nhs.uk/media/CLT/ResourceUploads/4055959/Primary_Care_Guide_Scotland_v.2.0_171114.pdfIn addition, the General Pharmaceutical Council (GPhC), the pharmacy regulator in Great Britain, sets standards for all registered pharmacies which includes requirements for medicines to be stored securely and supplied safely to patients, and for each pharmacy to identify and manage risks associated with the service they provide. GPhC inspections cover the full range of services a pharmacy provides, including any medicine delivery services. The GPhC also shares intelligence and works collaboratively with various regulatory bodies and organisations across Great Britain, such as the Home Office, the Medicines and Healthcare Products Regulatory Agency (MHRA) and local Controlled Drug Accountable Officer Networks to help achieve collective patient safety and public protection aims.

Full Coverage

Global Firms ‘Could Follow European Medicines Agency out of UK’

Press Association, Josie Clarke, 10 January 2017

 

An expert has raised concerns that international companies could follow the European medicines regulator out of the UK if it chooses to move away after Brexit.

Professor Sir Michael Rawlins, chairman of the UK’s Medicines and Healthcare Regulatory Agency (MHRA), said he “assumes” the European Medicines Agency (EMA) will leave its base at London’s Canary Wharf, where it employs 800 people.

 

Speaking to the Lords Science and Technology Committee on the impact of Brexit on standards regulation. Sir Michael said: “It seems to me politically difficult for the European Commission to have one of its significant agencies outside the borders of the EU. I assume it will go.”

He said such a move would be “a great loss for a number of reasons”, adding: “One of the reasons why international companies have put their base in the UK is because of the closeness of the regulator.

 

“That’s a great worry. Will they move to wherever the regulator goes?”

Sir Michael has previously said the MHRA is “certainly not” prepared to take responsibility for many roles currently provided by the EMA.

 

Asked by the committee on Tuesday if the UK would wish to replicate the EMA if it moved, he said: “We would continue unless we could come to some arrangement but we would no longer do the detailed scientific assessments, for which we are paid for. They would go too.”

Asked if the UK would simply “rubber-stamp” decisions made elsewhere, he said: “There are complications with just rubber-stamping … you would emasculate the MHRA and the UK would not have a strong regulator.”

 

But he said it was unlikely that consumers would see any change to the work of the MHRA after Brexit.

 

“Our job at the MHRA is to ensure that devices and medicines are of good quality and safe. I would hope that whatever happens we would provide that service ongoing.”

At present, when a company wants EU market authorisation for a new drug it goes to the EMA, which decides whether to approve a drug.

Detailed scientific evaluations are conducted, about 40% by the MHRA, and it is paid a fee.

Sir Michael has previously said 85% of the MHRA’s expenditure comes from fees and the rest comes from the Department of Health, adding: “We would have to get public money or we wouldn’t be able to register new drugs.”

 

HDA UK Media And Political Bulletin – 11 January 2017

From Factory to Pharmacy

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