News

Media And Political Bulletin-04 January 2018

Media and Political Bulletin

04 January 2018

Media Summary

Making a success of Brexit

MHRA, 03 January 2018

The MHRA has updated its response to Brexit and the ongoing EU negotiations, stating that the Medicines and Healthcare products Regulatory Agency is working closely with the Government to analyse the best options and opportunities available for the safe and effective regulation of medicines and medical devices in the UK.

While negotiations continue, the UK remains a full and active member of the EU, with all the rights and obligations of EU membership firmly in place. Working with our partners, stakeholders and customers, our focus remains: protecting health and improving lives.

The MHRA has also released a further guidance note on the “regulation of medicines, medical devices and clinical trials if there is no Brexit deal,” as well as its response to a consultation on the EU exit ‘no-deal’ legislative proposals.

Implementing ‘safety features’ under the Falsified Medicines Directive

MHRA, 03 January 2018

The Government has published its response to its consultation on implementing ‘safety features’ under the Falsified Medicines Directive. In addition to the response, additional guidance on Article 23 providers, Healthcare Institutions and Article 26 exemption have also been uploaded to their website.

BBC News at Six: Brexit medicine shortages

BBC News, 03 January 2018

BBC East ran a broadcast story yesterday which reported on calims that an unprecedented shortage of drugs is delaying treatment for patients in Northamptonshire.

The report includes an interview with a pharmacist from Kettering who claimed that the delay in supply is ‘the worst he has ever seen’ and that there is concern amongst his colleagues that Brexit uncertainty “could be to blame.”

The report also states that manufacturers have been asked by the Government to build up six weeks supply of any medicines that could be subject to delays at the border after Brexit, and speculates that it could be that that stockpiling for the future is leading to those shortages we are seeing now.

FMD rules exemption advice published

DDA, Ailsa Colquhoun, 4 January 2018

The DDA reports that the Government has clarified the circumstances in which a healthcare institution is exempt from its obligations to verify and decommission medicines under the Falsified Medicines Directive.

The clarification, contained within the response to an FMD consultation, contains a list of exemptions and also discloses further details on proposed sanctions for non-compliance with the FMD.

Brexit – UK Regulator Updates No-Deal Guidance

Politico, Sarah Wheaton, 04 January 2019

Politico reports that the U.K.’s Medicines & Healthcare products Regulatory Agency has published an update to its no-deal Brexit guidance, following a public consultation. The guidance is based on the same general framework released in August (refresher), including grandfathering medicines approved through the EU centralized process and recognizing CE-marked medical devices. The guidance now specifies the licensing process for wholesalers who want to import EU/EEA certified medicines into the U.K.

UK lays out no-deal Brexit plans for NHS

Politico, Katie Jennings, 21 December 2018  

Politico reported on the fact that the UK Government created a new national body to respond to disruption in the NHS caused by a ‘no-deal’ Brexit.

The new Operational Response Center “will lead on responding to any disruption to the delivery of health and care services in England” as a result of the U.K. leaving the EU without an agreement, according to Chris Wormald, permanent secretary of the Department of Health and Social Care.

The Government also said that it was “developing contingency plans” regarding the continued supply of medical devices and clinical consumables and was also “engaging with suppliers” regarding non-medical goods, such as food and laundry services at hospitals.

Pharmacy needs ‘Cobra’ meetings to handle no-deal Brexit shortages

Chemist and Druggist, Thomas Cox, 21 December 2018

Chemist and Druggist reports on comments made by the HDA’s Executive Director, Martin Sawer, who said in December that “daily war room” meetings could share information from across the supply chain, with the aim of preventing shortages.

Sawer said that the Department of Health and Social Care (DH) should chair the meetings, which would include the community pharmacy Brexit forum – a group of representative bodies from the sector and the supply chain set up by the Pharmaceutical Services Negotiating Committee.

He also said that the meetings should also include representatives from the General Pharmaceutical Council, the Medicines and Healthcare products Regulatory Agency, the NHS, the British Medical Association, the HDA and manufacturers.

Together they would try to “deal with any flashpoints as they arise, whether it’s a manufacturing problem or a shortage in one area”, Martin Sawer said.

Parliamentary Coverage

There was no parliamentary coverage today.

Full Coverage

FMD rules exemption advice published

DDA, Ailsa Colquhoun, 4 January 2018

The Government has clarified the circumstances in which a healthcare institution is exempt from its obligations to verify and decommission medicines under the Falsified Medicines Directive.

Guidance makes clear that dispensing GPs are considered a healthcare institution under the FMD.

The clarification, contained within the response to an FMD consultation, includes the following exemption, as long as all following conditions are met:

a) the person authorised or entitled to supply medicinal products to the public obtains the medicinal product through a wholesaler belonging to the same legal entity as the healthcare institution

b) the verification and decommissioning of the unique identifier is performed by the wholesaler that supplies the product to the healthcare institution

c) no sale of the medicinal product takes place between the wholesaler supplying the product and that healthcare institution

d) the medicinal product is supplied to the public within that healthcare institution.

Further details on proposed sanctions for non-compliance with the FMD are also given in the consultation response, published by the Government.

These include the introduction of statutory ‘enforcement notices’ for breaches of the requirements around supplying medicines to the public. These must be issued before criminal proceedings can be considered.

DDA advice remains that dispensaries should not purchase FMD compliant systems until DDA/BMA negotiations on IT funding have concluded.

The consultation response also provides guidance for dispensaries handling medicines that will pass through the system in the initial period following implementation which may be in scope of the new requirements but may not yet exhibit the new packaging, and it will not be immediately obvious to those asked to scan these products whether they should be scanned or not (ie, they were placed on the market before or after 9 February 2019).

This sets out the need for organisations such as dispensaries to:

prevent unnecessary disruption to the supply of medicine

have clear operating procedures in place

empower individuals to make judgment calls that they would feel able to justify.

Other aspects covered by the consultation response include:

Extending the scope of the unique identifier or tamper-evident packaging

Addition of a national reimbursement number

Allowing additional information to be added to the 2D barcode.

Brexit – UK Regulator Updates No-Deal Guidance

Politico, Sarah Wheaton, 04 January 2019

The U.K.’s Medicines & Healthcare products Regulatory Agency published an update to its no-deal Brexit guidance Thursday evening, following a public consultation. The guidance is based on the same general framework released in August (refresher), including grandfathering medicines approved through the EU centralized process and recognizing CE-marked medical devices.

The update offers more details on the grandfathering process, giving marketing authorization holders one year from EU exit to provide the MHRA with baseline data. It also outlines the MHRA’s assessment procedure for new active substances and biosimilars, including expected timelines for application review. The guidance now specifies the licensing process for wholesalers who want to import EU/EEA certified medicines into the U.K. And in a bid to “retain research,” the MHRA has decided it “will not charge a fee for scientific advice” to U.K.-based small and medium-sized pharma companies.

UK lays out no-deal Brexit plans for NHS

Politico, Katie Jennings, 04 January 2019

The U.K. government has created a new national body to respond to disruption in the country’s National Health Service caused by a no-deal Brexit.

The new Operational Response Center “will lead on responding to any disruption to the delivery of health and care services in England” as a result of the U.K. leaving the EU without an agreement, Chris Wormald, permanent secretary of the Department of Health and Social Care wrote today in a letter to health and social care providers.

The government released much of its health-related no-deal contingency planning in August, such as the stockpiling of medicines and regulatory alignment with EU clinical trial and medical device rules. But there has been growing concern that the U.K.’s National Health Service remains unprepared for a no-deal scenario.

Fewer than 10 percent of NHS Trusts in England surveyed by the British Medical Journal had established a committee to oversee Brexit preparations, according to a survey released this week. The findings are similar to a survey conducted by POLITICO in August, which found most hospitals had yet to start making no-deal plans.

The letter and EU Exit Operational Readiness Guidance released Friday afternoon, after MPs had already left parliament for Christmas, comes as the U.K. Cabinet agreed to trigger all remaining contingency plans for a no-deal scenario as the clock winds down to the March 29 deadline.

In the guidance, the government said it has “developed a UK-wide contingency plan to ensure the flow” of medicines and vaccines, including providing funding for additional storage to assist pharmaceutical manufacturers in stockpiling 6 weeks worth of medicines. The government reiterated that hospitals, doctors and communities should not stockpile additional medicines or write longer prescriptions for patients.

The government said it was “developing contingency plans” regarding the continued supply of medical devices and clinical consumables and was also “engaging with suppliers” regarding non-medical goods, such as food and laundry services at hospitals.

The guidance also says the government’s expectation for the numbers of staff leaving around Brexit day is that they will not be “significant.”

Pharmacy needs ‘Cobra’ meetings to handle no-deal Brexit shortages

Chemist and Druggist, Thomas Cox, 21 December 2018

The “daily war room” meetings could share information from across the supply chain, with the aim of preventing shortages, Healthcare Distribution Association (HDA) executive director Martin Sawer told C+D yesterday (December 20).

The Department of Health and Social Care (DH) should chair the meetings, which would include the community pharmacy Brexit forum – a group of representative bodies from the sector and the supply chain set up by the Pharmaceutical Services Negotiating Committee – Mr Sawer said.

The meetings should also include representatives from the General Pharmaceutical Council, the Medicines and Healthcare products Regulatory Agency, the NHS, the British Medical Association, the HDA and manufacturers, Mr Sawer said.

Together they would try to “deal with any flashpoints as they arise, whether it’s a manufacturing problem or a shortage in one area”, Mr Sawer said.

Wholesalers are able to deliver medicines overnight where necessary, he pointed out.

The DH said yesterday it is “still considering” responses to its consultation on the protocol for emergency powers for pharmacists to dispense an alternative medicine without contacting a GP in the event of a no-deal Brexit, which it will reply to in the new year, a solution which Mr Sawer first proposed to MPs in October.

Media And Political Bulletin-04 January 2018

From Factory to Pharmacy

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