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HDA UK Media and Political Bulletin – 17 September 2021

Media Coverage

‘Terrible’: 2.4k medicines at risk of withdrawal in Northern Ireland
The Chemist and Druggist, Valeria Fiore, 16 September 2021

The Chemist and Druggist reports that British Generic Manufacturers Association (BGMA) CEO Mark Samuels disclosed in an interview with BBC Today that 910 medicines have been discontinued in Northern Ireland, with many more on track to be withdrawn.

In the interview Mark Samuels said that manufacturers have “formally begun the withdrawal process” for over 2,400 drugs in total and the medicines that have been withdrawn or are at risk of withdrawal are generics.

In addition, he stated: “We have never seen medicines withdrawal on this scale and already to have almost 1,000 medicines withdrawn, it’s terrible.”

A Northern Ireland Department of Health spokesperson suggested that the Government is aware of “a large number of confirmed and potential discontinuations of medicines to Northern Ireland” that have been formally notified to the Department of Health and Social care (DHSC). The spokesperson asserted that there is no immediate risk to medicines supplies in Northern Ireland and patients do not need to take any action.

The DoH proposed that the issues causing the discontinuations need to be addressed as a matter of urgency to avoid a negative impact on patients. However, pharmacies and patients do not need to stockpile medicines, and prescribers should not issue longer prescriptions.

 

Parliamentary Coverage

MHRA launches public consultation on future of medical device regulation
Medicines and Healthcare products Regulatory Agency and The Rt Hon Sajid Javid MP16 September 2021

The Medicines and Healthcare products Regulatory Agency (MHRA) has launched a 10-week consultation to give the public an opportunity to contribute to the improvement of the regulatory framework and patient safety.

The MHRA is the regulator for medical devices used in the UK. The MHRA want to draw on views across the medical devices and healthcare sectors, including, medical practitioners, patients and the wider public, to inform the future approach. The MHRA are interested in gaining insights from those who research, manufacture, supply and use medical devices.

Medical devices in the UK are currently regulated under the Medical Devices Regulations 2002. Following the UK’s departure from the European Union, the MHRA now has the opportunity to create a world-leading regime that prioritises patient safety while fostering innovation, including streamlining the approval of medical devices.

The consultation is comprehensive, covering a broad range of regulatory issues, including how devices are assessed before being placed on the market, importer and distributor obligations, transparency, and the role of patients.

Dr June Raine, MHRA Chief Executive said: “The launch of this consultation is an exciting step towards a more robust, world-leading regulatory framework for medical devices in the UK, one that enhances medical device safety and quality, access to devices, and has patients at its heart.”

“This is your chance to make a difference to people’s experiences with devices by helping shape the regulations around medical devices – from how much scrutiny they face before they reach the market, to how they are tracked and monitored, and what actions are taken if problems with a device arise.”

Health and Social Care Secretary Sajid Javid said: “This consultation will allow us to revolutionise the regulation of medical devices, making sure our pioneering life sciences sector can continue to lead the world and safeguard the health of our nation.”

The consultation will close at 11.45pm on 25th November 2021.

 

Full Coverage

‘Terrible’: 2.4k medicines at risk of withdrawal in Northern Ireland
The Chemist and Druggist, Valeria Fiore, 16 September 2021

More than 900 medicines are no longer “readily available” in Northern Ireland, with many more on track to be withdrawn, British Generic Manufacturers Association (BGMA) CEO Mark Samuels has revealed.

In an interview with BBC Today yesterday (September 15), Mr Samuels revealed that 910 medicines have already been discontinued in Northern Ireland, while manufacturers have “formally begun the withdrawal process” for over 2,400 drugs in total.

“It takes six months, so for medicines to be withdrawn in January, that notification needed to have begun by now, which is why we know the figures in advance,” Mr Samuels added.

The medicines that have been withdrawn or are at risk of withdrawal are generics, Mr Samuels specified.

“We have never seen medicines withdrawal on this scale and already to have almost 1,000 medicines withdrawn, it’s terrible,” he added.

“No immediate risk to medicine supplies”

A Northern Ireland Department of Health (DoH) spokesperson told C+D yesterday that the government is aware of “a large number of confirmed and potential discontinuations of medicines to Northern Ireland” that have been formally notified to the Department of Health and Social care (DH).

“I want to reassure the public that there is no immediate risk to medicines supplies in Northern Ireland and there is no need for patients to do anything differently with regard to ordering or taking their prescribed medication,” they said.

The DoH argued that the “underlying issues” that have triggered the discontinuations need to be addressed with urgency to avoid a negative impact on patient health.

However, neither pharmacies nor patients need to stockpile medicines, and prescribers should not issue longer prescriptions, it advised.

C+D has asked for a list of the affected medicines, but the DoH spokesperson said that the information on confirmed or potential discontinuations is provided confidentially to the DH, which is therefore not at liberty to share information it receives from the suppliers.

“Phased process” and Northern Ireland Protocol

Before the UK left the European Union on January 31 last year, it reached a Brexit agreement with the EU, known as the Northern Ireland Protocol, which means Northern Ireland has remained in the EU’s single market for goods.

The government announced in November last year that the UK and EU had agreed on a “phased process” for the implementation of medicines regulations in Northern Ireland.

This means that until December 31, Great Britain can continue to supply medicines to Northern Ireland “with a pragmatic approach to applying EU rules on importation and unique identifier requirements”.

In June, Prime Minister Boris Johnson reportedly said that 30 medicines were no longer available in Northern Ireland because of the way regulations that were being phased in around the border were affecting the movement of goods, according to the Sunday Times.

In a document on the Northern Ireland Protocol published in July, the UK government acknowledged that the “current arrangements are creating considerable challenges with medicine supply to patients in Northern Ireland being put at risk for a number of products from the end of 2021”.

It suggested that the “simplest way forward may be to remove all medicines from the scope of the Protocol entirely”.

HDA UK Media and Political Bulletin –  17 September 2021

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.

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