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Media And Political Bulletin – 15 October 2018

Media and Political Bulletin

15 October 2018

Media Summary

Public Accounts Committee tells government to reveal how it will control generic drug costs by end of year

Pharmacy Business, Neil Trainis, 12 October 2018

Pharmacy Business reports that the Public Accounts Committee has called on the government to reveal by the end of the year how it intends to control the rising cost of generic drugs and ensure that patients in the UK do not suffer a shortage of medicines in the lead-up to and following Brexit.

The article states that five recommendations were put forward in a report by the PAC, as concerns over the increasing cost of generics, highlighted earlier this year by a National Audit Office report which claimed the price of some generic drugs greatly increased in 2017-18, persists.

The  PAC said the Department of Health and Social Care had failed to reveal the full range of actions it could take other than collecting information to keep generic prices under control and called for that to be disclosed by December.

Read the full report from the PAC here.

Medicines and Healthcare products Regulatory Agency – Supply of Investigational Medicinal Products for clinical trials in the event of a no-deal

MHRA, 12 October 2018

The MHRA has released guidance regarding the continuity of supply of Investigational Medicinal Products in the event of a ‘no-deal’ Brexit.

Within the guidance, the MHRA states that although the Government is ‘working to minimise possible border disruptions on the UK’s exit from the EU, it is sensible to assure clinical trial participants in the UK that their ongoing trials will not be disrupted.’

Parliamentary Coverage

There was no parliamentary coverage today.

 

Full Coverage

Public Accounts Committee tells government to reveal how it will control generic drug costs by end of year

Pharmacy Business, Neil Trainis, 12 October 2018

The Public Accounts Committee (PAC) has called on the government to reveal by the end of the year how it intends to control the rising cost of generic drugs and ensure patients in the UK do not suffer a shortage of medicines in the lead-up to and following Brexit.

Five recommendations were put forward by the PAC as concerns over the increasing cost of generics, highlighted earlier this year by a National Audit Office report which claimed the price of some generic drugs greatly increased in 2017-18, persists.

Legislation introduced last year gave the government powers to compel manufacturers, importers and wholesalers to provide it with information about pricing and purchasing of generic medicines and instruct pharmaceutical companies to lower the price of a generic where it is deemed excessive.

However, the PAC said the Department of Health and Social Care (DHSC) had failed to reveal the full range of actions it could take other than collecting information to keep generic prices under control and called for that to be disclosed by December.

The PAC also called on the DHSC and NHS England (NHSE) to produce updated guidance for clinical commissioning groups (CCGs) setting out contingency plans to lessen the financial impact on them in the event of unforeseen price rises.

According to the NAO, generic prices increases “resulted in additional unforeseen costs” for CCGs whose net spend on concessionary-priced medicines was estimated to be £315 million in 2017-18, seven times more than that spent in 2016-17. NHSE said CCGs were faced with a £250 million deficit at the end of 2017-18, something the NAO “partly attributed to concessionary pricing increases.”

The DHSC’s failure last year to address the rising price of some medicines quickly enough was also the subject of the PAC’s report. The PAC said “there were clear signs” that some medicines went up in price from June 2017 but it was not until November that the DHSC took action “to manage costs.”

“The Department told us it became aware of the price rises in summer 2017 but did not have the information it needed to take action. For the financial impact of the price rises, the Department relied on NHS England to alert it, which in turn relied on clinical commissioning groups,” the PAC said.

The DHSC’s power to collect thorough information from companies on the medicines they sell was called into question despite regulations compelling them to provide quarterly data and allowing the Department the right to request more information within two days if there are supply or pricing issues.

“The new regulations allow companies to give ‘reasonable estimates’ of how much they buy and sell medicines for in some cases, rather than actual figures, limiting the accuracy of the information available to the Department,” the PAC said.

“Companies are also required to notify the Department if they intend to stop supplying a medicine, or they expect a supply shortage. But this only applies if the company itself judges that its actions will affect patients and does not give the Department any control over which medicines companies notify it about.”

The PAC said the DHSC was only able to collect quarterly information on “a minority” of specials following concerns the NHS was paying high prices for those medicines.

The DHSC was urged to ensure that by September next year, its first annual review of the regulations “includes an assessment of how well the provisions for companies providing estimates and notifying the Department of an impending shortage are working, as well as the application of new information collection powers to ‘specials’ medicines.”

The Committee also called on the DHSC and NHSE to “establish clear and timely information flows between each other and local bodies to identify and inform about generic medicine supply and/or pricing issues.” That, the PAC said, should allow clinicians to have more transparency of the price of generic medicines they prescribe.

Mark Burdon, an independent community pharmacy contractor and PSNC regional representative for the North East and Cumbria who gave evidence to the PAC inquiry in July, said: “PSNC was pleased to assist the PAC in this inquiry and it is good to see that MPs recognise the important role that community pharmacy teams play in ensuring that patients do get their medicines when they need them.

“As we know and is made clear in the report, generic medicines shortages are a very complex global issue and with Brexit on the horizon that is likely to remain the case.

“We would now like to see the Department of Health and Social Care working with us to develop a fairer and more responsive concession system that ensures that hard working pharmacies do not face unfair risks, and that the impact of supply problems is not passed on to them or their patients.”

In giving evidence to the inquiry, the National Pharmacy Association said community pharmacies had “spent a considerable amount of extra time and effort sourcing generic medicines in order to meet patient expectations.”

It added: “In addition to the increases in workload, the situation has put immense financial pressure on pharmacies that have been forced to purchase medicines at inflated prices without knowing whether they will be adequately reimbursed.”

The NPA also said it was “reasonable to expect that wholesalers are transparent about their pricing and margins, as these feed through the supply chain and directly impact independent pharmacies and their patients.”

The NAO report identified a range of supply-related factors that may have been behind the price rises and an unexplained “unexpected growth” in the margins of wholesalers.

A spokesman from the NPA said: “This puts further pressure on the government to act on a matter of great importance to pharmacists and patients alike.

“The committee appears to have taken on board the points we, PSNC and others have made. Their focus is on the ultimate cost to the NHS, rather than on the costs to community pharmacy directly, but we all have an interest in a system that is cost-effective and works well for patients.”

Medicines and Healthcare products Regulatory Agency – Supply of Investigational Medicinal Products for clinical trials in the event of a no-deal

MHRA, 12 October 2018

A scenario in which the UK leaves the EU without agreement (a ‘no deal’ scenario) remains unlikely given the mutual interests of the UK and the EU in securing a negotiated outcome. With talks ongoing, we remain committed to reaching agreement in the Autumn. However, it’s our duty as a responsible Government to prepare for all eventualities, including ‘no deal’ and that is exactly what we are doing.

Although the Government is working to minimise possible border disruptions on the UK’s exit from the EU, it is sensible to assure clinical trial participants in the UK that their ongoing trials will not be disrupted. The Government has set up the Medicines Supply Contingency Programme to ensure the continued supply of licensed medicines in the UK in the event of a ‘no deal’ Brexit, read this page for more information.

We would encourage organisations running clinical trials in the UK to consider their supply chains for IMPs ahead of the 29th March 2019. Clinical Trials that use IMPs which come from or via the EU/EEA will need to ensure appropriate arrangements to assure supplies in the event of any possible border delays that may arise in the short term in the unlikely event of a no-deal Exit that we reach March 2019 without agreeing a deal with the EU.

It may be necessary to start making any contingency arrangements ahead of the 29th March 2019 to provide assurance to trial participants and for the trials.

The life sciences sector may also wish to consider the relevant technical notices published on 23 August, under the heading ‘Regulating medicines and medical equipment’.

Media And Political Bulletin – 15 October 2018

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