The Department for Health and Social Care must set out a detailed plan for how it will safeguard its medicines supply against external factors such as price hikes or disruption caused by Brexit, MPs have said.
The Public Accounts Committee said it was worried about whether the department was equipped to respond quickly to unexpected changes, after it was slow to address a sudden price hike for some medicines last year.
Its concerns stemmed from an unexpected increase in the price the NHS paid for a number of generic medicines – drugs that can be generically manufactured after their patents have expired, making them cost-effective for the NHS – last June, affecting an “unusually high number of medicines”.
The situation was worsened by panic-buying adding to stock shortages, and was mostly to blame for an overspend of some £250m among Clinical Commissioning Groups in England in 2017-18, the committee said.
Although it knew about the price increase in June, the department did not take any action to address it until November. The department told the PAC this was because it lacked the information it needed to act, relying on NHS England to inform it about the financial impact of prices rises.
Legislation passed this and last year gave the department more powers to collect information on the generic medicines market, and to limit price increases. However, the committee said it had “yet to be convinced” that the department’s new powers were “sufficient to enable it to act effectively should similar price rises happen again”.
The regulations compel companies to provide quarterly updates on drugs they sell and to provide further information if the department suspects there may be an issue with supply or pricing. However, the information DHSC can collect is limited as companies are allowed to provide estimates rather than concrete figures and they are only required to notify the department of expected shortages or plans to stop supplying a medicine if they judge their actions will affect patients.
“The department recognises the challenge it faces in getting right the implementation, and making the best use, of its new powers to gather information, identify issues in the generics market, and control price where needed,” the report said. It called on DHSC to include in its first annual review of the regulations an assessment of how well the new powers are working.
PAC chair Meg Hillier said that despite these new powers, the department had been unable to tell the committee how it could handle similar price increases and related shortages in the future.
“This is unacceptable and doubly worrying in the context of uncertainty over supply chains after Brexit, particularly for medicines with a short shelf-life,” she said.
The majority of generic drugs used in the UK are imported from outside the EU. However, DHSC did tell the committee it was looking at how to mitigate against supply issues that could arise as a result of Brexit, such as import processes.
“The department told us that different medicines, for example those with a short shelf-life, require different solutions, so there is no ‘one size fits all’ plan,” the report said. “The department was unable, however, to provide us with any detail of its plans, or to assure us and the public about the supply of medicines in the event of a ‘no deal’ exit.”
DHSC must produce a plan for maintaining the supply of medicines both before and after the UK leaves the EU in March 2019, the committee said. The department must share the plan with the committee by December 2018, it said, along with a plan to improve information sharing with NHS England about medicines supply and pricing issues.
Meanwhile, the department and NHS England should release updated guidance to clinical commissioning groups setting out contingency plans to mitigate the financial impact if they are hit by unexpected price increases again, the report said.
A spokesperson for the Department of Health and Social Care said that ensuring patients have access to safe and effective medicines was its “number one priority”.
“The government is confident of reaching a deal with the EU that benefits patients and the NHS is preparing for all situations. We are working closely with partners to ensure adequate stockpiles are in place for all medicines which may be affected in the event of a no deal Brexit,” they said.