The government has proposed several changes to regulations to ensure “fairer reimbursement” for pharmacies and improve its “ability to mitigate” drug supply issues.
In a consultation document published on February 10, the Department of Health and Social Care (DH) said the Health Service Products (Provision and Disclosure of Information) Regulations 2018 require “some amendments” to ensure that they “are aligned with recent reimbursement reforms and the increasingly complex supply chain”.
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The regulations require those who make, distribute or supply health service products in the UK to record information about the “purchase, supply, price and availability” of the products and provide it to the secretary of state.
Marketing authorisation holders and wholesalers must also inform the secretary of state about shortages and discontinuations under the regulations.
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The DH said its proposed amendments should “ensure that reimbursement arrangements are more reflective of market conditions and therefore fairer reimbursement for dispensing contractors”.
They also aim to improve the DH’s ability to mitigate drug shortages “in the most cost-effective way” by providing “a more complete market view” of supply, it said, and “improve suppliers’ compliance to the regulations” by enabling the DH to “update the compliance regime”.
Reimbursement proposals
In the document, the government proposed expanding “the scope of data collection” to be able to ask for “routine quarterly data” on products - including those not currently covered by the regulations - so that it can “make a decision about setting a reimbursement price” based on suppliers’ data.
And it proposed that, following the introduction of Category H to the drug tariff, it should be able to collect routine quarterly data for products which may have “several brands or generics” and consider whether it is suitable to set those products’ reimbursement price using the data.
“This would remove the need for the DH to seek this information through the ad hoc route it currently uses, making this more efficient for both the DH and industry,” it added.
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The government is also seeking to require suppliers and manufacturers to notify the DH about “new products classified as health service medicines and prescribed in primary care”, and keep the DH notified “if changes are made to the product including its price and pack size”.
This would ensure that dispensing contractors “have transparency as to what is marketed by which suppliers and at what list price” and that the DH “can accurately reimburse them”, it said.
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It added that following new legislation permitting hub and spoke dispensing between different retail pharmacy businesses, the DH wants hub pharmacies to record and provide data “in the same way as wholesalers currently do” to “underpin reimbursement prices if required”.
And it has proposed clearly defining what is classified as an invoice to “support pharmacies complying with” requests for participation in the margin survey, which is used by the DH to determine the medicine margin retained by pharmacy owners.
Other proposals
The government’s other proposed changes to the regulations include:
- An amendment to ensure “all situations that could lead to a supply shortage in the market are reported”
- Requesting data for products available on prescription and via retail “to inform a whole-market view of supply levels”
- Expanding the scope to enquire about supply levels “where there is an identified public health risk” to support the DH in managing shortages “in a cost-effective manner”
- “Changes and improvements to arrangements for penalties” for breaches of regulations
“Enormous complexity”
National Pharmacy Association (NPA) director of corporate affairs Gareth Jones told C+D it will “thoroughly examine the details” of the government’s proposals and discuss with its members “the potential impact on medicines supply and reimbursement”.
“Whatever the merits, or otherwise, of these specific changes, this consultation is another reminder of the enormous complexity of the overarching payment system relating to medicines,” he said.
“We would all be better off - especially patients - with a complete overhaul of contractual arrangements, not tinkering around the edges of current processes.”
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It comes after Medicines UK announced an “innovative collaboration” with NHS England and the UK drugs regulator that will see hundreds of “dormant” medicine licences revived to tackle shortages of “specific critical treatments”.
And it follows the NPA warning that the NHS is paying back pharmacists as little as 20% of the cost of common medicines including anti-depressants, pain relief and blood pressure medication.
The body said pharmacies are being left to cover the shortfall with their own money, and called on the government to end the “scandal of pharmacy owners subsidising the bill for the nation’s medicines”.
