The Department of Health and Social Care (DHSC) proposes to amend the Health Service Products (Provision and Disclosure of Information) Regulations 2018 (the information regulations). This consultation document seeks views on the proposals, particularly from stakeholders involved in the pharmaceutical supply chain.
The information regulations require persons who manufacture, distribute or supply any UK health service products to record, keep and provide information to the Secretary of State about the purchase, supply, price and availability of those products. They also require marketing authorisation holders and wholesalers to inform the Secretary of State about shortages and discontinuations. The information regulations ensure that DHSC:
- receives accurate up-to-date data from the industry on the provision of health service products to facilitate effective reimbursement arrangements for primary care
- can obtain cost data associated with the manufacturing of the products, which may be used to consider setting a maximum selling price through the National Health Service Act 2006 (NHS Act 2006)
- is able to request information on medicines supply issues to be able to take mitigating actions in the most cost-effective way to prevent shortages when such issues do occur
The information regulations require DHSC to review the information regulations on an annual basis to consider whether they are still required and are proportionate.
This consultation is published alongside the latest annual review. The review set out that although the objectives remain necessary and proportionate, some amendments are required to ensure that the information regulations are aligned with recent reimbursement reforms and the increasingly complex supply chain.
The aim of this consultation is to propose amendments to the information regulations that ensure:
- the reimbursement arrangements operate as effectively or efficiently as identified in the community pharmacy drug reimbursement reforms consultation
- DHSC is better positioned to prevent shortages (and to be able to take mitigating action in the most cost-effective way when they do occur) as much as it would be possible with access to more data particularly with regard to over-the-counter (OTC) medicines also used by the NHS and when there is an identified public health risk
- an effective compliance regime to address non-compliance of suppliers, which undermines the reimbursement arrangements and the ability to mitigate supply challenges effectively
These proposals should:
- ensure that reimbursement arrangements are more reflective of market conditions and therefore fairer reimbursement for dispensing contractors
- improve DHSC’s ability to mitigate supply issues in the most cost-effective way by providing it with a more complete market view of health service products supply
- improve suppliers’ compliance to the regulations by enabling DHSC to update the compliance regime, ultimately supporting better patient access to medicines both of which represent taxpayer value for money
The consultation will close at 11:59pm on 5 May 2026. You can read the consultation document here or respond to the online survey here.
