Open consultation

Proposed amendments to the Health Service Products (Provision and Disclosure of Information) Regulations 2018: consultation document

Published 10 February 2026

Summary

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^{[footnote 1]}
• 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

Why amendments are necessary 

The information regulations came into force on 1 July 2018, putting in place the regulatory framework established by sections 264A and 264B(1)(k) and (l) of the NHS Act 2006.

The main purpose of the information regulations is to 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 any shortages and discontinuations of medicines. The information that DHSC receives under the provisions of the information regulations may be used for the purpose of enabling or facilitating:

• the remuneration and/or payment of NHS chemists and primary medical service providers in, or in any part of, the UK
• the availability of products in, or in any part of, the UK and the assessment of whether the products represent value for money
• the cost control powers in the NHS Act 2006

The information regulations require DHSC to review them on an annual basis to consider whether they are still required and are proportionate. This consultation is published alongside the latest annual review which considers the extent to which the information regulations have achieved their objectives from July 2022 to June 2025. DHSC acknowledges the delay in publishing the most recent review. The information regulations are under constant review, but in order to allow for substantial experience operating under the provisions, the formal reporting of the review has occurred every other year.

As set out in the annual review, DHSC found that the objectives of the information regulations remain required and proportionate, but require some amendments to keep them fit for purpose. The data provided in accordance with the information regulations does substantiate the reimbursement arrangements in primary care. However, DHSC’s experience operating the information regulations since they came into force, recent developments to DHSC’s reimbursement policy, and the increasing complexity of the supply chain and the public health challenges that arise mean that some amendments are required to the information regulations to keep them fit for purpose. To that end, this consultation covers 12 proposed amendments to the information regulations, categorised under 3 subheadings:

• reimbursement
• availability and value for money
• improving the regulatory compliance regime

Reimbursement

The Drug Tariff for England and Wales (the Drug Tariff) is one of 3 such tariffs that apply in the UK. It sets out the main mechanism by which pharmacy businesses - and to a large extent dispensing doctors - are paid by the NHS in England and Wales for dispensing drugs against NHS prescriptions. It sets out both:

• the remuneration pharmacists receive for their services
• the reimbursement price they receive for dispensing drugs and other prescription items

NHS reimbursement prices of licensed products prescribed generically are in one of 4 categories in Part VIIIA of the Drug Tariff: Categories A, C, H and M. For products listed in Categories A, H and M, reimbursement prices are set using sales and volume data from suppliers obtained using our powers in part 2 (Category A and M only) and part 4 (Categories A, H and M) of the information regulations. Categories A and M only use data of licensed generic medicines. Category C lists products where there is less or no competition. When there is only one branded version of a product on the market, the Category C reimbursement price for a generic prescription is currently based on the list price of that brand. Category H (being introduced in March 2026) lists products where there are multiple suppliers. For these products the reimbursement prices are currently set using sales and volume data from suppliers obtained under part 4 of the information regulations and uses data of both branded and generic medicines where applicable.

Reimbursement prices for a subset of unlicensed products are set out in Parts VIIIB and VIIID of the Drug Tariff. These reimbursement prices are set using sales and volume data from suppliers obtained using our powers under regulation 14 of the information regulations.

Further, where a product does not have a reimbursement price set out in Part VIII in the Drug Tariff, dispensing contractors, subject to correct prescription endorsement, are reimbursed in accordance with Part II Clause 8C (Basic Price) of the Drug Tariff. In effect, this means the pharmacy will be paid the list price of the supplier they endorsed. Suppliers’ pack sizes and list prices, as much as suppliers notify and keep the NHS Business Services Authority (NHSBSA) updated, are set out in NHSBSA’s dictionary of medicines and devices (dm+d) and are typically used as the supplier’s list price for reimbursement purposes.

DHSC is looking to underpin the reimbursement price of more products using data from suppliers (for example, medicines listed in Category H) and therefore needs to expand the scope of these data collections. It also needs to ensure that the list prices in the dm+d are current. These proposals are informed by the Community Pharmacy Contractual Framework agreement (2024 to 2026) (CPCF) between DHSC and Community Pharmacy England. The CPCF agreement confirmed the funding arrangement that is delivered through fees and allowances and medicine margin. Funding through the CPCF settlement for 2024 to 2025 was increased to £2.698 billion (4.1%) and for 2025 to 2026 to £3.073 billion.

The proposals also bring the information regulations up to date with a new type of ‘supplier’ to community pharmacies and dispensing doctors. The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025, which came into force in October 2025, introduce ‘hub pharmacies’. The proposal is that they will provide data in the same way as wholesalers currently do, to underpin reimbursement prices if required.

Availability and value for money

The information regulations underpin DHSC’s work to prevent shortages and to take mitigating actions in the most cost-effective way when they do occur as they require marketing authorisation holders to inform the Secretary of State about shortages and discontinuations of medicines. Once a supplier issue notification has been received by DHSC, the process follows a structured decision-making pathway.

The process begins with an initial risk assessment of the potential influence on supply of products from that manufacturer and, if required, DHSC develops strategies to manage the supply issue. The initial risk assessment considers factors such as the nature of the problem, duration, market share, alternative products and clinical need.

Once a decision is made as to the severity of the medicines supply issue, it is then assigned one of 4 clinical escalation tiers, from low to very high patient safety risk. If no significant impact is identified, the process stops. Potential shortages trigger the use of different escalation or mitigation pathways such as serious shortage protocols (SSPs) and Medicine Supply Notifications (MSNs), which aim either to:

• minimise patient impact by determining alternatives and engaging the NHS
• engage with industry to assess their ability to fill gaps in shortfalls of health products

The proposals support the collection of more data so DHSC will have a more complete view of national medicine supply. This should help prevent medicine shortages and, where they do occur, allow DHSC to mitigate them in the most cost-effective way, in particular for OTC products also used in the NHS and when there is an identified public health risk.

Improving the compliance regime

Under part 8 of the current provisions, the Secretary of State may issue a compliance notice if they consider that a UK producer:

• has not complied with the reporting requirements of the information regulations
• has provided incorrect or incomplete information
• has not complied with a written request for data under the respective regulations

The compliance notice requires the producer to provide any of the relevant information or to provide relevant information that is accurate.

Where a UK producer fails to comply with a compliance notice, the Secretary of State is able to issue a penalty fine. The information regulations also outline the right of any UK producer to appeal against any relevant enforcement decision taken under the information regulations, in accordance with the Health Service Medicines (Price Control Appeals) Regulations 2000.

For various reasons, DHSC has not yet issued a penalty for non-compliance to the information regulations. However, an effective compliance regime is important to ensure that DHSC:

• receives accurate and complete information to facilitate the setting of reimbursement prices, improving the reimbursement arrangements for dispensing contractors
• can effectively manage supply chain issues that could influence patient access to the medicines they need

An effective compliance regime that encourages timely and accurate data reporting under the information regulations is fundamental in achieving the cost-effectiveness of medicine supply and patient access to the medicines they need.

The proposals refine the current compliance regime to encourage accurate and timely reporting to:

• support the effectiveness and efficiency of the reimbursement arrangements
• prevent shortages and ensure DHSC can react effectively to them and take mitigating action in the most cost-effective way when they do occur

Proposals

Reimbursement

Expand the scope of data collection to include products that are not currently covered by the information regulations in order to make a decision about setting a reimbursement price

The information regulations only permit the collection of data to underpin reimbursement prices for products that are already listed within the relevant parts of the Drug Tariff. However, DHSC constantly considers whether to add more products to these parts (or categories) of the Drug Tariff, and to set the reimbursement price of more products using suppliers’ sales and volume data.

DHSC does currently collect data to consider if it is possible to set a reimbursement price in the relevant part (or category) of the Drug Tariff using powers under regulation 18, which allows for data not needed routinely (‘ad hoc’ data collections). However, as the information regulations have operated over time it has become apparent that there is the need for such information to be provided regularly, on a quarterly basis, to build up a picture of the sales and volume over time to know whether it is suitable to set a reimbursement price using the data in accordance with the price-setting mechanism of the relevant part (or category) of the Drug Tariff.

Therefore, DHSC wants to expand the scope of the data collections in regulations 9 and 14 to be able to ask for routine quarterly data on any health service products, including licensed and unlicensed products, that might fulfil the criteria of the relevant part (or category) of the Drug Tariff. This is so that DHSC can consider if it is possible to set a reimbursement price using suppliers’ data. However, on collecting the data of a specific product it might show that it is not appropriate to include the product in the relevant part of the Drug Tariff. DHSC is therefore proposing that it should have the discretion, having seen the supplier data, to decide it is not appropriate to use that data to set a reimbursement price in the relevant part (or category) of the Drug Tariff.

By formalising a data request to regular quarterly reporting, rather than having to respond to ad hoc requests, this proposal should support industry with their planning by enabling them to incorporate the reporting into their business-as-usual processes.

Formalise regular quarterly data collections for medicines listed in Part VIIIA Category H of the Drug Tariff that includes branded medicines

Reimbursement prices for medicines in Category C Part VIIIA of the Drug Tariff are currently based on the price of a particular product or supplier. Historically, this category has been used when there were no generics and so no competition for a product. However, there are now some Category C products where there is competition between suppliers, marketed both as brands and generics. From March 2026 some of these products will move to Category H, with the reimbursement prices being set using the ad hoc data collection powers in regulation 18.

However, following the introduction of Category H, DHSC will need to collect this data routinely. Therefore, DHSC proposes a new provision in the information regulations that enables it to collect routine quarterly data for products where there may be several brands and/or generics of a product. This is so DHSC can consider whether the product is suitable to have its reimbursement price set using the data and if it is, use the data to set the reimbursement price. This would remove the need for DHSC to seek this information through the ad hoc route it currently uses, making this more efficient for both DHSC and industry.

The data for Category H products (or products that might go into Category H depending on the data) will be collected quarterly and used to set a quarterly reimbursement price. The quarter in which the reimbursement prices are set for products in Category H in Part VIIIA of the Drug Tariff will be a different quarter in which the reimbursement prices are currently set for products in Category A and M of Part VIIIA of the Drug Tariff and therefore suppliers will be required to provide the data in different quarters also. Category A and M products currently have their prices set in January, April, July and October. Category H products will be set in March, June, September and December.

DHSC is aware that NHSBSA already collects some information from branded medicines suppliers and manufacturers as part of the voluntary scheme for branded medicines pricing, access and growth (VPAG) scheme, and the statutory scheme for branded medicines (as contained in the Branded Health Service Medicine (Costs) Regulations 2025). The data that is collected through those schemes is not appropriate, nor eligible to use for reimbursement purposes as DHSC needs more granular data to set reimbursement prices than is provided under VPAG. DHSC is aware that this may seem like a duplication of obligations, but it is necessary to underpin the reimbursement arrangements.

Notification for all new products being put on the market and updates to pack sizes and prices to ensure that the dm+d can be populated with a reimbursement price

Under VPAG and the statutory scheme for branded medicines, members are required to alert DHSC of any new presentations of branded medicines including pack size and strength or formulation and to provide timely information on list price. However, outside of this scheme there is no reporting obligation for companies to notify DHSC of new health service medicines being placed on the market, nor for updates to products (for example, pack size and price changes).

However, where a prescription is for a generic medicine not listed in the Part VIII of the Drug Tariff, dispensing contractors are paid the list price of the supplier they endorsed and are reimbursed according to Part II Clause 8C (Basic Price) of the Drug Tariff. Typically, the supplier’s price in the dm+d is used as the reimbursement price, so up-to-date product information, such as pack and price, is crucial to ensure that NHSBSA can keep the dm+d up to date so community pharmacies have transparency and can be accurately reimbursed for products not listed in Part VIII. 

To that end, DHSC is seeking to add a provision in the information regulations to require suppliers and manufacturers to:

• notify DHSC, through NHSBSA (which operates the reporting system on behalf of DHSC), about new products classified as a health service medicines and prescribed in primary care
• keep DHSC notified if changes are made to the product including its price and pack size

This would enable DHSC to ensure that the NHSBSA administrators of the dm+d can keep it up to date and, in turn, ensure that dispensing contractors have transparency as to what is marketed by which suppliers and at what list price, and so DHSC can accurately reimburse them.

The annex sets out an exhaustive list of the properties that DHSC is proposing would be required:

• when a new product enters the market
• if there is any change to the properties of existing products

Introduce provisions to require product data returns from hubs to inform reimbursement prices

The Human Medicines (Amendments Relating to Hub and Spoke Dispensing etc.) Regulations 2025 came into force in October 2025. These regulations allow the activities of dispensing to be split between 2 pharmacies of different legal entities (or one pharmacy and a dispensing doctor):

• one will be operating as a hub (this must be a pharmacy), concentrating on core dispensing activities such as assembly and labelling, making use of large-scale dispensing efficiencies such as automation
• the other pharmacy (or dispensing doctor) will be operating as a spoke, dealing more with receiving the prescription and supplying the prepared medicines to the patient

Typically, there will be one hub to many spoke pharmacies.

These regulations enable independent pharmacies to benefit from centralised dispensing models the same way as the chain pharmacies who can already operate in this way. This new model will provide another route for the manufacturing, distributing and supply of UK health service products to primary care dispensers. Therefore, as with any other supplier of a health service product, DHSC proposes that hubs will be required to record, keep and provide information about the purchase, sale and supply of these products, which might be used alongside data already obtained from other persons who manufacture, distribute or supply any UK health service products, to inform price setting for reimbursement and provide an overview of product availability and value for money.

DHSC is proposing that hubs should be subject to the same data reporting requirements as wholesalers, given their position and role in the medicines supply chain. Currently, schedule 1 of the information regulations defines a medicines wholesaler as a “person who holds a wholesale dealer’s licence”. Since hubs are pharmacies, they will not be required to hold a wholesale dealer’s licence. Consequently, DHSC is seeking to expand or amend this definition so that it can adequately include hubs within its scope and thereby subject hubs to wholesaler record keeping and reporting obligations. 

A pharmacy operating as a hub may also dispense in the traditional way. DHSC will not want to include its sales or purchase data returns for products that it dispenses in the traditional way and are not part of its hub operation.

Defining invoices for the purpose of requesting participation in the margin survey

Regulation 23 enables a written request to be made on behalf of the Secretary of State requiring a UK producer to provide any of the statutory retained information as defined throughout part 4 of the information regulations. This request may be made with regards to determining medicine margin retained by pharmacy contractors. Medicine margin is the difference between the NHS reimbursement price and the price the pharmacy was charged by the supplier. Medicine margin contributes to the funding for services provided as part of the CPCF.

For example, for 2025 to 2026 £900 million of medicine margin is allowed as part of funding for CPCF alongside fees and allowances. Where more than the allowed amount of medicine margin is delivered, reimbursement is reduced, typically by reducing reimbursement prices in Part VIIIA Category M of the Drug Tariff. Where not enough margin is delivered reimbursement (typically Category M prices) is increased.

The medicine margin retained by pharmacy contractors is assessed through the quarterly margin survey. This survey selects a random sample of pharmacies to provide purchase and sales data. As part of this request, pharmacies are required to provide a full set of invoices for a given month for all their purchases.

However, currently, the information regulations lack clarity regarding what is defined as an invoice. This may result in incomplete information being provided to DHSC which hinders the ability to accurately estimate medicine margin retained by pharmacies and in turn set inappropriate reimbursement prices in Part VIIIA in accordance with the CPCF funding and the allowed amount of medicine margin. As such, DHSC is proposing to include a provision within the information regulations to define what is classified as an invoice in this request. DHSC proposes that an invoice includes any set of documentation that functions as an indication of the purchase of any presentations including reference to any discounts or rebates applied. Any documentation that provides the equivalent information of an invoice, for example monthly statements, enhanced delivery notes and credit notes for purchases, may fall within scope of this request.

Further, providing a clearer definition for what is required when invoices are requested from pharmacies under regulation 23 should also support pharmacies complying with the requests and therefore reducing the likelihood of being penalised.

Availability and value for money

Amending regulation 29 to ensure all situations that could lead to a supply shortage in the market are reported

Regulation 29 requires producers to provide information about discontinuation or anticipated supply shortage of certain health service medicines. This is to support DHSC’s Medicines Supply team to begin the necessary processes to manage any potential supply challenges. While this provision is pivotal in managing supply shortages, the current wording of regulation 29 refers to providing information where the producer considers there is likely to be a supply shortage. This has resulted in situations where potential supply issues have not been reported.

DHSC appreciates there are situations where the producer may not know if a reduction in their supply could cause a shortage because they are unaware of what else is going on in the market. This means that currently the information needed by DHSC to assess and manage potential shortages is not always available and where there is persistent non-reporting it is harder to enforce compliance.

To illustrate this proposal, the following example outlines a situation where a producer may not be clear if there is a potential for supply issues due to the current interpretation of reporting requirements.

Company A normally has a production of 20,000 products a month which accounts for 5% of the overall market. They have had temporary capacity issues at their manufacturing site, but they know that they can return to production in 6 weeks. Given the small percentage share in the market, and that these products will be back online soon, the company may not see this as an issue and therefore does not report it to DHSC.

Company B produces 100,000 products in year 1 which accounts for 25% of the market. In year 2 they only plan to produce 50,000, reducing their market size to 12.5%. So, the company may not see this as a shortage because they had always planned to produce less in year 2 as a business decision and therefore does not report it to DHSC.

In this example, because of the supply position of the 2 companies combined, the UK loses 17.5% of the market share, but DHSC may not be made aware about it. This could be a critical supply crisis depending on the product and/or time of year.

We are proposing to amend the wording of regulation 29 to ensure that all situations that could lead to a reduced supply (planned or otherwise) and in turn lead to supply issues in the market are reported. Enhancing the scope of the provision to include unexpected delays, non-supply, or planned supply reduction and planned withdrawal, will improve the ability of DHSC to understand and react to supply constraints and have more time to put in place the most cost-effective mitigation.

Supply data requests for products available on a prescription and as a retail sale to inform a whole-market view of supply levels to support DHSC mitigation of supply issues

There are many products that are available for OTC use and so are sold as a retail sale, but could also be supplied in accordance with an NHS prescription. A product may not meet the definition of a medicinal product (regulation 2 of The Human Medicine Regulations 2012 as a pharmacy (P) or general sales list (GSL) medicine) but can be considered as a “UK health service product” for the purposes of the information regulations and the NHS Act 2006 to the extent that the product is used in the NHS.

Without access to data on OTC supply, DHSC is limited in its ability to:

• assess knock-on effects on related prescription-only medicines, where increased demand may strain supply
• understand when patients are unable to access OTC medicines, potentially resulting in GP visits and the issuing of alternative NHS prescriptions
• identify when prescriptions for OTC products cannot be fulfilled, requiring the substitution of other medicines

DHSC is proposing to introduce a requirement for companies to share information on products that can be used in the NHS (even if they are intended for retail sale) in the event a shortage is identified. This will ensure that DHSC has a complete picture of the market and can better manage supply challenges.

Expanding the scope to enquire about a product’s supply level where there is an identified public health risk to support DHSC to manage shortages in a cost-effective manner

Currently, regulation 28 enables the Secretary of State to request data from marketing authorisation holders on:

• the quantity of packs that are available for supply by the producer
• the quantity of any alternative presentations as specified in the Secretary of State’s request that the provider can supply if there is a supply shortage of a given health service medicine

This return must be completed within 2 working days under the current information regulations. 

DHSC is proposing to amend regulation 28 so that on an ad hoc basis it can collect information on health service products where there is an identified public health risk. The data marketing authorisation holders report, depending on the nature of the risk, may be regularised to ensure that data is provided for the duration that DHSC deems necessary to minimise risk to the patient. This will enhance DHSC’s overview of medicines supply in the UK, enabling it to identify risks in advance and to develop and implement contingency plans. These changes will influence the scope of regulations 31 (compliance procedure) and 32 (penalties), which DHSC will seek to amend to ensure it has a compliance route for this provision.

This information will inform cost-effective decisions to manage supply challenges and mitigate identified public health risks early. This will reduce the effect of supply shortages and the associated health costs such as increased monitoring, GP visits or hospitalisations on patient care, while ensuring value for money for the NHS.

Currently, DHSC uses regulation 29 to collect information on marketing authorisation holders’ stock position of a product that another supplier has indicated they will not be supplying their usual quantity of or are discontinuing. DHSC would like to expand the requirement to be able to ask suppliers to report both current stock and planned future deliveries of identified health service products when DHSC has concerns that the market may struggle to meet demand because of identified public health risk but where there is not a current shortage.

An example would be preparing for identified threats during flu season where DHSC might need to ask for information on antibiotics. An alternative example is where DHSC might expect demand to outstrip supply due to a rapid increase in use either because they are new, as DHSC saw with Ozempic, or new evidence supports much wider clinical use, such as with hormone replacement therapy (HRT).

Increasing the scope of the data collected under regulation 29 would support future planning where a shortage, or an increase in demand, for a certain health service product is likely to have an effect on any patient who takes, or may need to take, the presentation for the prevention or treatment of a physical or mental illness.

Improving the compliance regime

Amending the reference to NHS England’s online gateway as the delivery point for submitting data to DHSC due to the portal now being hosted by NHSBSA - this should now reference NHSBSA

Currently, regulation 5(1) of the information regulations (and referenced elsewhere) specifies that suppliers’ volumes and sales data used to inform reimbursement prices should be provided “via an NHS digital online gateway”.

In 2023, when NHS Digital was merged into NHS England, the information regulations were revised to reflect this and now reference NHS England as the provider of the portal. However, the provision for the collection of data was transferred to NHSBSA in 2022, when it completed development of a new IT portal to collect data on generics and specials sales and volumes from suppliers and manufacturers. NHSBSA is also in the process of creating a portal for producers to provide information on products with concessionary prices to simplify the submission process. NHSBSA operates the portal and facilitates the resolutions of any issues associated with it (such as non-returns and questions about data submissions) on behalf of DHSC although they do not access the data itself.

To make it clear where suppliers and manufacturers should be submitting their data, DHSC proposes to amend the information regulations to reflect the current arrangement. DHSC is seeking to make a change that would replace the reference of “NHS England online gateway” with that of NHSBSA’s data portal to bring them into alignment with the data collection process.

Reporting of supply issues and discontinuations to a specific designated delivery point (currently the DaSH portal)

Regulation 29 currently requires marketing authorisation holders to inform the Secretary of State about any shortages and discontinuations of medicines. This requirement is needed to support DHSC’s management of supply issues.

The Discontinuations and Shortages (DaSH) portal was put in place in October 2020 to improve the process by which marketing authorisation holders of relevant products notify DHSC of potential shortages and discontinuations that may affect the supply of their medicines marketed in the UK. By March 2022 around 1,700 shortages and 1,500 discontinuations had been reported through the portal, allowing DHSC to take mitigating action. However, as drafted, the regulation is not prescriptive over where the data needs to be delivered, so enforcement becomes impractical.

DHSC is proposing that reporting requirements are linked to the specific delivery point. Not only will this bring the information regulations in line with current practice, but it will help industry identify where their reporting must go to support the operationalisation of the reporting requirements.

Changes and improvements to arrangements for penalties for contraventions

DHSC is proposing changes to the application of penalties under regulation 32 of the information regulations, specifically in relation to failures to provide timely information about:

• anticipated supply shortages
• product discontinuations
• new products or product updates (such as those required for the dm+d)

Under current arrangements, a penalty can only be issued if a producer contravenes regulation 31(5) by failing to comply with a compliance notice. However, in practice, by the time DHSC becomes aware of a supply issue or a product listing problem, it is often too late to issue a compliance notice and wait the required 7 working days for the company to respond. This delay significantly undermines DHSC’s ability to take early, effective action to mitigate the effect on clinical care and NHS resources.

Similarly, DHSC has experienced delays in receiving information that is essential for updating product listings, where the absence of timely updates can also disrupt supply management and downstream services.

These issues are compounded by the fact that some organisations may delay providing information out of concern that competitors could gain a commercial advantage.

While in the vast majority of cases shortages are reported in a timely way that helps DHSC mitigate patient impact, there are occasions where this is not the case. In these situations, to ensure an effective deterrent to suppliers or companies not providing data in accordance with the information regulations, DHSC proposes to be able to move straight to a penalty when it becomes aware that a supplier has not notified it of an anticipated supply shortage or discontinuation.

DHSC is seeking a change in relation to regulation 29 regarding information about discontinuations or anticipated supply shortages and in relation to the proposed provision requiring companies to provide product information updates to ensure the dm+d is updated (as addressed in a previous proposal). Currently, if a company does not tell DHSC about a shortage, DHSC has to issue a compliance notice that gives them 7 working days to correct the issue. Only if the company fails to comply with a compliance notice can a fine be imposed under regulation 32. However, in practice, by the time DHSC becomes aware of a supply issue, it is often too late to issue a compliance notice and wait the required 7 working days for a response in order to mitigate the supply challenge. Without a company providing the necessary information on a supply issue in good time to the DHSC’s Medicines Supply team, DHSC cannot take proactive measures to resolve the issue in a timely and cost-effective manner.

The same is true of updating the dm+d to ensure that accurate reimbursement prices are set for products under Part II Clause 8C (Basic Price) of the Drug Tariff. Without a company providing the necessary updates on product changes, in particular pack sizes and prices, or informing DHSC about a product listing problem, the dm+d cannot be updated and so reimbursement prices may not be reflective of the market. Even if updates are made retrospectively following the delay in providing the information, DHSC would have to reprice prescriptions that may result in the under or overpayment for medicines by the NHS.

To address this, DHSC is proposing a limited change: that in cases involving regulation 25(4) or 31(5), relating specifically to shortages, discontinuations or product information updates, a penalty may be imposed without the prior issuance of a compliance notice. The penalty would be a one-off sum of a reasonable magnitude, sufficient to deter non-compliance, especially by large producers. Provisions already exist in regulation 32(4) to ensure proportionality, depending on the size of the producer. The extent of the penalties will also be limited by having regard to section 265(1) and (2) of the NHS Act 2006.

This change is intended to support faster, more effective responses to supply risks and ensure that operational and clinical services are not compromised by avoidable delays in the provision of critical information. It is also intended to support timely updates to the dm+d regarding product information to facilitate the setting of accurate reimbursement prices for products that are not listed in Part VIII of the Drug Tariff.

Reduce the frequency of the information regulations reviews to every 2 years to align the provisions with practice and inform meaningful evaluation of the regulations’ appropriateness

Currently, regulation 36 states that the information regulations should be reviewed annually, and that DHSC must publish a report to Parliament outlining:

• the extent to which the regulatory objectives are being met
• whether the objectives remain appropriate
• if there are alternative, less onerous provisions that could replace the current information regulations

While the current information regulations stipulate that the review and report should be published at “intervals not exceeding one year”, following experience operating the information regulations and the length of time that the publication process takes, DHSC proposes increasing the amount of time between reviews. This will allow for more detailed evidence to be gathered on the efficacy of the current provisions by enabling the information regulations to run for more time between reviews and to allow ample time for thorough analysis and publication of the review. Since the information regulations came into force in 2018, DHSC has reviewed them twice, including the review published alongside this consultation.

The 2022 annual review, covering the period July 2020 to June 2022, recommended considering if the annual review could be less frequent.

Since the implementation of the information regulations, no significant concerns have been raised about the requirements of the information regulations. Despite minor issues with how companies submit their data, compliance has increased each year and therefore it is disproportionate to review the information regulations every year. Subsequently, coupled with experience of operating the information regulations, DHSC is now proposing to extend the frequency of these reviews to a 2-year period. This will provide sufficient time for any changes to the information regulations to be implemented and experience industry engagement with them, thereby enabling a more meaningful evaluation of their appropriateness in achieving their objectives.

Statutory duties

There are some specific duties that must be considered when proposing updates to the information regulations. These include consideration of the Secretary of State’s duties under the:

• NHS Act 2006
• public sector equality duty under the Equality Act 2010 
• Family Test

Duties under the NHS Act 2006

To promote a comprehensive health service (section 1 of the NHS Act 2006)

The Secretary of State is required to continue the promotion in England of a comprehensive health service designed to secure improvement in:

• the physical and mental health of the people of England
• the prevention, diagnosis and treatment for physical and mental illness

The proposals aim to establish more reimbursement prices in the Drug Tariff that are based on accurate market data, to ensure the NHS gets value for money from its spend on healthcare products. This will help increase the resources available to provide treatment and other services to patients, including those with protected characteristics.

Broadening the scope of information that is reported should promote a more comprehensive health system by informing reimbursement prices that reflect the market, ensuring value for money spent on health service products. This may free up resources for other priorities within the health system.

Greater supply data will also ensure DHSC is more informed about supply issues. This should support improved planning and targeted mitigations so that patients are able to receive the medicines they need, when they need them.

In contrast, if DHSC were to proceed with the ‘do nothing’ option and maintain the information regulations as they are, DHSC would have an inferior understanding of the market activity. Therefore reimbursement prices not already set using supplier data would be less reflective of actual sales and purchases, resulting in community pharmacies being over or underpaid. This would create an unsustainable financial system that would neither benefit the industry nor the government.

DHSC would also have a narrower overview of the medicines supply meaning that there would be less foresight into supply challenges that may lead to delayed mitigating actions that are not cost-effective for the NHS, nor effective in minimising the effect of the supply shortage on patients. The information regulations would also not be reflective of current practice, therefore hindering compliance measures.

DHSC therefore considers that the proposed changes improve the Secretary of State’s duty to promote a comprehensive health service and support the relationship between the Secretary of State and industry, ensuring that the information regulations have the confidence of all parties involved.

To act with a view to securing continuous improvement in the quality of services (section 1A of the NHS Act 2006)

The Secretary of State is required to exercise their NHS functions with a view to securing continuous improvement in the quality of services provided to individuals.

DHSC’s proposals will ensure the information regulations remain appropriate for achieving their objectives for retrieving data to facilitate the remuneration of NHS chemists and primary medical providers. It also ensures the necessary data is received to substantiate the oversight of availability of products in the UK to assess value for money by ensuring the information received is accurate and comprehensive. This will increase the resource available by ensuring that the NHS budget is managed effectively, and decisions about the provision of services are made in the best interests of patients, ensuring a quality service.

In discharging this duty, the Secretary of State must have regard to the National Institute for Health and Care Excellence (NICE) quality standards, which define quality and quality improvement for particular kinds of care and treatment. As set out above, a decision to broaden the scope of information that is returned to DHSC ensures effective NHS expenditure when reimbursing primary care and evaluating the value for money when making supply decisions about health service products, supporting the Secretary of State to meet duties in securing continuous improvement in quality of services.

To have regard to the NHS Constitution (section 1B of the NHS Act 2006)

Regard must be given to the values, principles, pledges and rights in the NHS Constitution for England.

The NHS Constitution has been taken into account when developing the proposals in this consultation. In particular, this has included considering the following principles:

• principle 1: the NHS provides a comprehensive health service available to all
• principle 4: the patient will be at the heart of everything the NHS does
• principle 6: the NHS is committed to providing the best value for taxpayers’ money

DHSC has also considered these proposals in the context of the constitution’s pledges to, and the rights of, NHS patients. In particular, this has included consideration of the rights in relation to nationally approved treatments, drugs and programmes, which set out patients’ rights to drugs and treatments that have been recommended by NICE for use in the NHS, where the patient’s doctor says they are clinically appropriate.

As set out above, DHSC’s proposals broaden the scope of data collection through the information regulations to inform accurate price setting, including potentially increasing the number of medicines included in the Drug Tariff, for reimbursement purposes. This will benefit the NHS and industry as it will mean that community pharmacists are reimbursed appropriately. This in turn will support the NHS to provide a more comprehensive health service by ensuring value for money for NHS budgets which increases resource available for the wider health service.

It will also ensure access to medicines recommended by NICE for all patients by ensuring that community pharmacies and dispensing doctors are reimbursed for their prescriptions, ensuring treatment is clinically effective and cost-effective for patients and also providing value for money to the NHS and taxpayers.

To have regard to the need to reduce health inequalities (section 1C of the NHS Act 2006)

With their functions in relation to the NHS, the Secretary of State must have regard to reducing inequalities between the people of England with respect to the benefits that they can obtain from the NHS.

DHSC does not envisage any negative effects on health inequalities as a result of the proposed amendments. Ensuring value for money for NHS spending through setting evidence-based reimbursement prices and cost-effective supply strategies is critical to enabling the NHS to provide widespread access to medicines and respond to health inequalities. This is likely to benefit all patients in the NHS, and particularly the most economically deprived in the population, as medicine usage is greater in this group.

All groups will benefit from a mechanism that ensures the NHS gets better value for medicines and has greater resilience and cost-effective response mechanisms to supply shortages.

To promote research (section 1E of the NHS Act 2006)

In exercising their functions in relation to the NHS, the Secretary of State must promote:

• research on matters relevant to the NHS
• the use in the NHS of evidence obtained from research

Setting accurate reimbursement prices in the Drug Tariff ensures value for money for the NHS, potentially freeing up more funds to invest in innovative products, in clinical research and in process innovation. Some elements of the proposal, namely formalising detailed supply data reports, will provide evidence of where the supply chain is not working properly and where there is potential opportunity to take action for improvements. Ensuring fair reimbursement mechanisms based on data will also encourage companies to invest in developing the latest cost-effective medicines and primary care providers to prescribe the most effective medicines while ensuring value for money for the NHS. The information will also provide evidence of where the supply chain is not working properly and where there is potential for the Secretary of State to take action.

To secure education and training (section 1F of the NHS Act 2006)

The Secretary of State must exercise their NHS (and other) functions to secure an effective system for the planning and delivery of education and training for the persons employed, or considering becoming employed, in the NHS or connected activities.

DHSC has considered this duty in relation to its proposals and does not consider that they would affect education and training.

To review treatment of providers (section 1G of the NHS Act 2006)

The Secretary of State is required to keep under review any matter that might affect the ability of healthcare providers to provide NHS services or the reward available to them for doing so.

DHSC has considered this duty in relation to the measures. It considers that they positively affect the ability of healthcare providers to provide NHS services by:

• supporting more accurate reimbursement of community pharmacy and primary care prescribers
• securing better value for money from, and availability of adequate supplies of, health service products

To report on workforce systems (section 1GA of the NHS Act 2006)

The Secretary of State must, at least once every 5 years, publish a report describing the system in place for assessing and meeting the workforce needs of the health service in England.

DHSC does not consider this duty to be affected by the proposals in this consultation.

Public sector equality duty

This duty comprises 3 equality objectives, each of which needs to be considered separately. Ministers must have regard to the need to:

• eliminate discrimination, harassment, victimisation and any other conduct that is prohibited by or under the Equality Act 2010
• advance equality of opportunity between persons who share a relevant protected characteristic and persons who do not share it
• foster good relations between persons who share a relevant protected characteristic and persons who do not share it

The protected characteristics covered by this duty are:

• age
• disability
• gender reassignment
• marriage and civil partnership
• pregnancy and maternity
• race
• religion or belief
• sex
• sexual orientation

Updating the information regulations to inform more accurate reimbursement prices and ensuring improved data for availability and value for money of medicines will mean they continue to meet their objectives in relation to:

• improving the comprehensiveness of community pharmacy reimbursement arrangements
• maintaining sales and purchase information for health service products for an accurate overview of the market
• supporting DHSC’s management of supply issues and ensuring value for NHS money

This should ensure equal access to medicines across groups with protected characteristics and those beyond by substantiating comprehensive and effective reimbursement of medicines and supply management.

DHSC considers that meeting these objectives is in the interest of all patients, which is likely to encourage good relations between different groups in society, including those who share a relevant characteristic and those who do not. Those who share protected characteristics will benefit directly, along with the rest of the population, from NHS financial sustainability and access to medicines. In particular, it is likely to provide greatest benefits to those individuals and groups that make greatest use of prescription products. This will include certain groups that share protected characteristics, such as older people, pregnant people and those with disabilities and long-term health conditions.

The proposals should ensure value for NHS money meaning it can continue to use its funds in the best interest of patients, including those with protected characteristics. Overall, all groups will benefit from a mechanism that ensures the NHS gets better value for money and mitigates supply challenges in a cost-effective manner, while minimising the effect on the care that all patients receive, including those with protected characteristics.

In particular, DHSC considers that ensuring the sustainability of the medicines reimbursement system and securing a better overview of the UK medicine supply is likely to benefit specific groups where illness and use of medicines tend to be higher than in the rest of the population. These groups include those sharing protected characteristics, such as older people and those with disabilities and long-term health conditions. Providing these specific protected groups with access to medicines will improve health outcomes in these groups, leading to greater equality of opportunity between these protected groups and the general population.

The Family Test

The Secretary of State must consider, where sensible and proportionate, whether to apply the Family Test, when making policy. The Family Test questions are:

• what kind of impact might the policy have on family formation?
• what kind of impact will the policy have on families going through key transitions such as becoming parents, getting married, fostering or adopting, bereavement, redundancy, new caring responsibilities or the onset of a long-term health condition?
• what impacts will the policy have on all family members’ ability to play a full role in family life, including with respect to parenting and other caring responsibilities?
• how does the policy impact families before, during and after couple separation?
• how does the policy impact those families most at risk of deterioration of relationship quality and breakdown?

DHSC has considered the Family Test and considers the proposals will not have a negative effect in relation to any of the relevant questions.

Environmental principles policy statement

The Environment Act 2021 requires ministers of the Crown, and those making policy on their behalf, to have ‘due regard’ to the environmental principles policy statement when making policy.

Ministers must identify the potential environmental effects (positive and negative) of the proposed policy and consider the 5 environmental principles:

• integration
• prevention
• rectification at source
• polluter pays
• precautionary

Ministers must incorporate the relevant principles in a proportionate manner.

Following consideration of this duty and the 5 principles, DHSC does not consider that there will be any disproportionate environmental impacts as a result of these changes.

DHSC considers that the use of medicines in the NHS may have some negative secondary (indirect) environmental effects. These include indirect greenhouse gas emissions, and contamination of the environment from the production and freight of medicines procured by the NHS. However, the changes to the information regulations will have no material additional impact on the production or freight of medicines procured by the NHS in comparison with the counterfactual (where the regulations are not updated). DHSC therefore does not consider the changes to the information regulations will result in environmental impacts from changes in patient use of medicines in the NHS.

With regard to the broader environmental impacts from the use of medicines in the NHS, environmental considerations have been integrated throughout the way the NHS purchases medicines. For example, the NHS England Public Board has approved a roadmap to help suppliers align with the net zero ambition between now and 2030. This approach builds on UK government procurement policy (Procurement Policy Note 06/20 and Procurement Policy Note 06/21).

Other policies that aim to address the environmental impacts of medicine use are in place across the UK.

Therefore, DHSC does not consider that it would be proportionate to include further measures within the information regulations to meet this duty, given the associated economic and social benefits to society of the policy’s primary objectives, and that impacts are being addressed through more proportionate means.

How to respond 

This consultation document is intended to provide stakeholders and members of the public with information about the policy proposals and an opportunity to comment. This consultation has also been developed alongside an impact assessment and DHSC invites any additional evidence to quantify the benefits and tests the assumptions made on cost to inform the final analysis.

This consultation is being made available in England, Wales, Scotland and Northern Ireland and the proposed changes to the information regulations would apply throughout the UK.

Please respond using the online survey.

Do not provide personal data when responding to free-text survey questions. Any personal data included will be removed before analysis of these responses and will therefore not be considered in the consultation outcome.

The consultation is open for 12 weeks and will close at 11:59pm on 5 May 2026. If you respond after this date, your response will not be considered.

If you have any queries on this consultation, contact informationregulations@dhsc.gov.uk. Do not send your consultation answers or any personal information to this email address.

Respond to the questions asked within the scope of this consultation. Responses covering areas that lie outside the scope of the consultation will not be analysed or considered in the government’s consultation response. If possible, cite evidence to support your views. If you are opposed to the proposal, provide alternative suggestions that would help the government to achieve its objectives.

Consultation questions

About you

In what capacity are you responding to this survey?

• An individual sharing my personal views and experiences
• An individual sharing my professional views
• On behalf of an organisation

Questions for individuals sharing their personal views and experiences

What is your age? (Optional)

• Under 16
• 16 to 24
• 25 to 34
• 35 to 44
• 45 to 54
• 55 to 64
• 65 to 74
• 75 or above
• Prefer not to say

What is your sex? (Optional)

• Male
• Female
• Prefer not to say

Question for individuals sharing their professional views

Which of the following best describes your area of work? (Optional)

• NHS or health service delivery
• Other public sector
• Charity or voluntary sector
• Private sector
• Other, please specify

Questions for organisations

What is the name of your organisation? (Optional)

Where does your organisation operate or provide services? (Optional, select all that apply)

• England
• Wales
• Scotland
• Northern Ireland
• The whole of the UK
• Outside the UK

Which of the following best describes the work of your organisation?

• A manufacturer or supplier of health service products and/or appliances
• A wholesaler of health service products and/or appliances
• A supplier of health service products and/or appliances
• An organisation representing the pharmaceutical industry
• Other pharmaceutical or life science sector, please specify
• A provider of goods or services to the NHS
• Other private sector organisation, please specify
• An NHS organisation
• Research or education
• Other public sector organisation, please specify
• An organisation representing patients, the public and carers
• Other voluntary sector organisation, please specify

If asked to specify, please provide further detail about the work of your organisation. (Optional, maximum 200 words)

Consultation proposals: reimbursement

DHSC proposes to introduce a provision to the information regulations that allows DHSC to routinely collect, on a quarterly basis, supply and purchase information on unbranded generic and special products, rather than relying on the current ad hoc provisions. This is with a view to adding the products to Part VIII of the Drug Tariff.

This would regularise the collection of data and allow for reimbursement prices to be considered for more products.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC proposes to introduce a provision to the information regulations that allows DHSC to routinely collect, on a quarterly basis, sales and volume data for branded and generic medicines in Category H of the Drug Tariff.

This would regularise the collection of data and allow for reimbursement prices to be considered for products in Category H of the Drug Tariff.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC proposes to introduce a provision to the information regulations to require producers of health service medicines to notify DHSC about any new health service medicines they place on the market.

This will ensure that the dm+d is updated accordingly and accurate reimbursement prices can be set in the Drug Tariff.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC also proposes to introduce a provision to the information regulations to require producers of health service medicines to notify DHSC about changes to any existing medicines (including price and pack size).

This will ensure that the dm+d is updated accordingly and accurate reimbursement prices can be set in the Drug Tariff.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC is proposing to include a provision in the information regulations that requires pharmacies acting in the capacity of a hub, as a supplier to community pharmacies providing NHS pharmaceutical services to record, to keep and provide information about their purchase, sale and supply of health service products that they supply to a ‘spoke’ business.

This will enable price setting for reimbursement and supply monitoring to reflect the whole supply chain where necessary.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

If you selected ‘agree’, do you agree or disagree that the best way to do this is by including hubs in the definition of a Category C purchaser as defined by regulation 15?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

In the information regulations, DHSC is proposing to define an invoice as ‘any set of documentation that functions as an invoice for the purchase of any presentations, specifically enhanced delivery notes (which provide all the equivalent information of an invoice) and credit notes for purchases.’

This would be for the purpose of informing the margin survey and will provide clarity and ensure medicine margin calculations are based on accurate data.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

If you have any comments on the proposals in this section, please include them here. (Optional, maximum 800 words)

Do not include any personally identifiable information.

Consultation proposals: availability and value for money

DHSC is proposing to amend regulation 29 so there are clear obligations to report any situation where supply might be reduced.

This will ensure that DHSC has sufficient notice of any potential shortages and will enhance DHSC’s ability to manage supply issues, as currently not all potential issues are being reported.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC is proposing to introduce a requirement for companies to share information on products that can be used in the NHS (even if they are intended for retail sale) in the event a shortage is identified.

This will ensure that DHSC has a complete picture of the market and can better manage supply challenges. Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC is proposing to include a provision in the information regulations that enables DHSC to make ad hoc requests about marketing authorisation holders’ stock position when there is no supply shortage or upcoming discontinuation.

This will enable DHSC to better respond to identified public health risks and minimise the effect of supply shortages on patients.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC is proposing to increase the scope of data that suppliers are required to provide when they anticipate a discontinuation or an upcoming supply shortage. The proposed scope of data would include current and future stock positions.

This will support future planning, horizon scanning and mitigation of supply risks.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

If you have any comments on the proposals in this section, please include them here. (Optional, maximum 800 words)

Do not include any personally identifiable information.

Consultation proposals: improving the compliance regime

DHSC is proposing to replace the reference to ‘NHS England online gateway’ with a reference to the NHSBSA’s data portal in the information regulations.

This will ensure the information regulations reflect the organisational changes that have taken place since they were first introduced.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC is proposing to amend the information regulations to define the specific delivery point for shortages and discontinuations to be reported.

This will provide further clarification and ensure the information regulations reflect current practice.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC is proposing to remove the requirement for DHSC to issue a compliance notice prior to imposing fines on companies that fail to comply with regulation 25(4) or 31(5) relating specifically to shortages, discontinuations or product information updates.

This will ensure faster, more effective responses to supply risks and allow for the dm+d to be updated to set accurate reimbursement prices.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

DHSC is proposing to reduce the frequency of the review of the information regulations to every 2 years.

This will enable adequate time for the information regulations to take effect and will enhance the quality of future evaluations.

Do you agree or disagree with this proposal?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

If you have any comments on the proposals in this section, please include them here. (Optional, maximum 800 words)

Do not include any personally identifiable information.

Impact of the proposals (file upload)

This section is intended to invite stakeholders to provide their own evidence to support the impact assessment. If you would like to provide any qualitative and quantitative data on any of the proposed amendments, please do so here. (Optional)

 Statutory duties

Several specific duties must be considered when proposing updates to the information regulations, including:

• duties under the NHS Act 2006
• the Family Test
• the environmental principles policy statement

DHSC considers the proposals will help ensure the Secretary of State for Health and Social Care continues to promote a comprehensive health service and that the proposed amendments support the efficient and effective operating of the reimbursement arrangements and is better positioned to prevent medicines shortages.

Do you agree or disagree with DHSC’s initial conclusions about the impact that the proposed updates to the information regulations will have in terms of the statutory duties of the Secretary of State?

• Agree
• Neither agree nor disagree
• Disagree
• Don’t know

Please explain your answer and provide evidence to support further development of our analysis. (Optional, maximum 500 words)

Do not include any personally identifiable information.

Privacy notice

Summary of consultation

The main purpose of the Health Service Products (Provision and Disclosure of Information) Regulations 2018 is to 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 or supply of those products. The information regulations also make provision in connection with the disclosure of such information and the purpose for which any information disclosed may be used.

This consultation seeks views and comments on proposals to amend the information regulations in order to provide additional flexibility for DHSC to obtain information on medicines supply. A number of data collections are currently done using ad hoc powers under regulation 18. The consultation seeks views on making amendments to formalise these collections in the information regulations.

Data controller

DHSC is the data controller.

What personal data we collect

The type of personal information we will collect is as follows:

• whether the respondent is sharing their personal or professional views or responding on behalf of an organisation
• age and sex of the respondent responding in an individual capacity
• the area of work of the respondent or organisation that the respondent works for
• area of the UK the organisation is based that the respondent works for
• the name of the organisation the respondent works for
• email address

How we use your data (purposes)

Your data will be treated in the strictest of confidence.

The data we collect is to:

• inform DHSC of the demographic of respondents
• understand whether views vary across demographics
• understand how representative the results are

Data collected will be held securely by SurveyOptic and will be downloaded and anonymised by DHSC.

Legal basis for processing personal data

Under Article 6 of the United Kingdom General Data Protection Regulation (UK GDPR), the lawful bases we rely on for processing personal data are:

e) the processing is necessary to perform a task in the public interest or for our official functions and the task or function has a clear basis in law

DHSC is required to conduct an annual review as per section 36 of the information regulations.

Data processors and other recipients of personal data

This consultation is hosted on an online platform owned by SurveyOptic, who are a contracted supplier of DHSC. SurveyOptic will delete any personal data in line with the retention and disposal periods outlined in this privacy notice, or earlier if instructed to do so by DHSC.

International data transfers and storage locations

Storage of data by SocialOptic is provided via secure servers located in the UK.

Retention and disposal policy

Any personal data that you provide will be held by DHSC for a maximum of one year.

SurveyOptic will securely erase the data held on their system one year after the online survey closes. This erased data will then be cycled out of SurveyOptic’s back-up storage within 6 to 8 weeks.

Data retention will be reviewed regularly. Anonymised data may be kept indefinitely. 

How we keep your data secure

DHSC uses appropriate technical, organisational and administrative security measures to protect any information we hold in our records from loss, misuse, unauthorised access, disclosure, alteration and destruction. We have written procedures and policies which are regularly audited and reviewed at a senior level.

SurveyOptic is Cyber Essentials certified.

Your rights as a data subject

By law, data subjects have a number of rights, and this processing does not take away or reduce these rights under the UK General Data Protection Regulation and the UK Data Protection Act 2018 applies.

These rights are:

1. The right to get copies of information - individuals have the right to ask for a copy of any information about them that is used.
2. The right to get information corrected - individuals have the right to ask for any information held about them that they think is inaccurate, to be corrected.
3. The right to limit how the information is used individuals have the right to ask for any of the information held about them to be restricted, for example, if they think inaccurate information is being used.
4. The right to object to the information being used individuals can ask for any information held about them to not be used. However, this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case.
5. The right to get information deleted this is not an absolute right, and continued use of the information may be necessary, with individuals being advised if this is the case.

Comments or complaints

Anyone unhappy or wishing to complain about how personal data is used as part of this programme, should contact data_protection@dhsc.gov.uk in the first instance or write to:

Data Protection Officer
1st Floor North
39 Victoria Street
London
SW1H 0EU

Anyone who is still not satisfied can complain to the Information Commissioner’s Office. Their website address is www.ico.org.uk and their postal address is:

Information Commissioner’s Office
Wycliffe House
Water Lane
Wilmslow
Cheshire
SK9 5AF

Automated decision making or profiling

No decision will be made about individuals solely based on automated decision making (where a decision is taken about them using an electronic system without human involvement) that has a significant impact on them.

Changes to this policy

We keep this privacy notice under regular review, and we will update it if necessary. All updated versions will be marked by a change note on the consultation page. This privacy notice was last updated on 10 February 2026.

Annex: information that providers would be required to report to NHSBSA

Information that providers would be required to report to NHSBSA should a new product be brought to market or if updates are made in any of the following areas:

• product name
• NHS list price or trade price (excluding VAT)
• pack size information
• effective date of product launch
• discontinued products or packs (including divestments and transfers)
• an authorised copy of the Summary of Product Characteristics (SmPC) with the marketing authorisation numbers (section 8 of the SmPC) and date of first authorisation (section 9 of the SmPC)
• marketing authorisation holder
• the product’s legal category
• availability restrictions (including, but not limited to, whether the product is only available in hospitals or via homecare)
• the licensed route of administration
• confirmation of licensing authority

Glossary of terms related to the Drug Tariff

Drug Tariff

The Drug Tariff for England and Wales is published each month on behalf of DHSC and sets out what pharmacy contractors will be paid for providing NHS pharmaceutical services, including:

• reimbursement (the cost of drugs and appliances)
• remuneration (for example, professional fees)

Part VIIIA

If a medicine is prescribed generically and the medicine is listed in Part VIIIA of the Drug Tariff, a pharmacy contractor in England will be reimbursed for it by the NHS according to the price listed in Part VIIIA. There are essentially 4 categories of drugs listed in Part VIIIA of the Drug Tariff, referred to by the letters A, C, H and M. 

Category A

Category A refers to drugs that are readily available. Information regulations data from manufacturers and wholesalers is used to set reimbursement prices. 

Category M

Category M refers to drugs that are readily available from more than one manufacturer and fulfil minimum spend and/or volume requirements. Category M prices are calculated based on quarterly information provided by all manufacturers and suppliers.

Category H

Category H refers to drugs that are not readily available as a generic, where there are multiple suppliers. Information regulations data from manufacturers and wholesalers is used to set reimbursement prices. 

Category C

Category C refers to drugs that are not readily available as a generic, where the price is based on a particular proprietary product, manufacturer or as the case may be supplier.

Part VIIID

Part VIIID sets out payment arrangements for specials and imported unlicensed medicines. 

dm+d

The dictionary of medicines and devices (dm+d) is a dictionary of descriptions and codes that represent medicines and devices in use across the NHS. It must be used when electronic systems exchange or share information about medicines relating directly to a patient’s care.

1. In 2019, DHSC publicly consulted on a range of ‘reimbursement reforms’ to the way community pharmacy contractors in England are paid for the drugs they dispense as part of providing NHS pharmaceutical services. These were not fundamental changes but improvements to ensure patients’ access the medicines they need in a timely manner, reduce perverse incentives and improve pharmacy contractors’ cashflow and distribution of medicine margin. Since publication of the consultation response, DHSC has implemented 3 reforms out of the 8 we consulted on. ↩