New Regulations Amend UK Branded Health Service Medicines Costs
On December 4, 2024, the UK government introduced the Branded Health Service Medicines (Costs) (Amendment) Regulations 2024. These regulations amend the existing Branded Health Service Medicines (Costs) Regulations 2012.
Key Changes
The new regulations make several key changes to the pricing of branded medicines dispensed in the UK. These include:
- NHS Discount: Increasing the mandatory discount on branded medicines supplied to the NHS from 15% to 20%. This discount is provided by pharmaceutical companies to the Department of Health and Social Care (DHSC).
- Patient Access Scheme (PAS) Threshold: Lowering the annual spend threshold for PASs from £30,000 to £20,000. PASs are voluntary schemes offered by pharmaceutical companies to provide financial assistance to patients using branded medicines.
- Price Controls: Introducing a new process to monitor and control the prices of branded medicines. If a medicine is deemed to be excessively priced, it could be subject to price reductions or restrictions.
Rationale
The government has stated that the new regulations are intended to:
- Reduce the cost of branded medicines for the NHS and patients.
- Improve patient access to affordable healthcare.
- Promote competition within the pharmaceutical sector.
Impact
The new regulations are expected to have a significant impact on the pharmaceutical industry in the UK. They are likely to lead to lower prices for a range of branded medicines, particularly those commonly used by the NHS.
Pharmaceutical companies may also need to adjust their PASs to meet the new threshold requirements. This could lead to changes in the availability and terms of these schemes.
Implementation
The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024 come into force on January 1, 2025. The DHSC will be responsible for implementing and enforcing the new regulations.
Additional Information
The full text of the Branded Health Service Medicines (Costs) (Amendment) Regulations 2024 is available on the UK government website:
www.legislation.gov.uk/uksi/2024/1379/contents/made
The Branded Health Service Medicines (Costs) (Amendment) Regulations 2024
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