Overview

This bill mandates the UK Secretary of State to seek licenses for off-patent drugs to be used for new medical purposes (indications) and requires the National Institute for Health and Care Excellence (NICE) to conduct technology appraisals for these new uses. The aim is to ensure that existing medicines are properly investigated and evaluated for potential new treatments.

Description

The Off-patent Drugs Bill outlines the Secretary of State's responsibility to apply for licenses when an off-patent drug shows promise for a new indication not currently covered by its existing license, provided certain conditions are met. This includes ensuring no other organization is already pursuing a license for the same new use. The Secretary of State can delegate this task to bodies like Innovate UK or other designated public bodies, under agreed terms. The bill further requires NICE to conduct technology appraisals for these off-patent drugs when used for new indications, following either a successful application for a new license or when specific criteria laid out in the bill are met. Regulations will specify the requirements for both licensing and NICE appraisals. The Secretary of State must produce an annual report on their actions under this bill.

Government Spending

The bill doesn't specify exact figures for increased government spending. However, it will likely lead to costs associated with licensing applications, NICE technology appraisals, and the production of the annual report. The extent of these costs depends on the number of off-patent drugs investigated for new uses.

Groups Affected

• The Secretary of State for Health and Social Care: Responsible for initiating license applications and directing NICE appraisals, creating substantial new responsibilities and potential costs.
• Innovate UK and other public bodies: May be tasked with applying for licenses, impacting their workload and potentially their budgets.
• NICE: Will conduct additional technology appraisals, increasing their workload and potentially requiring additional resources.
• Pharmaceutical Companies: May see increased opportunities if their off-patent drugs are licensed for new indications.
• Patients: Could benefit from access to new treatments arising from the bill's provisions.
• Taxpayers: Will ultimately bear the costs associated with the implementation of this bill.

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