Overview

This bill mandates the UK Secretary of State to seek licenses for off-patent drugs to treat new conditions (indications) and requires the National Institute for Health and Care Excellence (NICE) to conduct technology appraisals for these drugs. The aim is to increase access to affordable medicines for previously unapproved uses.

Description

The Off-patent Drugs Bill outlines the Secretary of State's responsibility to apply for licenses for off-patent drugs with new indications if certain conditions are met (no other organization is already seeking a license, requirements set out in regulations are satisfied, etc.). The bill allows the Secretary of State to delegate this responsibility to bodies like Innovate UK.

Licensing: Part 1 focuses on the licensing process for off-patent drugs in new indications. The Secretary of State must apply for a license within six months of becoming aware of a suitable drug.

NICE Appraisals: Part 2 requires the Secretary of State to direct NICE to conduct technology appraisals for off-patent drugs used in new indications, whether or not the Secretary of State is obligated to seek a license under Part 1. NICE's own prioritization criteria will be considered.

Regulations and Reporting: Part 3 details the creation of regulations to clarify the requirements for licenses and NICE appraisals. It also mandates an annual report to Parliament detailing progress.

Government Spending

The bill does not specify exact figures for government spending. However, it's likely to increase costs associated with licensing applications, NICE appraisals, and potential future drug provision if new indications are approved. The overall financial impact will depend on the number of off-patent drugs pursued and the outcomes of the NICE appraisals.

Groups Affected

• The Secretary of State for Health: Responsible for overseeing the implementation of the bill, including licensing applications and NICE directives.
• Innovate UK (and other specified bodies): May be delegated responsibility for applying for licenses.
• NICE: Will be responsible for conducting technology appraisals.
• Pharmaceutical Companies: May face increased competition or opportunities depending on the application and outcome of the licensing and appraisal processes.
• Patients: Could potentially benefit from increased access to affordable treatments if new indications for off-patent drugs are approved.
• The NHS: May experience changes in drug procurement and costs based on NICE decisions.

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