Overview

This bill aims to improve access to off-patent drugs (medicines whose patents have expired) for new medical uses. It mandates the Secretary of State to pursue licenses for these drugs in new indications and requires the National Institute for Health and Care Excellence (NICE) to conduct technology appraisals, leading to funding recommendations for their use.

Description

The bill comprises three parts. Part 1 compels the Secretary of State to apply for licenses for off-patent drugs to be used in new ways (indications) if certain conditions are met (e.g., no other organisation is already pursuing a license). The Secretary of State can delegate this task to specified bodies, like the Health Research Authority, under agreed terms. Regulations will outline further requirements. Part 2 directs NICE to conduct technology appraisals for off-patent drugs in new indications that meet specified minimum requirements. NICE must then recommend funding from relevant health bodies to make the drug available within three months. This part applies only when Part 1's conditions aren't met. Part 3 details an annual report to Parliament on progress, regulations for implementation, definitions of key terms (e.g., "drug," "indication," "license"), and the bill's extent and commencement.

Government Spending

The bill doesn't specify exact figures for increased government spending. However, it will likely lead to increased costs associated with licensing applications, NICE technology appraisals, and funding for the provision of off-patent drugs in new indications. The exact financial implications will depend on the number of drugs and indications involved.

Groups Affected

• Secretary of State for Health: Responsible for initiating licensing applications and directing NICE appraisals, potentially increasing their workload and budget.
• Health Research Authority and other specified bodies: May be tasked with licensing applications, impacting their workload and funding.
• NICE: Increased workload through conducting technology appraisals, which may require additional resources.
• NHS and other relevant health bodies: Will be responsible for funding the provision of approved drugs in new indications, increasing healthcare costs.
• Pharmaceutical companies: Indirectly affected by the increased availability of off-patent drugs in new indications.
• Patients: Could benefit from increased access to affordable treatment options for new medical uses of existing drugs.

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