Overview

This bill aims to improve access to off-patent drugs (drugs no longer protected by patents) for new medical uses. It mandates the Secretary of State to secure licenses for these drugs in new indications and requires the National Institute for Health and Care Excellence (NICE) to conduct technology appraisals to assess their value, ultimately aiming to ensure these drugs are made available to patients who need them.

Description

The bill comprises three parts. Part 1 requires the Secretary of State to apply for licenses for off-patent drugs when a new medical use is identified, unless another organization is already doing so. The Secretary of State can delegate this task to specified bodies, such as the Health Research Authority, under agreed terms. Part 2 mandates NICE to conduct technology appraisals for off-patent drugs with new indications, even if not yet licensed, provided certain minimum requirements are met. NICE must then recommend funding from relevant health bodies to make the drug available within three months of publication of its appraisal. Part 3 includes provisions for an annual report to Parliament on the bill's implementation, regulations making processes more specific, and definitions of key terms like "drug," "indication," and "license."

Government Spending

The bill does not specify exact figures for increased government spending. However, it will likely lead to increased costs associated with licensing applications, NICE technology appraisals, and potential funding for making off-patent drugs available for new indications. The extent of this additional spending will depend on the number of drugs and new indications considered under the bill's provisions.

Groups Affected

• Patients: Potentially benefits patients by increasing access to affordable treatments for new indications.
• Pharmaceutical Companies: May see increased costs associated with license applications if they are involved in the process.
• The Secretary of State and relevant government departments: Responsible for implementing the bill, including overseeing licensing applications and NICE appraisals.
• NICE: Will take on additional responsibilities for appraising off-patent drugs.
• Health Research Authority and other public bodies: May be involved in the licensing process.
• NHS and other health bodies: Responsible for funding the provision of approved drugs following NICE recommendations.

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