Overview

This bill aims to improve access to innovative medical treatments in England and Wales by creating a national database recording the use and outcomes of these treatments. This includes treatments using medicines "off-label" (for purposes not officially approved) or unlicensed medicines.

Description

The bill establishes a database managed by the Health and Social Care Information Centre (HSCIC). This database will collect information on innovative medical treatments used by doctors in England, including details of the treatments and their outcomes. "Innovative treatments" are defined as those departing from standard accepted treatments for a condition. The database will include information on off-label use of licensed medicines and the use of unlicensed medicines. The Secretary of State will have the power to make regulations governing the database's operation, including which information is recorded, procedures for recording this information, and who can access it. These regulations must be subject to parliamentary scrutiny and consultation with the HSCIC. The bill explicitly states that its provisions do not affect existing regulations on medical research and will not apply to solely cosmetic treatments. The bill covers only England and Wales.

Government Spending

The bill does not specify the exact cost of establishing and maintaining the database. The financial implications will depend on the scope and scale of the database as defined in future regulations, including staffing costs, data management, and ongoing maintenance. No figures are provided in the bill itself.

Groups Affected

• Doctors: Will be required to contribute data on innovative treatments to the database.
• Patients: May benefit from increased access to innovative treatments through the information gathered and shared, but also face data privacy implications.
• The HSCIC: Will be responsible for creating and managing the database.
• Researchers: May find the database a valuable resource for research into innovative medical treatments.
• Pharmaceutical companies: May be indirectly affected by the data collected on off-label use of their products.
• The public: Access to information will be regulated under future regulations.

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