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 database will include information on both licensed and unlicensed medicines used in novel ways, facilitating better understanding and potentially wider adoption of effective therapies.

Description

Establishment of a Database

The bill proposes the creation of a database managed by the Health and Social Care Information Centre (HSCIC). This database will collect information on innovative medical treatments used in England, including details on the treatments and their outcomes. "Innovative treatments" are defined as those departing from established medical practice for a given condition. This includes off-label use of licensed medicines and use of unlicensed medicines.

Data Collection and Access

The HSCIC will be responsible for determining what information is recorded and how it is collected. The bill allows for regulations to determine who can access the database information and under what conditions. The Secretary of State must consult the HSCIC before making these regulations.

Types of Treatments Included

The database will include information on the off-label use of authorized medicinal products (using a medicine for a purpose other than that specified in its license) and the use of unlicensed medicinal products. Treatments carried out for medical research purposes will also be included, although the bill does not change the regulations governing such research. Treatments solely for cosmetic purposes are excluded.

Government Spending

The bill doesn't specify the exact amount of government spending required for the database's establishment and maintenance. The cost will depend on the size and complexity of the database, as well as the staffing and infrastructure required by the HSCIC.

Groups Affected

Groups potentially affected include:

• Doctors: Will be required to contribute data on innovative treatments.
• Patients: May benefit from increased access to innovative treatments if the database leads to greater understanding of their effectiveness.
• Pharmaceutical Companies: May benefit from increased data on the effectiveness of their products in new applications.
• Researchers: May find the database a useful resource for conducting research.
• The HSCIC: Will be responsible for managing the database.

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