Overview

This bill establishes a Medicines Safety Evaluation Panel to review methods for testing medicine safety, comparing human biology-based tests with animal-based tests. The goal is to assess the effectiveness of different testing methods and inform future practices.

Description

The bill creates a Medicines Safety Evaluation Panel (the Panel) appointed by the Secretary of State. The Panel must include at least two statisticians from the Office for National Statistics and at least eight members from the National Institute for Health Research. The Panel will review medicine safety testing methods, comparing human biology-based tests (including computer simulations, tests using human cells and tissues, and early clinical trials) with animal-based tests (as defined by Directives 2004/27/EC and 2003/63/EC). The review must consider medicines licensed by the MHRA or MCA, including some withdrawn due to safety concerns. The Panel will commission necessary human biology-based tests and report its findings to the Secretary of State within two years. The Secretary of State will then publish the report, protecting commercially sensitive information. The Medicines and Healthcare products Regulatory Agency (MHRA) is required to provide the Panel with relevant information.

Government Spending

The bill mandates that any expenses incurred by the Secretary of State in implementing the Act will be paid from public funds. No specific figures are provided in the bill itself.

Groups Affected

• The Medicines Safety Evaluation Panel: Responsible for conducting the review and preparing a report.
• The Medicines and Healthcare products Regulatory Agency (MHRA): Required to provide information to the Panel.
• The Office for National Statistics and the National Institute for Health Research: Required to provide members to the Panel.
• Pharmaceutical Companies: Their testing methods will be evaluated, and commercially sensitive information may be involved.
• Animal welfare groups: The outcome of the comparison between animal and human-based testing may influence future animal testing regulations.
• The Public: The report will inform future medicine safety regulations and potentially influence the development of new medicines.

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