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 eight members from the National Institute for Health Research. The Panel's primary duty is to conduct a review of medicine safety testing methods, comparing human biology-based tests (e.g., computer simulations, tests using human cells and tissues, early clinical trials) with animal-based tests (as defined by Directives 2004/27/EC and 2003/63/EC). The review must include products licensed by the MHRA or MCA, some of which have been withdrawn due to safety concerns. The Panel will commission necessary human biology-based tests and submit a report to the Secretary of State within two years. This report will then be published, with appropriate protection for commercially sensitive information. The Medicines and Healthcare products Regulatory Agency (MHRA) is mandated to cooperate fully with the Panel's information requests.

Government Spending

The bill states that any expenses incurred by the Secretary of State in implementing the act will be covered by funds provided by Parliament. No specific figures are provided.

Groups Affected

• The Medicines and Healthcare products Regulatory Agency (MHRA): Required to provide information to the Panel.
• Pharmaceutical Companies: Their testing methods and products will be evaluated, potentially impacting future research and development.
• Animal Welfare Groups: The comparison of testing methods may inform the reduction or replacement of animal testing.
• Researchers and Scientists: Involved in human biology-based testing methodologies.
• The Public: Ultimately benefits from safer medicines through improved testing.

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