Overview

This bill mandates that all medicinal products sold in the UK must display a label declaring that animal research was used in their development, production, or testing. Failure to comply results in fines for pharmaceutical companies.

Description

Main Provisions

The Medicinal Labelling Bill requires a statement on every medicinal product label confirming the use of animal research at any stage of its development, production, manufacturing, safety assessment, or efficacy testing. This applies to all drugs, medicines, and vaccines listed in the British National Formulary, whether prescription or over-the-counter. The definition of "animal" includes all vertebrates except humans.

Penalties

Pharmaceutical companies failing to comply face fines. The penalty for each unlabelled product sold or dispensed is determined based on whether the case is dealt with summarily (maximum statutory fine) or on indictment (an unspecified fine).

Enforcement

The penalty section of the bill (Section 1(2)) will take effect six months after the bill is passed, allowing businesses time to adapt. The rest of the bill comes into effect immediately upon passage.

Geographical Coverage

The bill applies to England, Wales, Scotland, and Northern Ireland.

Government Spending

The bill doesn't directly specify government spending increases. However, there may be associated costs related to enforcement and potential legal challenges. No figures are provided in the bill itself.

Groups Affected

• Pharmaceutical Companies: They will incur costs associated with re-labelling products and potentially face significant fines for non-compliance.
• Consumers: They will be directly informed about the use of animal research in the production of their medicines.
• Animal Welfare Groups: This legislation may be seen as a positive step toward transparency regarding animal research.
• Government Agencies: Responsible for overseeing and enforcing compliance with the new labelling requirements.

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