Overview

The Medicines and Medical Devices Bill aims to update and improve the UK's regulatory framework for medicines and medical devices, allowing for greater international collaboration and streamlining the legislative process. It also mandates reviews and potential consolidation of relevant legislation within a five-year timeframe.

Description

The bill makes several key changes:

• Information Sharing: Allows relevant UK authorities to share information about human and veterinary medicines and medical devices with international bodies for pharmacovigilance (monitoring drug safety) and when in the public interest, while protecting commercially sensitive and patient information. The Commons amendments added a requirement for the disclosure to be necessary and proportionate for sharing commercially sensitive information. The House of Commons amendments further refined this by requiring the disclosure to be in the public interest.
• Legislative Consolidation: Requires the Secretary of State to publish draft legislation within three years to consolidate the regulatory regimes for human and veterinary medicines and medical devices. The House of Commons rejected this in favour of a five year review and report to address medicines and medical devices legislation more broadly.
• Regulatory Procedure: Modifies the process for making regulations, introducing "super-affirmative" procedures for significant policy changes to ensure greater parliamentary scrutiny. The House of Commons altered this to a tiered system which included "draft affirmative" and "negative procedures".
• Reporting: A new section added by the Commons requires a report on the operation of medicines and medical devices legislation be published within five years of the act's passing.

Government Spending

The bill doesn't directly specify any government spending figures. The costs associated with the review, drafting of consolidated legislation, and implementation of the new regulatory procedures are likely to be incurred. Specific budgetary information is not provided.

Groups Affected

• Government Departments: The Department of Health and Social Care and relevant departments in Northern Ireland will need to implement the new regulations and reporting requirements.
• Pharmaceutical Companies: Changes to information sharing and regulatory procedures may affect their operations.
• Medical Device Manufacturers: Similar to pharmaceutical companies, they will be impacted by changes to information sharing and regulatory procedures.
• Healthcare Professionals: The changes may affect how they access and use information concerning medicines and medical devices.
• Patients: The enhanced data protection provisions aim to protect patient confidentiality. Any changes in the regulatory landscape may indirectly affect patient access to medicines and medical devices.
• International Organizations: The bill facilitates increased collaboration and information sharing with international organisations involved in regulating medicines and medical devices.

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