Key Facts

• The Committee will meet at specified times on Monday 8 June and Wednesday 10 June.
• Amendments are grouped together based on similar issues but decisions are made in the order they affect clauses.
• Hansard reporters can be emailed electronic copies of speaking notes to enhance transcription accuracy.
• Amendment 9 aims to limit the Secretary of State's power to make individual decisions through statutory instruments for a period of two years.
• The amendment calls for comprehensive regulations to be developed within this timeframe, covering medicines and medical devices.
• Current regulation involves a 'triple lock' system with checks by multiple notified bodies from EU structures.
• The Bill provides a framework to update regulations for human medicines, veterinary medicines, clinical trials, and medical devices.
• A sunset clause would remove necessary legal powers after two years, potentially halting patient safety improvements.
• Secondary legislation allows for quick regulatory updates when needed.
• Amendment 22 removes the requirement to consider attractiveness in UK regulations.
• Amendment 23 requires primary regard to patient safety when making regulations under subsection (1).
• New clause 3 mandates reports to Parliament when a clinically beneficial medicine is not available on the NHS.
• Clause 1 focuses on patient safety, availability of medicines, and attractiveness of the UK for research and manufacturing.
• Amendment 23 aims to establish a hierarchy with patient safety as the most important consideration.
• The Cumberlege review is due to be published on 8 July.
• The cystic fibrosis campaign has a 98% sign-up rate from parents who have had children with cystic fibrosis.
• Amendments 22 to 27 relate to the considerations for medicines and medical devices regulations.
• The Government committed to supporting the life sciences sector through the industrial strategy.
• The life sciences sector in the UK is worth more than £74 billion per annum.
• The Bill seeks to ensure patients get access to innovative treatments as early as possible while maintaining patient safety.
• Amendments 22, 24 and 26 aim to remove a consideration intended to balance regulatory impacts on innovation.
• The amendment seeks to empower the appropriate authority to make provisions on the origin and treatment of human organs used in developing or manufacturing medicines.
• Evidence suggests that forced organ harvesting has occurred on a significant scale in China, primarily from Falun Gong practitioners but also Uighurs, conscientious objectors, and political prisoners.
• The World Health Organisation relies on self-assessment by signatory countries like China for ethical guidance on transplant systems.
• The Human Tissue (Quality and Safety for Human Application) Regulations 2007 and the Human Tissue Act 2004 set out requirements around donation, procurement, testing, processing, storage and distribution of organs, tissues and cells intended for human application.
• Safeguards are in place to ensure that human tissue or cell components used in medicinal products meet certain consent and traceability requirements when imported into the UK.
• The Minister commits to writing to her Foreign and Commonwealth Office counterpart to explore the issue further.
• The proposed new clause 2 requires reports detailing medicines under development from the date of the Act's passing.
• New clause 4 mandates prioritising antimicrobial resistance in medicine development and updating Parliament with a strategy report within 12 months after Royal Assent.
• The clause allows changes to the law relating to manufacturing, marketing, importation, distribution, and other aspects of human medicines.
• Subsection (1)(a) enables updating regulations on manufacturing to reflect advances in innovation.
• Subsection (1)(b) supports ensuring safe importation of medicines without unnecessary burden on companies.
• Subsection (1)(c) permits changes to law governing distribution by wholesale dealing to maintain quality and proper supply.
• Subsection (1)(d) allows for regulatory system updates to enhance the UK's attractiveness in marketing medicines.
• Subsection (1)(e) enables control of active substances to protect public health from contamination.
• Subsection (1)(f) restricts brokering activities to secure medicine supply chain and patient safety.
• Subsection (1)(g) amends registration requirements for pharmacy business premises for coherent regulation.
• Subsection (1)(h) enables changes to record-keeping requirements for evolving models of supply.
• Subsection (1)(i) provides for updates in reporting safety data about medicines for improved vigilance.
• Subsection (1)(j) allows innovation in labelling and packaging, including digital versions.
• Subsection (1)(k) enables updating advertising regulations to reflect digital communication channels.
• Subsection (1)(l) introduces a national registration scheme for online sellers of medicines with appropriate protections.
• Subsection (1)(m) outlines provisions for the validity requirements of prescriptions.
• Subsection (1)(n) amends rules around who can supply or prescribe human medicines based on healthcare needs.
• New clause 2 aims to increase transparency and public understanding of government-developed products, particularly those developed by Porton Down.
• In the past decade, Porton Down has experimented on 52,000 animals, which is six times higher than any other UK lab.
• The new clause for antimicrobial resistance proposes an annual report instead of a long-term strategy.
• The UK invests over £1 billion annually in health research through the NIHR.
• The UK Government published a vision to contain and control AMR by 2040 with a five-year action plan from 2019 to 2024.
• A subscription-style payment model for antibiotics was launched in July 2019, being the first country to test such a model.