Key Facts

• The new clause would be inserted after Clause 15.
• It provides power to make regulations for a database on medical devices managed by the Health and Social Care Information Centre.
• Amendments include considerations for human medicines safety, a sunset provision, origin and treatment of human organs in medicine development, veterinary medicine safety, and medical device safety.
• Medical devices are not subject to the same comprehensive pre-market assessment as medicines.
• New clause 1 aims to create a legal framework for data collection on medical device safety and performance.
• The Health and Social Care Act 2012 established NHS Digital, which can collect relevant data under direction from the Secretary of State.
• The National Joint Registry is highlighted as an exemplar for collecting information on joint implants and surgeries.
• Amendment 21 aims to make patient safety the uppermost priority.
• Amendments seek to establish patient safety as the primary consideration.
• The Bill includes changes allowing prescribing professions for veterinary medicines and reflects on patient safety in regulatory decisions.
• A sunset clause would compel the Government to return with new legislation within three years, limiting practical operation of the bill.
• The Government introduced a device registry, now called an information centre.
• The Cumberlege review will report on July 8th with potential impacts on the Medicines and Healthcare Products Regulatory Agency (MHRA).
• Amendment 20 proposes a sunset clause for regulatory powers after three years to allow a holistic evaluation of regulations.
• Paragraph 42 of the impact assessment discusses changes to the hub-and-spoke model in community pharmacy.
• Clause 1(2) prioritizes safety, availability, and market attractiveness for human medicines.
• Amendment 19 would empower authorities to regulate organ-related medicine processes.
• The China tribunal found evidence of forced organ harvesting in China.
• Imported human tissue for medical research does not require consent or traceability under current regulations.
• The Bill is part of the drive to maintain the UK’s position as a world leader in science and research post-Brexit.
• Queen's University Belfast leads the field in cancer research and has received a £20 million Government grant for covid-19 vaccine research.
• From 2004 to 2016, the UK collaborated with other EU countries in 5,000 clinical trials, ranking third highest among joint clinical trials with EU countries.
• The UK ranks fourth in Europe for cardiovascular disease clinical trials, with 586 CVD trials registered in the European database.
• Cancer survival rates in the UK are among the worst in Europe.
• The NHS long-term plan recognised significant issues with cancer survival rates.
• One in two people is likely to get cancer at some point in their lives.
• There has been a 60% drop in cancer referrals and a 20% fall in treatment starts during the pandemic.
• The statistics show a 60% drop in referrals and a 20% drop in treatments beginning.
• Britain represents only 3% of medicine sales globally compared to the EMA's 25%.
• NHS England agreed to roll out stereotactic ablative radiotherapy (SABR) technology, bringing it forward by a year after a 10-year battle.
• Only half of all radiotherapy centres are currently commissioned to provide SABR treatment despite being fully equipped.
• Machines should be replaced every 10 years but some are up to 17 years old, with replacement costs at about £400 per patient.
• A survey revealed a £140 million backlog in machine replacement costs.
• People in Westmorland face a three-hour round trip for radiotherapy.
• An investment of £250 million is needed for new network treatment delivery centres to serve 3.5 million people living farther than the recommended travel time.
• The Bill sets a new direction for regulating medicines and medical devices after the transition period.
• Smaller community pharmacies will be given the same dispensing opportunities as larger pharmacy businesses to level the playing field.
• The UK's life science industry employs around 240,000 people and is committed to global co-operation in research.
• Jo Churchill worked with Member for Central Ayrshire on the Bill.
• The Bill focuses on regulatory scrutiny, data use, and patient importance.
• Amendments were made to clarify regulations under Clause 12(1) and to ensure consultation before making regulations.