Key Facts

• The Bill aims to give the UK the means to move at a faster pace than EU rules permit.
• The Bill will allow research money from public, private, or third sectors to go further in bringing medicines and medical devices to NHS patients faster.
• The Bill includes provisions for updating human medicine regulations to reflect changes in manufacturing methods and new product types.
• It allows removal of barriers for small independent pharmacies joining hub-and-spoke dispensing arrangements.
• The Bill aims to make the UK the best place in the world for designing and trialling medical innovations.
• It proposes a statutory register of medical devices held by the MHRA, making registration mandatory with details such as manufacturer and supplier information.
• The legislation will enable enhanced patient safety through improved post-market surveillance and recall processes.
• The Medicines and Medical Devices Bill aims to replace delegated powers from the European Communities Act 1972.
• Existing regulatory frameworks will be preserved as retained EU law at the end of the transition period.
• Hancock clarifies that these new powers include safeguards on matters such as safety, availability, and attractiveness for the life sciences sector.
• The in vitro diagnostic medical devices regulation is due to be implemented in 2022.
• There were 62,000 adverse incident reports linked to medical devices between 2015 and 2018, with over 1,000 resulting in death.
• The UK has the highest number of phase 1 clinical trials across the EU, as well as the highest number for rare and childhood diseases.
• The life sciences sector contributes over £74 billion annually to the UK economy.
• It employs nearly 250,000 people in the UK.
• Data from personal medical devices can now be collected for long periods of time, generating vast amounts of data.
• There is a need for confidence that patient data is secure and anonymised when used.
• The statement highlights concerns about the current legal framework being complex and lacking consistency.
• There are approximately 20 chief innovation officers across hospital trusts in the UK.
• NICE prioritises level one data from randomised clinical trials ahead of real-world registry data for medical devices.
• The UK market represents only 3% of the world pharmaceutical market compared to the EU which is a quarter.
• Canada and Australia experience delays of six to twelve months before new drugs are launched in their markets.
• The clinical trials directive (CTD) was first devised in 2001 but has not been updated yet.
• The new measures on falsified and counterfeit medicines include unique identifier numbers and barcode scanning.
• Collaboration in rare disease research is vital due to low patient numbers per country, involving international trials.
• Half of all UK cancer trials are international with a significant portion involving at least one EU state.
• The BEACON trial for recurrent neuroblastoma involves 10 countries.
• There were 4,800 UK-EU clinical trials between 2014 and 2016.
• The son of a constituent obtained large quantities of dihydrocodeine over the internet without seeing a GP.
• In Scotland, optometrists can diagnose cataracts directly without referral through a GP.
• Part 3 sets maximum sentences for offences against the Bill at six months in England and Wales, compared to 12 months in Scotland.
• The MP is concerned about losing access to insulin and medical radioisotopes due to potential trade barriers post-Brexit.
• Prescription waste is estimated to cost £300 million annually.
• Some patients have been found to return up to 100 boxes of unused medication.
• Evans suggests pharmacies should collect statistics on returns.
• Charitable donation practices for medications need review.
• GPs struggle with time constraints for reviewing repeat prescriptions each month.
• The speaker references cases of valproate, Primodos, and surgical mesh as examples where patient safety standards were disregarded.
• A private Member’s Bill is being brought forward by a colleague to address issues related to lip filler procedures.
• An independent China tribunal report was released recently, detailing organ harvesting from unwilling political prisoners including Falun Gong practitioners and Uyghur Muslims.
• The Bill does not give the Government power to create new regulations but only amend existing ones.
• A comprehensive registry for medical devices is needed to track their journey from implantation to removal or replacement.
• The International Medical Device Regulators Forum set out best practices for such registries in 2016.
• There are no provisions in the Bill regarding increasing access to new medicines.
• The Medicines and Medical Devices Bill is necessary to regulate medicines and medical devices post-Brexit.
• Patients with Phenylketonuria (PKU) face difficulties accessing Kuvan, a drug available in other countries.
• Concerns are raised about the digital exclusion of patients needing medication information.
• Sodium valproate continues to be prescribed despite known risks to unborn children.
• The speaker previously worked in the pharmaceutical industry before entering Parliament.
• The Bill allows regulatory divergence from EU rules, raising concerns about patient safety and market competitiveness.
• The EMA covers 25% of global medicines sales compared to the UK's 3%, potentially leading to slower access to new drugs for British patients.
• Since 2016, the number of clinical trials conducted in the UK has fallen behind those in other countries like the USA and Germany.
• The EU’s Clinical Trials Regulation (CTR) is due to be implemented in 2022 and could improve trial setup times and safety reporting.
• The Bill aims to improve patient safety and availability of medicines and medical devices post-transition period.
• Valproate, Primodos, surgical mesh, breast implants, and metal-on-metal hip implants have raised concerns about past patient safety issues.
• There are approximately 80,000 different medical devices on the UK market.
• Kuvan is a drug for PKU patients that has been unavailable on the NHS for over 10 years.
• The Medicines and Medical Devices Bill is the first opportunity in 40 years for the UK to regulate medicines, veterinary medicines, and medical devices.
• The life science sector contributes over £75 billion to the UK economy and almost 250,000 jobs.
• The Bill aims to ensure patient safety, access to medicines and devices, and maintain market attractiveness for clinical trials.
• The Bill includes regulation-making powers to address future technological advancements like artificial intelligence.
• The MHRA will conduct inspections for manufacturing, distribution, clinical trials, laboratories, and pharmacovigilance.
• The debate aims to ensure robust patient and clinician support in the UK.