Queen's Speech December 2019 - Medicines and Medical Devices Bill

Medicines and Medical Devices Bill

The purpose of the Bill is to:

● Ensure that our NHS and patients have faster access to the best innovative medicines while supporting the growth of the UK life sciences sector to ensure we remain at the forefront of the global life sciences industry. Allow the UK to take a leading role in global research to develop rapid diagnostics and advanced therapies and devices to provide transformational care for patients around the world after Brexit.

The main benefits of the Bill would be:

• ●  Making it simpler for NHS hospitals to manufacture and trial the most innovative new personalised and short life medicines, as their usage increases, and they are taken up in local clinics and theatres.

• ●  Developing a streamlined, internationally competitive approach to the licensing and regulation of innovative medicines and devices, to give patients access to the best possible treatments and support the UK’s life sciences industry.

• ●  Updating safety requirements relating to medical devices, medicines, veterinary medicines, new innovative practices and clinical trials, in response to new evidence or risks, and as we agree the future global relationship of the UK.

  The main elements of the Bill are:

  • ●  Removing unnecessary bureaucracy for the lowest risk clinical trials, to encourage rapid introduction of new medicines.

  • ●  Protecting public health by implementing a scheme to combat falsified medicines entering supply chains, and a registration scheme to set standards for online sellers.

  • ●  Increasing the range of professions able to prescribe and supply certain medicines to make the most effective use of the NHS workforce where recommended by experts, as well as developing more innovative ways of dispensing medicines in local pharmacies.

  • ●  Enabling our regulators, the Medicines and Healthcare products Regulatory Agency and the Veterinary Medicines Directorate, to develop innovative regulatory approaches to respond quickly to developments such as artificial intelligence in treatments and ensure the UK can break new ground in complex clinical trials.

33

● Simplifying and strengthening the system of enforcement where medical devices regulations are breached.

Territorial extent and application

● The Bill’s provisions would extend and apply to the whole of the UK. Human and veterinary medicines are reserved in the case of Scotland and Wales, but are devolved to Northern Ireland.

Key facts

• ●  The life sciences sector, encompassing pharmaceuticals, medical devices and medical technology, is worth over £74 billion per annum. The sector also employs close to 250,000 people.

• ●  In 2018, there were more than 950 UK clinical trials of investigational medicinal products and over a million new participants were recruited in research trials.

• ●  We have created the Accelerated Access Collaborative to increase the use proven technologies and treatments within the NHS, which have the potential to benefit up to 500,000 patients and save the NHS up to £30 million and is selecting more products to realise the benefits of innovation in the NHS year on year.

• ●  The Government have launched two Life Science Sector Deals, which include over £500 million of government funding and over £2 billion of industry investment leveraged through new partnerships and strategic commitments to secure the future of the UK’s life sciences sector.

• ●  The Prime Minister recently announced a £200 million investment programme to support the scale-up of the very best and most innovative life sciences companies. This is expected to leverage a further £400 million in private sector investment and will help ensure the UK life sciences sector remains dynamic and robust.