Beyond Brexit: Smart Regulation for Investment and Patient Safety

The shape of the post-Brexit regulatory landscape has been the subject of much discussion in recent months. With the end of the transition period looming and the Government remaining scant on details, many academics and stakeholders have been exploring the possibilities. Reform, a Westminster think tank for public service reform, invited Dr Laura Downey, Dr … Continue reading “Beyond Brexit: Smart Regulation for Investment and Patient Safety”

Briefing note: Medicines and Medical Devices Bill (July update)

Originally posted here. Executive summary Patient and user safety with regards to medical devices is paramount. This should be prioritised in situations where there are competing considerations such as “attractiveness of the UK” as to the conduct of clinical trials and supply of medicines and medical devices. The existing regulatory framework for medicines and medical … Continue reading “Briefing note: Medicines and Medical Devices Bill (July update)”

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Written evidence: We shouldn’t rush the Medicines and Medical Devices Bill

Although the Medicines and Medical Devices Bill received its first reading in the House of Commons on the 13th of February, progress on the Bill was interrupted by the Covid-19 crisis in March 2020. The Bill has since been re-introduced, passing quickly through the House of Commons. Professor Muireann Quigley, Professor Jean McHale, Dr Rachael … Continue reading “Written evidence: We shouldn’t rush the Medicines and Medical Devices Bill”

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Medicines and Medical Devices Bill 2019-20: Patient safety must be the priority

This piece was originally posted on the Birmingham Law School news page. The committee stage of the Medicines and Medical Devices Bill 2019-20 resumed this week. The government has brought forward this new legislation to regulate medicines and medical devices following Brexit. Progress on the Bill paused in March 2020 due to the Covid-19 crisis, … Continue reading “Medicines and Medical Devices Bill 2019-20: Patient safety must be the priority”

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The DIY artificial pancreas: Who is liable if something goes wrong?

In this post we sketch out different parts of the ‘looping’ ecosystem and start to consider the issue of liability if something should go wrong. In a series of posts, we have been looking at the use of DIY Artificial Pancreas Systems (DIY APS or ‘looping’). These systems – made up of an insulin pump, … Continue reading “The DIY artificial pancreas: Who is liable if something goes wrong?”

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DIY Artificial Pancreas Systems: Safety concerns and potential risks in perspective?

In this post we explore some of the risks and benefits of DIY Artificial Pancreas technologies. In future posts we will take a look at the law, ethics, and policy implications of these. In a previous post we explained how Do-it-Yourself Artificial Pancreas Systems (DIY APS) are systems made up of four interconnected components: a continuous … Continue reading “DIY Artificial Pancreas Systems: Safety concerns and potential risks in perspective?”

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Patients are doing it for themselves: DIY artificial pancreas systems and the challenge for doctors

Some people with type 1 diabetes (T1D) find current treatment options to be inadequate and unsatisfactory and have taken it upon themselves to design technological solutions which work for them. Tired of waiting for commercial solutions that meet their needs, patients are constructing their own Do-it-Yourself Artificial Pancreas Systems (DIY APS). Although still confined to … Continue reading “Patients are doing it for themselves: DIY artificial pancreas systems and the challenge for doctors”

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Briefing note: How we can improve the Medicines and Medical Devices Bill?

Currently, a large part of the UK’s regulatory regime governing medicines and medical devices is derived from EU law. The Medicines and Medical Devices Bill (MMDB) 2019-20 sets out a suite of provisions for the regulation of medicines and medical devices in the UK at the end of the EU exit transition period, currently 31 … Continue reading “Briefing note: How we can improve the Medicines and Medical Devices Bill?”

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Introducing Everyday Cyborgs 2.0

As technology increasingly blurs the boundaries between the biological and the synthetic, law struggles to keep up Increasing numbers of people worldwide rely on medical devices to help them to function. These devices range from the relatively simple, like hip replacements and aesthetic prostheses, to the complex, such as insulin pumps, pacemakers, and the total … Continue reading “Introducing Everyday Cyborgs 2.0”

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