Lords keep up pressure on Government over Medicines and Medical Devices Bill in 2nd & 3rd Committee Stage Sessions

This is the third post looking at the main points of contention so far at Committee Stage in the House of Lords for the Medicines and Medical Devices Bill 2019-20. [Part I available here, Part II available here] In another busy week of Brexit-related Parliamentary business, two further Committee sessions took place in the House … Continue reading “Lords keep up pressure on Government over Medicines and Medical Devices Bill in 2nd & 3rd Committee Stage Sessions”

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Lords take Government to task over future of medicines and medical devices regulation: Part 2

This is the second of our posts looking at the main points of contention so far at Committee Stage in the House of Lords for the Medicines and Medical Devices Bill 2019-20. [Part 1 available here] In this post, which reports on the first session of the Lords Committee Stage for the Medicines and Medical … Continue reading “Lords take Government to task over future of medicines and medical devices regulation: Part 2”

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Lords take Government to task over future of medicines and medical devices regulation: Part I

This is the first of a series of posts looking at the main points of contention so far at Committee Stage in the House of Lords for the Medicines and Medical Devices Bill 2019-20. [Part 2 available here] The second session of the Lords Committee Stage on the Medicines and Medical Devices Bill starts today … Continue reading “Lords take Government to task over future of medicines and medical devices regulation: Part I”

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Perspectives on DIY APS: Users, Healthcare Professionals, and Bioethicists

A number of groups have a stake in DIY Artificial Pancreas Systems (APS) technology including users, healthcare providers, manufacturers, and clinicians. Given their diverse goals, needs, and professional commitments, these different groups have different perspectives on DIY APS use. A recently published paper by Dr Jaclyn Shepard and colleagues reports the views expressed by stakeholders … Continue reading “Perspectives on DIY APS: Users, Healthcare Professionals, and Bioethicists”

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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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