On Monday 11 October Life Science Law will be moving over to the Mills & Reeve website. It will sit alongside nine other blogs to further enhance our ever expanding legal insights section, also containing legal briefings, news, webinars and events. The new blog will continue to publish the same regular flow of legal expertise but because it will be hosted on our main website it will be easier to find further relevant content, whether that’s legal insights or details about Mills & Reeve’s legal offering and services. If you visit this blog after 11 October you will simply be redirected ..read more

The EU is now well on its way to completing the roll out of its new regulatory system for medical devices. The Medical Devices Regulation is now in force, and the In Vitro Diagnostics Regulation will follow next May. Meanwhile, the UK is taking the opportunity offered by Brexit to steer a different course. A recently launched MHRA consultation proposes a national system that aligns closely with best practice developed by the International Medical Device Regulators Forum, while adopting measures to ensure patient safety and promote innovation. The consultation addresses the overall objectives t ..read more

The EU is now well on its way to completing the roll out of its new regulatory system for medical devices. The Medical Devices Regulation is now in force, and the In Vitro Diagnostics Regulation will follow next May. Meanwhile, the UK is taking the opportunity offered by Brexit to steer a different course. A recently launched MHRA consultation proposes a national system that aligns closely with best practice developed by the International Medical Device Regulators Forum, while adopting measures to ensure patient safety and promote innovation. The consultation addresses the overall objectives t ..read more

It has been a while, but the EU Clinical Trials Information System (CTIS) is set to go live on 31 January 2022. This means that the system set up in 2014 under the Clinical Trials Regulation will finally come into effect. The European Medicines Agency has published a set of training and information resources to assist users to prepare, including a detailed Sponsor Handbook. A three year transition period will allow sponsors of EU clinical research time to transfer to using the new system, although EU member states are expected to start using it from the go-live date. Sponsors will be able to c ..read more

UK watchdog, the Competition and Markets Authority (CMA), is coming down hard on anti-competitive pricing practices. Following hot on the heels of fines totalling over £260m for competition breaches relating to the supply of hydrocortisone tablets, and fines and repayments to the NHS of over £10m concerning fludrocortisone used to treat primary or secondary adrenal insufficiency, the CMA has now fined Advanz over £100m for inflating the price of liothyronine tablets used to treat thyroid hormone deficiency. What is particularly interesting about these cases is that the medicines in question ar ..read more

Simon Elsegood explains how this will change public sector investment aimed at developing the economy, following the UK's departure from the EU: Move over State Aid - make room for the Subsidy Control Bill ..read more

The UK Government has published draft legislation targeting a major restructuring of the National Health Service. This will see the abolition of CCGs (Clinical Commissioning Groups) and the creation of statutory Integrated Care Systems (ICSs). Our specialist health team has produced initial thoughts on the structure and likely impact of the Bill: A new Health and Care Bill graces our shores. The Bill builds on the proposals for reform made in NHS England’s Long Term Plan to make the NHS less bureaucratic, more accountable and more integrated, particularly in light of the Covid-19 pandemic. New ..read more

The EU has adopted final versions of the two adequacy decisions that were issued in draft earlier this year. These permit personal data flows to the UK under the GDPR and the Law Enforcement Directive. This is just in time - the interim arrangement under the EU-UK Trade and Cooperation Agreement was due to end on 30 June. The decisions come into force today and will expire after four years, unless renewed. The Commission will monitor the legal situation in the UK for any deviation from the level of protection currently in place. This could lead to the decisions being suspended, repealed or ame ..read more

The UK pharma sector is readying itself for the introduction of the new ABPI Code, bringing in extensive changes to the industry's self-regulatory system. See our article here: A new ABPI Code for 2021   ..read more

Proposals for a joint approach to the analysis of pharmaceutical industry mergers are under way. This sees the European Commission, the US Federal Trade Commission, the Department of Justice Antitrust Division and Offices of State Attorneys General, the Canadian Competition Bureau and the UK Competition and Markets Authority forming a working group to develop a coordinated approach. The aim is to identify concrete and actionable steps to review and update the analysis of pharmaceutical mergers, and address perceived harms around price increases and anti-competitive conduct. Areas such as the i ..read more