The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021 (the “Guidance”). It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement. In summary: From 1 January 2021, different rules … Continue Reading
On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19. The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as office-based assessments and information-exchange with … Continue Reading
On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19. The DHSC is making £500,000 available, with funding of up to £25,000 per company. The challenge, named TechForce19, aims to increase community support for the elderly, vulnerable and … Continue Reading
On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers. The Department of Education and Cabinet Office has published guidance on key workers for COVID-19. The guidance … Continue Reading
The UK Food Standards Agency has announced a deadline of 31 March 2021 for companies marketing cannabidiol (CBD) extracts as foods or food supplements industry to submit novel food authorisation applications. After 31 March 2021, the FSA stated that only products with a fully validated novel food authorisation application will be permitted and all other … Continue Reading
NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized later … Continue Reading
On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance). This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. The UK Information Commissioner’s Office (ICO) has launched an informal survey of current practices relating to the use of data-enabled medical devices and apps. The short and anonymous survey explores whether organisations have put in place specific policies and procedures, asset registers, IT security requirements for … Continue Reading
In the wake of the financial crisis and the so-called ‘shareholder-spring’ of 2012 (a period during which many shareholders refused to endorse directors’ remuneration policies), the government has introduced new rules on directors’ remuneration reporting. The new rules: (i) increase the compliance burdens regarding the reporting of directors’ remuneration policies; (ii) increase shareholder control over … Continue Reading
On 11 July 2013, the ABI published the findings of its extensive review of processes for initial public offerings (IPOs) and secondary capital raisings in the UK public market. The ABI Report follows a government-funded independent review by Professor Kay (released July 2012), which examined investment in UK equity market and its impact on the … Continue Reading
OBR is a dynamic and energetic organisation which was founded in 2011 in Oxford, UK and now has chapters across the UK and the US. OBR’s mission is to engage academic and industry communities on-campus to foster a conversation about the health care and life sciences industry. OBR seeks to create a global network of … Continue Reading
By Morag Peberdy and Christina Helden Life sciences companies are already contemplating changing their patent strategies in anticipation of the EU’s Unitary Patent. However, the timeline for the EU Unitary Patent has been delayed. When the legislative package was agreed last December, many speculated that the 1 January 2014 date for the implementation of the … Continue Reading
The times when private antitrust damages claims were not a serious risk in the European Union are gone. The European Commission and national competition authorities are actively promoting follow-on damages claims by private plaintiffs, and national health authorities are themselves bringing huge claims for damages arising from anticompetitive practices. The following are examples of recent … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. Just days before the UK Parliament broke up for its February recess, the introduction of deferred prosecution agreements (“DPAs”) in the UK came a step closer to realization when the Crime and Courts Bill completed its Committee Stage in the House of Commons. The anticipated introduction of DPAs in … Continue Reading
This post originally appeared on our sister blog, InsideMedicalDevices. The General Medical Council in the UK has issued new prescribing guidance for doctors that includes detailed provisions on prescribing medical devices and managing patients using medical devices. The GMC’s previous guidance was focused almost exclusively on medicines. The new guidance recognizes that medical devices — particularly software-based devices … Continue Reading
Originally published as Covington E-Alert on November 10, 2010 The UK government will consult in the coming year on proposals to move the UK’s National Health Service (NHS) towards a value-based system of pricing medicines from 2014. While official details are yet to be published, it is expected that doctors will be given powers to … Continue Reading
Article originally published in RAJ Devices, September/October 2009 The UK government in 2004 asked Philip Hampton, a leading businessman, to lead a review of regulatory inspection and enforcement across a number of the country’s regulatory agencies. The report of the review, called the Hampton Report, was published in March 2005 and set out an ambitious … Continue Reading
