Tag Archives: UK

NHS England Publishes Draft Commercial Framework for Medicines

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

UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation

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

UK Data Protection Regulator Surveys Use Of Smart Medical Devices

 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

New Directors’ Remuneration Regime: The Facts for Life Sciences Companies

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

The Association of British Insurers (ABI) Publishes a Review of Capital Raising in the UK Market

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

EU Unitary Patent is Likely to be Significantly Delayed

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

Private Antitrust Damages Claims in the Pharmaceuticals Sector: Gaining Momentum

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

Deferred Prosecution Agreements in the UK: One Step Closer to the Introduction of a New Enforcement Tool in Bribery and Corruption Cases

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

New UK Guidance for Doctors on Prescribing Medical Devices and Medicines

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

Nice Powers May Be Clipped In UK Pharmaceutical Pricing Overhaul

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

No More Red Tape: MHRA Awaits Tougher Sanctioning Powers in the UK

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
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