French “anti-gift” rules strictly regulate the relationship between the life sciences industry and healthcare professionals (“HCP”) and the possibility for companies active in the health sector to offer benefits, in cash or in kind to healthcare professionals, medical students or associations representing them.  This includes a general prohibition against offering such benefits.

To strengthen the

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 the UK should be of particular interest to medical device companies that are incorporated in – or otherwise carry on business in – the UK.  Their introduction is expected to lead to an uptick in major enforcement actions in the years ahead.

How UK DPAs Will Work

Under the proposed legislation, the UK Serious Fraud Office (“SFO”) and Crown Prosecution Service (“CPS”) would be given the authority to use DPAs to resolve a limited list of economic crimes, including bribery, fraud and money laundering cases.  Organizations entering into DPAs would be required publicly to admit certain facts indicating wrongdoing and to comply with rigorous conditions (e.g., the payment of a financial penalty, implementation or updating of a compliance program, payment of compensation to any victim(s), and disgorgement of profits).  In return, the SFO/CPS would agree to suspend criminal charges and, crucially for medical device companies, the organization subject to the DPA would not face mandatory debarment from competing for potentially lucrative government contracts.
Continue Reading Deferred Prosecution Agreements in the UK: One Step Closer to the Introduction of a New Enforcement Tool in Bribery and Corruption Cases

Originally published as Covington E-Alert on February 13, 2012

New Advertising Rules

Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the ‘New Law’) will have a tremendous impact on the medical devices industry. The industry will now be subject to new advertising rules, sunshine-like

Originally published as Covington E-Alert on January 20, 2012

Law No 2011-2012 of 29 December 2011 on the Strengthening of Health Protection for Medicinal and Health Products (“loi relative au renforcement de la sécurité sanitaire du médicament et des produits de santé”) (the “New Law”),creating Articles L. 1453-1 and L. 1454-3 to L. 1454-5 of

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

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