The UK has enacted new legislation to address the issue of so-called ‘legal highs’ following a number of cases of paranoia, seizures, hospitalisation and even death after consumption of certain psychoactive substances. The Psychoactive Substances Act 2016 (the “Act”) was granted Royal Assent on 28 January 2016. It is expected to come into force on 6 April 2016. The Act makes it an offence to produce, supply, offer to supply, possess with intent to supply, possess in a custodial institution, import or export psychoactive substances.
Continue Reading The Psychoactive Substances Act 2016: An Example of Poor Drafting and Unintended Consequences for Food?
New Novel Foods Regulation: A Step Towards a Simpler and Faster Procedure?
A new Novel Food Regulation (EU) 2015/2283 (“Regulation”) was published in the Official Journal of the European Union on 11 December 2015. The Regulation aims to make it easier for food business operators to place novel foods and food ingredients on the EU market, while ensuring high level of consumer protection.
Under the Regulation, novel food is defined as food that has not been consumed to any significant degree in the EU before May 1997 (when the first novel food legislation entered into force). This can be newly developed, innovative food or food produced using new technologies and production processes as well as food traditionally eaten outside of the EU. The definition now also includes food consisting of engineered nanomaterials and derived from animal clones. The Regulation also makes it clear that insects can fall under the definition of a novel food. The Regulation introduces the following main changes:
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General Court Makes Interim Order to Protect Confidentiality in Pari Pharma Transparency Case
Raj Gathani, a Trainee Solicitor in Covington’s London office, contributed to this post.
On 1 September 2015 the General Court issued an interim order in favour of Pari Pharma GmbH (“Pari”) to suspend the European Medicines Agency’s (“EMA”) decision to grant a third-party, Novartis Europharm Ltd (“Novartis”), access to certain documents prepared during the Marketing Authorisation (“MA”) application process (the “MA Documents”). The MA Documents at issue included EMA Assessment Reports on similarity and superiority between Pari’s product (Vantobra) and Novartis’ product (TOBI Podhaler), which has an EU MA as an orphan medicine. Novartis made the request to the EMA for access to the MA Documents under the Transparency Regulation 1049/2001. The main case is currently pending before the General Court (Case T-235/15).
The thrust of Pari’s argument before the General Court was that the MA Documents contain Pari’s regulatory strategy for obtaining MA approval, disclosure of which might cause Pari serious and irreparable financial damage. The President of the General Court acknowledged that the case raised complex issues in the area of confidentiality and stated that the main proceedings (rather than an interim hearing) is the appropriate forum to address such issues.. As such the President considered that the MA Documents fell under a presumption of confidentiality and ordered the EMA not to disclose the MA Documents.
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Comprehensive New EU Food Labeling Regulation Goes Into Effect December 13
A new food labeling regulation, which revamps the entire EU regulatory framework on food information, including labeling, starts to apply from this Saturday, 13 December 2014. Regulation 1169/2011 on the provision of food information to consumers (FIC Regulation) consolidates a number of EU food laws and establishes some new principles to provide better consumer protection in relation to food information whilst ensuring smooth functioning of the EU market.
The FIC Regulation governs all food information provided to the consumer through any commercial communication, including in particular labeling and websites. The Regulation affects all food business operators along the whole supply chain as it changes the existing provisions and introduces new ones:
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PARNUTS: Out with the Old and in with the New
Regulation (EU) No 609/2013 on food intended for infants and young children, food for special medical purposes and total diet replacement for weight control, was published in the Official Journal of the European Union on 12 June 2013. The new Regulation allows the Commission to create specific compositional and information requirements and update the list of categories of allowed nutrient ingredients in these foods from 19th July 2013.
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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
CJEU Clarifies Medical Device Borderline
This post originally appeared on our sister blog, InsideMedicalDevices.
The Court of Justice of the European Union (CJEU) has recently ruled that products which fall within the definition of a medical device, but are not intended by their manufacturer to be used for a “medical purpose,” do not fall within the scope of the Medical Devices Directive 93/42/EEC (MDD).
Case C-219/11 Brain Products GmbH V BioSemi VOF and Others, concerned the product ActiveTwo, a “biopotential measurement system” that records electrical signals from the brain, heart and muscles, manufactured and is marketed by Dutch company BioSemi. ActiveTwo is not designed for use in any medical diagnosis or treatment, but is used by researchers for clinical investigation of cognitive sciences. BioSemi’s website and promotional material state that the product is “not designed or intended to be used for diagnosis or treatment of disease.” As such, BioSemi argued that the ActiveTwo was not a medical device and so did not require CE-marking.
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European Commission Adopts List of General Health Claims
Originally published as Covinton E-Alert on May 25, 2012
On 16 May 2012, the European Commission adopted the much delayed list of permitted general health claims (Permitted List) for foods after scrutiny of the list by the European Parliament and the Council ended on 27 April 2012. The Permitted List contains just 222 health claims
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
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