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UK ‘Sugar Tax’ – Draft Regulations Published

The UK tax authority HM Revenue and Customs (HMRC) has published draft Regulations setting out further details on the new UK ‘Soft Drinks Industry Levy’, which will apply from 6 April 2018. The new levy applies to all soft drinks packaged in or imported to the UK that contain added sugar and at least 5

UK Advice on Mental Health in Advertising

On the back of a number of high profile initiatives to raise awareness of mental health issues in the UK this year, the UK Committee of Advertising Practice (CAP) has published a timely reminder for advertisers of how mental health is addressed under the UK advertising rules (the CAP and BCAP Codes). There is no

UK Food Standards Agency reviewing Feed Law Code and Guidance

The UK Food Standards Agency (FSA) is consulting on its proposals to amend the Feed Law Code of Practice and Practice Guidance. The Code and Guidance have to be taken into account by local authorities when enforcing feed law requirements in England (there are separate documents for Wales, Scotland and Northern Ireland).

What blockchain can learn from the net neutrality debate: antitrust and regulatory aspects of “paid prioritization” for a nascent technology

First come, first served. That’s not the principle behind the clearance of Bitcoin transactions. Equally for other blockchain technology networks, the relevant factor to get a transaction on the next available block is not time, but often: money. “Paid prioritization” is a reality. Miners will first pick and clear those transactions which will most highly

Draft EU List of Authorised Novel Foods Published

The European Commission has published a draft implementing Regulation setting out the proposed official EU list of authorised novel foods. A ‘novel food’ is a food or ingredient that has not been consumed to a significant degree in the EU prior to 15 May 1997. These include products traditionally eaten outside the EU prior to

Majority in favour of improving fairness in EU food supply chain

Initial responses to the European Commission’s public consultation on how to make the EU food supply chain fairer suggest that, bar retailers, the majority of significant stakeholders (including Member States, farmer groups, agricultural organisations and NGOs) are in favour of action at EU level to increase fairness and balance in the food supply chain. The

Gender stereotyping in UK advertising – staying on the right side of the line

Unlike some other European countries, the UK does not currently have specific rules prohibiting or restricting gender stereotyping in advertising. To date, complaints about ads featuring stereotypical gender roles or characteristics have been brought based on the requirement in the UK non-broadcast and broadcast advertising codes (the CAP Code and BCAP Code) that advertising must

UK MHRA Issues New Guidance on Human Factors and Usability Engineering for Medical Devices

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published new guidance on taking human factors into account when designing medical devices and ensuring that they meet the essential safety and performance requirements for devices. ‘Human factors’ refers to how a person uses or interacts with a device taking into account the context and

ECJ sides with farmers on genetically modified crops

The European Court of Justice has held that Member States may not adopt emergency measures prohibiting genetically modified food and feed (GMOs) unless there is clear evidence that a particular GMO presents a serious risk to health or the environment in accordance with Article 34 of the GMO Regulation (EC) No 1829/2003. Ruling in favour

UK MHRA Publishes Guide to the New EU Medical Device and IVD Regulations

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published an interactive guide to assist companies with understanding the requirements of the new EU Medical Device Regulation (“MDR”) and In Vitro Diagnostic Medical Device Regulation (“IVDR”). The MDR and IVDR entered into force on 25 May 2017. Most of the requirements under the MDR

FDA Seizes Stem Cell Therapy—A First of Many?

On August 25, 2017, U.S. Marshals Service, at the request of FDA, seized five vials of ACAM20000—a smallpox vaccine containing live vaccinia virus (cow pox), which is reserved for people at high risk of contracting the disease—that were discovered during an FDA inspection at StemImmune Inc., a San Diego, California company that purports to specialize

House Subcommittee on Health Opens Floor for Discussion of FDA Regulation of Off-Label Speech

The House Subcommittee on Health has announced a hearing entitled “Examining Medical Product Manufacturer Communications” for Wednesday, July 12, 2017, at 10:15am EDT, in which it intends to examine two discussion-draft bills seeking to amend the Federal Food, Drug, and Cosmetic Act (“FDCA”) to clarify how drug and device manufacturers can legally discuss uses of

CJEU upholds principle of free movement of goods for food supplements

The Court of Justice of the European Union (“CJEU“) has issued a ruling on the interpretation of Directive 2002/46/EC on food supplements, finding that a French law prohibiting the sale of food supplements from other EU Member States containing vitamins and minerals above French national limits is contrary to EU law. The CJEU held that

New EASA Consultation: Are Drone Pilots Heading for a Period of Regulatory Turbulence?

On 12 May 2017 the European Aviation Safety Agency (“EASA”) opened a consultation regarding sweeping new regulations on the operation of unmanned aircraft systems (“UAS” or drones) in European airspace. Individuals and companies that are interested in the future of UAS operations in the European Union (“EU”) should carefully review the Notice of Proposed Amendment and consider participating in the review process by submitting comments and letting EASA know their views on all aspects of the proposed regulations.
Under current regulations, EASA only regulates large UAS with a take-off weight of 150kg or more and the regulation of UAS weighting less than 150 kg is reserved to Member States. The European Commission and European Parliament are currently trying to extend the EU’s regulatory competences (jurisdiction) to include authority over all UAS weighing more than 250g. EASA’s new proposal will likely spur debate among industry stakeholders over whether this new and innovative technology should be regulated more broadly by EASA or by the individual Member States.

TCPA for the Boardroom – An Executive Focus

How do you protect your business from costly Telephone Consumer Protection Act (TCPA) lawsuits and regulatory enforcement actions? In this webinar, we will focus on the key decisions facing company executives as they navigate TCPA risks and assess compliance strategies. Businesses must stay in touch with their customers and their partners in order to succeed. But

UK to Seek Close Relationship with EMA Post-Brexit

UK Secretary of State for Health, Jeremy Hunt, has stated in a Health Select Committee meeting that he does not expect the UK to remain part of the European Medicines Agency (“EMA”) or the EU medicines regulatory framework post-Brexit, but that the UK should seek a very close working relationship with the EMA and the

UK MHRA to develop quality standards for biological medicines

The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological medicines. Public quality standards form part of the regulatory framework governing the quality of all medicines. Both documentary and physical standards exist to ensure that medicines are of acceptable quality for use by

Scottish government to reform approval process for new end-of-life and orphan medicines

The Scottish government has announced plans to implement the 28 recommendations proposed in an independent review of access to new end-of-life, orphan and ultra-orphan medicines by patients in Scotland, published in a report on 14 December 2016. The recommendations aim to further improve the process by which these types of medicines, in particular ultra-orphan products,

California Tries the “Right to Try” Act — FDA’s Expanded Access Regulations Remain in Force

On September 27, 2016, California Governor Jerry Brown signed into law the so-called “Right to Try Act” (AB-1668) (the “RTA”), which allows qualifying patients to request from manufacturers unapproved drugs, biologics, or medical devices that have successfully completed FDA-sanctioned Phase I clinical trial(s). In general terms, this law allows a manufacturer of an investigational drug,

FDA Issues Draft Guidance on Co-Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices

On September 21, 2016, FDA issued a draft guidance titled “Coordinated Development of Antimicrobial Drugs and Antimicrobial Susceptibility Test Devices – Draft Guidance for Industry and Food and Drug Administration Staff.”  This draft guidance describes FDA’s suggested steps for seeking approval of an antimicrobial drug and any related antimicrobial susceptibility test (AST) devices in order

Don’t Blink: 9th Circuit Issues Pivotal Decision on Enforcement of CSA Against Cannabis-ness

As reported here, earlier this month the U.S. Drug Enforcement Administration (DEA) issued a decision declining to transfer marijuana out of Schedule I.  As marijuana remains a Schedule I controlled substance under the federal Controlled Substances Act (CSA), marijuana businesses operating in compliance with state law, and those who contract with such businesses, continue to