Food & Drug Regulatory

The High Court has quashed decisions by the Food Standard Agencies in England, Wales and Scotland (“the FSAs”) that concluded that monk fruit decoctions are a novel food.  The Court ordered the FSAs to re-consider their position by assessing all of the evidence submitted to the FSAs on its own merits, rather than the FSAs’ previous approach of rigidly applying (non‑binding) European Union guidance.  The judgment is available here.  This case is the first of its kind in Great Britain and is relevant for individuals and companies considering whether or not their foods or food ingredients are novel under the GB novel food regime, which requires evidence of significant consumption of a food prior to 1 May 1997 to conclude the food is “non‑novel”, and not requiring a novel food approval. Continue Reading Food Standard Agencies in Great Britain unlawfully classified monk fruit as novel, High Court rules

On March 11, 2023, the UK Government published its response (“Government Response”) to an independent review on equity in medical devices commissioned by the Department of Health and Social Care (“Review”).  The Government Response is not guidance nor policy rather it is intended to act as an action plan for tackling potential bias in the design and use of medical devices.  The Government Response fully accepts, and in turn makes a series of commitments in response to, the findings of the Review (which is broken down into 18 recommendations, 51 sub-recommendations, and 3 further calls to action).  Importantly, the Government “wholeheartedly agrees…that medical technology should be unbiased and equitable.” 

Bias in the medical device space, and within healthcare more broadly is (quite rightly) a topic of growing importance to governments, regulators and industry alike.  We set out some key points of interest from both the Review and the Government Response below.  We look forward to seeing more developments and guidance in this area going forwards given its significance to patients and the delivery of healthcare.  Continue Reading UK Government Outlines New Action to Tackle Biases in Medical Devices

A UK judge has decided that Odysea Ltd, an artisan food company, can use the word “raw” to describe its small-batch, minimally‑processed honey.  Judge Neville, of the First‑tier Tribunal (General Regulatory Chamber), gave the decision on 26 February 2024.  The judgement is available here and opens with a classic reference to Winnie the Pooh:

  1. “The things that make me different are the things that make me me”, said Piglet, who must have seen quite a bit of honey eaten over the years.  If he treated Pooh to some “raw honey”, what would be different about it?
  2. Plenty, says Odysea, who have sold thousands of jars of honey proudly labelled as “raw”: unlike ordinary honey, ours has not been heated above its natural temperature and has undergone far less processing, so is of better quality.  Describing one of Odysea’s raw honey products, the judges at the Great Taste Awards complimented the “subtle pine and fir flavours, the perfect level of sweetness, the hint of saltiness, the sheer sexiness of this honey”.
  3. Nothing, says Waltham Forest Trading Standards, who wants them to stop: all honey is raw because it has not been cooked, so it misleads consumers to suggest that yours is special.  Odysea has had to reprint its labels to say “artisan honey” instead.  The Tribunal must decide if that is right.

Continue Reading UK Judge Permits “Raw” Label for Honey

On 26 January 2024, the European Medicines Agency (EMA) announced that it has received a €10 million grant from the European Commission to support regulatory systems in Africa, and in particular for the setting up of the African Medicines Agency (AMA). Although still in its early stages as an agency…

Continue Reading EMA announces €10 million of funding to support the establishment of the African Medicines Agency

In a move that is sure to be welcomed by the diagnostics industry, on 23 January 2024, the European Commission announced proposals (Commission proposal and press release) to extend the transitional periods for certain in-vitro-diagnostic medical devices (“IVDs”) under Regulation (EU) 2017/746 (“IVDR”).  This follows similar action taken by the Commission in early 2023 to extend the transitional provisions under Regulation (EU) 2017/745 (the “MDR”) (see our prior blog post here).  The rationale applied for the latest proposal is the same as before – it aims to “ensure availability of safe devices, essential for healthcare systems, and protect patient care”.  Specifically, the latest IVD proposals are intended to address ongoing concerns regarding the availability and readiness of notified bodies to perform IVDR conformity assessments and the high number of IVDs that have yet to transition to the IVDR.  The new proposals (once adopted) will provide manufacturers with more time to comply with the new requirements of the IVDR.  Relatedly, manufacturers will be required to give notice if they foresee interruption of supply of their devices.

In addition, to improve the transparency and coordination, the Commission has proposed to accelerate the roll out of the European database on medical devices (“EUDAMED”) so that certain modules are mandatory as from late 2025.   Continue Reading European Commission Proposes to Extend Transitional Periods for In-Vitro-Diagnostic Medical Devices

The European Parliament and Council are currently negotiating the wording of a new Regulation establishing a Single Market emergency instrument (“SMEI”).  This new measure builds on the experience gained from the COVID-19 crisis and gives new powers to the Commission, in close cooperation with the Member States.  This blog briefly…

Continue Reading Single Market Emergency Instrument: Potential Impact on Medical Devices

On 20 November 2023, the UK Government and the Association of the British Pharmaceutical Industry (“ABPI”) ‒ the industry body representing the innovative pharmaceutical industry in the UK ‒ announced a new 5-year voluntary scheme for branded medicines pricing, access and growth (“VPAG”).

Although the parties have announced agreement upon heads of terms, it is already clear this is very significant news for the pricing and reimbursement of branded medicines in the UK.  It is likely to represent a paradigm-shift in the way the innovative pharmaceutical industry will view reimbursement.Continue Reading VPAG – New 5-Year Pricing Agreement Agreed between UK Government and the UK Pharmaceutical Industry Body (ABPI)

On October 19, 2023, the World Health Organization (“WHO”) published a set of regulatory considerations on artificial intelligence (“AI”) for health (press release and full publication).  The publication is not guidance or policy but is intended as a resource for relevant stakeholders in medical devices ecosystems, including manufacturers…

Continue Reading WHO Publishes Regulatory Considerations on AI for Health

Roughly a decade ago, countries such as the USA and France introduced ground-breaking transparency and disclosure legislation under so-called “Sunshine Acts.”  Broadly speaking, such legislation made it mandatory for pharmaceutical companies to publish records of payments or other transfers of value made to healthcare professionals (HCPs) and healthcare organizations (HCOs).…

Continue Reading UK Government Consults on Proposals Mandating the Disclosure of Industry Payments to the Healthcare Sector