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Dan Spivey

Dan Spivey is an associate in the Life Sciences Regulatory team. Dan advises clients in the pharmaceutical, healthcare, medical device, and food and beverage sectors on a range of regulatory matters.

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Big news for manufacturers: the UK Government announced on 1 August 2023 that it will indefinitely recognize the EU’s product conformity assessment mark (the “Conformité Européenne” or “CE” mark), with respect to a range of manufactured goods placed on the UK market. 

The move is a significant reversal of the UK’s previous, post‑Brexit policy.  In a bid to separate the UK’s internal market from the European market, the UK promised to phase out CE marks for products marketed in England, Scotland and Wales (Great Britain or “GB”), and replace them with an equivalent “UKCA” mark.  However, the project suffered from numerous delays, and the UK repeatedly extended the deadline for transitioning from the CE mark to the UKCA mark, before the recent announcement that the UK will accept CE marks indefinitely.  Despite this change of policy, the UK has not abandoned the UKCA mark yet, and manufacturers may still choose to use it.  Even so, it is not obvious why a manufacturer would choose conformity assessment that is recognized only in the UK over (or even as well as) conformity assessment that is recognized across the UK and the EU.  What remains to be seen is whether differences between the UK and EU conformity assessment standards will lead to a kind of “forum shopping” by manufacturers. 

Also, and of significant importance for medical device manufacturers, the indefinite extension of CE mark recognition does not (at least currently) cover medical devices nor in vitro diagnostic medical devices (“IVDs”).  The Medicines and Healthcare products Regulatory Agency (“MHRA”) is separately consulting on international recognition of foreign approvals (including CE marks) in the medical device space.Continue Reading UK Government to Recognize CE Marks Indefinitely (other than for Medical Devices and IVDs)

On 9 June 2023, the UK Government published further guidance relating to the practical implementation of the Windsor Framework (agreed between the UK and the EU on 27 February 2023, please see our client alert here).  This overarching guidance contains further detail from the Medicines and Healthcare products Regulatory…

Continue Reading New MHRA Guidance on the Windsor Framework: Timings Confirmed but More Details to Follow

The Voluntary scheme for branded medicines pricing and access (“VPAS”) is a voluntary agreement that regulates the price of the vast majority of branded medicines sold in the UK (including branded generics and biosimilars).  VPAS is critical to the commercial interests of most innovative pharmaceutical companies operating in…

Continue Reading Update on the VPAS Judicial Review brought by the British Generic Manufacturers Association

As highlighted in our recent series of blog posts (please see our Inside EU Life Sciences blog series here), the European Commission has at long last published its proposal to overhaul EU legislation for human medicinal products. 

On 26 April 2023, the Commission published its proposal for a new human medicines directive (the “Proposed Directive”) to replace the current European Medicines Directive (Directive 2001/83/EC); as well as a regulation for centrally authorised medicines (the “Proposed Regulation”) to replace the current Regulation 726/2004. 

Medicines advertising and promotion rules are of key interest to pharmaceutical companies operating in the EU.  This blog looks into how the new legislative proposal might affect the advertising landscape, focusing on the Proposed Directive (whose advertising provisions also apply to products covered under the Proposed Regulation).

For those of you who are perhaps breathless from the suite of new proposals, advertising and promotion may appear to be one small area to exhale in relief.  However, some of the proposed changes may have significant practical implications, particularly for comparative advertising.

The headline news is that – for advertising – the Proposed Directive largely maintains the status quo.  It remains aligned almost entirely with the current framework, supplementing rather than revolutionizing current law. 

The evolutionary approach is unsurprising.  EU-level law is really only the “tip” of the proverbial “iceberg” when it comes to pharmaceutical advertising in Europe.  Many operational rules are nationally diverse, and found in national laws, codes and rulings.  Moreover, in practice, pharmaceuticals advertising is often largely governed and enforced through the self-regulatory system and self-regulatory codes, such as the Code of Practice of the European Federation of Pharmaceutical Industries and Associations (the “EFPIA Code”) and its various national incarnations.  The Explanatory Memorandum to the Proposed Directive suggests legislators have tried to avoid overhauling the intricate framework regulating advertising. Nevertheless, the Proposed Directive does make some changes to advertising rules.  Most are generally uncontroversial and/or “tidy ups”; but others may be more significant, particularly supplementing the definition of “advertising” and new provisions on comparative advertising. Continue Reading EU Pharma Legislation Review Series: Advertising Updates Reflect Evolution Rather than Revolution

On 21 March 2023, the UK Government published its response to the consultation on legislative reform proposals for clinical trials that took place from January to March 2022. 

The current legislation governing clinical trials in the UK is the Medicines for Human Use (Clinical Trials) Regulations 2004, as amended.  This implements the EU Clinical Trials Directive 2001/20/EC and has not been amended to align with the subsequently introduced EU Clinical Trials Regulation 536/2014.

The proposed reforms centre on delivering “a more agile and flexible UK regulatory framework”, as part of the Government’s broader ambition to create a more appealing regulatory environment for life sciences innovation in the UK.  The emphasis on promoting clinical research in the UK was highlighted by the recent Government announcement of an independent review into UK clinical trials, prompted by figures suggesting that the number of industry clinical trials initiated in the UK per year fell by 41% between 2017 and 2021.  In addition, a decline in public engagement with clinical research (with a 44% drop in the number of participants recruited to commercial clinical trials in the last five years) highlights the need for reform in this area.

The Government’s proposed reforms involve streamlining the procedures supporting the approval and conduct of clinical trials, removing duplicative requirements, and enabling flexibility in a risk-based and proportionate manner. 

The proposals also envisage a clinical trials regime that requires greater transparency and encourages, though notably will not require, a diverse range of patient and public involvement.

The main proposals with which the Government intends to move forward are discussed below.Continue Reading Legislative Proposals for Clinical Trials Aim to Streamline, Simplify and Stimulate UK-based Innovation

On 2 March 2023, the Court of Justice of the EU (“CJEU”) issued a preliminary ruling  clarifying various aspects around the classification of products as foods for special medical purposes (“FSMPs”).  The CJEU reinforced and supplemented its prior ruling in Case C-418/21 Orthomol (see our blog here for further details).

This case touches on a number of concepts in the FSMP definition.  As a reminder, Article 2(2)(g) of Regulation (EU) 609/2013 (the “FSG Regulation”) defines an ‘FSMP’ as:

“food specially processed or formulated and intended for the dietary management of patients, including infants, to be used under medical supervision; it is intended for the exclusive or partial feeding of patients with a limited, impaired or disturbed capacity to take, digest, absorb, metabolise or excrete ordinary food or certain nutrients contained therein, or metabolites, or with other medically-determined nutrient requirements, whose dietary management cannot be achieved by modification of the normal diet alone” (emphasis added).

In summary, the CJEU concluded:

  • In determining the borderline between an FSMP and a medicine, all characteristics of the product need to be taken into account to determine whether it is intended to meet particular nutritional requirements or to prevent or cure human disease.
  • The concept of ‘dietary management’ has to be understood to require a link between the disease and the nutritional requirements arising from it, the satisfaction of which is indispensable to the patient.  The nutritional requirements do not necessarily have to be satisfied through digestion.  
  • The concept that the dietary management of the patient cannot be met through ‘modification of the normal diet alone’ means that meeting nutritional requirements through supplementing or changing the normal diet is impossible, dangerous or very difficult for the patient.
  • The term ‘nutrient’ has to be interpreted in accordance with Regulation (EU) 1169/2011 on food information to consumers (the “FIC Regulation”). 
  • A product is ‘used under medical supervision’, “if the recommendation and subsequent assessment of a health professional are necessary in light of the dietary management needs arising from a particular disease, disorder or health condition and the effects of the product on the patient’s dietary management and on the patient” (paragraph 81).
  • In determining the borderline between an FSMP and a food supplement, all characteristics of the product need to be taken into account to determine whether it is intended to meet the nutritional requirements of a patient that could not be achieved through regular diet or whether it is intended to supplement the normal diet.

Continue Reading CJEU Provides Further Clarifications on Food for Special Medical Purposes

The Medical Device Coordination Group (“MDCG”) has published a new position paper (MDCG 2022-14) acknowledging the significant and urgent lack of capacity of EU notified bodies.  It acknowledges the risk that this could lead to many existing and new medical devices and in vitro diagnostic medical devices (“IVDs”) not undergoing timely conformity assessments under Regulation (EU) 2017/745 (the “MDR”) or Regulation (EU) 2017/746 (the “IVDR”) (together, the “Regulations”)).  In turn, this could mean patients miss out on access to, potentially, lifesaving medical devices and IVDs.  As such, the MDCG has suggested actions for mitigating such challenges.  Importantly, there is a focus on flexibility and pragmatism.Continue Reading Notified body capacity needed! MDCG proposals recognize need to increase notified body capacity to ensure device availability