Last week, Jeremy Hunt, Chancellor of the Exchequer, published his Spring Budget for the UK. It identified life sciences and digital technologies as “high growth sectors,” which the UK Government wishes to prioritize. Among other things, the Budget outlined the Government’s plans to simplify medicines and technology approvals, plus changes to the regulation
UK PMCPA Publishes First Ever Guidance to Pharmaceutical Companies about Social Media
On 26 January 2023, the UK’s Prescription Medicines Code of Practice Authority (“PMCPA”) published its “Social Media Guidance 2023” (the “Guidance”).
The Guidance is the first of its kind in the UK and is long-awaited.
The PMCPA is the self-regulatory body that administers and enforces the ABPI Code (the voluntary advertising code that many pharmaceutical companies adhere to in the UK). The ABPI Code sets out a number of overarching principles but does not address social media in detail. The PMCPA had some years ago published “digital guidelines” but these were archived for updating.
The first – and probably most important – thing to say about the Guidance is that it (finally) exists. Social media has become a major compliance headache for UK pharmaceutical companies. These days a significant number of PMCPA complaints, investigations and adjudications concern corporate or employee social media activity, particularly on LinkedIn. The absence of clear and codified guidance until now led to a lack of clarity. Key regulatory principles had evolved through a series of case rulings, which were often highly fact-dependent. While dissecting cases into the early hours may be interesting for us pharmaceutical advertising lawyers, compliance teams will likely appreciate having codified guidelines to refer to.
Secondly, the Guidance is likely to disappoint anyone hoping for seismic shifts in the PMCPA’s regulatory approach. Much of the Guidance aligns closely to rules and principles that had developed in the Authority’s case history. It also broadly aligns with EFPIA’s and IFPMA’s recently published “Guidelines Concerning the Use of Social Media and Digital Media Channels” (see our blog post).
EU Plans Ban on Titanium Dioxide in Food
On 6 May 2021, the European Food Safety Authority (“EFSA”) published its updated safety assessment on titanium dioxide as a food additive (E171). EFSA examined new evidence on nanoparticles and found that there was uncertainty about E171’s ability to accumulate in the body and damage genetic material in cells; i.e. genotoxicity. The agency could not calculate an Acceptable Daily Intake (“ADI”), nor could it determine a safe cut-off value for particle size and distribution. On that basis, it could not confirm the safety of E171 in food. However, since it found no evidence of acute toxicity, an immediate ban is not warranted. France previously initiated a national ban in 2019/2020; following EFSA’s revised opinion, the EU is likely to adopt an EU-wide ban early 2022. In this blog, we briefly review the planned EU-level response and the developments in the Netherlands, Germany and the UK.
Brexit: UK Guidance on Regulation of Medical Devices from 1 January 2021
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published Guidance on the regulation of medical devices from 1 January 2021 (the “Guidance”). It discusses the regulatory requirements that apply to medical devices after the end of the Brexit transitional period under the EU-UK Withdrawal Agreement. In summary:
- From 1 January 2021, different rules will apply to medical devices placed on the market in Great Britain (e., England, Wales and Scotland) and those placed on the market in Northern Ireland and elsewhere in the EEA.
- Manufacturers may continue to use the CE-mark and it will be recognised in Great Britain until 30 June 2023.
- Manufactures may continue to rely on EEA Notified Body certificates until 30 June 2023 for products placed on the market in Great Britain.
- There will be a new route for conformity assessment of medical devices placed on the market in Great Britain from 1 January 2021.
- All medical devices and in vitro diagnostic medical devices (“IVDs”) placed on the market in the UK have to be registered with the MHRA. There will be certain grace periods for registering existing devices.
- Manufacturers based outside the UK will need to appoint a UK Responsible Person.
Continue Reading Brexit: UK Guidance on Regulation of Medical Devices from 1 January 2021
MHRA announces a risk-based prioritisation of on-site Good Practice inspections during COVID-19
On 20 March 2020, the Medicines and Healthcare products Regulatory Agency (“MHRA”, the “Agency”) announced it will be conducting only ‘essential’ on-site Good Practice (“GxP”) inspections of laboratories, clinical trials, manufacturing, distribution and pharmacovigilance during COVID-19. The Agency will replace ‘non-essential’ on-site inspections with remote regulatory supervision approaches, such as office-based assessments and information-exchange with
TechForce19: UK Government promises up to £25,000 for innovator companies that develop digital support solutions for COVID-19
On 23 March 2020, the Department of Health and Social Care (“DHSC”) issued a plea to technology companies to come up with digital support solutions for COVID-19. The DHSC is making £500,000 available, with funding of up to £25,000 per company. The challenge, named TechForce19, aims to increase community support for the elderly, vulnerable
DEFRA announces raft of new measures to support food supply and key workers in response to COVID-19
On 20 March 2020, the Department for Environment, Food and Rural Affairs (“DEFRA”) has announced a raft of measures relating to food supply and key workers with the easing the impact of COVID-19 for UK retailers and workers.
The Department of Education and Cabinet Office has published guidance on key workers for COVID-19. The guidance
UK sets deadline for novel food authorisation of CBD products
The UK Food Standards Agency has announced a deadline of 31 March 2021 for companies marketing cannabidiol (CBD) extracts as foods or food supplements industry to submit novel food authorisation applications. After 31 March 2021, the FSA stated that only products with a fully validated novel food authorisation application will be permitted and all other
NHS England Publishes Draft Commercial Framework for Medicines
NHS England has recently published draft proposals on how it plans to approach doing commercial deals with pharmaceutical companies for branded medicines. This draft “Commercial Framework” is now open for comment and consultation (stakeholders can submit their views here). The consultation period ends on 10 January 2020, with Commercial Framework expected to be finalized
UK regulator provides further ‘no deal’ Brexit guidance for medical devices regulation
On 26 February, the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) published further guidance (available here) setting out the anticipated regulation of medical devices in the UK, should the UK leave the EU without a deal (Guidance). This Guidance will apply from ‘exit day’ (expected to be 11 p.m. 29 March 2019) subject to the (currently draft) Medical Devices (Amendment) (EU Exit) Regulations 2019 (UK MDR 2019) (available here) being passed by UK Parliament. This latest Guidance follows on from the MHRA’s previous ‘no deal’ scenario further guidance note in January regarding medicines, medical devices and clinical trials regulation (available here).
- Legislative Background
The Medical Devices Regulations 2002 (UK MDR 2002) implement Directives 90/385/EEC, 93/42/EEC and 98/79/EC on active implantable medical devices, medical devices, and in vitro diagnostic medical devices (IVDs), respectively (EU Directives) into UK law. Pursuant to the European Union (Withdrawal) Act 2018, the UK MDR 2002 will continue to apply.