As a New Year present to us all, on 3 January 2019, the MHRA published updated guidance on the regulation of medicines, medical devices and clinical trials in the event that the UK leaves the EU on 29 March 2019 without a deal, known as a “hard Brexit”.

Following publication of the technical notice in August 2018, which we considered in an earlier blog, a consultation was launched in order to seek views on the mechanics behind some of the proposals. The consultation ended on 1 November 2018; the responses were reviewed and the technical notice updated. However, the notice states in a number of places that further guidance will be published in due course.

Continue Reading MHRA’s updated guidance on a hard-Brexit

Arnold & Porter’s Future Pharma Forum invites you to a complimentary regulatory seminar aimed at junior lawyers and new joiners in the UK/EU life sciences industry. We will provide a comprehensive introduction to key EU regulatory law topics from an in-house practitioner’s perspective and touch on the implications of Brexit.

Topics

  • Overview of the EU pharmaceutical law framework
  • Clinical trials, unlicensed supply and compassionate use
  • Obtaining marketing authorisations
  • Incentives: regulatory data protection, marketing protection, orphan market exclusivity and paediatric rewards
  • Pharmacovigilance
  • Advertising and promotion of medicinal products
  • Pricing and reimbursement in the UK
  • Supply chains

Who is it relevant for?

The Future Pharma Forum is a group established to provide training and networking opportunities for junior and mid-level lawyers in the life sciences industry. We conduct seminars and events aimed at junior and mid-level lawyers up to around 8 years PQE. There are no formal entry or membership requirements— please feel free to pass this to colleagues who might be interested in attending.

More information is on the website, and you can sign up here.

Publication of clinical trial data and results continues to be a hot topic in the EU. A recent BMJ article investigated the level of compliance with the European Commission’s requirement that the results of all trials are published within 12 months of completion. The Commission guidance expands on the obligations in the Clinical Trials Directive, and states that for all trials (paediatric and non-paediatric), result-related information should be supplied and made public within 12 months of the completion of the trial (not after grant of the marketing authorisation), including a summary of the results and conclusions.

The retrospective cohort study found that despite the Commission guidance, of the 7,274 trials where results were due, only 49.5% reported results, although trials with a commercial sponsor were substantially more likely to post results than those with a non-commercial sponsor (68.1% compared to 11.0%).

Continue Reading Update on Clinical Trials Transparency in the EU

Earlier this month, the European Commission published a “rolling plan” for the implementation of the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR). As we mentioned in our blog from last year, CAMD’s (Competent Authorities for Medical Devices) Implementation Taskforce published a high-level MDR/IVDR roadmap setting out how the Regulations will be implemented, and the order in which key guidance and clarification will be developed. Now, the Commission has published the rolling plan, which contains a list of the essential implementing acts and actions that need to be introduced, as well as providing information on expected timelines and the current state-of-play.

Continue Reading Update on the European MDR and IVDR

On 12 October 2018, the MHRA issued Guidance for products without an intended medical purpose (Annex XVI) under the new Medical Device Regulation (EU 2017/745) providing guidance on the expansion of scope of the medical devices regime to include certain products which had been previously unregulated at EU level.

Article 1(2) of the Medical Devices Regulation (MDR), in force from 25 May 2017, explains that the MDR will regulate “certain groups of products without an intended medical purpose” as though they were medical devices.

There are currently six types of products in this category which are listed at Annex XVI of the MDR.

Continue Reading New MHRA guidance on non-medical devices

The International Federation of Pharmaceutical Manufacturers & Associations (IFPMA) has recently published a new version of its Code of Practice that will come into force on January 1, 2019, updating the current Code of 2012. IFPMA members, including the EFPIA and PhRMA, must incorporate the new provisions into their own codes by this date, to the extent necessary.

In addition to the text of the Code, the IFPMA has provided detailed guidance on the key amendments made. First, the Code is now underpinned by a guiding Ethos that replaces the previous iteration’s ‘Guiding Principles’. Secondly, several provisions have been updated, notably the section on gifts. We highlight the key changes below.

Continue Reading The new IFPMA Code of Practice

In July, we considered the implications of the UK Government’s Brexit White paper, setting out its proposals for the UK’s ongoing relationship with the EU post-Brexit and how this would apply to the supply and manufacture of medicinal products and medical devices. Acknowledging the need for a contingency plan if no agreement can be reached, the Medicines and Healthcare Regulatory Agency (MHRA) has now published guidance entitled “How medicines, medical devices and clinical trials would be regulated if there’s no Brexit deal“. Below, we set out the key points arising from that guidance.

Withdrawal Act

The regulation of medicines and medical devices in the UK is currently subject to both EU and UK legislation and oversight. For example, in relation to medicinal products, Directive 2001/83 and Regulation 726/2004, which govern marketing and supply in the EU, are implemented into UK law by the Human Medicines Regulations 2012 (HMR). For medical devices, Directives 93/42 (on medical devices), 98/79 (on in vitro medical devices) and 90/385 (on active implantable medical devices) set out the regulations in the EU, and are implemented in the UK through the Medical Devices Regulations 2002 (MDR). In addition, the new Regulations 2017/745 (on medical devices) and 2017/746 (on in vitro medical devices) will apply from 2020 and 2022, respectively.

In the event of a no-deal Brexit, full regulatory authority will pass to the UK, and the European legislation will cease to apply to the UK on 29 March 2019 (exit day), although UK legislation that implements EU law will remain in force. Under the EU (Withdrawal) Act 2018 (EUWA), all existing EU rules will be converted into UK law at the moment of exit to the extent they are not already part of UK law.

Continue Reading MHRA guidance on no-deal Brexit

Data-driven technologies, particularly artificial intelligence and other complex algorithms, have the potential to enhance patient care and catalyse medical breakthroughs. However, these technologies are heavily reliant on data, which poses challenges in ensuring that patient information is handled in a safe, secure and legally compliant way.

In response to early issues with the deployment of artificial intelligence and other algorithmic tools in healthcare, on 5 September 2018 the UK Department of Health & Social Care (DH) published an Initial Code of Conduct for Developers and Suppliers of Data-driven Health and Care Technology (the Code). The Code is not legally binding but aims to raise standards by establishing best practices.

Continue Reading UK guidance for developers of health care software and technologies

The next Future Pharma Forum will be on 27 September: Implications of Recent EU and UK Court Decisions in the Pharmaceutical Sector

Emily MacKenzie, Barrister at Brick Court Chambers, will join us to recap on how challenges to pharmaceutical decisions may be brought to the European and domestic courts. Emily will provide a summary of recent European Court and English Court decisions in the pharmaceutical area and we will explore the implications for pharmaceutical companies.

Topics

  • How to bring challenges to the European Court
  • The interplay of domestic proceedings
  • Summary of recent European Court decisions, including:
    • Shire on orphan market exclusivity and;
    • Astellas on the role of the Concerned Member State
  • Summary of recent English Court decisions, including Napp on the Article 10(3) hybrid-abridged procedure
  • Changes in the Notice to Applicants regarding RDP, including the “reverse combination” principle
  • The implications for pharmaceutical companies

More information can be found on our website, and you can sign up here. Hope to see you there!

The European Commission has published a consultation on proposed changes to its 2011 Note on the handling of duplicate marketing authorisations. The Consultation Document explains that the objective of the consultation is to seek views on the impact of duplicate authorisations of biological medicinal products on the availability of biosimilars to healthcare professionals and patients.

Continue Reading Consultation on duplicate marketing authorisations in the EU