A quick note to inform you that the EMA launched its new improved version of the Eudravigilance system on 22 November 2017. It is now mandatory to report suspected ADRs through the new system.

The new system has been designed to offer “enhanced features for the reporting and analysis of suspected adverse reactions, to support stronger safety monitoring of medicines and a more efficient reporting process for stakeholders”. It will be interesting to monitor whether the system delivers these improvements, as time passes, and users become more familiar with it.

For further information, please refer to our previous blog and the attached guidance.

The Competent Authorities for Medical Devices (CAMD) was established to enhance collaborative working, communication and surveillance of medical devices across Europe. With the introduction of the Medical Devices Regulations (the MDR and IVDR), two groups were set up within the CAMD: (i) the Transition Subgroup, which will develop guidelines on the application of the MDR/IVDR during the transitional period, and details of which aspects of the Regulations devices will have to meet to be placed on the market during this time, and (ii) the Implementation Taskforce to facilitate collaboration and cooperation during the implementation phase of the new Regulations.

Earlier this month, the Implementation Taskforce published a high-level MDR/IVDR Roadmap. The Roadmap is the first glimpse into the intentions of the Commission and authorities across the EU as to how the Regulations will be implemented, and the order in which key guidance and clarification will be developed.

Continue Reading Roadmap on MDR/IVDR published

The awaited decision of the EU Member States on the new home for the European Medicines Agency (EMA) was published today. The final destination, Amsterdam, does not come as a complete surprise, despite the fact that the key institutions involved in the process, the Commission, the EMA and the Council, have consistently avoided naming preferred locations. As of today, the EMA has 17 months to conclude its move and take up its operations from Amsterdam by the end of March 2019.

The decision to relocate the EMA, although a consequence of the UK’s decision to leave the EU, does not form part of the Brexit negotiations. The procedure leading up to a decision on the relocation of the EMA was proposed by the Presidents of the Commission and the Council and was endorsed at the European Council meeting of 22 June 2017. Member States had up to the end of July 2017 to submit their offers to host the Agency.  Nineteen Member States put in bids.

Continue Reading EMA’s New Home

The European Commission has finally published the draft amendment to Regulation No 847/2000 regarding the concept of “similar medicinal product” for the purposes of the Orphan Medicinal Products Regulation. A key incentive of this Regulation is the ten-year market exclusivity that protects an orphan medicinal product, whereby national competent authorities shall not accept an application for authorisation, or grant an authorisation, or accept an application to extend an existing authorisation, “for the same therapeutic indication, in respect of a similar medicinal product” as the orphan product. Regulation 847/2000 defines “similar medicinal product” in this context, and sets out a number of examples of what kind of products will be similar.

Following a consultation last year, the Commission intends to make changes to the 17-year-old text to account for the rise of cell therapies and other advanced therapy medicinal products, the nature of which do not fit neatly into the current definitions.

Continue Reading Draft Regulation amending definition of “similar medicinal product”

In July, we reported that the European Medicines Agency (EMA) and the US Food and Drug Administration (FDA) had announced a joint proposal to promote the use of innovative approaches to paediatric drug development. We noted that the EMA expected to publish a Reflection Paper setting out a systematic approach to extrapolation of paediatric data by the end of the year. This has now been published.

Continue Reading EMA Reflection Paper on paediatric extrapolation

EU Life Sciences: Product Liability Update

Please join us on 28 November 2017 for our Product Liability Update. This full-day seminar will provide in-house counsel with key insights into the latest developments in product liability and related areas in the context of medicinal products and medical devices. Our EU Life Sciences team will discuss issues related to the assessment of defect, responding to regulatory actions, off-label use, and clinical trial claims.

Topics include:

  • Implications of Regulatory Action/Status When Assessing “Defect”
  • Group Actions: Developments and Future Direction
  • Case Law in the UK, France and Germany: Update and Review
  • Update on Medical Devices
  • Medicinal Product- or Medical Device-Associated Deaths and Coroners’ Inquests
  • Clinical Trial Claims
  • Claims Handling and Procedures

The full agenda and link to RSVP can be found on the website. Hope to see you there!

Last week, the European Commission published its ten-year report on the implementation of the Paediatric Regulation 1901/2006 (together with a useful Questions & Answers document). The report provides an account of the Regulation’s achievements, both in public health and economic terms, and an analysis on the extent to which its objectives and aims have been met.

It concludes that positive advances in the development of medicines for children could not have been achieved without specific EU legislation, and that 260 new medicines (new marketing authorisations and new indications) have been authorised as a result. However, certain problem areas have been identified, in particular in relation to the interplay between the Paediatric Regulation and the Orphan Medicinal Products Regulation 141/2000. The report does not set out any proposals for amendments to the Regulation, but states it will be for the next Commission, after 2019, to implement any necessary changes.

Continue Reading Ten-year report on Paediatric Regulation published

Last month, the oral hearing before the Court of Justice of the European Union took place in Case C-557/16 relating to the role of the Concerned Member States (CMS) in the Decentralised Procedure (DCP). During the DCP, the Reference Member State (RMS) has primary responsibility for preparing the assessment report on the medicinal product, and CMSs can raise questions or objections on the grounds of a potential serious risk to public health. This case, a referral from the Finnish Court, asks whether, and if so how, administrative and legal questions, such as the length of the regulatory data protection period, should be resolved in the CMSs, considering that national marketing authorisations (MA) are granted at the end of the DCP.

The hearing highlighted that the Member States and Commission do not agree as to the interpretation of the legislation and case law, and there is a real dispute for the Court to answer. The Advocate General has said he will deliver his opinion on 30 November.

Continue Reading European Court considers role of Concerned Member States

The first implementing act under the new Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) has been published for consultation and relates to the Notified Body product codes for medical devices and IVDs. Only Notified Bodies that have been designated under the Regulations can carry out conformity assessment procedures, and only for certain types of devices listed in their designation. This draft implementing regulation sets out the list of codes and corresponding types of devices, and is intended to aid clear identification of the expertise of Notified Bodies to perform conformity assessment procedures.

Continue Reading First implementing act under MDR

What does “defect” mean?

Rarely has the Court of Appeal been required to examine the meaning of “defect” within Section 3(1) of the Consumer Protection Act 1987 (the Act). In Baker v KTM Sportmotorcycle UK Ltd and another [2017] EWCA Civ 378, the Claimant, a maxillofacial surgeon, had suffered severe personal injuries when the front brakes of the second-hand motorbike he was riding seized without warning and he was thrown off. The motorbike had been well-maintained, had low mileage and was only two years old. The Claimant sued the motorbike manufacturers (KTM) under the Act and in negligence, and won (under the Act) at first instance. KTM appealed, on the basis that the Recorder was wrong to conclude that the corrosion which led to the brakes failing was a “defect” within section 3 of the Act. The Appeal was unsuccessful—the Court of Appeal found that the brakes failed because they were defective. The Court explained that the Claimant did not have to prove the existence of a specific design or manufacturing defect for there to be a finding of defect within the meaning of section 3, nor did he have to show how the defect was caused. The Claimant merely had to show that a defect existed at the relevant time and that this caused the accident. The Court found on the expert evidence that there must have been a defect in the brakes of this particular motorbike, which Hamblen LJ described as “a susceptibility for galvanic corrosion to develop in the front brake system when it should not have done i.e. after limited and normal use and notwithstanding proper servicing, cleaning and maintenance”. This susceptibility was not present in other bikes of the same type, and therefore the Court was entitled to infer that these particular brakes were defective, and the Claimant had proved his case.

Continue Reading Meaning of defect? Court of Appeal clarifies s3 Consumer Protection Act 1987