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

The European Federation of Pharmaceutical Industries and Associations (EFPIA) has issued this week new guidance on working with patient groups. The document has been prepared by the EFPIA Patient Think Tank, which is a forum comprised of representatives of patient organisations and the research-based pharmaceutical industry.

The new guide provides an additional point of reference and supplements the 2011 EFPIA Patient Organisation Code of Practice. It underlines the rationale for interactions between the pharmaceutical industry and patient organisations, providing clear principles that justify engagement between these two groups and a practical list of potential hurdles and proposed solutions. It is not applicable to interactions with individual patients but the rationale underpinning the guide may be applied to such interactions too.

Principles for Engagement

The guide recognises the benefits of effective collaboration between patient organisations and industry in ensuring that the patient perspective is taken into account when decisions which affect patients are made. However establishing an appropriate engagement between the industry and patients organisations without breaching the legal restrictions governing these interactions represents a challenge. The following 5 principles have been distilled by the Think Tank as necessary to ensure compliance:

  • Clarity of Purpose – a legitimate need for the interaction and the desired outcomes must be identified in advance.
  • Transparency – of aims and in particular of financial relationships between the two groups; any compensation paid to patient organisations and their representatives, should be proportional and commensurate with experience, expertise and time invested.
  • Independence – of decision-making, policies and communications helps to ensure credibility; funding from a wide range of sources is therefore always preferable. (NB: the EFPIA Patient Organisation Code prohibits its members from requiring to be sole funders of patient organisations or patient organisation’s activities.)
  • Mutual Respect – reflecting a collaborative approach, valuing the contribution of both parties.
  • Non-interference in the healthcare professional-patient relationship.

Continue Reading New European Guidelines on working with patient groups

Legal clarity on the meaning of ‘commercially confidential information’ within sight

Demand for greater transparency and disclosure of pre-clinical and clinical data by industry continues to attract significant debate. Recent academic studies, published in Current Medical Research and Opinion and the British Medical Journal, have systematically assessed the disclosure policies of trial data arising from studies sponsored by pharmaceutical companies. In the EU, the European Medicines Agency (EMA) has adopted policies and guidance setting out its approach to data disclosure. Certain aspects of the adopted policies are currently being considered by European Courts, to address the nature of the balance to be struck between the public interest in transparency and the interest (both public and private) in protecting innovative research from unfair commercial use. In a broader context, the prevailing legal framework is based on a need for coherence and equilibrium between the general regulation governing public access or freedom of information and the sector-specific legislation regarding authorisation and supervision of medicines. In this blog post, we provide a summary of these cases, as heard in the European Courts to date.

Continue Reading Update on transparency of clinical data

Last month, the UK MHRA published new guidance on human factors and usability engineering for medical devices to be taken into account when designing medical devices in accordance with the regulatory framework. ‘Human factors’ refer to how a person interacts with a product, and will depend on, among other things, the design of the product, the education and training of the intended user population, the environment in which they will be using the product, competing distractions, usability and ergonomics.

Continue Reading MHRA guidance on human factors for medical devices