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

The new General Data Protection Regulation 2016/679/EU (GDPR), which will apply throughout the EU from 25 May 2018, has strengthened the protection of individuals’ personal data. Data subjects have new rights to help ensure their data are processed securely and with adequate protections (such as the right to erasure of personal data—the “right to be forgotten”—and to data portability), and there are clearer responsibilities and obligations placed on companies using such data (such as the need to appoint a data protection officer and to carry out a data protection impact assessment). Penalties are also substantial: national regulators will have the power to impose fines of up to €20 million or four percent annual global turnover, whichever is the higher.

How these strengthened rights fit with other sector-specific legislation where large quantities of data are collected and processed, such as clinical trials, is currently unclear. Added to this, there are no transitional rules governing how data currently held and being collected will be dealt with once the GDPR becomes applicable. Our recent article discusses some of the implications for clinical trials, focusing on the changes that affect the collection of data from data subjects, and their rights under the GDPR.  It is clear that all organisations should consider their processes in light of the GDPR, and understand the remit of their compliance responsibilities, particularly for trials and data processing that have already started.

On 26 May 2017, the new EU Medical Devices Regulation (MDR) and In Vitro Diagnostics Regulation (IVDR) entered into force. In order to aid preparations for the provisions taking effect, the Medicines and Healthcare products Regulatory Agency (MHRA) has published materials to help manufacturers understand the new requirements, and in particular, has published an introductory Interactive Guide to the Regulations. The MHRA’s director of Medical Devices, John Wilkinson, explained that “We live in an increasingly digital world, and the way we provide our guidance is changing. We want to help manufacturers to comply with the new regulations as easily and as early as possible.”

The Interactive Guide allows users to navigate through key topics and provides a high level overview of the Regulations for manufacturers who may be looking at them for the first time, and also seeks to help experienced manufacturers navigate the changes. A brief summary of the key points is set out below.

Continue Reading MHRA’s guide to the new EU Medical Devices Regulations

One of the obligations imposed on Member States under the Falsified Medicines Directive 2011/62/EU (FMD) is to put in place a medicines verification system by 9 February 2019. In the UK this is being managed by Securmed UK, a non-profit organisation established by the relevant supply chain stakeholders.

On 19 July 2017 Securmed UK announced that it had entered into a letter of intent with Arvato Systems GmbH to provide the IT platform that will underpin the UK’s medicines verification system. This represents a key milestone in the UK’s journey to meeting its obligations under the FMD and associated Delegated Regulation 2016/161.

Continue Reading Arvato to implement UK falsified medicines verification system

In advance of the launch of the new EudraVigilance System, on 22 November 2017, the EMA has published (on 5 July 2017) a 29 page Q&A, which is a summary of the broad ranging pre-launch questions submitted by stakeholders and the EMA’s answers. Answers have been kept succinct, with URL links to any further relevant guidance. The document is split into separate topics, including: Eudravigilance organisation and user registration;  Reporting to National Competent Authorities in the EEA; and Technical Questions, with an index and a useful glossary of terms at the beginning of the guide. The Q&A will be updated regularly. The EMA recommends that the Q&A be treated as a first reference point for queries, before users contact the Agency’s service desk.

Continue Reading EudraVigilance – What’s next?