Following the implementation of the new EudraVigilance system, reported in our previous post, and in an attempt to streamline the monitoring of safety signals in EudraVigilance, the European Medicines Agency (EMA) has recently announced that the marketing authorisation holders (MAHs) of 300 specific active substances and combinations of active substances will be required continuously to monitor activities in relation to their substances in EudraVigilance. The scheme will begin on 22 February 2018 and will last one year. During the pilot period, the affected MAHs will be required to inform the EMA and national competent authorities of validated safety signals relating to their medicines. MAHs who are included in the pilot scheme should refer to the guidance contained in the Good Pharmacovigilance Practices (GVP) Module IX – Signal Management in relation to the monitoring and reporting of safety signals. MAHs who are not part of the pilot scheme will not be required to monitor EudraVigilance or to inform the regulatory authorities of validated signals while the scheme is in operation. However, they will have access to EudraVigilance data and will be able to incorporate any relevant new safety data into their own safety monitoring systems. The EMA will use the experience gained during the pilot period to improve the next phase of safety signal detection.
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.
- 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
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  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.