Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
Commission Outlines How EU Data Protection Rules Affect Clinical Trial Sponsors
The European Commission has published a document detailing the interplay between clinical trial rules and the General Data Protection Regulation (GDPR). The document sets out the data protection requirements of the incoming Clinical Trials Regulation (CTR) and how they interact with GDPR.
CTR places stronger requirements on sponsors to record, process, store and handle data in ways that enable accurate reporting and interpretation, without threatening the confidentiality of the records.
However, the data are also subject to the trans-industry requirements imposed by GDPR. As such, the Commission thinks the onus is on sponsors to “implement the appropriate technical and organizational measures to ensure and be able to demonstrate that the personal data are processed in accordance with the data protection rules.”
Exactly how CTR and GDPR apply depends on whether data is being processed purely for research or if the activity has a health protection objective. The question and answer document created by the Commission sets out the regulations that apply in each situation and their implications for sponsors.
Other parts of the document deal with specific situations that can arise during clinical development, such as the implications of a subject withdrawing their consent for participation in a study. In that situation, the investigator should talk to the trial subject to determine whether they are withdrawing their consent to participate in trial activities or if they are also barring the processing of their data.
Dutch MEB Started 2019 With Growing Workload and Fiscal Deficit, Despite Job Cuts
The Dutch Medicines Evaluation Board (MEB) has detailed the “significant difficulties” it faced last year as a result of Brexit and other forces. These factors created financial pressures, leading MEB to reduce its staffing at a time when it is taking on more European Medicines Agency (EMA) work.
MEB went into 2018 touting how it had expanded its capacity “to take over work from the United Kingdom in the European network” and offset the impact of Brexit on EMA. However, as the year went on, MEB discovered that its structure was financially unsustainable.
“It turned out to be essential to make some significant adjustments halfway through the year because an imbalance became apparent in the development of income and expenditure. A whole host of factors played a role in this. One of those was, without doubt, the impending Brexit,” Ton de Boer and Hugo Hurts, respectively the chair and director of MEB, wrote in the annual report.
The Dutch government provided temporary financial support last year to help MEB prepare for the impact of a no-deal Brexit but, despite that and reductions to its staff, the agency ended 2018 running a deficit. The effects of MEB’s attempts to balance its books continue to be felt in 2019, Boer and Hurts wrote, but “considerable efforts on the part of MEB employees” have enabled the agency to become more flexible.
MEB will need that increased flexibility as it tries to fulfill its new, larger role in the European regulatory landscape using finite resources. As the new host of EMA, the Netherlands has stepped up its involvement in region-wide regulatory activities to offset the effect of the loss of the support of the UK’s Medicines and Healthcare products Regulatory Agency (MHRA).
In 2018, MEB was rapporteur or co-rapporteur on 23 projects assigned via the centralized procedure, compared to 15 in the previous year. The increased workload made MEB the second most active national authority in centralized procedures after Sweden, but it took on too little work to fully mitigate the loss of MHRA, which was only involved in one project last year.
The rest of the work that would otherwise have been handled by MHRA went to Spain and a long tail of agencies that took on a small number of rapporteurships or co-rapporteurships. Only Bulgaria, Cyprus and Luxembourg had zero rapporteurships or co-rapporteurships, suggesting MEB’s plan to spread the work around and build up the capacities of other agencies may work. Croatia, Poland, Lithuania and Malta also began contributing to the scientific advice program for the first time.
UK MHRA Advises ‘Extreme Caution’ After Yellow Fever Vaccine Linked to Deaths
The UK MHRA has told healthcare professionals to exercise “extreme caution” before giving Sanofi’s yellow fever vaccine Stamaril to people who may be immunosuppressed or age 60 or older. MHRA issued the warning after receiving reports of two fatal adverse events.
The adverse events involved a person who had undergone a thymectomy to treat a tumor originating in the thymus and a 67-year-old with no known risk factors. Stamaril is contraindicated in people who have had their thymus removed, meaning the labeling should have prevented one of the two people from receiving the vaccine.
The labeling did not prohibit the use of Stamaril in the 67-year-old. In response to the death, MHRA reminded healthcare professionals that the vaccine should “only be given [to people over 60] when it is considered that there is a significant and unavoidable risk of acquiring yellow fever.”
Both people are thought to have died of yellow fever vaccine-associated viscerotropic disease, a condition that affects around one in every million people who receive Stamaril. The risk is greater in people with thymus disease, immunosuppression or an age of 60 years and older.
Officials at MHRA have previously issued warnings that live attenuated vaccines such as Stamaril should not be given to people who are clinically immunosuppressed, be it due to therapy, underlying illness or pregnancy.
Ireland’s HPRA Steps in to Fill Information Vacuum Created by Company Closure
Ireland’s Health Products Regulatory Authority (HPRA) has issued a medical device safety notice to fill an information vacuum created by the dissolution of a company. The company, ARB Medical, issued a field safety corrective action in October but then went quiet.
ARB issued the notice after receiving complaints about a fault with its hernia repair device Rebound HRD/HRD-V. HPRA subsequently became concerned about ARB’s ability to spread the message and took action.
“In the intervening months, HPRA understand that ARB Medical LLC has dissolved as a result of which, further information on supply has been difficult to obtain. HPRA is therefore issuing this safety notice as a precautionary measure, as we do not have oversight of the distribution network for the Irish market,” HPRA wrote.
HPRA has told users to pull affected devices, forward a copy of its notice to all relevant people and follow ARB’s advice on the management of patients who have already received Rebound HRD/HRD-V.
’s Pharmacovigilance Risk Assessment Committee
(PRAC) has initiated a review of the safety of high-strength estradiol-containing creams five years after finishing its last assessment of the vaginal atrophy treatment. The review was necessitated by the Court of Justice’s decision to partially annul the findings of the 2014 assessment on procedural grounds, invalidating some of the risk-minimization measures. PRAC Notice
’s National Agency for the Safety of Medicines and Health Products
(ANSM) has published a guide to the storage of medicines in rooms near a manufacturer’s main location. ANSM permits the storage of medicines in such annexes, provided the room is under the oversight of a pharmacist. ANSM Guide