Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
UK Government Criticized for Failing to Provide Certainty in Response to Brexit Report
Politicians have criticized the British government’s response to a report on the impact of Brexit. The government is accused of offering the drug and device industries little more than good intentions, leaving businesses in the dark about issues critical to their operations.
The criticism centers on the government’s response to a report published by the Health and Social Care Committee earlier this year. The report looked at issues including regulatory alignment after Brexit, multi-country clinical trials, supply chains and pharmacovigilance to assess how leaving the European Union may affect patients and businesses in the United Kingdom. Two months later, the UK government has responded to each of the 34 recommendations made in the report.
The government’s 22-page response covers the committee’s request for details of preparations for a no-deal Brexit, call for EU-UK regulatory alignment and belief Britain needs an immigration policy that makes it easy for talented researchers to come to the country. However, in the committee’s view, the responses fall short of the level of detail and commitment needed to reassure stakeholders.
Sarah Wollaston, chair of the committee behind the report, said the government’s response “is full of good intentions, but does little to provide certainty for UK patients, [healthcare service] the NHS and businesses.”
Wollaston picked out several key areas in which the committee wants the government to go further. Regulatory alignment is one of the areas. The government ruled out deliberately diverging from the EU in a bid to create a leaner, speedier regulatory system a long time ago and reiterated its desire to form a close relationship with the European Medicines Agency (EMA) in its response. However, the committee thinks the government must do more to provide certainty.
Businesses have little certainty about what will happen if negotiations between the UK and EU break down. That could cause the UK to leave the EU without a deal or a transition period, turning it into a third country overnight in 10 months time. The government has resisted sharing details of what it is doing to prepare for this eventuality in a belief that doing so would undermine its negotiating position. That view, which the government reiterated in its response, was dismissed by Wollaston.
“Our view remains that the publication of contingency planning would strengthen, rather than damage, the UK’s negotiating position,” the committee chair said.
The committee’s view is based on the belief that the government’s contingency plans must undergo extensive public scrutiny to cut the risk of patient safety and health supplies being harmed by Brexit. In doing so, the committee thinks the government could show the EU it has a credible fall-back option, thereby strengthening its hand in the negotiations.
, Committee Comments
Ireland’s HPRA Shares Advice for Academic Sponsors in Update to Clinical Trial Guide
The Health Products Regulatory Authority (HPRA) of Ireland has updated its guide to clinical trial applications. HPRA’s latest version of the text features new sections to help academic and other noncommercial organizations sponsor trials and prepare for good clinical practice (GCP) inspections.
Academic sponsors are subject to the same regulations as commercial drug developers, but they face some unique challenges. Many academic groups have less experience in applying to run clinical trials and ensuring studies are compliant. The effect of this inexperience is compounded by the fact that some regulatory documents are written primarily for companies that are advancing pipeline candidates toward marketing authorization applications.
Recognizing these issues, HPRA is providing advice tailored to noncommercial sponsors. The agency recommends noncommercial organizations and their investigators assess whether they have the resources, infrastructure, systems and procedures to run compliant clinical trials. As HPRA states, sponsoring a trial entails assuming legal responsibilities such as safety reporting that necessitate a certain level of preparedness.
The guide recommends sponsors look at European and International Conference on Harmonisation documents on clinical trials to ensure they can comply with all their obligations. HPRA also thinks new sponsors should have an expert assess their systems and procedures before starting a clinical trial.
In some exceptional cases, HPRA will help academic sponsors make submissions to the EudraVigilance safety database. Sponsors that want such support must request it when submitting their clinical trial applications. If HPRA agrees to help, the timelines for submission will be truncated so the agency can process cases before filing. HPRA and the sponsor will decide on the timelines as part of the broader agreement on the collaboration.
The other new, academic-focused section addresses GCP inspections. Academic sponsors can draw on existing European documents to help prepare for inspections. However, while these documents apply to all sponsors, HPRA thinks they are tailored to commercial organizations. As such, HPRA has shared descriptions of the key systems inspectors will check when assessing an academic sponsor.
The descriptions cover organization, personnel, facilities, quality risk management and other factors that are important to the compliant running of all clinical trials. In each case, HPRA zeros in on details of particular significance for academic sponsors. For example, the section on organization and personnel states principal investigators, safety committees and other noncommercial entities often serve as the medical expert in academic-sponsored trials. This is acceptable, but the sponsor must be able to show inspectors the organization was considered as part of its quality risk management.
HPRA also used the update to change sections of the guide about end of trial declarations, substantial amendments to trials and other topics.
The document sets out who MHRA collects data from, what types of data it processes, how it uses the data and which groups it may share the information with. In providing a full account of how data flows through its organization, MHRA has revealed the extent to which it relies on the processing of personal information to perform its regulatory functions.
MHRA lists 15 groups from which it collects personal data. The groups include drug and medical device manufacturers and wholesalers, current and former employees and members of the public. MHRA collects data including bank details, political opinions and genetic data from these and other groups to perform its regulatory functions, process requests and promote its policies.
The agency may share the data with more than 25 groups, including credit reference agencies, debt collectors, trading standards and EMA. MHRA said it shares data “where necessary, required and within the law.”
MHRA published the policy on 25 May, the same day as new data protection regulations came into force in Europe. The agency’s document refers repeatedly to how the policy fits with data protection rules.
has stated it will not accept pediatric investigation plan submissions that fail to follow its published guidance. Applicants that do not follow the guidance must resubmit their filings. If the refiling comes after the targeted deadline, EMA will not accept it for the start of procedure. To avoid such issues, EMA is advising applicants unfamiliar with the eSubmission Gateway to file early. EMA Update