Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
European Commission Advises Sponsors on the Effect of Brexit on Clinical Trials
The European Commission has advised sponsors on how Brexit will affect clinical trials. The notice picks out the supply of investigational products, need to have a representative in the European Union and the submission of clinical trial information as the key points to consider ahead of Brexit.
With the United Kingdom now a little more than six months from leaving the EU, authorities on both sides of the English Channel are helping the biopharma industry step up its preparations for the upcoming separation. The UK published its position on the likely effect of Brexit on clinical trials last month. Now, the Commission has shared its advice with the industry.
The Commission notice focuses on three “legal repercussions” of the UK becoming a third country. Due to what the Commission calls the “considerable uncertainties” about the state of the UK’s future relationship with the EU, the advice could be rendered void by developments in the coming months. However, in keeping with the EU’s position throughout the Brexit negotiations, the Commission is advising sponsors to be cognizant of what will happen if the UK leaves without securing a deal.
If that happens, the UK will be treated as a third country as of 29 March. That will affect the supply of investigational medicines. If any part of the production of an investigational medicine takes place in a third country, the sponsor must have at least one qualified person “permanently and continuously at his disposal” in the EU. This person must ensure the imported medicine was produced in accordance with good manufacturing practices equivalent to those applied in the EU.
The requirement for sponsors to apply these processes to medicines imported from the UK is one of several repercussions of Brexit highlighted by the Commission. The second repercussion cited by the Commission is the need to have a legal representative in one of the remaining 27 EU member states. It typically takes a substantial amendment to change a legal representative.
The Commission’s third and final point covers the submission of clinical trial information. After the UK leaves the EU, sponsors will no longer have to file UK-specific clinical trial information to EudraCT, unless the country is the only location in a study run as part of an agreed pediatric investigation plan.
UK Politician Warns Hologic Risks Losing Major Contract Amid Brexit Fallout
A British politician has warned that Brexit-triggered changes to the regulatory framework for batch release could cause job losses in her constituency. Hannah Bardell made the comments after talking to people at a business owned by Massachusetts-based medtech company Hologic.
Since the UK voted to leave the EU, there has been lots of talk about the threat the separation poses to British businesses, but the prospect has remained largely theoretical. Now, with the UK’s departure date nearing, that talk is solidifying into concrete threats to companies. Some of these threats relate to the ways Brexit may affect the regulatory relationship between the UK and EU.
“In my constituency, I have a life sciences company called Hologic, which has just told me that it is on the verge of losing a major contract because of the threat in relation to reciprocal agreements and the regulatory framework for batch releases. It is very concerned about job losses and about losing contracts,” Bardell said during a debate about Brexit in the UK parliament.
Matt Warman, a member of the ruling Conservative party who represents a pro-Brexit constituency, responded by stating politicians are trying to “provide as much certainty as they possibly can.” However, Warman acknowledged that “until there is a done deal, many businesses will take the cautious approach,” adding that he and his colleagues “must do everything we can to avoid that.”
Bardell’s comments refer to Hologic’s Tepnel Pharma services unit that is based in her constituency in Scotland. Tepnel was bought in 2009 for around $130 million by Gen-Probe, which was later acquired by Hologic for $3.7 billion.
A Hologic spokesperson declined to provide a statement about Bardell’s comments when contacted by Regulatory Focus
MHRA Defines Inspection Findings in Update to GCP Guidance
The UK Medicines and Healthcare products Regulatory Agency (MHRA) has provided definitions for the inspection outcome terms “critical,” “major” and “other” in an update to its guidance on good clinical practices (GCPs).
MHRA has long used the three terms to indicate the significance of the findings of its GCP inspection teams. However, the agency’s guidance on GCPs lacked definitions for the important terms. MHRA has addressed the gap in its GCP information in its fourth update to the guidance document of the past 12 months.
The new section describes three scenarios in which MHRA will class a finding as critical. This status is applied to “significant and unjustified” departures from legislative requirements that may jeopardize the safety of patients or the reliability of clinical trial data. MHRA will also issue critical warnings when a sponsor takes “inappropriate, insufficient or untimely” actions to fix major failings, and when its inspectors are unable to do their jobs because the trial master file is inaccessible or incomplete.
MHRA’s updated guidance also defines when less severe failings will be classed as “major” and how it uses the catch-all outcome “other.”
Dutch MEB Details How it is Preparing for Hard Brexit
The Dutch Medicines Evaluation Board (MEB) has shared information about how it is preparing for a hard Brexit. As the Netherlands is the new host of EMA, MEB is likely to be more affected by Brexit than other national competent authorities and is taking steps to mitigate the impact.
Preparations in the Netherlands and elsewhere in Europe are proceeding on the assumption the UK may leave the EU in March without a deal. Even if the UK secures a deal, EMA is likely to stop working with MHRA, cutting it off from an agency that performed many regulatory tasks for it in recent years. In anticipation of that happening, MEB has expanded its capacity.
MEB received money from the Dutch government to facilitate the expansion, but the funding boost is expected to be temporary. In the longer term, EMA looks unlikely to be able to rely as heavily on MEB as it did MHRA. To mitigate the capacity loss, MEB is working to build up the regulatory capabilities of other member states so they can take on some of the work.
The strategy outlined by MEB is in line with the plan it put forward in a report in April. Back then, MEB executive director Hugo Hurts said the agency may not need to grow, as in the future “fewer procedures will be carried out by large agencies, but more by a number of countries together.”
has revealed the extent to which EMA
out of its operations last year. In the 2016 fiscal year, MHRA received 41 of the 87 rapporteurships it applied for, giving it a success rate of 47%. Last year, MHRA received 11 of 66 rapporteurships it applied for, giving it a success rate of 17%. The number of rapporteurships awarded to MHRA fell by 73% year on year. Written Answer