Euro Roundup: MHRA seeks feedback on patient engagement strategy

RoundupsRoundups | 27 May 2021 |  By 

The UK Medicines and Healthcare products Regulatory Agency (MHRA) is seeking feedback on how it engages with patients and involves them in its activities. MHRA is initiating the review in the wake of criticism of how it responded to patient concerns about the safety of products such as surgical mesh.
In the consultation document, MHRA describes five strategic, patient-focused objectives and shares details on how it intends to achieve the goals. The first goal is to “develop and introduce clear processes for engagement and involvement, to ensure teams have a systematic means of engaging and involving patients and the public in their work and that we publish how we do that.”
MHRA plans to achieve that goal by June 2022 and has shared details of how it will do so. The list of examples of how MHRA intends to achieve its objective include the development of “a process to more systematically involve patients and the public in our regulatory decision-making processes, committees and governance.” That will entail incorporating the views of patients into the Innovative Licensing and Access Pathway and building patient-reported outcomes into licensing decisions.
Other objectives include the implementation of a “process allowing for more agile and regular review of high-risk issues,” a change to MHRA’s culture, the creation of “a clear patient outcome evaluation framework” and the formation of a cross-sector partnership plan. The agency is aiming to meet the five broad objectives between December 2021 and December 2022.
MHRA is doing a survey to learn whether the public has confidence in its strategy. The survey poses three open-ended questions, only one of which must be completed. MHRA wants people who lack the time to answer all the queries to still respond to the mandatory question, which asks whether the respondent expects the agency’s strategy to improve how it engages and involves patients.
The agency is accepting feedback until 28 June.
MHRA Notice, Consultation Document
MHRA updates device guidance as MDR takes effect in Northern Ireland
MHRA has updated its guidance on clinical investigations of medical devices in Northern Ireland. The MHRA update reflects the implementation of the European Union Medical Device Regulation (MDR) in Northern Ireland.
While the post-Brexit UK government is creating its own medical device policies for England, Scotland and Wales, the terms of the split from the EU leave Northern Ireland subject to European Medicine Agency rules. As such, when MDR belatedly took effect in the 27 EU member states this week, it also came into force in Northern Ireland.
The change led MHRA to add a new section on Northern Ireland to its guidance on how to notify it of plans to run a medical device clinical trial. The guidance now features different advice for Northern Ireland and the rest of the UK.
Sponsors that want to study devices in Northern Ireland need to make applications to MHRA that are in line with the MDR requirements. MHRA will take up to 10 days to write to applicants to confirm its assessment has started, as opposed to the five-day response window for filings to run trials in Great Britain. The review may take 45 to 65 days, rather than the 60 days for submissions in Great Britain.
Northern Ireland also has its own processes for serious adverse event reporting, amendments and post-market studies. Again, sponsors need to notify MHRA, but the details are determined by MDR. For example, MHRA expects sponsors to use the MDCG 2020-10/2 SAE reporting table to notify it of serious adverse events.
MHRA Guidance
Notified body challenges court decision about liability for breast implant scandal
Notified body TÜV Rheinland has challenged the conclusion of a Parisian court about its liability for the PIP breast implant scandal. The Paris Court of Appeal found the notified body was negligent in its awarding of safety certificates to a French manufacturer of breast implants.
In responding to the ruling, TÜV Rheinland welcomed the court’s decision to dismiss the claims of people who received breast implants prior to September 2006 or could not prove that they used the affected products. However, the notified body pushed back against the ruling that it could have taken additional measures and is therefore partly liable for the safety scandal.
“TÜV Rheinland ... challenges [the court’s] decision for holding the notified body liable, even partly,” Maître Christelle Coslin, lawyer for the notified body, said. “The evidence in this case clearly shows that TÜV Rheinland acted diligently, in compliance with applicable regulations, and it was not its role to track down the fraud pursuant to regulation.”
Coslin added that at “no time in the scope of its mission” was the notified body “aware of elements suggesting that breast implants manufactured by PIP were not compliant.” TÜV Rheinland suspended the certificates when the fraud by the manufacturer came to light in March 2010.
As TÜV Rheinland sees it, the ruling goes against the decision of the Court of Justice of the European Union, which found notified bodies are under no general obligation to pay unannounced visits, and a later conclusion of the Versailles Court of Appeal.
Press Release, Reuters
MHRA advertising investigations plummet as work referred to another agency
The number of advertising investigations initiated by MHRA fell 61% last year, despite a 7% rise in the number of complaints it received. MHRA attributed the steep fall in investigations to a change in how it works with the Advertising Standards Authority (ASA).
As in previous years, MHRA received the most complaints about the promotion of botulinum toxin products by clinics. MHRA used to investigate the complaints itself. However, last year the agency referred most cases about advertising for botulinum toxin products on social media to ASA, leading to the drop in the number of cases it handled internally.
The figures exclude cases that never reach MHRA because they are handled by the self-regulatory body set up by the UK pharma industry. MHRA encourages companies to resolve advertising issues through the self-regulatory regime where appropriate. MHRA steps in if the advertiser refuses to accept the jurisdiction of the relevant self-regulatory body.
MHRA Report
Denmark steps up vaccine information campaign as survey exposes knowledge gaps
The Danish Medicines Agency (DKMA) is planning to step up its vaccine information campaign after a survey revealed gaps in understanding of the effects of products used to prevent COVID-19.
DKMA, which ran the survey with the research company Epinion, found the Danish population is generally well-informed about how COVID-19 vaccines prevent disease but underestimates how often mild side effects occur. Almost 40% of people said they would contact their doctor if they developed a fever after getting a COVID-19 vaccine.
Given fever affects up to one-third of COVID-19 vaccine recipients, DKMA calculated 500,000 Danes could contact their doctors over the side effect. Knowledge of the frequency of mild side effects may have improved since the survey took place in April, when relatively few people had been vaccinated.
Even so, DKMA has identified a need to do more to raise awareness about the effects of vaccines and prevent doctors being flooded with calls. DKMA is focusing its information campaign on social media, where its survey found the discussion about vaccines is perceived to be negative and characterized by misinformation.
DKMA Notice, More


© 2022 Regulatory Affairs Professionals Society.

Tags: EU, MHRA

Discover more of what matters to you

No taxonomy