Regulatory Focus™ > News Articles > 2019 > 11 > EU Regulatory Roundup: Health Group Raises Concerns About Delays to Clinical Trial Portal and Databa

Posted 14 November 2019 | By Nick Paul Taylor 

EU Regulatory Roundup: Health Group Raises Concerns About Delays to Clinical Trial Portal and Database

3003 Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EU Health Group Raises Concerns About Delays to Clinical Trial Portal and Database
The European Parliament’s public health committee has raised concerns about the delayed rollout of a clinical trial portal and database. Committee members made the comments shortly after the European Medicines Agency (EMA) provided an update on the repeatedly delayed system.
Writing in response to EMA’s 2018 accounts, the Committee on the Environment, Public Health and Food Safety (ENVI) said it “is concerned about the delays observed in the development of the EU clinical trials portal and database.” ENVI made the comment alongside other statements about EMA’s budget and the stresses placed on it by Brexit and the move to Amsterdam, the Netherlands.
The statement came shortly after a meeting of the EMA management board that reviewed recent progress on the portal and database, now known as the Clinical Trials Information System (CTIS). The system was originally due to be ready for audit in July 2017 but has been subject to repeated delays.
In June, EMA said work had now advanced to the point that it was gearing up for an audit. Since then, the product owners have validated the first release, confirming the delivery of the 79 required items. EMA said the release enhanced functions related to clinical trial submission and assessment, as well as other areas including user management. EMA is yet to set a date for an audit, though.
“The product owners will begin to carry out an operational assessment of the system to identify critical business blockers, in order to enable EMA's management board to consider the timing of the audit of the system,” the agency wrote in an update.
ENVI Opinion, EMA Update
French Pharma Body Hits Back Against ‘Vilification’ of Industry-Physician Links
French pharma trade group Leem has hit back against a study that identified a correlation between the prescribing practices of physicians and the receipt of gifts from companies.
The study, which was published in The BMJ, found physicians who received no benefits from pharma or medical device companies were more likely to prescribe generic antibiotics, antihypertensives and statins than their counterparts who received at least one gift. The authors of the observational study noted no causal link between the gifts and prescribing habits can be drawn from the results.
Despite offering that caveat, the study, which was widely reported on by French news outlets and discussed on social media, prompted a strong, immediate reaction from the French pharma industry.
“Leem strongly deplores this new vilification of an industry whose primary vocation is to provide patients with ever safer and more effective therapeutic solutions,” the trade group wrote. “Legislation and regulation have been considerably tightened over the past 10 years. Pharmaceutical companies have always and consistently supported this move to greater transparency; a fact that should restore confidence rather than fuel suspicion.”
The study was made possible by the passage of legislation to increase transparency, specifically the adoption of a French equivalent of the United States Sunshine Act in 2011. That legislation required drug and medical device companies to declare financial ties to healthcare professionals and bodies.  The resulting database became accessible to the public last year.
Advocates of a new strategy for managing potential conflicts of interest used the study results to support calls for a system-wide approach. 
“The influence of organizational or individual conflicts on clinical practice demands a system-wide strategy to manage and mitigate such conflicts. Our current understanding of the effects of conflicts of interest is impeded by ineffective strategies to search for, report, and record them,” academics at the University of Oxford wrote in a BMJ editorial.
Leem Statement, BMJ, Editorial
UK Biotech Industry Pushes for EU Regulatory Alignment Ahead of General Election
The UK BioIndustry Association (BIA) has put regulatory alignment with the European Union at the heart of its wishlist to politicians competing to lead the United Kingdom after the upcoming election.
With the UK set to go to the polls on 12 December, BIA has set out what it wants no matter who wins the election to do to support the biotech industry in the next parliament. BIA’s wishlist features three requests, one of which addresses the Medicines and Healthcare products Regulatory Agency (MHRA) and the UK’s relationship with the EU after Brexit.
“The government should seek the closest possible alignment between UK and EU on medicines and medical devices regulations, while assisting the MHRA to develop existing national flexibilities to modernise clinical trials to enable rapid access to innovative new treatments for patients in the UK,” BIA wrote in its manifesto.
BIA went on to call for the new government to maintain the UK’s participation in EU pharmaceutical regulatory regimes, bodies and networks. The trade group thinks such ongoing links to the EU will help ensure the UK is a “key global launch location” and prevent duplicative red tape.
The political parties are yet to publish their manifestos but have touched on issues relevant to BIA’s concerns in the run up to the long-anticipated election. The Conservative Party, which has been in power throughout the Brexit process, has expressed some desire to diverge from EU regulations and flirted with the prospect of a hard split. The Labour Party, which is behind in the polls, wants to keep the UK closer to the EU and hold a second referendum on whether Brexit should happen at all.
However, Labour has caused alarm in the UK biopharma industry by proposing to use compulsory licenses on drugs perceived to be too expensive. The compulsory license proposal is part of a wider package of ideas that could see the state take a more active role in drug research and production.
BIA Manifesto
Finland Moves to Electronic Clinical Trial Submissions to Mitigate Postal Strike
The Finnish Medicines Agency (Fimea) is allowing companies to send clinical trial materials via email to mitigate the impact of a postal strike in the country.
Fimea is in the process of moving to electronic submissions of clinical trial materials, with the agency due to accept annual drug safety update reports (DSUR) via the Common European Submission Portal (CESP) from next week onward. However, Fimea has pulled forward and temporarily expanded its acceptance of electronic submissions in response to a strike by the Finnish postal service.
During the postal strike, Fimea will accept materials via email. Sponsors that take advantage of this temporary option will need to resend the materials, plus a cover letter referencing the earlier electronic submission, in the post once the strike ends. Fimea has also pulled forward the date on which sponsors can start using CESP to file DSUR by one week.
It is unclear how long Fimea will need to keep the temporary measures in place. Finnish postal workers initially planned to strike for two weeks starting 11 November. However, the union has now threatened to extend the industrial action by a further two weeks if negotiators are unable to agree on a new collective bargaining settlement.
Fimea Notice
Other News:
EMA has published a response to questions about the safety of the animal medicine Bravecto. In the responses, EMA committed to work to “improve the communication of information on relevant changes to product information to prescribers and end users.” EMA Responses


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