European Regulatory Roundup: The EU's Tough Road to New Device Regulations (7 May 2015)

Regulatory NewsRegulatory News | 07 May 2015 |  By 

Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.

EU Council Calls Medical Device Revision Negotiations ‘Particularly Difficult’

The Council of the European Union has called negotiations over revisions to medical device regulations “particularly difficult” in a response to a request to see documents. Axon Lawyers founding partner Erik Vollebregt made the request but was rejected by the council.

As Vollebregt writes on his blog, the rejection reveals a lot about the current state of the medical device regulation revision process. The council justified the rejection by explaining that discussions relating to the requested documents are “particularly difficult” and their release “would severely impair the Presidency’s ability to work towards compromises.” The statements give credence to reports that negotiators are struggling to establish a consensus on some topics.

The council’s refusal to release documents mean it is unclear which topics are proving to be the most problematic, but a presentation made by the United Kingdom’s Medicines and Healthcare Products Regulatory Agency (MHRA) in April gave some clues. Vollebregt reports questions remain about whether ingested products should be classed automatically as very high risk, how to define companion diagnostics and who has responsibility for regulating genetic testing.   


EMA Reports Drop in EudraVigilance Drug-Adverse Event Pairs

The number of links between drugs and adverse events identified by the European Medicines Agency (EMA) using its EudraVigilance system fell by 17% last year. EMA attributed the drop to its increased familiarity with EudraVigilance and technical improvements to the system.

EudraVigilance has become the cornerstone of EMA’s adverse event monitoring strategy in recent years. In 2014 it accounted for almost 87% of potential adverse event signals identified by EMA — down from 91% the year before — but it was less prolific than usual. The 2,030 signals identified in EudraVigilance last year is the second smallest total in its five-year history. EMA is unconcerned about the dip, though.

“[The decline] most likely reflects the experience with [EudraVigilance] monitoring, as well as improvements to the screening of the electronic reaction monitoring reports, notably the inclusion of hyperlinks to line listings in the EudraVigilance Data Analysis System,” EMA wrote in its annual EudraVigilance report to European politicians. A similar number of signals were validated by EMA and sent to its Pharmacovigilance Risk Assessment Committee (PRAC) in 2013 and 2014.

EMA’s Pharmacovigilance Inspectors Working Group (PhV IWG) also provided an update on its activities this week. The group is working on a handful of documents, including a checklist of key questions to guide pharmacovigilance inspections of manufacturers of pandemic flu vaccines. EMA posted an update to two of its existing documents this week, too, giving the industry more detail about what happens when concerns are raised during the evaluation of pharmacovigilance data.

If the concerns are serious enough to consider suspending or revoking a marketing authorization, an urgent union procedure is initiated. EMA has updated a question and answer document about this process with details of what companies can expect and how they can contribute to the review. The regulator also updated its Q&A covering Article 31 referrals, which are initiated when the concerns raised during an evaluation of pharmacovigilance data are less severe. 

EudraVigilance Report, PhV IWG Work Plan, Urgent Union Procedure Q&A, Article 31 Q&A

EMA Plans Changes to Adverse Event Data Gathering in Oncology Trials

EMA has published a draft concept paper on the need to revise guidelines covering human trials of anticancer products. The proposed changes are intended to rework the reporting of adverse events to deliver a clearer picture of the toxicity and tolerability of oncology treatments.

Concerns about the current guidelines center on the difficulty in comparing adverse event rates between trials of different lengths and the lack of data showing how the incidence and severity of side effects changes over time. EMA wants to address these limitations by incorporating new ways to report adverse events into an updated version of its “Guideline on the evaluation of anticancer medicinal products in man.”

How EMA will achieve its goals is still being discussed. The concept paper proposes tracking the incidence and prevalence of side effects over a period of time or running time-adjusted analyses of adverse events. Such a detailed approach is likely to be limited to adverse events that lead to a dose reduction or otherwise affect the tolerability of the treatment. EMA is also interested in having data on whether dose reductions actually stop the adverse event from occurring.

The concept paper is open for comment until the end of July. EMA is aiming to have revised draft guidelines ready within six months of the adoption of the concept paper.

EMA Concept Paper

PMLiVE: GSK’s Witty met with UK Government at Height of PPRS Negotiations 

GlaxoSmithKline CEO Andrew Witty met with the United Kingdom health secretary and other government officials to discuss the Pharmaceutical Price Regulation Scheme (PPRS) six months before the current version was finalized, according to documents seen by PMLiVE.

The heavily redacted documents obtained by PMLiVE under a freedom of information request show Witty met with Jeremy Hunt in May 2013, at which time value-based pricing (VBP) was still being considered by the government. Emails and letters seen by the publication reportedly suggest Witty wanted to present an alternative PPRS arrangement to the government. Redactions to the minutes of the meeting mean it is impossible to ascertain exactly what was said by Witty.

A few lines escaped the censor’s pen, in which Hunt agreed to assess whether “generic comparators would strengthen innovation” and if the definition of value was sufficiently broad in certain disease areas. Contentious plans for VBP were largely absent in the final version of the PPRS. PMLiVE also discovered Roche Diagnostics asked Health Minister Lord Howe to visit its offices but was rebuffed. Howe cited “diary pressures” in his response.  


EMA Puts 14-day Deadline on Defendants in Breach of Trust Cases

EMA has revised its procedure for handling breach of trust cases as part of a wide-reaching rethink of its policy on declarations of interests by members of its scientific committees. Anyone found to have failed to declare information now has 14 calendar days to clarify and correct the situation.

The 14-day timeframe is a new addition to a document EMA originally published in 2012, in which the regulator did not define a limit on how long defendants have to respond to the allegations. EMA’s decision to cap the length of time people have to respond is one of the few notable changes to the document, which has been slightly reworked in several areas but retains the core procedures and punishments laid out in the 2012 version.

EMA made more significant changes to its policy on committee members taking jobs in the pharma industry and its guide to completing a declaration of interest form. Collectively, the changes are intended to counter criticisms of EMA’s approach to conflicts of interest and the employment of its former staffers by pharma companies.

EMA Procedure, Regulatory Focus, Press Release

Other News:

EMA’s Committee on Herbal Medicinal Products (HMPC) has published the agenda for the meeting that took place this week. HMPC discussed a number of herbal monographs and planned revisions to quality guidelines. The committee is looking to revise its “Guideline on quality of herbal medicinal products/traditional herbal medicinal products.” HMPC Meeting Agenda


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