Posted 20 July 2017
By Nick Paul Taylor
Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe.
EU Watchdog Probes Whether Pre-Submission Meetings Enable Industry to Influence EMA
The European Medicines Agency's (EMA) relationships with the companies it regulates are under investigation. European Ombudsman Emily O'Reilly began the probe after becoming concerned EMA's pre-submission meetings with sponsors could influence its decisions about their marketing authorizations.
O'Reilly wrote to EMA Executive Director Guido Rasi to open the strategic investigation and start the process of gathering evidence. The letter sets out why O'Reilly thinks the probe is warranted and raises a list of questions she expects EMA to address at a meeting penciled in for September.
EMA is under investigation because of the perception marketing authorization applicants may use pre-submission meetings to influence regulatory decisions. To O'Reilly, this perception of bias is important even if the checks and balances in place at EMA ensure its decisions are objective. EMA must do more than be objective. It must be seen to be objective by the public. This thinking is in line with the Ombudsman's long-running focus on fostering trust between citizens and European Union institutions.
Currently, O'Reilly thinks the risk of perceived bias is real. O'Reilly bases this position, in part, on a press release about a marketing authorization submission from an unnamed company. The drug developer used the release to talk up its interactions with EMA, reportedly stating that it had received indications of support for the application from the rapporteurs. O'Reilly thinks the public could see this as evidence of bias and wants EMA to do more to allay such perceptions.
The investigation could pressure EMA to be more transparent. O'Reilly described transparency as one way to prevent the perception of bias. The Ombudsman thinks EMA is currently falling short in this regard. "A preliminary assessment suggests that more could be done in this area," O'Reilly wrote.
The list of questions O'Reilly expects EMA to discuss include two about transparency. O'Reilly wants to know whether EMA is willing to make basic information about pre-submission activities available publicly. This could include information "categorized in aggregate format about the type of pre-submission activity or the type of medicine developer." O'Reilly also wants to get EMA's take on the merits of publishing detailed minutes of pre-submission meetings.
Other questions raised by O'Reilly dig into the checks and balances already in place at EMA. O'Reilly asked Rasi for information about the rules governing contact between his staff and drug developers, whether the agency allows the people who make marketing authorization decisions to participate in pre-submission meetings and if it tries to avoid pre-evaluating data before receiving filings.
The investigation is the fourth into EMA O'Reilly has instigated since taking office in 2013. O'Reilly is still working toward a decision in a case involving an alleged lack of transparency for a referral procedure for a pharmaceutical product. Decisions in two other cases involving access to AbbVie drug studies and the sharing of public consultation documents were reached last year.
EMA Establishes Principles for Involving Young Patients in Regulatory Activities
EMA has laid the groundwork for greater involvement of patients aged 18 years and younger in its scientific committees and working parties by publishing principles for engagement. The principles define how young patients can contribute and how to best gather their views.
Officials plan to consider whether to involve young people in EMA activities on a case-by-case basis. Examples of situations in which EMA would engage with young patients include discussions about the designs of pediatric clinical trials, acceptability of a route of administration and dosing regimen and pre- and post-authorization assessments.
If EMA thinks the views of young people could enhance scientific discussions about the testing and evaluation of medicines relevant to them, the agency will consult with the demographic.
EMA wants these consultations to take into account the age range of the patients consulted. This will affect the format of the consultation. EMA plans to gather the views of some patients in writing. This will entail giving patients questions, background information and a deadline to reply by. In other cases, EMA will hold a meeting via teleconference or in person. EMA will structure face-to-face meetings so young people only have to attend part of the event.
Regardless of the format of the consultation, EMA wants staff involved in interviewing young patients to be "sufficiently prepared in order to respect the sensitive nature of the interaction."
Publication of the principles comes one year after EMA made engagement with young people a top priority in its annual report on its links to patients, consumers and healthcare professionals. EMA's prioritization of involving young people in regulatory processes followed the creation of a Patients' and Consumers' Working Party (PCWP) group in 2015. All three actions are intended to ensure regulatory decisions take the views of young patients into account.
Press Release, EMA Principles
Swissmedic Stops one-off Updating of Manufacturer Information
The Swiss Agency for Therapeutic Products (Swissmedic) is stopping the one-off updating of manufacturer information. Swissmedic took the decision after analyzing how to implement electronic standards for the identification of medicinal products (IDMP).
Officials began assessing their options for implementing IDMP in the second half of last year. The electronic standards reviewed by Swissmedic codify parameters related to drug products, such as identifiers of the manufacturer, ingredients and indications. Following the review, Swissmedic plans to introduces these standards, starting with those covering the electronic recording of information about manufacturers and other technical data.
The review and subsequent decision led Swissmedic to end one-off updates of manufacturer information.
Instead, Swissmedic will gather and update manufacturer information when it receives filings for marketing approvals, variations and other regulatory processes. Then, when the IDMP standards come into force in 2020, Swissmedic will codify and update all manufacturer information in a one-off process.
Swissmedic expects companies to have all information required by the manufacturer information and responsible person forms available at all times. The agency is taking a risk-based approach to requests for additional manufacturer information forms.
PRAC Starts Recruiting Independent Experts to Drug Safety Review Committee
EMA's Pharmacovigilance Risk Assessment Committee (PRAC) is recruiting independent experts. The committee is looking for pharmacovigilance specialists to replace its current independent members when their terms end this time next year.
Independent experts attend PRAC meetings once a month to support its work assessing and managing the risks posed by drugs sold in the EU. PRAC expects its independent experts to prepare for its meetings and actively participate in its scientific discussions. The experts will serve three-year terms that start in July 2018 and can be prolonged and renewed.
PRAC has six scientific experts appointed by the European Commission, but some of the places may be retaken by incumbents in July 2018. The committee allows current independent experts to reapply for their positions.
The six experts will join members appointed by each member state and representatives of patients and healthcare professionals on the committee. PRAC looks to the independent experts to add to the expertise provided by its other members.
ACE Pharmaceuticals has withdrawn its application for approval of nephrotic syndrome treatment Elmisol. The Dutch drugmaker took the action after the Committee for Medicinal Products for Human Use raised concerns with the way the study was performed and whether it complied with good clinical practices. EMA Notice