Welcome to our new website! If this is the first time you are logging in on the new site, you will need to reset your password. Please contact us at email@example.com if you need assistance.
Your membership opens the door to free learning resources on demand. Check out the Member Knowledge Center for free webcasts, publications and online courses.
This comprehensive resource covers product change evaluation, postmarket surveillance, audit/inspection compliance, and various other laws and regulations pertaining to maintaining a product on the market.
Hear from leaders around the globe as they share insights about their experiences and lessons learned throughout their certification journey.
Regulatory News | 07 September 2017 | By Nick Paul Taylor
Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
A health committee has criticized plans to cut staffing levels at the European Medicines Agency (EMA) next year. The Committee on the Environment, Public Health and Food Safety (ENVI) said it “strongly disapproves” of the European Union’s proposal to reduce the number of EMA positions authorized by the budget.
ENVI said the cuts “will almost inevitably negatively impact” EMA’s work as it is dealing with a growing workload while preparing for the major upheaval of relocating to a new city. Given the potentially tricky transition facing EMA, ENVI wants the European Commission to “make available additional staff and budget resources in 2018” and as such is disappointed the agency’s headcount is going in the opposite direction.
That response was prompted by a relatively small change in the number of authorized posts. The 2017 budget authorized EMA to have 596 temporary posts, although as of the end of last year it had only filled 587 of the positions. The 2018 budget cuts the number of temporary posts by five, to 591.
The headline drop in the number of posts hides changes that suggest while staff numbers may fall, the resources available to EMA may improve. The budget states how many administrators and assistants EMA can hire and at what level of seniority. EMA can employ more senior administrators — and the same number overall — as last year. Administrators are graduates who draft policies and implement EU laws.
The cuts focus on near-entry-level assistant posts. Overall, EMA is authorized to employ five fewer assistants, a group of workers who perform technical tasks. This drop stems from a reduction in the number of grade 2 assistant posts, the second rung on an 11-rung ladder. EMA is cleared to employ seven grade 2 assistants, down from 23 last year. The agency can employ more people at higher grades. For example, the budget authorizes a 16% increase in grade 7 positions.
These mitigating factors failed to spare the budget from ENVI’s criticism. The committee’s opinion returned to some of the topics it raised in a statement to the Committee on Budgetary Control in February. That statement was triggered by a review of EMA’s budget for 2015, but ENVI used it as a chance to look forward to what the agency will need to ease the Brexit transition.
In both documents, ENVI takes EU budget holders to task for cutting staffing levels without taking the rising number of applications or income these generate into account. ENVI argues this may “have meant a reduction in staff working on tasks that are actually funded by applicants' fees” and represents a missed opportunity to grow EMA’s headcount without increasing the amount of money it receives from the EU.
ENVI also used its statement on the 2018 budget to reiterate its belief EMA needs a budgetary reserve to ensure it can cope with Brexit-related volatility, such as unfavorable changes to exchange rates.
ENVI Opinion, Proposed Budget
The Spanish drug regulator has started a hiring drive to strengthen its capabilities ahead of Brexit. Officials plan to take on 40 more staff in the coming months in response to the upheaval likely to be created by the United Kingdom leaving the EU.
Spain’s Agency of Medicinal Products and Medical Devices (AEMPS) is hoping to hire 30 people to work at its human drug unit. The veterinary medicine unit will take on six additional workers, with the remaining four new posts boosting headcount at the inspection team. AEMPS plans to employ the staff under a temporary scheme that permits contracts of up to three years.
The same AEMPS unit has made three hiring proposals since June, but the latest plan differs from these initiatives in some notable ways. One is its scale. The three earlier recruitment drives sought to take on 12 people between them. Another difference is the motivation for adding the staff. The latest recruitment effort is the first to cite Brexit as the motivation for taking on the extra staff.
News of the hiring comes about two months after EMA said it would survey member states to see where gaps in their collective capabilities exist and gauge which member states will invest to fill them. AEMPS’ hiring of additional staff will help EMA adjust to the expected loss of assistance from U.K. regulators and potentially bolster Spain’s bid to host the agency after Brexit.
The list of what AEMPS is looking for in candidates reflects the outward-looking nature of the posts. While the job title and pay grade are the same as for an earlier AEMPS’ hiring program, the points scheme used to assess candidates is different. Notably, AEMPS is placing far more importance on candidates’ English-language abilities than it did when taking on people earlier in the year.
Recruitment Posting (Spanish), Reuters
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) has recommended the removal of modified-release paracetamol from the market. PRAC made the recommendation on the basis that it is difficult to treat patients who overdose on modified-release formulations.
Procedures designed to manage overdoses on immediate-release paracetamol are inappropriate for the management of patients who have taken too much of a modified-release formulation. The timing of antidote administration differs between the formulations. Applying immediate-release timings to modified-release overdoses can lead to severe liver damage and death.
This would be a manageable problem if doctors always knew which paracetamol formulation a patient had taken. However, this is not the case. This led PRAC to conclude there is no feasible and standardized way to adapt paracetamol overdose procedures across the EU to ensure patients always receive the most appropriate care.
The committee concluded the risks posed by inappropriate overdose management procedures outweigh the benefits of the longer-acting formulation, despite it having an acceptable profile when used as intended.
PRAC made the recommendation at a meeting at which it also confirmed the lack of consistent evidence showing one class of factor VIII medicines is more prone to inhibitor development than the other. The committee reached that conclusion previously but reassessed its position at the request of a marketing authorization holder.
EMA is surveying patients and healthcare professionals to gauge their awareness of processes for reporting adverse events. The survey will also look at the attitudes and reporting behaviors of both groups.
Officials are looking to the survey to generate information about how likely people are to report adverse events and whether they are more or less likely to report those that cause a death or are a known side effect. The survey also assessed differences in attitudes to reporting adverse events tied to vaccines, biologics and new medicines.
Another section covers awareness of the black-triangle scheme that indicates a drug is subject to additional monitoring. EMA singled out its interest in learning more about awareness of the scheme in a statement to disclose the start of the survey.
The survey is open until 9 October. EMA plans to publish its findings next year.
Tags: European Regulatory Roundup, Brexit, EMA staff cuts