Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
EU Committee Chides Council for Cutting Parliament out of EMA Relocation Decision
A European Union committee has criticized the process used to pick the new home of the European Medicines Agency (EMA). Members of the European Parliament’s public health committee said excluding them from the decision shut representatives of EU citizens out of the process.
Leaders from the 27 countries that will still be in the EU after Brexit decided on the selection process in June. That decision took place “in the margins of the European Council,” the Committee on the Environment, Public Health and Food Safety (ENVI) wrote in its response to legislation on relocating EMA to the Netherlands, and resulted in Parliament taking a back seat.
ENVI is unhappy about that turn of events.
“The Rapporteur regrets that the European Parliament, and ultimately the EU citizen representatives, were not fully involved in the procedure to select the new seat of EMA, which was eventually concluded by a draw, despite it being such an important decision,” ENVI wrote.
The rapporteur behind the document is Giovanni La Via, an Italian politician. Milan narrowly lost out to Amsterdam in the race to host EMA. Both cities received the same number of votes. The tie was settled by drawing names out of a bowl.
That mechanism was criticized by some other Italian politicians, who said it lacked “guarantees or transparency” and questioned whether the search for a new home for EMA should be reopened. The
question was framed as a response to the revelation that EMA will need to move into temporary accommodations while waiting for Amsterdam to finish work on its permanent home.
In theory, Italian politicians could use the need for Parliament to sign off on legislation enacting the relocation to Amsterdam to mount a last-ditch attempt to divert EMA to Milan. In practice, this is unlikely to happen, but La Via has used the legislative process as an opportunity to voice criticisms of how the decision was reached and seek reassurances about the effect of the move on EMA.
ENVI’s draft response to the relocation legislation calls on the European Commission to ensure that the Dutch government swallows the cost of moving EMA into and out of its temporary home. The committee is also pressuring the Commission to take steps to prevent this double transfer from detrimentally affecting EMA’s operations.
, Draft Report
EMA Adds Brexit-Focused Staffers to 2018 Budget as Contractor Costs Soar
EMA has included 20 Brexit contract agents in its budget for 2018. The new line item on the budget contributed to an anticipated 40% jump in the number of contract agents employed by EMA over the past two years and an even more precipitous rise in the salaries of this group of staffers.
The regulator closed out 2016 with 143 contract agents on its books. EMA’s budget for 2017 cleared it to increase the number to 158, but the big jump is set to come this year. The budget provides for the employment of 200 contract agents in 2018. Ten percent of those people are classed as “Brexit CAs,” a group that never previously existed.
EMA is also taking on more contract agents in two of the four pre-existing categories. Notably, the extra staff fall into the higher categories that cover executive, drafting, accountancy, advisory and linguistic tasks. From 2016 to 2018, the number of contract agents employed in the two categories that comprise these tasks will jump by 67% and 57%. Employment of lower-ranked clerical and secretarial contract agents will fall over the same period.
The rise in the overall number of contract agents taken on by EMA and shift in the types of roles they perform are driving up salary costs at the agency. In 2018, EMA expects to spend €10 million ($12 million) on the basic salaries and allowances of contract agents. That is 63% more than EMA spent to employ contract agents in 2016.
EMA’s budget reflects the actions it is taking to handle extra Brexit-focused work and mitigate the potential loss of staff resulting from its move from London to Amsterdam. The agency indicated how costly these actions could be last year when it put out temporary worker contracts worth almost £32 million ($45 million).
The focus on Brexit will necessitate cutbacks in some areas. EMA’s budget for staff training — an area executive director Guido Rasi said has already been hit by Brexit — has fallen year on year. EMA’s budget for attending and holding meetings is also down from 2017.
Cuts in those and other areas have enabled EMA to protect spending on core areas. The amounts set aside for the evaluation of medicinal products and pharmacovigilance procedures are up more than 10% from 2016.
Danish Regulator Posts Guide to What GMP Changes Require Notifications, Inspections
The Danish Medicines Agency (DKMA) has released a guide to when companies need to file notifications or undergo good manufacturing practice (GMP) inspections before making changes to their production sites.
DKMA breaks the guide up into four sections covering buildings, equipment, plants and products. The agency expects companies to notify it of all changes related to plants and products. Companies can make some changes to their buildings and equipment without sending a notification. Examples of such changes include the addition of external storage facilities or an autoclave.
The guide gives a yes or no answer to the question of whether the changes require a notification but the situation for inspections is less clear. DKMA lists four changes that definitely necessitate an inspection, including the addition of new production rooms and GMP laboratories, and seven minor equipment changes that definitely do not require an inspection. The agency will decide whether the other changes require inspections on a case-by-case basis.
DKMA has created the document to guide companies that are planning to make changes but warned them the list has limitations. Some changes companies can make are not included on the list. Others that are on the list may require the marketing authorization to be changed in some circumstances. DKMA cites the opening of a production room in a new location as an example of an action that would necessitate a change to the marketing authorization.
, GMP Guide
is surveying pharma companies to understand how prepared they are for Brexit
. The agency is sending the survey to marketing authorization holders of centrally authorized drugs that run certain operations out of the United Kingdom
. EMA sees the survey as a way to identify companies that need to take concerted actions to ensure the supply of medicines post-Brexit. EMA Notice
’s Medicines and Healthcare products Regulatory Agency
(MHRA) has issued a warning about an ingredient used in the manufacture of in vitro
fertilization media. Some batches of the ingredient contained higher than expected levels of histamine, MHRA said, because of CooperSurgical’s decision to change supplier. MHRA Notice
’s Committee for Medicinal Products for Veterinary Use
(CVMP) has adopted a guideline on the chemistry of active substances. The CVMP guideline is due to come into force on 19 July. Final Guideline
has shared a document with veterinary MAHs to highlight ways to reduce, refine and replace animals used in their activities. EMA Document