Euro Roundup: EU Parliament and Council reach provisional agreement to strengthen EMA

The European Parliament and Council have reached a provisional agreement on changes intended to improve the management of future health crises and shortages of drugs and medical devices.
 
One year ago, the European Commission adopted a legislative proposal designed to strengthen the region’s health security framework and reinforce the role of key agencies. The European Medicines Agency (EMA) was a focal point of the proposals, with the Commission setting out plans to enable the regulator to coordinate a region-wide response to future crises, for example by monitoring the risk of shortages of critical health products and coordinating clinical trials.
 
Having decided their own positions over the summer, the Parliament and Council have now reached a provisional agreement on a shared platform. The Parliament and Council still need to endorse the content of the agreement, but reaching the provisional stage marks a big step forward for a policy that will affect EMA and the companies it regulates during crises and beyond.
 
“With this agreement, Parliament makes both the Agency and all actors in the supply chain more transparent, involving them more in the process and fostering synergies between EU agencies. Moreover, we pave the way to promoting clinical trials for the development of vaccines and treatments, boosting transparency on those issues,” Nicolás González Casares, rapporteur for the Parliament’s health committee said.
 
Casares said the provisional agreement features a new European Shortages Monitoring Platform. In responding to the Commission’s original proposal, the Parliament passed an amendment to require the creation of an interoperable digital platform to monitor and report on medicines shortages. The amendment described the development of a European medicines supply database and proposed giving member states 30 months to develop platforms to monitor supply in real time.
 
Press Release
 
European Commission tells Grail to prepare to undo $8B Illumina merger
 
The European Commission has told Grail to “actively work on alternative options” in case it requires Illumina to undo the $8 billion takeover, escalating a case that is emerging as a major test of EU competition powers.
 
Earlier this year, Illumina closed its long-pending takeover of liquid biopsy company Grail, despite the Commission still having an active investigation into the merger. Closing the deal exposed Illumina to potential risks including significant fines and a demand to undo the merger. However, Illumina has argued the EU lacks jurisdiction and is preparing for a long legal scrap if the Commission opposes the deal in the coming months.
 
The Commission unveiled the latest phase of its response to the closing of the deal last week, putting in place interim measures intended to “restore and maintain the conditions of effective competition” in the EU. As foreseen by Illumina, the Commission has required the sequencing giant to keep Grail separate, but the requirements are intended to go beyond the voluntary measures already in place.
 
The Commission has told Grail to “actively work on alternative options to the transaction to prepare for the possible scenario in which the deal would have to be undone in case the Commission were to declare the transaction incompatible with the internal market.” Illumina will fight a demand to undo the deal in the courts, potentially for years, but has already discussed options for Grail in the event its attempt to resist the Commission is unsuccessful.
 
Other measures adopted by the Commission include a ban on the sharing of confidential information between the two companies outside certain situations and an obligation for Illumina to “finance additional funds necessary for the operation and development of Grail.” The Commission also wants Illumina to have an arm’s length relationship with Grail and not “unduly” favor it “to the detriment of its competitors.”
 
Press Release
 
Swissmedic adds e-signature and data export advice to decentralized trial guide
 
The Swiss Agency for Therapeutic Products (Swissmedic) has updated its recently adopted guidance on decentralized clinical trials with advice on the use of e-signatures and the export of health data.
 
Swissmedic’s original guidance, which it published in September, said handwritten signatures are still needed to declare consent to participate in clinical trials, even though e-signatures are considered as equivalent under Swiss law. The agency has deleted the section on the need for wet-ink signatures and added the statement that e-signatures do not yet appear to be a “practicable solution.”
 
The barrier to the use of the technology relates to the “effort every single trial participant would have to undertake to be able to deliver such a qualified electronic signature.” Until an e-ID is set up in Switzerland, Swissmedic expects handwritten signatures to be “regularly required.”
 
Swissmedic has also added a paragraph on the export of health-related data to foreign countries. The paragraph explains that Swiss law allows the export of non-genetic data without a written informed consent, provided certain conditions are met, and details the implications of the regulations for clinical trial sponsors. 
 
Swissmedic Notice
 
MDCG calls for member states to discuss how to boost IVDR notified body capacity
 
The Medical Device Coordination Group (MDCG) has updated the joint implementation plan for the In Vitro Diagnostic Regulation (IVDR). Changes to a version released in June include the addition of a call for member states to discuss increasing notified body capacity.
 
Since June, warnings from industry about the lack of notified bodies have prompted the Commission to propose new timings for the implementation of IVDR. The new joint plan references the results of surveys that show “a very significant gap” between supply and demand and notes the need to “identify and concretely address root causes.” MDCG updated its priority actions to cover the need.
 
The updated plan also adds development of guidance on “significant changes” to the list of priority actions. MDCG added the action after identifying a need for clarification of the changes that are seen as significant amendments in design or intended purpose under IVDR.
 
Implementation Plan
 
Pharma industry accepts ‘significant’ change to clinical trial fees in Ireland
 
A human medicine trade group has accepted “a significant change” in clinical trial fees on the basis that there will be no further increases “for some years.” However, the Health Products Regulatory Authority (HPRA) has warned it will review fees annually and they could go up.
 
With the Clinical Trial Regulation taking effect early next year, HPRA sought feedback on its proposed fees for the new framework in September. HPRA summarized the feedback and responded to it in a document published this week. The document reveals a potential point of friction, with industry and HPRA having different views on what will happen to fees in the coming years.
 
“In relation to the proposal that the fees be fixed for the coming years, this does not reflect the HPRA commitment and process of reviewing fees annually. The fees represent our best estimate of the work involved. Once the regulation is experienced in practice, we will review the fees to see if they are fit for purpose and as result of that, review fees may go up or down,” HPRA wrote.
 
HPRA Report
 
Other News:
 
EMA has started a pilot project to support the repurposing of authorized medicines by not-for-profit organizations and academia. The initiative is designed to help generate evidence to support the use of medicines in new indications. EMA Notice