Welcome to our European Regulatory Roundup, our weekly overview of the top EU regulatory news.
ENVI Proposes Changes to Regulation on Health Technology Assessment Cooperation
The Committee on the Environment, Public Health and Food Safety (ENVI) has submitted proposed changes to the European Commission’s planned regulation on cooperation between health technology assessment (HTA) bodies.
Members of the Commission are seeking to implement the regulation to clear away three perceived problems with the current model, in which national HTAs work largely independently of each other. The Commission thinks this results in a patchwork of data requirements that impede market access and cause duplication of work. When HTAs do cooperate, it is on a project basis. Starting up and winding down takes time and resources, leading the Commission to deem the model unsustainable.
The Commission has drafted regulations to address these issues by promoting the convergence of the tools and procedures used by HTAs and mandating joint assessments of clinical evidence. This should contribute to a reduction in the amount of HTA and industry work that is unnecessarily duplicated across the region.
ENVI’s feedback on the draft suggests the influential health committee is broadly behind the plan but wants to make a large number of tweaks to the wording. The amendments proposed by ENVI make up an 87-page document that addresses the committee’s concerns with the first draft. ENVI’s changes seek to focus the document more on medical devices and ensure its primary goal is broader than just improving the functioning of the internal market.
The committee also used the amendment process to bring up broader concerns with the risks of the approach taken by the Commission. The proposal would force member states to participate in the HTA cooperation, an action ENVI fears will create tension if the joint assessment process is flawed. ENVI has some tips for how the Commission can avoid such difficulties.
“For the proposal to succeed, it must generate sufficient levels of trust among the parties, in keeping with the overriding interest of patient welfare, and, at all events, improve the member states’ decision-making capacity, the clinical evidence available, the effective use of research resources, predictability and competitiveness for the industry and the quality of innovative research,” ENVI wrote.
Milan Mayor Bemoans ‘Blatant Violation’ of Rules in Parliament Discussion of EMA Move
The mayor of Milan has taken his criticisms of the European Medicines Agency (EMA) relocation process to the European Parliament. Giuseppe Sala told the Committee on Petitions (PETI) the way the agency’s new home was chosen was a “blatant violation of the rules of transparency.”
Objections to the selection process and choice of Amsterdam as EMA’s new home have mounted as details of factors complicating the relocation have emerged in recent months. That led Italy and the city of Milan, which lost out to Amsterdam on a coin toss, to seek the annulment of the decision by the European Court of Justice and the General Court. With a decision on those cases pending, Sala made his argument to PETI.
“Milan believes it has been damaged due to the opacity of the decision-making method and the blatant violation of the rules of transparency that jeopardize the correct functioning of a fundamental agency for the health of European citizens,” Sala said.
Some members of PETI were receptive to Sala’s argument. The committee has itself criticized the process for failing to meet expected standards of democracy and transparency, in part because its members and other European parliamentarians were shut out of the decision. Italian members of PETI and other parliamentary groups have been particularly vocal critics of the decision.
The bigger question is how European courts will receive Italy and Milan’s arguments. Annulling the choice of Amsterdam would derail the already time-pressured relocation, potentially diminishing EMA’s ability to perform its core functions. Sala thinks Milan could step up if required, though.
“Milan confirms not only the offer contained in the dossier presented almost a year ago, but also its willingness and capacity to welcome EMA, ensuring its relocation and operational continuity,” Sala said.
EMA Clarifies Position on GCP and Provider-Qualified Electronic Systems
EMA has clarified what is expected of sponsors who deploy provider-qualified electronic clinical trial systems. The advice gives sponsors the option to leverage vendor qualification documents but notes they must still bear ultimate responsibility for validating clinical trial processes.
With electronic systems playing a central role in many clinical trial processes, sponsors are turning to vendors to meet their needs. Some sponsors install a vendor-designed system at their own sites. Others access a vendor system on a software-as-a-service basis. Either way, the sponsor faces the question of how much to rely on qualification performed by the vendor.
EMA has addressed this question in an update to its advice on good clinical practices. Pointing to an International Conference on Harmonisation document, EMA states sponsors are responsible for their systems. However, EMA is also giving companies scope to rely on the work of vendors.
The agency will allow sponsors to use providers’ work “if the qualification activities performed by the vendor have been assessed as adequate.” Sponsors must do some work to ascertain if their vendor meets this standard. This could entail performing an in-depth audit, knowing the documentation so well it is like the sponsor did the activities itself or performing an installation qualification. Other options are also open to sponsors.
In some cases, the documented risk assessment requested by EMA may reveal the sponsor can only partly rely on the qualification of the vendor. Sponsors that face this situation must perform additional qualification activities to address the gaps.
EMA’s statement also points to the specific requirements for electronic systems involved in the handling of clinical trial data or maintenance of control over study processes. Inspectors view documents related to the validation and qualification of these systems and processes as essential and will likely ask to see them when visiting sites. Sponsors cannot outsource responsibility for the documents.
“This is irrespective of whether or not the sponsor has contracted out activities related to electronic systems and whether the sponsor choses to consider as an audit the above mentioned assessment of vendor systems/processes/documentation,” EMA wrote.
Going Against EMA, Denmark Opts to Keep Modified-Release Paracetamol on the Market
The Danish Medicines Agency (DKMA) has decided to keep modified-release paracetamol products on the market. DKMA told the industry the products would be withdrawn in line with an EMA ruling, only to change its position after hearing from manufacturers and reviewing the overdose treatment guide.
EMA’s Pharmacovigilance Risk Assessment Committee (PRAC) recommended the withdrawal of the products last year after concluding they complicated the treatment of overdoses. Doctors may not know what paracetamol formulation a person overdosed on, making it impossible for them to know when to administer the antidote.
PRAC concluded there is no feasible way to ensure patients across Europe receive the appropriate treatment for overdoses, prompting it to recommend the withdrawal. DKMA thinks the products can be used safely in Denmark, though.
has recommended placing restrictions on the use of uterine fibroid drug Esmya
to mitigate the risk of liver injury. The committee wants to stop the use of the drug in people with liver problems and mandate regular liver tests. PRAC Statement