Welcome to our EU Regulatory Roundup, our weekly overview of the top regulatory news in Europe.
Parliament Think Tank Finds Flaws With Commission’s HTA Agenda
The think tank of the European Parliament has found fault with preparations to increase cooperation among health technology assessment (HTA) bodies. The group found an impact assessment from the European Commission failed to present a convincing range of options for how to address the issues created by today’s fragmented HTA landscape.
In January, the Commission laid the groundwork for planned changes to legislation covering HTAs by publishing an impact assessment document that discussed three current problems and four possible remedies. As with all policies with significant implications, a unit within the European Parliamentary Research Service (EPRS) assessed the document to help parliamentarians prepare responses to the Commission’s proposals.
EPRS’ assessment highlighted shortcomings in the potential remedies presented by the Commission. One of the options was to retain the status quo. Taking any of other three options would result in changes but, as EPRS sees it, the ideas outlined by the Commission are weak or underdeveloped.
“The [impact assessment] does not appear to have succeeded in presenting a convincing range of options. One of the three options retained appears rather artificial, and its real added value is not clear, while another would have benefited from clarification of the envisaged joint output as well its differences with respect to the baseline,” EPRS wrote
EPRS was most dismissive of the idea of voluntary, project-based cooperation, which it deemed to be a slight upgrade to the existing system that offers little added value. The think tank also highlighted similarities between the other two options and the impact assessment’s failure to explain the value of distinguishing between them. EPRS sees one of these options as “rather artificial.”
Seen from EPRS’ perspective, the impact assessment does not compare three viable, distinct options, as it initially appears. Rather, it compares variations of one new proposal and the status quo.
That narrowness of thinking is one perceived problem with the impact assessment. Another is the quality of the discussion of the Commission’s preferred option. This option envisions joint relative effectiveness assessments and other forms of permanent cooperation between HTAs. EPRS’ report makes little comment about the merits of the proposal, but takes the Commission to task for a lack of clarity, noting that the impact assessment leaves many questions unanswered.
The Commission adopted the legislative proposal earlier this year. The European Parliament and Council are now reviewing the proposal with a view to agreeing on and adopting changes next year.
EMA Prepares to Shut UK out of EudraVigilance After Brexit
The European Medicines Agency (EMA) is preparing to shut the United Kingdom out of drug safety system EudraVigilance. EMA will spend the rest of the year assessing the impact of Brexit on the IT system in anticipation of the UK’s withdrawal from the European Union in March.
The agency detailed the Brexit-related tasks in its EudraVigilance operational plan for 2018 to 2020. As with all of EMA’s preparations, the plan operates from the assumption that the UK will become a third country and withdraw from the EU without a Norway-style agreement next year. That outcome would preclude the UK from participating in EMA systems, including EudraVigilance.
“As of 30 March 2019 the UK will no longer participate in the work of the agency. This means that access to a number of systems and applications supporting the approval and safety monitoring of medicines across the EU would have to be closed to the UK as of that date,” EMA wrote. “The agency is currently working on a plan that identifies possible changes and proposes consistent solutions across all concerned IT systems.”
EMA expects to spend the rest of 2018 making the preparations. The agency is currently analyzing the changes Brexit may force on EudraVigilance. Later this year, EMA will consider the resources that will be needed to implement the changes and, beyond that, enter a change management phase.
The activities form part of a far broader operational strategy laid out by EMA. The strategy detaIls the activities that will occupy EMA’s EudraVigilance in every quarter from now until the end of 2020. By setting out its planned technical and operational activities, EMA aims to prepare its teams for the tasks and ensure member states, marketing authorization holders (MAHs) and other stakeholders are ready.
Ireland’s HPRA Seeks Feedback on Framework to Handle Drug Shortages
The Health Products Regulatory Authority (HPRA) of Ireland has put a draft framework on handling drug shortages out for consultation. HPRA thinks the document can prevent and mitigate shortages by facilitating more effective, coordinated responses.
Irish officials want all stakeholders, not just MAHs, to report any supply delays that look likely to stem from a shortage. MAHs are the only group that can send HPRA notifications about shortages, though. HPRA expects MAHs to alert it to medium- and high-impact shortages immediately, and to low-impact shortages at least one month before they occur. The agency has created a process that MAHs can use to gauge the likely impact based on the effect on patients and availability of therapeutic alternatives.
HPRA will publish details of medium- and high-impact shortages on its website. As HPRA thinks pharmacists can resolve many low-impact shortages, it will not routinely publish these events. HPRA will update its website once a shortage is resolved.
Most of the current version of the document focuses on these topics and others related to the quick communication of details of current or impending shortages. However, HPRA is also interested in strategies to prevent shortages. The current text features a brief section on how factors such as corporate quality culture and the preemptive identification of supply risks can prevent shortages. HPRA plans to expand this section as part of the iterative development of the document.
The current version of the document is open for comment until 26 June.
EMA Starts Work on Revising Antibacterial Clinical Development Guidelines
EMA is set to revise its guideline on the clinical evaluation of antibacterial therapies. The agency got the process underway with the publication of a draft concept paper that proposes the merger and revision of two existing documents.
EMA established its position on evaluating treatments for bacterial infections in 2012 but, in a rush to get the document out, it left out details regarding data requirements. The agency addressed these data issues in an addendum that came into force in 2014. Now, EMA plans to merge the documents while making changes to bring them into line with its current thinking.
The updates will clarify EMA’s preferred options for clinical programs of drugs expected to address unmet needs. EMA is also using the revision process to adapt the text to the outcome of its meetings with American and Japanese regulators on the alignment of requirements. These changes are expected to affect matters including primary analysis populations and non-inferiority margins.
EMA is accepting feedback on the draft concept paper until 13 September, and aims to have a first draft of the revised guideline ready for review in the fourth quarter.
has started accepting orphan designation applications through its new online portal. The agency has released a guide to registering on the portal to support the introduction of the process. EMA Notice