Euro Roundup: Trade groups criticize joint HTA plan

The trade groups EFPIA and MedTech Europe have issued statements criticizing a European Council proposal on joint health technology assessments (HTA), noting that the proposal could lead to greater inefficiency.
 
The proposed regulation aims to support cooperation between national authorities on the clinical assessment of health technologies. HTAs currently are handled independently by national bodies, with limited voluntary cooperation, causing health technology developers to be “confronted with multiple and divergent requests for data,” the Council wrote. Greater cooperation could improve patient access to medicines and medical devices while lowering HTA costs and eliminating duplicate work.
 
The Council’s 57-page proposal includes a mechanism that would enable companies to make a single, European Union-level submission of the evidence required for joint clinical assessment. Non-clinical aspects of the HTA process would remain the jurisdiction of national bodies, which would retain the right to assess the clinical value of technologies.
 
Officials prepared the document to inform negotiations with the European Parliament, which agreed its position early in 2019. The Council and Parliament will now seek to reach a common position.
 
In the eyes of trade group EFPIA, the proposal is already too compromised to be beneficial. “We regret that the Member States’ compromise risks creating a more inefficient system. The resulting lack of predictability for all parties may not only lead to suboptimal and inefficient use of limited HTA capacity of Member States but also risks to further delay patient access,” EFPIA wrote.
 
MedTech Europe also criticized the proposal. “It is unclear how the Council proposal, as it stands now, would contribute to better or earlier patient access to medical technology innovation.”
 
Council Notice, EFPIA Notice, MedTech Statement
 

MHRA shares guidance on Innovative Licensing and Access Pathway

The UK Medicines and Healthcare products Regulatory Agency (MHRA) has published guidance on a new pathway designed to accelerate the development of certain medicines.
 
Late last year, MHRA shared an overview of the Innovative Licensing and Access Pathway (ILAP), which went into effect 1 January. The two guidance documents posted this week consolidate existing information, tweak the wording of the criteria for ILAP participation and provide additional details of the Target Development Profile (TDP) toolkit.
 
The updated TDP toolkit states that adaptive inspections, which MHRA describes as “tailored flexible and pragmatic supervisory and licensing inspections,” benefit patients through “assurance that products that come through the pathway are approved based on valid and reliable data, and that the developer has the necessary infrastructure to support risk identification and management.”
 
MHRA also has provided information on enhanced patient engagement. In keeping with the pilot program announced last month, MHRA will “ask if you have already engaged with patients in developing the product.” MHRA also will “explore what additional approaches you have identified for patient engagement” and ask applicants to consider how “to engage and involve not just patients but others such as carers and a patient’s family.” MHRA wants engagement to continue post-approval.
 
MHRA also has removed text found in its original advice on the TDP toolkit, shortening the description of Clinical Practice Research Datalink assisted patient recruitment. MHRA previously said the “two-phased highly selective approach results in only patients who are suitable for a trial presenting for screening” but has removed the section describing such benefits of the model.
 
ILAP Guide More
 

ANSM accepts fine for role in deaths linked to Servier weight-loss drug

A Paris court has fined the French National Agency for Medicines and Health Products Safety (ANSM) €303,000 ($356,000) over its role in deaths linked to Servier’s Mediator weight-loss pill.
 
The court found Servier guilty of deception and manslaughter and sentenced a former executive to a four-year suspended jail sentence. Servier suffered the sanctions in relation to the sale of Mediator (benfluorex), a drug estimated to have caused fatal heart-valve damage in at least 500 people. Magistrates said the French drugmaker “knowingly concealed the medication’s true characteristics.”
 
ANSM was covered by the same ruling. The magistrates said ANSM’s predecessor, AFSSAPS, failed to take timely action in response to warnings about the safety of the amphetamine derivative, leading them to impose a €303,000 fine.
 
The regulator has accepted the fine and will not appeal the decision. ANSM previously opted against pleading for acquittal. The regulator framed its approach as part of a desire to take responsibility and ensure the truth is known.
 
ANSM also sought to distance itself from AFSSAPS, noting that it is fundamentally different from its predecessor. The French government founded ANSM in the wake of the Mediator scandal as part of an effort to create a more transparent regulatory system and increase confidence in the oversight of medicines and medical devices sold in France. 
 
ANSM Notice (French), Reuters
 

MHRA shares advice on responding to GLP and GCP inspection reports

MHRA has published guidance on how to respond to good laboratory and clinical practice (GLP/GCP) inspection reports, including an optional format for submissions designed to cut the time it takes to reach a post-inspection compliance decision.
 
Most of the guidance addresses responding to major deficiencies. MHRA recommends choosing a new text color for the first set of responses and answering the deficiencies directly underneath where they are raised in a Word version of the inspection report. Responses should be clear and concise. MHRA may return responses that diverge from the key point with a request to rewrite and simplify.
 
“Responses with information not directly relevant to the remediation actions ... are not an efficient use of the inspectors’ or the company’s time,” MHRA wrote.
 
The text lacks specific guidance on critical deficiencies as these “may be more complex in nature and responses may take different formats depending on the issues cited.” The general principles for major deficiencies still apply.
 
MHRA Guidance
 

HPRA’s Clinical Trials Regulation project calls for sponsors to participate

The Health Products Regulatory Authority (HPRA) of Ireland has published a guide to its Clinical Trials Regulation-National Collaboration Project (CTR-NCP). HPRA is seeking sponsors to participate in the project as part of its preparations for the upcoming change in the regulation of clinical trials.
 
Through CTR-NCP, HPRA will work with the National Office for Research Ethics Committees on the joint scientific and ethical assessment of clinical trial applications. Currently, clinical trial procedures at HPRA and the ethics committees are separate. That will change when the Clinical Trial Regulation (CTR) takes effect as the new rules require a single decision from a member state.
 
CTR-NCP is intended to ease the transition to CTR by supporting the development of joint processes and procedures and enabling the evaluation and modification of existing ways of working. The end goal is to have an efficient system in place by the time CTR is implemented.
 
HPRA is encouraging drug developers to voluntarily participate in CTR-NCP, describing the project as a chance for them to “test their own processes with regard to the timelines and procedures of the CTR.” Participation will incur no additional costs. HPRA will assess applications in accordance with current legislation but through a process in keeping with the planned post-CTR system.
 
The initiative is similar to a clinical trial evaluation pilot project already underway in FInland. In both cases, European regulators are reviewing some applications under current legislation using processes intended to facilitate preparations for CTR. 
 
HPRA Guide
 

Other news:

MHRA has recommended against home use of pulse oximeters. The only exception is if a person has been advised to record their blood oxygen by a qualified clinician and has been shown how to take an accurate measurement. MHRA “is not aware of any incidents where skin colour has had an adverse effect on the use of pulse oximeters when providing effective clinical care.” MHRA Guidance