Euro Roundup: EFPIA calls for harmonization to improve access to digital therapeutics

Harmonized regulatory requirements with clear guidance are needed to ensure Europeans’ access to digital therapeutics, according to a new report from EFPIA.

The use of digital therapeutics is limited to a small number of European countries, according to the trade group’s analysis. Belgium and Germany are the only countries in the region that offer value assessment, reimbursement and funding pathways for the products. France and the UK offer two of the three approaches, but gaps in their offerings are impeding access, according to EFPIA.

“The shortcoming of the UK’s current progress is that there is no funding mandate for digital health technologies that are recommended by [the National Institute for Health and Care Excellence], in contrast to pharmaceuticals,” the report states. “NICE [is] making conditional recommendations for digital cognitive behavior therapies as part of an Early Value Assessment pilot.”

Spain and the Netherlands have funding mechanisms but lack national value assessment frameworks and reimbursement pathways. None of the approaches are available in Italy. In EFPIA’s view, the lack of a consistent approach is limiting the use of technologies it sees as a way to “empower patients by improving their experience and outcomes.”

EFPIA highlighted the lack of harmonized regulatory requirements as a barrier to access. The Medical Devices Regulation (MDR) covers digital therapeutics. Yet, “interpretation of the dossier requirements can vary between Member States as [digital therapeutic] products are novel and innovative, and expertise is still building,” according to EFPIA.

The trade group thinks “harmonization of regulatory requirements across the Member States would facilitate development and commercialization for developers, leading to faster access for patients and [healthcare professionals].” EFPIA sees a role for the Medical Device Coordination Group in clarifying the interpretation of MDR. Clarification and harmonization could increase investment in startups and help companies “bridge the ‘valley of death’ between incubation and commercialisation,” EFPIA said.

EFPIA also wants to see “improvements to the existing regulatory pathway that would allow a flexible risk-based approach to regulation would foster innovation and minimize risks to patients by not inhibiting the fast pace of software changes while maintaining high safety, efficacy and quality standards.”

Days after EFPIA published the report, the European Commission and World Health Organization (WHO) revealed a digital health partnership. The partnership will see WHO use the European Union (EU) digital COVID-19 certification model to establish a global system that will help facilitate “mobility and protect citizens across the world from on-going and future health threats.”

EFPIA Notice, Commission Statement

Denmark creates new notification criteria for medicines supply shortages

New drug shortage notification criteria from the Danish Medicines Agency (DMKA) aims to make it easier for companies to know when they must report shortages.

Under the incoming system, companies will use DKMA’s new list of critical medicines to determine if they need to notify the agency about a supply shortage. All supply shortages involving products on the list of critical medicines must be reported to DKMA.

“We want to make it easier for the companies to know for which medicines, notification of supply shortages is always requested. The list provides a complete overview so that you only need to look for information in one place, which makes the process easier for all parties involved,” said Jeanne Majland, director of department, control and security of supply at DKMA.

DKMA created the critical list in collaboration with “external parties,” Majland said and has submitted it to medical societies and Danish patients for review. Regular updates are planned.

The Danish regulator also will require companies to notify it of shortages expected to last for more than 60 days and supply disruptions they think could have a “critical” impact on patients.

DKMA shared details of the revised notification criteria alongside a new form for sharing information with the agency. Officials expect companies to communicate shortages at least two months before they occur and have created a form “to facilitate notification for the companies and at the same time ensure that the relevant data are reported correctly from the start.”

The form replaces a free-text Microsoft Word file, Majland said. DKMA needed to send multiple follow-up emails to gather information absent from initial notifications sent using the old file. The new form categorizes many of the possible answers to ensure DKMA gets more of the information it needs in the initial submission and can act sooner to mitigate shortages.

DKMA Notice

Trade groups join forces to push back against EU health data opt-out, citing ‘real risk’ of bias

EFPIA, MedTech Europe and 29 other health stakeholders have published joint recommendations on how to mitigate the potential for an opt-out mechanism to bias the European Health Data Space (EHDS).

As plans for EHDS have advanced, policymakers have proposed adding an opt-out mechanism that would allow citizens to stop their data being used for research, regulatory purposes and evidence-based policy making. The mechanism was absent from the European Commission’s original proposal and the trade groups think it could have negative consequences.

“Any form of opt-in or opt-out mechanism would introduce the real risk that data bias will form part of the EHDS from its inception and thus undermine its principal value for secondary use research purposes. We believe this risk to be substantial,” the stakeholders wrote in the joint letter.

The claim of substantial risk is based on evidence about “the complexities of including certain populations, including ethnic and deprived groups in Member States’ data” and “many healthy citizens having little interest in actively providing their information.” As such, the stakeholders think providing the existing opt-out may lead to the underrepresentation of certain groups in EHDS.

If an opt-out mechanism is needed, the trade groups want it to be “applicable across all Health Data Access Bodies in EU Member States,” “routinely monitored as part of a regularly updated HealthData@EU data governance framework” and “have a limited, but well-defined, consistent and transparent scope.”

Joint Statement

EMA follows WHO’s lead with recommendation on updated targets of COVID-19 vaccines

The European Medicines Agency (EMA) has published recommendations on updating COVID-19 vaccines to target new SARS-CoV-2 variants. EMA, which jointly published the advice with the European Centre for Disease Prevention and Control, based its recommendations on the position taken by WHO.

In line with WHO and the International Coalition of Medicines Regulatory Authorities, EMA is advising vaccine manufacturers to update their products to target XBB strains, a subgroup of omicron. The advice reflects the fact that the strains have been dominant in Europe and other parts of the world. XBB 1.5 accounted for an estimated 89.5% of European COVID-19 cases in the most recent analysis.

EMA said monovalent vaccines targeting a single strain, such as XBB 1.5, are a “reasonable choice.” The agency also recommended marketing authorization holders discuss their product information with the Committee for Medicinal Products for Human Use “to reflect the proposed simplified approach.” The proposed approach covers dosing.

EMA Notice

Euro Roundup: EFPIA calls for harmonization to improve access to digital therapeutics

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