Pharma Wary Of Over-Flexible EU Plan For Electronic Product Information

The pharmaceutical industry is concerned that too much flexibility may result in a “fragmented and cost intensive implementation” of the EU electronic product information framework.

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Pharma Wants Same Standards For E-Product Info Within EU Network

Drug companies are worried that they may have to develop costly parallel processes if EU member states are given “broad flexibility” in allowing the provision of drug product information in electronic format (ePI).

Flexibility as to when EU countries and companies can implement ePI was the cornerstone of a regulatory proposal on this topic issued earlier this year. (Also see "EU Steps Up Electronic Product Information Plans; Promises Flexibility " - Pink Sheet, 4 Feb, 2019.)

In the proposal, the EU regulators envisaged that some early-adopter member states would want to implement ePI throughout the medicines authorization process and use it for exchanges on the PI with the applicant during the assessment. Other member states might, however, wish to have the summary of product characteristics, labeling and patient leaflet converted to ePI format only once the evaluation process had been finalized.

The industry is concerned that allowing such broad flexibility on the uptake of ePI would create problems because marketing authorization holders (MAHs) would need to implement all necessary systems and processes even if only one NCA were to start requiring ePI.

In their joint written feedback to regulators, six EU pharmaceutical industry associations representing various sectors have explained that they support submission of ePI at the time of marketing authorization application, “but not as an extra step after authorisation” as this could result in the benefits of ePI being lost.

For MAHs, this would “mean running parallel processes (with and without ePI) for the same submission in different markets,” the companies said. They are worried that if flexibility is not accompanied by a clear and binding phased roadmap and value-added milestones, the consequence will be a “fragmented and cost intensive implementation” and the loss of opportunity to impose optimal practice across the EU regulatory network.

The industry believes the level of “acceptable flexibility” for an ePI approach can be tested in a proof of concept phase. It has called for a “reasonable application” of the flexibility principle that can “help guarantee the success of the ePI Programme” while maintaining the same standards across all member states.

This means that countries and companies thatcan move swiftly should be allowed to do so, but support (resource/financial/expertise) should be provided to others to ensure no one is “left significantly behind and that parity of opportunity across European patients is achieved as soon as possible.”

Other areas in the proposed ePI framework that have drawn industry’s attention include:

• Legislation: The industry believes the current legislation and regulatory framework tends to limit the development of patient-relevant digital innovations. It has suggested undertaking an EU-wide pilot study to investigate current practices and possible exemptions to replace paper package leaflets with ePI (or other alternatives such as printing at pharmacy level).

• Retrospective implementation: Industry is concerned that converting existing PIs (in Microsoft Word and PDF formats) into ePI would pose significant challenges, especially for companies with many marketing authorizations and for SMEs. To help overcome this, the industry has suggested several “essential incentives” that should be provided, such as allowing implementation of changes without any regulatory submission/approval process.

• Batch-specific implementation: The industry wants discussion on batch-specific changes and ePI as part of the ePI implementation roadmap (including for new classes of medicinal product, such as advanced therapies), but says this should not hinder the implementation of the ePI framework.

• Harmonization of standards: The industry says the choice of the common electronic standard for ePI should also take into consideration the regulatory dialogue and co-operation between EU and the US. The ePI system standard should be designed with the aim of building a framework that facilitates collaborative cross-stakeholder management of product information involving the European Medicines Agency, NCAs, medtech notified bodies and industry.