Choice Assessment Framework (CAF)

The proposal includes an important safeguard: safety information must remain on the product itself or in paper form. This protects vulnerable users from the worst-case scenario of being left without safety information. However, for all non-safety content the consumer must actively request a paper copy, and the request mechanism is not specified at EU level. Requiring users to take action to get information that was previously included by default does not make the paper option easy to access, particularly for consumers without advanced digital skills. Thanks to the safeguard of safety instructions, the score is −1 rather than −2.

Consumers have the explicit right to request a free paper copy. No fee is foreseen. Score is neutral.

The default flips for non-safety instructions. Until now, the manufacturer was obliged to provide paper instructions; under Omnibus 4, the consumer must take action to obtain them. Hence the burden shifts to the consumer. The score is −1 rather than −2 because the safety-critical content remains on paper or on the product by default. This limits, without eliminating, the impact of the new digital default.

The patient information leaflet is a safety-critical document used disproportionately by older adults, people with chronic conditions, and patients in moments of acute illness. Under Article 66, the primary delivery mechanism for this safety-critical information becomes a QR code. A QR code requires having a smartphone at hand, digital skills, and the ability to scan and navigate to the content at a moment of need. For the user population most reliant on patient leaflets, this is a fundamental barrier to access. The text requires that a paper version be made available on demand and without additional cost, with the duty on the marketing authorisation holder, but it does not specify how a patient makes that request. Stakeholders including pharmacist associations have flagged practical concerns with print on demand (pharmacist time, desktop printers for safety-critical text, cost shift onto pharmacies). But a request route is a recovery mechanism, not equivalent ease of access: it does not change the fact that the default delivery for both safety-critical information and general information is digital. The −2 reflects the severity of digitalising safety-critical content for this user population.

The Directive guarantees that the printed copy must be provided free of charge upon request. Score is neutral at the EU level. Questions arise however regarding the cost burden shifting to the pharmacies that will need to bear the printing costs, and potentially the staffing costs if this ends up taking up pharmacists’ time. It is also foreseeable that these effects will differ among Member States and regions, for example in rural areas with lower digital skills the population may request paper leaflets in higher numbers, hence burdening these pharmacies with higher costs than their counterparts in metropolitan areas.

Where a Member State exercises the option, paper is physically removed from the medicine box. The patient must take active steps, either scanning a QR code or requesting a paper copy, to obtain safety information that has been included in the box on paper for decades. The reversal of the norm is sharper and the burden on the user heavier than in any other comparable file. The combination of a safety-critical document and a physical removal from the point of need warrants the −2.

The expanded digital-only option applies to devices for professional users, who have institutional digital access and who, in the Commission’s own consultation, overwhelmingly preferred electronic instructions. For the consumers KMPEU represents the picture is different: where a device is reasonably expected to be used by lay persons, paper instructions stay mandatory by default, emergency information must remain on the device or on a paper leaflet, and manufacturers must run a documented risk assessment that takes account of users’ access to technology and the need for paper in emergencies. The residual risk sits at the margin, where a borderline device used at home is classified as professional-use. On balance the effect on consumers’ ease of access is neutral, so the score is 0 rather than negative.

Paper instructions must be provided free of charge on request. No fee is foreseen for the paper option, so the score is neutral.

For professional-use devices the default moves to digital, with paper on request. But that default sits with professional users, not with consumers, and those users have signalled a clear preference for electronic instructions. For lay-use devices the long-standing paper default is left in place. From a consumer-choice standpoint the default is therefore not reversed, so the score is 0. The point to watch is how the “reasonably expected to be used by lay persons” test is applied in practice, since a manufacturer could classify a borderline device as professional-use.