Paper + NFC: the coexistence standard for EU ePI.

1 · The false debate — and the word that ended it

Read any EU pharma policy brief on electronic leaflets and you will find the same rhetorical scaffolding: one camp defends paper, the other celebrates digital, a third proposes a hybrid. The fight is staged as a choice between two paradigms. It is not.

The European Commission's own proposal — COM(2023) 192 final, 26 April 2023, the text that became the politically adopted Pharma Package on 11 December 2025 — explicitly grants Member States the autonomy to make paper leaflets available, electronic leaflets available, or both. The regulatory intent was always pluralistic. The shouting match between paper defenders and digital evangelists obscures the fact that the underlying text already permits — and in most cases expects — coexistence.

The trilogue that concluded at the end of 2025 made the word explicit. As the MLPS coalition summarised in an April 2026 briefing: “At the heart of the agreement is a simple but powerful principle: complementarity. The new Directive confirms that medicine leaflets should be available in both paper format, inside the box, and in electronic form. Digital tools are recognised as valuable, but paper leaflets remain the standard.” That is the operative word — complementarity — and it is now the legal baseline, not an industry aspiration.

What changes is the architecture. Not whether digital should happen (it will). Not whether paper should disappear (it will not, for at least a decade and in many Member States probably forever for vulnerable populations). What changes is the design choice MAHs make when procuring a digital leaflet solution today. That choice commits them to an architecture. And most of the architectures on offer are brittle.

2 · The data the paper-leaflet defenders got right

Before arguing for a coexistence model, honesty requires acknowledging the data the paper side has correctly cited. Ataa Elfaquih of Mayr-Melnhof Group, writing in European Pharmaceutical Review on behalf of MLPS (Medical Leaflets = Patient Safety, a subgroup of ECMA), laid out three empirical points that are simply true:

These numbers are not fringe lobbying. They are Eurostat and BEUC primary data. Any ePI design that ignores them will fail regulatory scrutiny, fail patient safety scrutiny, and — critically for MAHs — fail the political acceptability bar that the co-legislators will impose on the 10-year transition window.

The paper side has the data right. The question is what architecture answers it.

3 · Why QR-only approaches walk into the trap

A large fraction of "digital leaflet" pitches currently running through European pharma procurement are built on a single technology: the QR code. QR is attractive to vendors because it is cheap, needs no special hardware, and prints into existing artwork. On paper (pun intended) it looks like the easiest migration path.

QR has three structural weaknesses that make it unfit as the primary access layer for an ePI that must serve every EU patient:

• The app gap. Every additional step between a patient and the leaflet is a point of failure. Some smartphones open QR natively in the camera; many older Android builds do not; some pharmacies dispense to patients without a compatible phone; some hospitals do not allow personal Wi-Fi. The population most in need of the leaflet is the population most affected by these gaps.
• The physical fragility of the scan. QR codes fail when smudged, torn, covered by a pharmacy dispensing sticker, or printed on curved cardboard surfaces — all routine events in a European supply chain. NFC does not require visual integrity; a magnetic-field tap works even through a damaged label.
• The connectivity dependency. A QR code resolves to a URL. Without mobile data or Wi-Fi, the URL resolves to nothing. A patient in a rural area, in a hospital basement, or at home on a slow connection gets an error page — at the exact moment they were trying to read critical information about their medicine.

Each of these weaknesses aligns, almost perfectly, with the Eurostat / BEUC criticism of digital-first leaflets. QR-only is the implementation that confirms the digital-divide worries. It does not solve them.

This is why labs that procure a QR-only solution in 2026 will be back in RFP mode by 2029: the coexistence requirement that regulators will enforce by then will have turned their chosen architecture into a liability.

4 · NFC changes the equation

Near-field communication is different. A passive NFC chip on the carton is a contactless label that any modern smartphone (iPhone 7 and later, essentially all Android phones from the past eight years) can read with a single tap — no app, no camera framing, no line-of-sight, no Wi-Fi prerequisite on the chip side, no pharmacist-dispensing-sticker-over-the-code failure.

The architectural claim is specific and testable: NFC preserves the three virtues the paper leaflet has always had — universal access, offline reliability, and no cognitive load — while adding the advantages a paper leaflet cannot have: always the latest approved version, multilingual on demand, accessible zoom, text-to-speech audio for low-vision or low-literacy patients, lot-specific recall messaging, and anti-fraud geolocation signals.

Three properties the paper leaflet already solves — and NFC inherits

• Universal reach. Paper works for everyone holding the box. NFC also works for everyone holding the box and a smartphone — a population that grows monthly, and already includes the vast majority of patients even in the 55–74 segment.
• Offline reliability. Paper is offline by definition. The correctly designed NFC digital leaflet stack serves the approved leaflet from the NFC chip itself or a local cache; no Wi-Fi dependency at the point of reading.
• No cognitive overhead. No app, no login, no account, no "accept cookies". Scan, leaflet, done. The interaction cost is lower than unfolding a paper leaflet — especially for elderly patients.

The NFC layer is not a substitute for paper. It is the universally accessible electronic companion that makes the paper leaflet stay relevant for another decade without leaving any patient behind.

5 · The architectural principle: additive, not replacement

PharmaTag's design is explicit about this, and it is worth stating in one sentence: the NFC label is applied on top of the existing packaging. The paper leaflet remains mandatory inside the carton.

Three consequences follow:

1. No disruption to the carton supply chain. Printers, folding-carton makers and leaflet producers retain their role. There is no business case for ECMA, MLPS or the paper-first coalition to oppose NFC — the NFC layer sits outside their category and does not cannibalise it.
2. No disruption to the pharmacist workflow. Pharmacists do not have to print on demand, do not have to triage between paper and digital requests, do not take on liability for substitution errors. The PGEU 2023 position paper explicitly opposes print-on-demand on workflow and liability grounds. A coexistence model with paper-in-box + NFC-on-box removes that debate entirely.
3. No disruption to the regulator's signal. The paper leaflet keeps carrying the full, approved, static content — exactly the way CMDh readability guidelines (CMDh/223/2005 Rev.2) and the Commission's recurring readability research have specified for twenty years. The NFC layer adds an updated, accessible, multilingual version for the patients who want it.

This is not a rhetorical sleight of hand to appease paper defenders. It is the architectural principle that makes the system work operationally, legally, and politically.

6 · Regulatory alignment: the EU's own direction already IS coexistence

The policy record supports the coexistence thesis without ambiguity:

• EMA/493897/2015 Rev.1 (November 2018) already authorises NFC, QR and 2D barcodes as additional technologies on the labelling — on top of the mandatory paper leaflet.
• EMA / HMA / European Commission Key Principles on ePI (January 2020, EMA/766923/2019) lay out harmonisation, interoperability and technology neutrality. The principles treat ePI as an additional delivery channel for the same approved content.
• COM(2023) 192 final, the Pharma Package, grants Member States the choice of paper, electronic or both. The political adoption on 11 December 2025 preserves the plural choice — not a forced replacement.
• Directive (EU) 2019/882 — the European Accessibility Act, in force since 28 June 2025 — requires accessible digital formats for private-sector services. This is exactly what NFC with audio TTS, zoom and multilingual delivers, and what a paper-only stance cannot satisfy alone.

Every line of the EU's own regulatory record supports a both / and architecture. The policy window is not asking MAHs to pick paper or digital; it is asking them to pick which digital architecture they adopt alongside paper. Coexistence is the baseline, not the compromise.

7 · The stakeholder landscape — and the bias behind each voice

One of the least noticed features of the current debate is how unusual the stakeholder landscape is. Positions that are normally adversarial end up at the same operational conclusion — coexistence — but they arrive there for very different reasons. Intellectual honesty requires naming those reasons, including the commercial ones.

The carton-maker trade bodies (ECMA, MLPS) defend the retention of paper leaflets because their members' revenue depends directly on the volume of paper leaflets printed in Europe. Their advocacy is legitimate industry communication, but it is not neutral expert opinion. When the consumer organisation BEUC publishes a survey, it reflects the view of European consumers. When MLPS publishes a policy brief, it reflects the view of the European carton industry dressed in patient-safety language. Both are useful inputs. Neither should be confused with the other.

This matters for MAHs evaluating digital leaflet architectures. The regulatory outcome the carton industry has successfully lobbied for — coexistence, with paper remaining mandatory for the next decade — is now the baseline EU legal reality, whatever its motivation. MAHs therefore need an architecture that operates inside that reality. That is a technology question, not a political allegiance.

Italy is already showing what patient-centred national implementation of the revised Directive looks like: in March 2026, Undersecretary of Health Marcello Gemmato told the Social Affairs Committee of the Italian Chamber of Deputies that digital tools must complement, not replace, printed leaflets — explicitly because nearly half of Italians aged 16–74 lack basic digital skills (Eurobarometer) and older patients are the most reliant on regular medication.

There is no opposing industry coalition arguing for the wholesale replacement of paper by digital. The "paper vs digital" frame is a rhetorical construct. In practice, every stakeholder that has stated a position publicly has landed on some version of coexistence — but for very different reasons, including some commercial ones. What makes the coexistence outcome stable is not the motivations behind it but the fact that the revised EU Directive now makes it the legal baseline.

PharmaTag's position is deliberately positioned one layer above this debate. We do not argue that paper should remain forever, nor that it should disappear. The EU legal framework currently requires paper; our architecture operates inside that requirement. If the framework evolves — for specific product categories (OTC, consumer health), for specific settings (hospitals, HCP-administered products), or for specific Member States moving faster than the average — the same NFC infrastructure accommodates the new state without re-procurement. Technology neutrality is the architectural property that survives any plausible future.

8 · What coexistence looks like operationally — the PharmaTag model

The operational form of coexistence is narrower than most MAH regulatory teams initially assume. It comes down to five architectural commitments:

1. The paper leaflet stays untouched. Same carton, same inner leaflet, same CMDh-compliant text, printed industrially by the same suppliers. No print-on-demand. No pharmacy liability shift.
2. The NFC label is applied on the carton as an additional layer — either during pharma packaging line assembly or during post-manufacturing finishing. No re-engineering of artwork, no re-validation of the existing printed leaflet.
3. The digital leaflet served from the NFC chip is a patient-friendly rendering of the approved SmPC / PIL: audio TTS, accessible zoom, multilingual on demand (every EU language), lot-specific content, always the latest approved version.
4. No patient account, no app, no data capture. GDPR Article 6(1)(f) legitimate interest. No first-party patient data flows into any marketing system. The digital layer is as privacy-safe as the paper layer.
5. Lot-level traceability built into every chip — enabling surgical recalls, expiry management, anti-fraud geolocation signals, and pharmacovigilance integrity. None of this is possible with paper alone; none of this needs the paper to disappear.

Each of these five commitments is a policy-compatibility test. An architecture that fails any one of them will drift out of alignment with the EU's direction during the 10-year transition window and cost the MAH a re-procurement round.

9 · What this means for MAHs running ePI RFPs right now

If you are a Regulatory Affairs, QA or Packaging director in a European MAH currently evaluating digital leaflet proposals, the practical consequence of the coexistence argument is procurement-specific:

1. Disqualify any vendor that positions itself as a paper-leaflet replacement. The political and regulatory consensus is coexistence. A vendor whose value proposition is "eliminate paper" is selling against the direction of EU policy.
2. Disqualify any QR-only architecture that cannot explain how it serves the 40% of the EU population affected by the digital divide. QR-first approaches cannot pass the accessibility test BEUC / Eurostat data imposes.
3. Require NFC as the primary access layer for the electronic companion. Use QR as a secondary fallback if the MAH's budget allows both on the pack. NFC is the technology that preserves universal reach, offline reliability and zero cognitive overhead — the three virtues of the paper leaflet.
4. Require explicit paper-preservation commitments in the vendor contract. The MAH, not the vendor, controls whether the paper leaflet stays. The vendor's architecture must not force paper removal in any future upgrade.
5. Require lot-level traceability, GDPR Article 6(1)(f) compliance, and compliance with the EU ePI Common Standard (once operationalised). These are the tests the surviving architectures will all pass — and the brittle ones will all fail.

The winning ePI architecture is not the one that digitises the most. It is the one that digitises without subtracting.

10 · Closing the loop

The digital-divide argument is real and it is politically decisive. Ignoring it is expensive. Pretending digital can replace paper within a decade is not realistic in EU pharma. But the argument does not support the conclusion some industry voices — including those with direct commercial interest in the paper leaflet itself — draw from it: that the ePI deployment should be slowed, watered down, or limited to PDFs on a QR code.

The correct conclusion is the opposite: the digital-divide argument is the strongest case for NFC-based coexistence. It rules out QR-only approaches, it rules out replacement-first vendors, it leaves standing exactly the architecture that MAHs should be procuring in 2026.

PharmaTag's position is not a defence of paper. It is a defence of the architectural property that makes the digital layer universally accessible — which, as long as EU law preserves the paper baseline, implies paper-compatible NFC infrastructure. If EU law evolves, the same architecture adapts. That is the definition of infrastructure, and the opposite of an industry lobby.

The stakeholders who look like adversaries in the policy debate — consumer groups, pharmacists, carton makers, regulators, Parliament, digital-leaflet providers — already converge on the operational conclusion, even when their motivations diverge. What remains is to make the MAH procurement match the architecture.

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