The European Accessibility Act as implemented in Italy: What’s new for online pharmacies?

The main purpose of the EAA and of the Implementing Decree is to make the products and services expressly listed therein accessible to persons with disabilities. The relevant accessibility requirements supplement those provided for by already existing laws, specifically Law n° 4 of January 9th, 2004, (the so called “Stanca Law”), to the extent applicable.

Online operators, pharmacies included, must pay the utmost attention to their e-commerce portals and mobile apps and to in-store digital touchpoints or kiosks (e.g., displays providing the consumer with any information and self-service/payment terminals).

The Implementing Decree also sets out transitional arrangements (notably until June 28th, 2030, for services that rely on products already in use) and provides clarity on the enforcement of the accessibility requirements, market surveillance and applicable sanctions.

What is in scope for pharmacies?

Although the products and services offered by pharmacies are not specifically named in the EAA or the Implementing Decree, the accessibility framework hereby introduced applies to pharmacies too insofar as they provide digital services to consumers. Typical products and services falling within the scope of the accessibility requirements concerned include:

• E-commerce and online booking: websites or apps used to sell products to consumers, manage orders, or book services such as vaccinations, swabs, and first-instance diagnostics; access to audiovisual content through in-store interactive screens (e.g., videos needing captions/audio-description where appropriate);
• Electronic communications with the public: chat or messaging features embedded in the pharmacy’s website/app;
• In-store touchpoints and payments: if a pharmacy uses self-service terminals (for example, ticketing or information kiosks) or payment terminals, those devices fall under the accessibility requirements set for product and therefore shall abide by the applicable accessibility requirements if placed on the market after June 28th, 2025; quite the contrary, service providers may continue to provide their services using products which they were lawfully using before June 28th, 2025 by benefitting from the transitional regime described below.

Key dates and transitional arrangements.

At EU level, Member States were required to transpose the EAA by June 28th, 2022 with the framework becoming applicable from June 28th, 2025, although specific transitional measures may apply: as a matter of fact, although the provisions of the Implementing Decree take effect from June, 28th, 2025 (the “Effective date”), service providers may continue using products legitimately in use before the Effective date for analogous services until June 28th, 2030. In addition, service contracts concluded before the Effective date may remain unchanged until their expiry, but not beyond five years from that date. Finally, self-service terminals already in use before the Effective date may remain in service up to their economic end-of-life and no longer than 20 years from their initial commissioning.

The applicable exemptions for micro-enterprises. Fundamental alteration and disproportionate burden.

Of note, micro-enterprises (i.e., enterprises employing less than 10 employees and having an annual turnover or an annual balance sheet total not exceeding EUR 2 million) providing services are exempt from the service-side accessibility requirements of the Implementing Decree.

In addition – and for all operators – requirements will apply only to the extent that compliance does not entail a fundamental alteration of the product/service or a disproportionate burden; operators invoking a fundamental alteration or disproportionate burden must assess and document this against the Implementing Decree’s criteria, with specific record-keeping and renewal duties.

What compliance looks like in practice.

The EAA takes a performance-based approach via Annex I (e.g., perceivability, operability, understandable content, compatibility with assistive technologies), rather than mandating a single prescriptive checklist.

Under Article 23 of the Implementing Decree, conformity with harmonised standards or technical specifications adopted at EU level creates a presumption of conformity. In the web/app context, EU accessibility frameworks reference WCAG 2.1 (via EN 301 549) as the practical benchmark for web and mobile content.

Pharmacies planning or upgrading their websites/apps should therefore align to the current harmonised international standards, using WCAG criteria as the operative reference in development and auditing.

Service/product providers shall also prepare and keep information that explains how accessibility requirements are met, making such information available in accessible written and oral forms for as long as the service operates. Businesses will also be expected to maintain conformity over time, considering changes to the service and align to the applicable standards from time to time.

In addition, service/product providers are called to inform AgID if a service/product is found to be non-compliant with the accessibility requirements set forth in the Implementing Decree (and thus with those set forth in the EAA) by indicating which requirements are currently not satisfied and what corrective actions have been taken.

Governance, market surveillance and the applicable sanctions.

The Agenzia per l’Italia Digitale (“AgID”) will act as the market-surveillance authority for services: AgID may order corrective measures, order the takedown/withdrawal of non-compliant services and will also be tasked with examining user complaints. AgID has also been called to issue guidelines governing the enforcement of the accessibility requirements for services: at the time of writing the guidelines have not been adopted yet. Following the public consultation held by AgID earlier this year, the draft guidelines have been submitted to the European Commission for its review under the so-called TRIS procedure pursuant to (EU) Directive 1535/2015. The review is expected to be completed by the end of November 2025.

The Ministry of Enterprises and Made in Italy (“MiMIT”) will instead act as the market-surveillance authority for products, with powers to require corrective actions and, if needed, to restrict/withdraw non-compliant products.

The administrative fines for non-compliance range from €5,000 to €40,000, with further penalties for failure to cooperate with the authorities as well as with possible market withdrawal of non-compliant products/services.

Final remarks:

The EAA and the Implementing Decree definitely imply a substantial change for pharmacies. As a matter of fact, strategic planning for compliance with the applicable accessibility requirements will be of the utmost importance. Aligning with harmonized standards such as WCAG 2.1, maintaining thorough documentation to demonstrate compliance, if need be, preserving ongoing conformity, and proactively managing communications with AgID and MiMIT will become crucial for pharmacy operators.

While the phased implementation and exemptions provide some degree of flexibility, it is still vital to perform a preliminary analysis and maintain consistent monitoring of digital solutions: ensuring clarity regarding obligations and regularly consulting official AgID resources is essential for maintaining compliant operations in such a dynamic and layered regulatory environment as this approach will help businesses to reduce the risk of sanctions and reputational damage, while enhancing accessibility for everyone.

More information on accessibility requirements is available on AgID website.