Zero-price and complimentary commercial models are increasingly embedded in commercial strategies across the pharmaceutical, medical device, and digital health industries. Companies now routinely offer free initiation kits, companion devices, bundled hardware and software, and trial access to digital platforms or monitoring tools. These offerings aim to facilitate product adoption, support adherence, enable data-driven care pathways, and integrate digital functionality into treatment ecosystems.

While these “free” models are often driven by legitimate commercial and patient-centric objectives, they operate in a regulatory environment that is not legally neutral in Italy. As a result, zero-price strategies raise significant regulatory and compliance questions that must be assessed at an early stage of commercial and product design.

From a regulatory perspective, the provision of free goods or services in the health care sector may trigger pharmaceutical and medical device promotion rules as well as restrictions governing interactions with health care professionals (HCPs) and health care organizations (HCOs). Even where a product, device, or digital tool is presented as non-promotional or ancillary, regulators will look at its practical function and context of use. Where a free component is closely linked to the use of a regulated product, that constitutes a condition for treatment eligibility or workflow integration, or generates downstream commercial value through data, interoperability or patient lock-in, it may be recharacterized as a form of indirect promotion or inducement capable of influencing prescribing or purchasing behavior. In such cases, companies may face exposure not only under promotion and inducement rules, but also under broader transparency, anti-corruption, and public-procurement compliance frameworks.

Beyond regulatory considerations, zero-price and complimentary commercial models may also give rise to competition law concerns, depending on the market context in which they are deployed. In particular, when implemented by undertakings with significant market power, such strategies may influence competition on non-price parameters, such as choice, quality, interoperability, and innovation. In this context, zero-price and complimentary models may reinforce lock-in effects, increase switching costs, or operate as bundling mechanisms, thereby foreclosing competing products or services, potentially constituting an exclusionary abuse under Article 102 of the Treaty on the Functioning of the European Union (TFEU).

As zero-price strategies become more embedded in health care markets, commercial innovation, regulatory compliance, and competition law increasingly converge, making a cross-practice assessment essential to distinguish value-creating models from those that carry material legal risk.