Abstract [En]: The essay develops preliminary observations on the application of the theory enucleated by M. Porter, namely the so-called value based health care theory, in the field of purchases of biomedical devices. In particular, the institution of project financing is analysed as a tool to develop a culture of purchases in healthcare that considers the clinical outcome for the patient as a parameter to, first, value the offers of biomedical devices and, second, establish the remuneration of the supplier. This approach is confirmed also by the recent EU regulation 2017/745 which imposes specific obligations to the producers and promotes the creation of a database that allows an effective comparison of the outcomes of the devices at the EU level.
Abstract [It]: Il contributo sviluppa preliminari osservazioni in merito all’applicazione della teoria di M. Porter sulla cd. Value Based Health Care nell’ambito degli acquisti di dispositivi biomedicali. Si considera in particolare l’istituto del project financing quale strumento per favorire una cultura degli acquisti in sanità che consideri l’outcome clinico del paziente quale parametro su cui valutare le offerte di dispositivi e servizi biomedicali e a cui correlare la remunerazione del fornitore. Tale approccio trova conferme anche nel recente Reg. (UE) 2017/745 che impone ai produttori specifici obblighi e favorisce la creazione di una banca dati che permetta una reale comparabilità dell’outcome su scala comunitaria.
Sommario: 1. The development of the concept of “Value Based Health Care”. 2. Application of the concept in the Italian, and other, legal systems. The problem of ‘strategic acquisitions’ in Health Care. 3. The project financing in tender for services: problematic aspects with regard to the application of Value Based Health Care. 4. Innovative procurement in Health Care under the scope of Reg. (UE) 2017/745 and the need for applying the value-based paradigm.