The impact and benefits for all stakeholders directly involved in the medicines data value chain, but also for health systems and societies will be multi-faceted and very substantial:
- Any patient can obtain seamlessly at least a medicine equivalent to the one prescribed in another country (in line with respective local regulations), and enabling patients is supported by simplifying product identification in patient-empowering systems.
- Clinicians reviewing a patient’s summary, electronic health record or other documents containing information on medications prescribed and dispensed understand fully the medicinal therapy information contained.
- An individual patient’s medication records originating from diverse sources can easily be integrated, validated, and used as input to computerised physician order entry (CPOE), clinical decision support and other (software) systems.
- Community pharmacists can fully identify what is the most appropriate medicinal product in their country that meets the specification and fulfils the therapeutic requirements of the product prescribed abroad, in accordance with their country’s laws and substitution rules.
- Different actors like regulators (e.g. EMA, national agencies); healthcare professionals, providers of national/regional medicinal product information systems; pharmaceutical companies; sponsors of clinical trials, medical researchers are enabled to meaningfully exchange MP data globally and share the same sources of information.
- The pharmacovigilance cycle is closed, by ensuring that from marketing authorisation to adverse event reporting and product discontinuation the pharmaceutical products and their active ingredients are univocally identified, even if they are specified in different ways by clinical actors during this cycle.
- The quality of data and evidence for pharmacovigilance and pharmacoeconomics will be greatly enhanced, their integration as well as their analysis for public health policy decision facilitated.
- Identifiers or descriptive attributes can be used by any actor, also patients, in any country for obtaining the product’s “properties”, e.g. in an emergency for the reverse identification of a medicinal product.
UNICOM will also contribute towards
- fostering the innovation capacity of pharmaceutical companies by simplifying and speeding up the registration of new products and afterwards pharmacovigilance activities, they will benefit from a more efficient, one-time electronic submission of information necessary for marketing authorisation of new medicinal products and other related regulatory processes, and of follow-up information on already marketed products.
- supporting the digital economy by providing a standard approach to identifying products across clinical and regulatory systems, as well as production and logistic processes.