What happens if you are travelling outside your home country and you run out of your prescription medicine, or your luggage is stolen, or you simply forgot to pack your pills? Anyone who has experienced this knows that it’s not always that easy to find a similar commercial drug product or dosage in the country where you are travelling, or to get authorization for your prescription to be filled. This is because drugs are managed at the national level so in theory, your prescription is only valid in the country where it was issued. The European Commission intends to change this, however it’s not as simple to implement as it may seem.
In Europe today, there are more than 600,000 different medicinal products on the market but on average, the list of authorized medicine products in a single member state rarely exceed 30,000 products. From the standpoint of a patient simply trying to get medicine outside of their home country, this may seem like systemic inefficiency. But medicine is a highly regulated industry and each country has its unique history and legislation that pharma companies must adhere to in order to in order to enter that market. So what would be the first logical step towards a world in which European citizens have safer and easier access to prescription medicine in cross-border use cases? It would certainly be helpful to have a unique ID for each drug product that was designed especially for this emerging international use case, because currently, unique medicine ID’s are distinct for each nation, but not designed to ‘cross the border’.
This is the “raison d’être” of UNICOM, a large EU-funded project with the mission of up-scaling the global univocal identification of medicines, in which Datawizard, the only Italian SME company involved in the project, will lead the activities related to Patient Information Empowerment Apps and support those of Clinical Applications. While the true ‘need’ for this new standard stems from a regulatory context (because National Drug Agencies need an infrastructure for cooperation in order to authorize ‘smart substitutions’ when the drug product that Country B will dispense is slightly different than the one that Country A prescribed), this process of harmonisation could have a significant impact on the efficacy of clinical trials on a large scale and even the future of medicine production and and distribution throughout Europe and worldwide.
One name, a thousands pitfalls
Nowadays, the complex differences and variations in the regulatory-pharmaceutical sectors of the different Member States make it difficult to create a unique and transnational identification system for the various products released in the European market. In this context, a univocal ID is a key starting point for making safe, cross-border ePrescriptions possible. UNICOM’s mission is to kick-start the implementation of ISO IDMP (ID of Medicinal Products) standards in EU Member States drug databases which requires participation and adoption among all National Drug Agencies, The European Medicine Agency and many other relevant stakeholders in the healthcare and medicine domains.
During the project, Datawizard and our team of experts, will lead the exploration of how the implementation of IDMP will provide specific benefits to patient health, how to improve pharmacovigilance activities, how to better support clinical actors (doctors, pharmacists, nurses) with decision support, and how to enable more powerful and effective clinical studies as big data related to medicine will now be easier to harmonize across many countries.
A large Consortium to make a real-world impact
UNICOM has some impressive figures: 48 partners, 19 countries represented, including 26 national Drug and eHealth Agencies, the European Medicine Agency, a range of stakeholders involved through their associations and the USA Food & Drug Administration (FDA) as an Advisory Board Member. Italian partners, beside Datawizard, include the Region of Lombardy (ARIA Spa) and Azienda Ospedaliera Universitaria Federico II Campania.
The UNICOM Innovation Action (Grant Number 875299) kicked off on December 1st 2019 and will run for 4 years. It is a truly challenging activity to coordinate, despite the wide range of qualified partners and stakeholders. But our vision is that once EU-interoperable data on medicines becomes available, the positive impact that follows will have justified the great effort we are investing. The expected results of this implementation include: safer and easier patient mobility in the EU, more efficient regulatory management of medicine, better access and quality of health data for improved pharmacy and clinical decision support, clinical research, patient empowerment and overall public health.