Fimea involved in developing safe cross-border prescription service activities

Fimea participates in the 19-million-euro UNICOM health project funded by the European Commission.

UNICOM (Up-scaling the global univocal identification of medicines) is a new EU-supported digital health innovation project aimed at harmonising the health processes related to European medicines data. In addition to patient safety, the project promotes public healthcare, clinical trials and pharmaceutical business and enhances the effectiveness of pharmacovigilance.

During the next four years, the UNICOM project will:

• develop new information system and data repository solutions that enable the implementation of the International Organization for Standardization (ISO) suite of IDMP (IDentification of Medicinal and pharmaceutical Products) standards in key medicines databases and pharmaceutical regulation processes across Europe
• ensure the functionality of the developed solutions by testing them in national and cross-border pharmacy and healthcare system pilots. At the same time, the aim is to identify potential shortcomings and needs for further development in the system solutions produced.

Launched at the turn of the year, the project involves medicines and health agencies of 19 countries as well as dozens of stakeholder organisations. From Finland, the other participants, in addition to Fimea, include the Social Insurance Institution of Finland and the Finnish Institute for Health and Welfare. Responsible for the coordination of the project is a German communication and technology research company named Empirica.

Towards improved pharmacovigilance and new business opportunities

The IDMP standard has been developed for 10 years. The UNICOM project is very extensive and demanding, as it requires that the information value chains used by pharmaceutical operators be converted to the IDMP standard, from the input of data to data repositories up to the data utilisation stage.

The project will enable the safe dispensation of the correct medicine to the patient immediately irrespective of the European country in which the prescription was issued. Improved access to pharmaceutical and health information and faster transmission of data will step up the prevention of adverse drug reactions and the combating of abuse across Europe.

In the longer term, the project will also promote innovation activities in the pharmaceutical sector in clinical trials, for example, and enable the development of new forms of service and business. Following the implementation of the IDMP standard, Finnish pharmacies, for example, can retrieve prescriptions issued in other European Union and European Economic Area Member States for dispensing with improved security of supply via national contact points and thus develop their own business.

Read more:

UNICOM project website