Product information: EMA starts digitization

The product information is approved by the competent regulatory authorities when the marketing authorization for the relevant medicinal product is issued. It includes the summary of product characteristics (RCP), intended for health professionals, and the patient package leaflet (FI). This documentation shows the conditions of use of a medicine, as well as all the information necessary for its prescription and safe use.

The Recommendations of the European Commission

With its action plan dedicated to product information, the EMA implements a report published by the European Commission (Commission) in March 2017. This report concluded that, despite ongoing efforts to make information on products easy to read and useful, it is necessary to improve the way in which information on medicines is passed on to patients and healthcare professionals.

In particular, the Commission highlights how electronic formats offer new opportunities for the transmission of RCP and FI. As more and more European citizens have access to information technology, there are many potential benefits to using electronic formats. First of all, it is possible to provide information to individual EU citizens in accordance with existing legislation, for example, in terms of presentation, format or use of multiple languages. In any case, the electronic formats should be complementary to the paper formats required by law and, at this stage, they should not replace them, so as to ensure the availability of information to all patients, including those less open to digitalization.

Therefore, the Commission recommended exploring the use of electronic systems to provide the information included in the RCP and FI as well as all the opportunities that new technologies offer to optimize the presentation and design of these documents. For example, according to the Commission, electronic tools should be considered to inform patients and healthcare professionals about changes in the RCP and in the FI.

Product Information, EMA and the EU Commission Launch a Workshop to Develop the Key Principles on the Use of Electronic Formats

For the purpose of translating the Commission’s recommendations into concrete actions, EMA, together with the Commission, will organize a workshop in the third quarter of 2018 to develop key principles on the use of electronic formats. To this end, all interested parties will be involved. In fact, the shift towards digital must necessarily take place through the involvement of all stakeholders from the pharmaceutical industry, patients, consumers, healthcare professionals and national competent authorities.

All these interested parties are invited to provide information, by the end of February 2018, on the initiatives they are aware of or work on. The operative indications for the transmission of such information can be found in the EMA’s website.

Further Activities to be Developed

In its action plan, EMA also included other initiatives to improve product information, in addition to the digital aspects, such as:

• how to make the package leaflet easier to understand for EU citizens;
• updates of the EU guidelines available to companies to prepare the package leaflet;
• strengthening of the contribution of patients during the preparation of the package leaflet;
• evaluation of the opportunity to insert a section in the RCP and in the FI with the key information on the drug (in this regard, the EMA’s project to add a “key information section” to the European Public Assessment Report for every centrally authorized medicine could be useful).

The Italian Situation

Italy seems to have already embarked on the path suggested by the Commission aimed at enhancing digital technologies for the transmission of the product information. For instance, the very recent law No. 124 of 4 August, 2017, provides that, in the case of changes to the package leaflet, the patient has the right to choose how to receive the updated leaflet, whether in paper or analogical form or through the use of alternative digital methods. Therefore, it seems that, from this point of view, our country has already started to prepare the most suitable instruments to face this new digital challenge.