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Electronic product information – where are we at?

In April, DRA participated in the Pharmaceutical Information Centre’s Ajankohtaista myyntilupa-asioista 2021 webinar, where one of the topical issues discussed was electronic product information.

When it comes to electronic product information, a central question is the patient’s digital health information literacy. At the moment, there is electronic product information available, but the challenge is how accessible and easy-to-find it is. A key goal is to direct the patient to reliable, generally accepted information, which may decrease the number of questions the medical info service receives, for instance. Other advantages include the improved availability of medicinal products, automated data transfer, the electronic assessment of product information, regulatory efficiency and cost savings when paper package leaflets are no longer needed. This may also result in smaller package sizes.

There are numerous electronic product information pilot projects of different sizes under way around the world. For instance, there are pilot projects in Germany, Norway, Belgium and Luxembourg, which have already proceeded far. The EMA and the HMA have published a “mindset” for electronic product information, with one of the main goals being to improve public health through electronic product information. Brexit has slowed down the EMA’s electronic product information project. The next step consists mainly of introducing electronic product information to an increasing extent alongside paper package leaflets.

To quote Gunilla Englund (Specialist, The Swedish Association of the Pharmaceutical Industry, LIF), who concluded the section (freely translated): “Personally, I believe that electronic product information will become reality. The next question is: when, by whom and how? Especially the ‘how’ still raises a lot of questions.”