Around the Globe: Europe

The European Commission Roadmap:
From Sector Strategy to the Dynamic e-PIL
Thomas Kühler
Sanofi R&D

n June 2, the European Commission (EC) published a Roadmap detailing the future Pharmaceutical Strategy with the telling subtitle Timely patient access to affordable medicines. The pharmaceutical sector is important to the EU economy, and in 2018 it offered approximately 850,000 jobs in the sector and created a €91 billion trade surplus. To this end, the Roadmap is important to the European Union (EU) pharmaceutical industry as it aims to ensure that the sector remains a competitive innovator and world leader in advancing regulatory science for the benefit of patients worldwide.

Work on the Pharmaceutical Strategy has been ongoing, but the current COVID-19 crisis has highlighted additional opportunities for Europe – that is, expanding the ambition beyond “future-proofing” the healthcare system to also incorporating learnings from the pandemic and “crisis-proofing” the healthcare system.

The Roadmap identifies no fewer than six problem statements that the EC believes must be addressed:

  • Access to medicines that are not always affordable: Innovative and promising therapies come with high prices that disadvantage small markets and strain national healthcare budgets.
  • Medicine shortages often have very complex underlying reasons but frequently affect access to mainstream generic medicines, which we should be able to take for granted.
  • Innovation efforts are not always aligned with healthcare needs: Medicines development does not always focus on the greatest unmet medical need, especially concerning development of novel antimicrobials or new treatments for neurodegenerative conditions such as dementia.
  • Benefiting from the pharmaceutical innovation ecosystem: Value generated by the combined EU scientific enterprise are not always harnessed internally (within the union) but are commercialized elsewhere.
  • Rapid technological and scientific developments require regulatory framework agile enough to keep pace with them. For instance, existing rules must be able to address self-learning artificial intelligence (AI), real world data and evidence, and complex clinical trials to support the authorization of medicines.
  • Environmental implications of the manufacture, use, and disposal of medicines must align with the objectives of the green economy defined in the Green Deal.

In response to these challenges, to ensure the supply of safe and affordable medicines to meet patients’ needs, and to support the continuing role of the pharmaceutical industry in the EU as an innovator and world leader, the Roadmap lays out four proposals that address all levels of the value chain from discovery and development through regulatory authorization to the availability of medicines in the healthcare system(s). The EC discusses both legislative and non-legislative changes in this context, an important observation since legislative proposals may imply a review of the basic pharmaceutical legislation as defined in Directive 2001/83/EC and Regulation (EC) 726/2004.

There are a number of very interesting proposals put forward in the Roadmap that the pharmaceutical industry welcomes. But one in particular, namely the “…better use of electronic product information …,” would probably require a change to the current legislation – at least if one were to exploit technology to the fullest extent possible and retire the paper based leaflet in favor of a dynamic e-PIL (patient insert leaflet).

The dynamic e-PIL is medicinal product information, approved by a health authority, that is accessible by digital means. Different “customers” of the information, such as Healthcare Providers (HCPs) or patients, can tailor which sections of the product information they want to access. In this process, they cannot manipulate the product information per se but they can choose what to display and how to display it.

It is the author’s opinion that the pharmaceutical sector should not only be allowed but should be asked to take advantage of current technologies and make available product and labeling information through digital means. This would increase product information utility and improve the value for patients. Digital media-based product information should be the default, and paper-based options should only be offered when appropriate as a fallback position (to individuals who are not comfortable with using digital tools). You can read more about the concept in a recently published paper.

The dynamic e-PIL would also have a direct impact on mitigating shortages, especially shortages of vaccines, a great concern in many regulatory jurisdictions and a problem recognized by the entire healthcare sector. The number of different labelling requirements adds complexity to the supply chain and has on occasion precipitated vaccine shortages. The requirement for country-specific packs, including leaflets, does reduce packaging line capacity and jeopardizes cold chain integrity. These two factors have immediate and profound effects on the availability of vaccines.

This self-inflicted situation originates from the mosaic of country- and region-specific regulatory requirements and could easily be remedied and overcome by retiring dated paper-based product information requirements in favor of digital media versions. For vaccines, such a transition should be particularly straightforward, considering that they are administered by well-educated and highly trained healthcare professionals.