EMA and Heads of Medicines Agency published their final joint strategy 2025 document that should set out the plan and focus of the network activities for the next five years. As we have argued before, such strategy document could be crucial for the industry’s near and long-term future. Especially considering the pandemic’s “silver lining” impact on wider adoption of digital technologies, modern practices in the workplace, and undoubtedly the apparent ability to approve much needed medicines in a very short time.

It is the next few years that can show whether or not we’ll have taken the opportunity to reinvent ourselves as we, hopefully, finally start to emerge from the pandemic. 2020 is no doubt a pivotal year and the chance to lay out a 5-year plan with this year’s lessons behind us, the strategy document can in fact be crucial and it has the potential to be of great influence and help navigate our industry to a better tomorrow, which may include abandoning the old expensive labor-intense business model, as well as tedious and unnecessary long clinical and regulatory processes.

Big plans, no steps

With that in mind, one can be easily disappointed with the result. This was an opportunity to set an example and show commitment to innovation and necessary change. On that, the strategy document falls short in most aspects. While we are happy that strategic areas talk about the need for adopting digital technologies and foster innovation, the actual text does not offer anything beyond abstract and vague phrases. We appreciate that EMA published an analysis of the public consultation that was open for several weeks (and where we also made contributions in several areas). As the document authors admit, many respondents have made relevant points asking for specific examples how EMA will tackle the challenges in the strategic themes (Tepsivo also called for these). However, these calls were brushed off by labeling the document as “high-level strategy” which should not be concerned with specifics.[i]

In that case, we and other stakeholders in the industry should rightfully ask why the document is not called a “high-level strategy 2025”, or more accurately “high-level areas of interest”. The document is presented as the strategy for the next 5 years, and as such, it should definitely include specifics on how the network is going to move forward, as concrete plans are crucial to any real strategy document. The result is, perhaps expected, “fluff” around important areas of interest for the future, it is not really a strategy and it does not help us understand much what really the plan forward is.

Let’s think positive

This criticism we provide here does not question the network’s ability to innovate and we in fact hope that the agencies will provide specific plans on how to move forward, and more importantly, execute on these. We also acknowledge that there are several individual sub-groups (i.e. Telematics) that will be tasked to execute in these areas. However, the apparent avoidance of outlining concrete steps and identifying the right solutions, including digital tools, in what could be a critical strategy document, does not instill much confidence. Perhaps what can be learned for 2025, is a rethink of how strategy is communicated to the public.

There is more to unpack from the EMA’s, commendably thorough, analysis of the public responses, and we will follow up with our views on this in the next posts.

References

[i] Analysis and summaries of public consultation results

EMA/564811/2020, https://www.ema.europa.eu/en/documents/report/analysis-summaries-public-consultation-results-european-medicines-agencies-network-strategy-2025_en.pdf, p.25