Diverging Roads

Guest post by Mark H Mayer, Senior Advisor–Global Regulatory Policy and Intelligence, Eli Lilly and Company.

The essential role of the regulatory system is even more evident in the global fight against COVID-19. This leads to the question, how will the speed of regulators’ decisive actions and engagement with industry endure across and beyond pandemic actions?

Representing the innovative pharmaceutical industry, the European Federation of Pharmaceutical Industries and Associations (EFPIA) recently highlighted that the EU regulatory system is adapting quickly and partnering effectively to address the extraordinary challenges presented by COVID-19. Does industry have any concrete ideas that could be implemented to better facilitate novel approaches to science and technology today and into the future? Yes, it does, and in the Regulatory Road to Innovation, EFPIA outlines a number of attainable recommendations. If you haven’t already, I encourage you to read EFPIA’s Regulatory Road to Innovation[1]. I think it well worth a few minutes of your time.

The Regulatory Road to Innovation notes that “EFPIA and its members are ready to work together with regulators to make safe and high quality COVID-19 diagnostics, vaccines and treatments available to patients, as fast as possible”1. EFPIA also underscores the immeasurable role that Europe’s regulatory system has had over the years to ensure safe and effective new treatments for patients across Europe and beyond. Since 1995, the European Medicines Agency (EMA) has recommended the authorization of over 1,400 medicines1!

As I was reading EFPIA’s plan, I remembered a poem that I had memorized years ago as a student – Robert Frost’s The Road Not Taken[2]. It starts…

Two roads diverged in a yellow wood,
And sorry I could not travel both
And be one traveler, long I stood
And looked down one as far as I could…

At the moment, there seem to be diverging roads as the global and EU regulatory systems tirelessly navigate the untraveled paths of this pandemic. If you will, we stand at a proverbial ‘fork’ in this road. One roadway has the well-worn tread of traditional practices and processes that would maintain the status quo. Currently, it takes around 436 days (median) for the EMA to assess a new active substance, compared to 244 days in the USA, 323 in Japan, 348 in Canada, and 363 in Australia[3]. During these unprecedented times, how will global regulators facilitate timely approvals of novel medicines?

There is an alternative pathway that, while more challenging to transverse, could practically and permanently advance the regulatory system. Exploring this often-uncharted path requires short- and long-term strategic focus, resources, collaboration, and persistence. However, if Europe does not travel this ‘new’ path, there is significant risk of being left behind. Opportunely, a roadmap has recently been drafted to assist in navigating this journey. The EMA’s Regulatory Science Strategy to 2025[4] maps a course of travel for Europe to be on the leading edge of medicine regulatory innovation. Many of its elements can be deployed to optimize research and streamline regulatory processes to address health challenges introduced by the COVID-19 crisis, and then also carried forward into the future. Similarly, EFPIA’s Regulatory Road to Innovation offers recommendations to progress regulatory science in four important areas:

  • Encourage the use of new types of clinical trials;
  • Allow greater use of data from real world use;
  • Allow ongoing dialogue and discussion about a treatment throughout development;
  • Simplify how medicines and other healthcare products are regulated.

 

In more detail, EFPIA’s recommendations include for “EMA to design guidelines for a flexible regulatory pathway which includes an iterative process for seeking early and continuous dialogue on data, as they are generated.”1; and for the “European Commission to accelerate the review of EMA recommendations for approval”1. These are important actions with an impact today and into the future. Frost’s poem concludes:

…Two roads diverged in a wood, and I,
I took the one less traveled by,
And that has made all the difference.

Which road will the EU regulatory system traverse to evolve and adapt to the forthcoming opportunities science offers to fight this COVID-19 emergency? Upon traveling, what actions will have made the ‘difference’ for European patients who will benefit from the ensuing medicines for COVID-19 and for other health conditions?

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[1] EFPIA Regulatory Road to Innovation Brochure. Published April 2020. https://efpia.eu/about-medicines/development-of-medicines/regulations-safety-supply/regulatory-road-to-innovation/
[2] Frost, R. The Road Not Taken by Robert Frost. 1916.
[3] CIRS, RD Briefing 70, New approvals in six regulatory authorities 2009-18, https://www.cirsci.org/wp-content/uploads/2020/02/CIRS-RD-Briefing-70-New-approvals-in-six-regulatory-authorities-2009-18.pdf
[4] EMA Regulatory Science to 2025: Strategic Reflection. March 2020. https://www.ema.europa.eu/en/about-us/how-we-work/regulatory-science-strategy#regulatory-science-strategy-to-2025-section
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