Supporting Pharmaceutical Innovation in Europe – A round up

Earlier this week, Maddy Dawson, Analyst and Eleanor Butler, Consultant attended a webinar that focussed on supporting pharmaceutical innovation in Europe. Speakers Sandra Gallina, Director General for Health and Food Safety, Stefan Oelrich, Board of Management at Bayer and Bill Anderson, CEO Roche Pharmaceuticals discussed the challenges of creating a new pharmaceutical innovation ecosystem in Europe and the methods that can be implemented to support and maintain innovation in Europe. In this article, Maddy and Eleanor provide a round up of the key topics the panel covered during the webinar.

Since the European Commission announced the new pharmaceutical strategy for Europe on 25 November 2020, a key objective has been to re-structure the EU’s approach to incentivising and rewarding innovation. With the potential not only to save lives but to lead to millions of euros of savings in healthcare costs, innovative treatments should be a priority to the European economy. However, due to several barriers such as the high price tag associated with expensive research and development (R&D) processes, some countries are less willing to fund innovative therapies. The panel discussed the current barriers to innovation and the factors that could help to overcome them.

The lack of clinical trials in Europe compared to those registered with the FDA in the US, and the inefficiency of these trials, were agreed to be limiting factors in advancing innovation.

It was noted that a higher number of clinical trials in the US compared to the EU may be attributed to the greater presence of pharmaceutical companies in the US. In order to create a greater geographical link to clinical innovation globally, pharmaceutical companies must be incentivised to operate out of Europe. It was also highlighted that the efficiency of clinical trials could be improved with better utilisation of digitalisation (e.g., Artificial Intelligence and 3D printers), thus facilitating innovation. Furthermore, simplifying clinical trials through creating agreements between regulators (e.g., a single approach for the review of clinical trials) would lead to better access to trials, decrease clinical trial burden and save money, ultimately leading to lower priced innovative medicines across Europe.

Another current barrier to innovation that was discussed, is the burdensome and lengthy process for the approval of innovative drugs, due to the differing health technology assessment (HTA) pathways across Europe. The panel believe that streamlining the clinical review process is an important factor in reducing access timelines, and that the European joint HTA, which will centralise clinical assessment, could achieve this once it is established.

Finally, to make innovation attractive in Europe, the speakers stressed the importance of improving infrastructures and creating incentives for research and development into therapy areas of high unmet need. The panel discussed the need for non-financial incentives in addition to the more common financial incentives such as tax breaks and government grants. Current examples of non-financial incentives in the European member states include creating centres for information pooling and facilitating collaboration between different research institutes.

Other topics discussed in the webinar included the extent to which pharmaceutical companies promote the Environmental, Social and Governance agenda, as well as their efforts to curb the silent pandemic of antimicrobial resistance (e.g., the AMR Action Fund).

The panel hopes that the new pharmaceutical strategy can promote advances in European R&D, in-line with the unprecedented pace of innovation resulting from the Covid-19 pandemic, in order to achieve more efficient patient access to therapies.

If you’d like to understand more about how Lightning Health can help you to launch an innovative medicine in Europe, or to better understand the R&D incentives that exist at European and the member state level, get in touch.

 

 

 

Article published 28 January 2022.