In the last year, there has been a wave of changes made to the policies that govern the European life sciences industry.
With only 22% of new global treatments originating in Europe - and nearly 50% being developed in the United States (1) - these new regulations are a concerted effort to increase the R&D attractiveness of Europe.
Not only that, but these updates are making clear strides in increasing the accessibility of clinical research to patients across Europe, a model Curebase firmly stands by.
With so many recent shifts in regulation, we’ve compiled a brief overview below.
At the end of 2020, the European Commission (EC) adopted the Pharmaceutical Strategy for Europe to both ensure that patients have access to innovative and affordable medicines, and to also support innovation, competition, and the sustainability of the EU's pharmaceutical industry.
In 2021, the European Medicines Agency (EMA) launched the Regulatory Science Research Needs initiative.
The EMA issued a list of about 100 regulatory science topics that need further research to close gaps and improve medicine development in an effort to improve innovation. The initiative also highlights five goals for human medicines regulations:
1. Catalyze the integration of science and technology in medicines’ development.
2. Drive collaborative evidence generation, thus improving the scientific quality of evaluations.
3. Advance patient-centered access to medicines in partnership with healthcare systems.
4. Address emerging health threats and therapeutic challenges.
5. Enable and leverage research and innovation in regulatory science.
Due to the diversity in the region, the clinical trial environment in the EU can be challenging. Differences in regulatory requirements between member states complicate the submission of multi-state trial applications. This slows down trial authorization and can negatively affect research agility as well as cost efficiency.
The EU Clinical Trial Regulation (EU-CTR) was implemented in early 2022 and designed to simplify and harmonize clinical trials in the EU by replacing EU-CTD and aims to overcome EU-CTD’s shortcomings.
The EMA Network Strategy to 2025 outlines how the EMA will enable the supply of safe and effective medicines. This strategy also takes into account how this will be done amidst developments in science, medicine, digital technologies, globalization and emerging health threats.
The EMA Network Strategy also highlights six focus areas that are in line with the EC’s Pharmaceutical Strategy for Europe.
ACT EU aims to transform how clinical trials are initiated, designed and run. Six key objectives have been proposed to foster innovation in clinical trials.
1. Optimize the environment for clinical research in Europe, whilst maintaining high-level participant protection, data robustness and transparency, by:
a) Strengthening leadership and coordination on clinical trial authorization and execution.
b) Optimizing ethical oversight and further integrating ethics committees into the clinical trial and medicines regulatory lifecycle.
c) Supporting the conduct of large-scale multinational clinical trials with broader geographical scope.
d) Reducing administrative burden and increasing efficiency.
2. Strengthen clinical trials that deliver decisional evidence for unmet medical needs, rare diseases, and on vaccines and therapeutics for public health crises and pandemics, ensuring support for HTA bodies as well as for academic and SME sponsors.
3. Heighten the impact of European clinical trials through excellent and coordinated scientific advice as a complement to trial authorization and to support marketing authorization and access throughout the medicine lifecycle.
4. Engage all stakeholders to proactively deliver inclusive patient-oriented medicines development and delivery across populations.
5. Ensure a clear and unified European position on clinical trials in strategic matters at the international level.
6. Build capacity in all aspects of drug development and regulatory science through, amongst others, research collaboration and training with academia. Governance will be handled by a group that is chaired by the Commission and includes EC, HMA and EMA members.
There are several structural factors that impact this and new thinking is required to address these. These new initiatives in Europe sound promising and there are some new ideas that will hopefully lead to the necessary action that will impact multiple stakeholders in the ecosystem.
Across the board, this wave of regulatory changes solidifies the need for increased innovation, efficiency, accessibility and diversity within the clinical research space - not only in Europe, but globally.
As the landscape of traditional clinical trials and DCTs merge, it will require all stakeholders to have a seat at the table in moving policy forward.
As one of the innovation engineers, Curebase applauds these efforts. They hold a lot of promise in helping the community get the most out of the technological and operational research capabilities we already have available in Europe.
For our part, and as Curebase continues to expand our presence across the European market, we commit ourselves to helping advance the field and welcome invitations to work with us to see how we can help.
Click to learn more about Why you need to engage DCT study vendors earlier to assist in designing decentralized clinical trials.
1. The Pharmaceutical Industry in Figures, Key data 2021, Pharmaprojects & SCRIP, March 2021
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