EU Regulations Are Holding Back Gene and Cell Therapy Clinical Trials

European regulations might be responsible for lower numbers of advanced therapy clinical trials running in the region when compared to the US and Asia. 

Europe has historically been a pioneer in advanced therapies, such as cell and gene therapy. Europe was the first region to approve a gene therapy, and it boasts the highest number of marketing authorizations of advanced therapies worldwide. 

However, in the past four years, the number of clinical trials with advanced therapies has stalled in Europe, growing by just below 2%. Meanwhile, the number of trials went up in North America and Asia by 36% and 28%, respectively, in the same period. 

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This conclusion was drawn from the analysis of the 2,097 clinical trials of advanced therapies conducted worldwide between 2014 and the first half of 2019. The study was carried out by the Alliance for Regenerative Medicine (ARM), an international community of stakeholders in the development of new medical technologies.  

Current EU regulations could be to blame. Any clinical trial that is conducted across multiple European countries requires separate review and approval in each country. 

“When national authorities review clinical trial authorizations independently, they may have diverging opinions that create a delay for the companies,” said Annie Hubert, Senior Director of European Policy at the ARM.

The issue becomes even bigger with advanced therapies, as the requirements regarding testing donors and starting materials vary across different countries. 

In particular, gene therapies are the most affected. The study found that while in North America 71% of advanced therapy trials involve any form of gene therapy or gene editing, in Europe that percentage is only 55%. 

Gene therapies face an additional hurdle in Europe; they are considered genetically modified organisms and must therefore additionally comply with GMO regulation, which falls under the umbrella of environmental or agricultural legislation depending on the country. 

“The complexity in the GMO regulation may be the reason why we see fewer clinical trials with gene therapy in Europe compared to other regions,” Hubert told me.

“A company that applies for a clinical trial with a gene therapy needs to secure the review and approval by the GMO authority in that country on top of having the approval for the clinical trial for the medicinal product. There have been situations where, for the same gene therapy, the decision from different GMO authorities in Europe was different.”

The study concluded that streamlining the regulatory process might make Europe more competitive in the development of advanced therapies. This can already be seen in certain European countries, such as Belgium, Denmark and Switzerland, where the amount of clinical trials is actually higher than in the US when accounting for their size.  

“Belgium for instance has an approval time of 15 days for phase I clinical trials. That acts as an incentive,” said Hubert. “In the UK and in Denmark, companies have access to a central point of contact that liaises with the GMO authorities and facilitates the review of clinical trial applications.”

The European Commission has been aware of these issues for several years. Previous studies reported that the current clinical trial legislation, which dates to 2001, resulted in a decline in the overall number of clinical trials running in Europe. 

The Commission has already created new regulations that seek to address some of these problems through a centralized application system where one national authority takes the lead in reviewing the application, while the others can either agree or disagree with it. 

However, there have been delays in the creation of the application platform and the regulations have not yet been implemented. Hubert expects this could happen sometime in late 2020 or 2021. 

“I think we need to be realistic. Any significant change will probably take a number of years before we can see the number of clinical trials increasing significantly in Europe.”

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