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Posted 12 May 2022 | By Denise Fulton 

Pandemic highlighted challenges of ATMP clinical trials in Europe

2701 AMSTERDAM - A conflict between European regulations governing clinical trials and those governing the use of genetically modified organisms (GMO) was distinctly exposed by the COVID-19 pandemic, Charlie Mortazavi said here at RAPS Euro Convergence.
 
That attention and future clarification of the regulations could help clear the way for clinical trials of advanced therapy medicinal products (ATMP) in Europe, said Mortazavi, senior manager of global regulatory affairs at Sanofi in Paris.
 
During the COVID public health emergency, the European Commission waived compliance with the GMO directives for vaccines and therapeutics to address the pandemic. As a result, vaccines and treatments were able to come to market very quickly.
 
“This was motivated only by the health crisis and when it is over, sponsors will need to comply with the GMO directive again,” Mortazavi said.
 
He pointed out that between 2014 and 2018, new clinical trials for ATMPs started in the US increased by 36%, while Asia saw a 28% increase. During the same period, trials started in Europe increased by less than 2%.
 
While the reasons behind this stark difference are multifold, the European GMO legal framework plays a part, he added.
 
If a vaccine or therapy with a GMO component seeks approval in the EU, it must comply with both the Clinical Trial Regulation (Directive 2001/20/EC) and the GMO legal framework (Directive 2000/54/EC as well as Directive 2001/18/EC and Directive 2009/41/EC). Each Member State has implemented the GMO directives with different requirements and procedures. The additional requirements, combined with the lack of alignment on GMO requirements, cause a significant lag in getting trials completed in Europe.
 
“So, in Europe, unfortunately, in many other regulations, we have no alignment, and it impacts the European approval schedule for clinical trials,” Mortazavi said. “It can take from three months to more than one year to have the GMO approved and the clinical trial approved to start your trial. Imagine you're a sponsor and you want to [bring your product to] two or three countries in Europe. You have to juggle between three months until approval to sometimes more than a year. How do you manage your teams and your vendors and your clinical trial contractors?”
 
Mortazavi outlined the four basic processes that Member States use to assess therapeutics that have a GMO component:
  • GMO authorization required prior to clinical trial application (CTA) submission
  •  
  • GMO authorization required prior to CTA approval, though both can be submitted in parallel
  • CTA and GMO dossiers submitted in parallel
  • CTA and GMO dossiers are a single submission
In the coming years, the EU could consider potential revisions to this situation, in order to foster a more streamlined environment for ATMP clinical trials, according to Mortazavi, who offered five potential options for such a reform.
 
In the first option, the EU could amend the current GMO directives to exempt clinical trials; however, the EC is likely to prefer to do so via directive, Mortazavi said.
 
The second option – which he characterized as possibly the most likely of the options – would have the EU create a new stand-alone directive or regulation. Because of the current Euroseptic environment between EU countries as well as an increased appetite from the EC to use regulation as a legal instrument of choice these days, this is a likely scenario for future change, Montazavi said.
 
Additional options that have been suggested include changes to the Clinical Trials Regulation – which statutorily cannot be used – and a revision of the general pharmaceutical legislation. The final option would include transferring the competences for GMO requirements from the Member States to the EU and having the European Medicines Agency act as the single competent authority.
 
“A stand-alone directive will also imply what we did at the commission with the two GMO directives and to have it implemented identically by countries. Right now, it is two directives and the way they are implemented and translated into national laws are completely different between countries,” Mortazavi said. “I think it would be a stronger directive. It would encompass more human medicines.
 
“Changes will come,” he said. “It’s a matter of time. Perhaps in another 5 years, I am sure that one or two of the options will be a reality.”

 

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