The Commission made the prediction in a new reportanalysing cell and gene therapy development in Europe.
The main aim of the analysis was to find out why only four ATMPs have been approved in Europe despite the fact that more than 250 have been registered in the EudraCT database since 2004.
One of the key findings of the research is that development is dominated by smaller companies and non-profit organizations. Almost 70% of sponsors for clinical trials on ATMPs reported in EudraCT are not-for-profit organisations or SMEs, while big pharma companies account for less than 2% of all sponsorships.
The report, which was submitted to the European Parliament and Council, also notes that on average, less than a quarter of the molecules that are tested in clinical trials obtain a marketing authorisation. The path from identification of an active substance to the authorisation of the medicinal product can take more than ten years.
Regulatory issues
The report also takes a look at the ATMP Regulation, which was the subject of considerable industry criticism when it came into force in June 2013 with the key concern being that the regulations lacked the flexability necessary to permit the effective development of complex therapies.
And even when developers have followed the regulations there have been difficulties according to the Commission, which noted cases where the competent authorities of different member states had reached divergent conclusions as to whether a product should be considered an ATMP.
Therefore the same product can be marketed under different regulatory regimes, which the Commissions claims “is not only undesirable from a public health standpoint but it also undermines the incentives to develop ATMPs.”
The Commission suggested that any uncertainty as to the market potential of a product discourages investments, distorts competition between developers and hinders the movement of ATMPs across member states.
To ATMP or not to ATMP?
Another limitation of the current system, according to the report, is that the competent authorities of the member states do not have the possibility to “seek the view of the CAT [Commission on Advanced Therapies] when they are confronted with the question whether a product should be considered as ATMP.”
The 2013 ATMP Regulation also empowered the Commission to adopt specific requirements regarding the content of marketing authorisation applications, good manufacturing practices, good clinical practice, and the traceability of ATMPs. But some in industry have complained of the lengthy approval times.
The Commission noted that “the experience acquired since the entry into force of the ATMP Regulation shows that there is room for streamlining the procedure for the evaluation of ATMPs.
“Simplification of this procedure should not only bring benefits for prospective applicants but should also ensure that there is a robust assessment of these complex products and clear allocation of responsibility within the Agency for this task,” according to the Commission.