Overcoming the hurdles in bringing ATMPs to the European market

By Vassia Barba contact

- Last updated on GMT

Image: Getty/Stefan_Alfonso
Image: Getty/Stefan_Alfonso

Related tags: cell and gene therapy, Alliance for Regenerative Medicine, Europe, Cell therapy

Modifications on the regulatory framework and focus on funding schemes are the first steps on the path for healthcare systems to adapt to ATMPs’ ‘new ground’, says ARM head for Europe.

During this year’s UK Bioscience Forum that took place in London, Annie Hubert, senior director of European Public Policy for the Alliance for Regenerative Medicine, spoke on a panel titled ‘Overcoming the barriers to cell and gene therapies’ about successfully bringing ATMPs to markets and healthcare systems that have not yet fully adapted to the newly-established therapies.

BioPharma-Reporter spoke with the executive after the panel about where Europe is currently standing on the path to sufficiently providing patients with the full potential of cell and gene therapies, including complex autologous products in the developer’s pipelines.

“ATMPs form a new ground not only for companies but also for patients, healthcare systems and regulators; ARM is trying to look at all the different aspects, such as the technical challenges faced by autologous product manufacturers, which increase the complexity for distributors,” ​the executive said.

However, apart from the technical issues, Hubert noted that one of the most important aspects is the regulatory assessment, in which “we have come a long way, and Europe has taken the lead to adapt – with the first regulatory framework for ATMPs established in 2007.”

According to the executive, European regulators have collaborated extensively with organizations such as the Alliance, to reform the healthcare regulations for that purpose. 

The biggest hurdles, Hubert noted, are found in market access and funding-seeking for ATMPs developers, for which a valuable option could be a ‘pay-for-performance scheme’.

“In many cases of integrating groundbreaking therapies into healthcare systems, we believe that pay-for-performance schemes need to be put in place, meaning that the product is put on the market with a certain price tag, but there is a ‘discount’ according to its performance after some time,”​ she noted.

Such funding schemes, according to Hubert, offer some certainty to healthcare systems and help to avoid investment loss – such payments schemes are already found in countries including Italy and the UK.

Related topics: Markets & Regulations

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