EU Cross-Border Access Laws Present ‘Unique Challenges’ For ATMPs

 
• By Eliza Slawther
  
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EU citizens can access medical treatments in countries other than their own through cross-border health care regulations – but these legislations were not built with advanced therapy medicinal products (ATMPs) in mind, experts warn.

Gene Therapy
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EU legislation around cross-border access to medical treatments poses the risk of “inconsistent decisions,” particularly when it comes to advanced therapy medicinal products (ATMPs) for rare diseases, according to Amber Werbrouck, a senior consultant at Belgian health care consultancy Hict.

Key Takeaways

  • Patients who need treatment with an advanced therapy product, such as a gene therapy, often need to travel abroad for treatments, and those with rare diseases face excessive logistical and financial hurdles.

“We’re looking at products where prior (reimbursement) authorization will be required, because we’re talking about orphan drugs, quite expensive drugs,...

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