Prof. Volker ter Meulen, Co-chair of the EASAC-FEAM Working Group and Past President of EASAC, said: “Stem cell and gene-based therapies hold great medical promises. But we are alarmed over a trend to lower requirements of evidence. Also, we see an increasing problem of commercial clinics offering unregulated products and services”
The Academies say the idea of regenerative medicine is to tackle diseases which up to now are incurable. According to the report, cosmetic applications, for example, are inappropriate for the time being.
“So far, regenerative medicine has proven itself only in few specific clinical indications, for example for skin disorders. Yet, we see an increasing number of unregulated clinics promising a wide range of benefits on the basis of poorly characterised medicinal products with little evidence of effectiveness. They usually advertise their services via the internet with the primary intention of financial profit,” explains EASAC Biosciences Programme Director Dr. Robin Fears.
The scientists urge the EU to resist the pressure and put patients first. “When countries lower regulatory standards in their eagerness to support national economic interests, it is even more important for the EU as a major global player to defend the principles of international cooperation in health regulation”, says Prof. George Griffin, Co-chair of the Working Group and President of FEAM.
“We all want cures to be available in the shortest time frame possible. But our analysis and recommendations aim at ensuring that regulatory procedures are robust, transparent and evidence-based,” concludes Cossu. “Scientific research and proof are more important than ever. The EU and national regulators should be wary of not undermining public trust in science.”