Cultivating biotechnology in Europe: EuropaBio makes recommendations

Cultivating biotechnology in Europe: EuropaBio makes recommendations

He says the current regulatory system is too cumbersome for the latest technologies; while the data generated by clinical trials lack common standards and interoperability. But the organization – which represents corporate and associate members across industries, as well as national and regional biotech associations – says now is the time to create a better environment for biotech companies.

“We are entering a time of significant legislative changes for many aspects of healthcare that will impact Europe on multiple levels. The revision of pharmaceutical legislation, the regulations on orphans and children, the establishment of a new European health data space and the latest advances in advanced therapy medicinal products (ATMPs) will significantly shape Europe’s innovative landscape. ” says EuropaBio.

“These developments will affect the translation of science into therapies, the ability of small businesses to start and grow, and long-term investment decisions for large companies and European countries.”

“Europe has the financial means to invest in SMEs, but it is structurally too conservative”

Developing new drugs from biotechnology is a long-term, high-risk undertaking that requires an agile business environment. However, the current European regulatory system is not prepared for the latest technologies, says the EuropaBio report.

“EMA’s authorization procedures are too complex and present significant administrative barriers that make it difficult for patients to access essential innovative medicines in a timely manner.

“In addition to the complexity of approval procedures, national pricing and reimbursement systems are not adequately adapted to new products, such as gene and cell therapies.

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