Biotechnology SMEs are the frontier for successful therapeutics developed to patients. They represent the pipeline through which Europe’s excellence in research is translated and matured, both for patient and economic benefits in Europe.
It is critical that SMEs mature innovations quickly to patients and the market, so that Europe is globally competitive and patients everywhere can access life saving and life changing medicines.
Pharmaceutical legislation creates the world in which SMEs emerge and thrive, and the future of Europe’s healthcare is directly linked to its ability to bring medicines to patients through SMEs. We have a window of opportunity to bring the critical voice of SMEs into the conversation at the highest political levels in Europe, and show how their journey to the patient is the story of healthcare.
SMEs are uniquely vulnerable to hurdles in their journey to the patient. Intellectual property to secure investment into high risk science, time to regulatory approval, market fragmentation, reimbursement and long term data requirements – these are shaped by pharmaceutical legislation and Europe is undergoing a transformation that will define the SME landscape for Europe in the next 20 years. We must find the balance for incentives that enable and protect SMEs to deliver transformative therapies, and the rights for citizens to access those transformative therapies and the benefits that they bring.
As the voice of SMEs across Europe, EuropaBio launched its SME BioForum in 2022, with the first edition dedicated to advanced therapies (ATMPs). SME Executives highlighted the challenges that face small companies and how the European legislative and regulatory framework can serve SMEs and patients, in addition to the vital economic and skills development that biotechnology delivers.
The BioForum recommendations underpin the effective delivery of science in Europe – from the beauty of discovery to the impact on health, economy and society.
• Accelerate approval times for advanced therapies and engage early in the regulatory process
• Unlock the power of Europe’s 500 million citizens for clinical trials and access to medicines
• Harness the power of regulatory expertise across countries to serve the whole of Europe
• Simplify GMO requirements for advanced therapies
• Complement early access pathways with innovative reimbursement and modernised HTA
• Build the skills needed to deliver advanced therapies across the whole healthcare ecosystem in Europe
EuropaBio and SME community calls for Europe to seize the opportunity with the pharmaceutical legislative review to ensure that patient access to advancing healthcare and a thriving SME landscape are two sides of the same coin. Europe has within its hands today, the power to deliver competitive and fast moving SMEs which in turn deliver the medicines for patients worldwide.