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.
“The lack of data interoperability and what needs to be generated for the HTA [Health Technology Assessment] processes and regulatory approval represent a significant challenge for European SMEs. It is essential to harmonize the requirements between regulators and HTA bodies across Europe. Although Europe has the financial means to invest in start-ups and SMEs, it is structurally too conservative compared to other regions of the world (state aid is one example).
“The COVID-19 pandemic highlighted the inability of private companies to bear on their own all the technical and financial risks associated with the research, development and forecasting of drugs, vaccines and diagnostics. The result of this is that innovations with global impact are emerging in disproportionate numbers outside of Europe and deeper infrastructure and skills development is not being developed to allow for rapid scientific response or industrial scale when needed. “
“Europe is not competitive enough in terms of overall timing for the review and approval of regulatory proposals. This forces European experts to look abroad for more favorable environments for innovation, jeopardizing Europe’s strategic autonomy “.
• Create regulatory frameworks suitable for accelerating the placing on the market of new technologies
• Improve timing and procedural transparency for patients to access new advanced therapies and healthcare across Europe
• Strengthen national cooperation for data alignment to enable greater international advantage
• Align information required for regulatory and HTA frameworks
• Review tools such as state aid to strengthen European competitiveness globally for higher risk investments,
• Promote industry engagement to strengthen the capacity of ERNs in research and innovation
Beyond the borders
The EU biotech industry is still limited by national borders, the report said. Removing these would help link the search and avoid duplication.
“When it comes to clinical trials, more digitization could support efforts to reduce duplication and administrative burden,”Says EuropaBio.
“Industry, Regulators, HTA agencies, payers and other stakeholders must have equal access to critical information and engage in early dialogues on topics such as appropriate clinical study design. The data generated in these clinical trials lack common standards and interoperability. These challenges limit the potential for cross-border collaboration and the search for new medical solutions ”.
In the meantime, systems need to be created to make it easier for Europeans to cross borders to other Member States to receive specialized medical care.
“Europeans have the right to access healthcare in any EU country and to be reimbursed for care received abroad from their country of origin. Therapies such as ATMPs are very specialized treatments that can only be administered in specialized treatment centers which do not exist in all Member States. Support to improve cross-border health for patients who need access to innovative therapies is needed at EU and national level. Furthermore, cross-border access for patients can support SMEs that do not have the financial resources to apply for pricing and reimbursement in all European countries. ”
The bloc created the European Reference Networks (ERNs) – virtual networks involving healthcare professionals across Europe to discuss complex or rare diseases that require highly specialized care – but these “have not yet reached their potential,” the report said. .
The report can be found in full here.