It says the current regulatory system is too cumbersome for the latest technologies; while data generated from clinical trials lacks common standards and interoperability. But the organization - which represents corporate and associate members across sectors, plus national and regional biotechnology associations - says now is the time to create a better environment for biotech companies.
“We are entering a time of significant legislative change for many aspects of healthcare which will impact Europe on multiple levels. The revision of the pharmaceutical legislation, the Orphan and Paediatric regulations, the establishment of a new European Health Data Space and the latest progress on Advanced Therapy Medicinal Products (ATMPs) will significantly shape Europe’s innovative landscape," says EuropaBio.
“These developments will influence the translation of science into therapies, the ability of small companies to start and grow, and long-term investment decisions for large companies and countries within Europe.”
'Europe has the financial means to invest in SMEs - but is too structurally conservative'
Developing novel medicines from biotechnology is a long-term, high-risk venture that requires an agile business environment. However, the current European regulatory system is not prepared for the latest technologies, says EuropaBio's report.
“EMA authorisation procedures are too complex and have considerable administrative barriers which makes patients’ timely access to essential innovative medicines difficult.
“In addition to the complexity of the approval procedures, national pricing and reimbursement systems are not adequately catered to new products, such as gene and cell therapies.
“The lack of interoperability of data and what needs to be generated for HTA [Health Technology Assessment] processes and regulatory approval poses a significant challenge to European SMEs. It is crucial to harmonise requirements between regulators and HTA bodies across Europe. Whilst Europe has the financial means to invest in start-ups and SMEs, it is too structurally conservative compared to other global regions (state aid being a direct example).
“The COVID-19 pandemic highlighted private companies’ inability to bear alone all technical and financial risks associated with research, development and prediction of drugs, vaccines and diagnostics. The result of this is that globally impactful innovations emerge in disproportionately higher numbers outside Europe, and the deeper infrastructure and skills development is not developed to enable rapid scientific response or industrial scale up when needed.”
“Europe is not sufficiently competitive in terms of overall timelines for review and approval of regulatory submissions. This forces European experts to seek innovation-friendlier environments abroad, jeopardising Europe’s strategic autonomy.”
• Create regulatory frameworks suited to accelerating novel technologies to market
• Improve timelines and procedural transparency for patients to access advanced novel therapies and healthcare across Europe
• Enhance national cooperation for alignment of data to enable greater international benefit
• Align the information required for regulatory and HTA frameworks
• Review instruments such as state aid to enhance European competitiveness globally for higher risk investment,
• Promote industry engagement to strengthen the ability of ERNs within research and innovation
The EU's biotech industry is still restrained by national borders, says the report. Removing these would help connect up research and avoid duplication.
“When it comes to clinical trials, increased digitalisation could support the efforts to reduce duplication and the administrative burden," says the EuropaBio.
"Industry, regulators, HTA agencies, payers and other stakeholders must have equal access to critical information and engage in early dialogues on topics 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.”
Meanwhile, 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 be reimbursed for care received abroad by their home country. Therapies such as ATMPs are very specialised treatments that can only be administered in specialised treatment centres that do not exist in every Member State. Support to improve cross-border health for patients who need access to innovative therapies is needed at the EU and national levels. Furthermore, cross-border patient access can support SMEs that do not have the financial resources to apply for pricing and reimbursement in all European countries.”
The bloc has created European Reference Networks (ERNs) - virtual networks involving healthcare providers across Europe to discuss complex or rare diseases that require highly specialised treatment – but these have ‘not yet reached their potential’, says the report.