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PHARMA DEUTSCHLAND
Feedback to the European Commission Proposal for a European Biotech Act I
(Health)
Strengthening Europe's Biotechnology Ecosystem through a
Future-Oriented Regulatory Framework
05/08/2026
Executive Summary
Pharma Deutschland welcomes the European Commission's proposal for a European Biotech Act
as a landmark initiative to strengthen Europe's competitiveness in biotechnology and
biomanufacturing. The proposal rightly recognises biotechnology as a strategic sector for Europe's
health security, economic resilience and technological sovereignty. It also acknowledges that Europe
must become a more attractive location for research, clinical development and manufacturing if it
wishes to remain competitive with global innovation hubs.
The proposed legislation introduces several important measures that will contribute to this objective,
including the acceleration of clinical trial procedures, the establishment of regulatory sandboxes,
improved coordination between regulatory authorities and stronger support for strategic
biotechnology projects. Pharma Deutschland strongly supports these objectives.
However, achieving the full potential of the Biotech Act requires that the legislation goes beyond
creating new structures. It should fundamentally reduce regulatory complexity, improve legal
certainty and establish a coherent European innovation framework across the entire biotechnology
value chain.
In particular, Pharma Deutschland recommends that the final legislation should:
further simplify and accelerate multinational clinical trials across the European Union;
strengthen the Clinical Trials Information System (CTIS) as the central digital platform for
clinical research;
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establish a clear and proportionate regulatory framework for the use of Artificial Intelligence
throughout the medicinal product lifecycle;
ensure seamless interaction between the Biotech Act, the European Health Data Space
(EHDS), the AI Act and the revised pharmaceutical legislation;
provide greater legal certainty regarding supplementary protection certificates (SPCs);
strengthen regulatory sandboxes as permanent instruments for regulatory learning and
innovation;
improve coordination between newly established governance structures and existing
European regulatory authorities;
promote investment in European biomanufacturing, including innovative biologics and
biosimilars, through a predictable and innovation-friendly regulatory framework.
Europe already possesses world-class scientific excellence. The challenge is no longer generating
innovation but successfully translating scientific discoveries into products that reach patients and
global markets. The Biotech Act should therefore become a cornerstone of a modern European life
sciences strategy that enables research, attracts investment and accelerates patient access to
innovative therapies.
General Remarks
Pharma Deutschland welcomes the Commission's ambition to establish Europe as the world's
leading biotechnology location by the end of this decade. The Biotech Act represents an important
opportunity to strengthen Europe's innovation ecosystem and to improve the Union's long-term
competitiveness in health biotechnology. These objectives fully reflect the increasing strategic
importance of biotechnology for public health, industrial resilience and economic growth.
The proposal appropriately recognises that biotechnology has become a key enabling technology
across modern healthcare. Beyond innovative biological medicines, biotechnology increasingly
shapes advanced therapies, vaccine development, precision medicine, diagnostics and digital drug
development. Consequently, the regulatory framework governing biotechnology must evolve at the
same pace as scientific progress.
Pharma Deutschland particularly welcomes that the Biotech Act adopts a broad perspective on
health biotechnology and combines measures addressing research, regulation, manufacturing,
digitalisation and investment. This integrated approach reflects the reality that Europe's
competitiveness depends on the interaction of these different policy areas rather than isolated
legislative initiatives.
At the same time, Europe continues to face structural disadvantages compared with other global
innovation regions. Clinical development remains slower than in competing jurisdictions, regulatory
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requirements are frequently fragmented, access to capital remains challenging for innovative
companies, and manufacturing investments increasingly migrate outside Europe.
The Biotech Act therefore should not merely introduce additional governance mechanisms. It should
establish a genuinely innovation-oriented regulatory environment that reduces administrative
complexity, increases predictability and enables faster translation of scientific discoveries into clinical
applications.
From Pharma Deutschland's perspective, five overarching principles should guide the final
legislation.
First, regulatory procedures should become significantly faster and more predictable. While
maintaining Europe's high standards for quality, safety and scientific assessment, unnecessary
administrative complexity should be eliminated wherever possible. Accelerating innovation requires
not only shorter legal timelines but also simpler regulatory pathways and better coordination between
authorities.
Second, digitalisation should become a core principle of biotechnology regulation. Modern clinical
research, regulatory submissions, data exchange and manufacturing increasingly rely on digital
infrastructures. The Biotech Act should therefore actively promote fully digital regulatory processes
and facilitate the use of innovative technologies throughout the product lifecycle.
Third, the legislation should create an enabling environment for responsible innovation in Artificial
Intelligence. AI has the potential to fundamentally transform drug discovery, clinical development,
manufacturing and regulatory science. The regulatory framework should encourage this
transformation while ensuring appropriate oversight through science-based regulation.
Fourth, Europe requires a coherent legislative framework across the rapidly evolving life sciences
landscape. The implementation of the Biotech Act should be closely coordinated with the revised EU
pharmaceutical legislation, the AI Act, the European Health Data Space and other relevant horizontal
legislation. Overlapping obligations, inconsistent requirements and regulatory duplication should be
avoided.
Finally, the Biotech Act should strengthen Europe's attractiveness for investment throughout the
biotechnology value chain. Regulatory excellence is increasingly becoming a decisive factor in global
investment decisions. Predictable legislation, efficient procedures and legal certainty are therefore
essential preconditions for maintaining research, development and manufacturing activities within
the European Union.
Taken together, these principles provide an opportunity to position Europe not only as a global leader
in scientific research but also as the preferred location for translating biotechnology innovation into
products that benefit patients worldwide.
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Accelerating Clinical Research in Europe
One of the most important contributions of the Biotech Act is its proposed revision of the Clinical
Trials Regulation. Faster and more efficient clinical development is essential if Europe is to regain
its position as one of the world's leading regions for pharmaceutical innovation. Pharma Deutschland
therefore strongly supports the Commission's objective of reducing unnecessary administrative
delays while maintaining the high scientific and ethical standards that characterise the European
regulatory system.
The proposed shortening of assessment timelines for multinational clinical trials represents a
significant improvement. In particular, Pharma Deutschland welcomes the reduction of validation
periods, shorter assessment timelines for initial applications and substantial modifications, the
strengthened role of the Reporting Member State, the possibility to submit parallel substantial
modifications, and the improved coordination between scientific and ethical assessments. Together,
these measures have the potential to significantly improve the efficiency and predictability of
multinational clinical research in Europe.
Further ambition on timelines
While the proposed timelines constitute a major step forward, Europe should continue to pursue the
objective of becoming the most attractive region globally for conducting multinational clinical trials.
Pharma Deutschland believes that further reductions in assessment timelines should be considered
where operationally feasible, provided that scientific quality and patient safety are fully maintained.
At the same time, accelerated procedures must remain realistic for both sponsors and competent
authorities. Certain deadlines proposed in the draft legislation may prove too restrictive in practice.
In particular, the proposed 7-day deadline for responding to complex requests relating to substantial
modifications appears challenging for scientifically complex amendments. Unrealistically short
timelines may inadvertently lead to unnecessary refusals, additional requests for clarification or
repeated submissions, thereby delaying rather than accelerating clinical development.
Recommendation
Pharma Deutschland recommends reconsidering the proposed 7-day timelines introduced
through the amendments to Articles 18(6), 22(1) and 22(3) of Regulation (EU) No 536/2014,
as these may not be operationally feasible for complex substantial modifications. Slightly longer
but realistic procedural deadlines would better support efficient assessments while avoiding
unnecessary refusals and re-submissions.
Pharma Deutschland recommends reviewing the further proposed procedural timelines to ensure
that they remain both ambitious and practically achievable. A balanced approach should seek to
accelerate assessments while maintaining robust scientific review and reducing unnecessary
administrative burden.
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Further opportunities to simplify multinational clinical trials
Beyond legislative timelines, the Biotech Act should further simplify the practical conduct of
multinational clinical trials.
In particular, the Commission should consider:
allowing core dossier changes and trial-specific modifications to be assessed in parallel
through a coordinated procedure, thereby reducing unnecessary sequential assessments;
enabling sponsors to engage with concerned Member States during the assessment process
to resolve outstanding issues before a formal refusal becomes necessary;
facilitating the establishment of EU-wide recognised lists of qualified investigational
sites and principal investigators, thereby reducing repetitive administrative verification for
each individual trial.
These pragmatic measures would complement the proposed legislative amendments and contribute
to a more efficient and predictable regulatory framework for clinical research across the Union.
Towards greater harmonisation of ethics assessments
Although the Clinical Trials Regulation has substantially harmonised the authorisation process,
ethics assessments continue to be organised at national level and remain highly heterogeneous
across Member States.
Pharma Deutschland recognises that the organisation of ethics committees falls largely within
Member State competence. Nevertheless, the Biotech Act provides an opportunity to promote
greater convergence through non-legislative measures. The Commission should therefore support
the development of common guidance, best practices and coordinated methodologies for ethics
assessments in multinational clinical trials. Greater alignment of review procedures, timelines and
governance would complement the objectives of the Clinical Trials Regulation and further strengthen
Europe's attractiveness as a location for clinical research.
Beyond legislative timelines, further improvements are necessary to fully realise the Commission's
objective of making Europe a globally competitive location for clinical research.
First, the Clinical Trials Information System (CTIS) should become a truly user-centred digital
platform. Although CTIS represents an important step towards harmonised European clinical trial
management, practical experience demonstrates that significant improvements in usability, workflow
design and system performance remain necessary. A modern digital infrastructure should reduce
administrative workload rather than create additional complexity. Continuous investment in user
experience and functionality should therefore accompany the legislative reforms.
Second, the Biotech Act should further promote fully digital clinical trial processes. Electronic
informed consent (eConsent), digital documentation, electronic signatures and remote regulatory
interactions should become standard practice wherever scientifically and ethically appropriate.
Digitalisation has the potential not only to reduce administrative burden but also to improve patient
participation and facilitate multinational research.
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Third, the legislation should encourage greater use of risk-based and remote inspections where
appropriate. Modern digital technologies enable secure access to documentation and quality
systems while reducing unnecessary administrative effort for both sponsors and authorities.
Finally, Europe should continue moving towards a genuinely integrated clinical research
environment. While the proposed legislative amendments significantly strengthen coordination
between Member States, further harmonisation of regulatory practices, scientific interpretations and
administrative implementation will remain essential for achieving a truly European clinical trial
ecosystem.
Artificial Intelligence and Health Data as Enablers of Biotechnology
Artificial Intelligence is rapidly becoming one of the key drivers of innovation throughout the
pharmaceutical lifecycle. AI has the potential to accelerate target identification, optimise clinical trial
design, improve manufacturing processes, strengthen pharmacovigilance and support regulatory
decision-making. The European Biotech Act therefore provides an important opportunity to establish
a regulatory framework that enables the responsible use of AI while maintaining Europe's high
standards for safety and scientific excellence.
Pharma Deutschland welcomes the Commission's intention to promote the use of Artificial
Intelligence within health biotechnology. However, the final legislation should provide greater legal
certainty regarding the interaction between the Biotech Act, the AI Act and existing pharmaceutical
legislation.
Avoiding overlapping regulatory requirements
AI systems that are developed and validated as part of the medicinal product lifecycle should not be
subject to unnecessary parallel regulatory assessments.
Where AI-supported methodologies are evaluated within established pharmaceutical regulatory
procedures, the scientific assessment performed by competent medicines authorities should remain
the primary regulatory pathway. Duplicate conformity assessments under horizontal legislation
should be avoided wherever equivalent scientific requirements are already fulfilled.
The Biotech Act should therefore explicitly promote regulatory coherence between sector-specific
pharmaceutical legislation and the AI Act, thereby reducing unnecessary administrative burden while
maintaining an appropriate level of oversight.
Regulatory acceptance of innovative AI methodologies
The increasing use of AI creates opportunities to modernise regulatory science itself.
The Commission should therefore encourage the development of European regulatory guidance on
innovative AI-supported methodologies, including:
AI-assisted drug discovery;
Digital Twins;
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AI-generated clinical endpoints;
synthetic control arms;
model-informed drug development;
AI-supported manufacturing and quality assurance.
Providing early scientific guidance in these areas would increase regulatory predictability and
encourage investment in innovative development approaches within Europe.
In particular, Pharma Deutschland supports empowering the European Medicines Agency to further
develop scientific guidance on the regulatory acceptance of AI-generated evidence where
scientifically appropriate. Such guidance would facilitate innovation while ensuring that scientific
standards remain fully preserved.
AI-ready regulatory infrastructure
Innovation in AI requires not only legal certainty but also adequate digital infrastructure.
The Health Biotechnology Clusters envisaged by the Biotech Act should therefore become centres
of excellence for computational biotechnology by facilitating access to high-performance computing
resources, particularly for SMEs, start-ups and academic spin-offs. Access to advanced computing
capacity remains a decisive factor for many AI-driven biotechnology projects and should be
considered an integral component of Europe's competitiveness strategy.
Recommendations
Pharma Deutschland recommends that the final Regulation should:
explicitly establish the principle of sector-specific primary regulation, ensuring that AI
systems scientifically evaluated within pharmaceutical legislation are not subject to
duplicative conformity assessments under the AI Act;
strengthen Articles 39 and 40 by establishing dedicated AI regulatory sandboxes covering
Digital Twins, AI-generated clinical endpoints and other AI-enabled development
methodologies;
explicitly empower the European Medicines Agency under Article 28 to develop scientific
guidance on AI-generated evidence, including synthetic control arms and AI-supported
clinical development;
strengthen European high-performance computing infrastructure for biotechnology
innovators, particularly SMEs and start-ups.
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Unlocking the Potential of European Health Data
Europe possesses one of the world's most valuable health data ecosystems. The successful
implementation of the European Health Data Space (EHDS) creates a unique opportunity to
strengthen biomedical research, accelerate innovation and improve regulatory science.
Pharma Deutschland strongly welcomes the close interaction between the Biotech Act and the
EHDS. Both initiatives should be implemented as complementary elements of a coherent European
Life Sciences Strategy rather than as separate legislative initiatives.
Facilitating secondary use of health data
Secure and trustworthy secondary use of health data will become an essential driver of
pharmaceutical innovation.
The Biotech Act should therefore actively facilitate access to high-quality, anonymised and
harmonised health datasets for research and innovation purposes, while fully respecting the
European framework for data protection and patient privacy.
Predictable and harmonised access procedures across Member States will be essential for enabling
multinational research projects and AI development.
Legal certainty for clinical research
The proposed clarification of the interaction between the Clinical Trials Regulation and the General
Data Protection Regulation represents a significant step towards greater legal certainty.
Pharma Deutschland welcomes the proposed clarification of the legal basis for processing personal
data in clinical trials as well as the harmonised interpretation of the responsibilities of sponsors and
investigators under the GDPR. These amendments have the potential to substantially reduce
divergent national interpretations that currently create unnecessary legal uncertainty for multinational
clinical research.
The final legislation should preserve this harmonised European approach and avoid introducing
additional national requirements that could undermine the objective of a truly integrated European
research area.
Data access for strategic biotechnology projects
Strategic biotechnology projects supported under the Biotech Act should benefit from efficient and
predictable access to European health data infrastructures.
This is particularly important for research into rare diseases, personalised medicine, advanced
therapies and AI-supported drug development, where robust datasets are essential for scientific
progress.
The Commission should therefore ensure that the implementation of the Biotech Act and the EHDS
remains closely coordinated in order to maximise the value of European health data for research,
innovation and public health.
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Recommendations
Pharma Deutschland recommends that the final Regulation should:
ensure seamless interoperability between the Biotech Act and the European Health Data
Space;
facilitate timely access to harmonised, anonymised health datasets for Strategic
Biotechnology Projects;
maintain the proposed amendments to Article 93 CTR clarifying the legal basis for
processing personal data and the responsibilities of sponsors and investigators under the
GDPR;
explicitly facilitate the secondary use of clinical trial data for scientific research without
creating additional consent requirements beyond those already established under EU
legislation.
Regulatory Sandboxes as Drivers of Innovation
Pharma Deutschland strongly supports the Commission's proposal to establish regulatory
sandboxes as a permanent instrument for fostering innovation in biotechnology.
Regulatory sandboxes have the potential to significantly accelerate the development and regulatory
acceptance of emerging technologies by enabling innovators and regulators to collaborate at an
early stage of development under clearly defined conditions. They also provide valuable
opportunities for regulatory learning, allowing competent authorities to adapt regulatory approaches
in parallel with scientific progress.
To maximise their effectiveness, the Biotech Act should establish a harmonised European framework
for regulatory sandboxes that ensures consistent implementation across Member States.
Participation criteria, governance structures and evaluation procedures should be transparent and
predictable, allowing companies of all sizes—including SMEs, start-ups and academic innovators—
to benefit from these initiatives.
In addition, regulatory sandboxes should explicitly support the validation of novel scientific
methodologies, including AI-supported development tools, Digital Twins, advanced manufacturing
technologies and innovative clinical trial methodologies.
Finally, experience gained within regulatory sandboxes should systematically contribute to future
regulatory guidance and legislative development. The Biotech Act should therefore establish clear
mechanisms through which lessons learned from sandbox projects can inform the continuous
evolution of European pharmaceutical regulation.
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Recommendations
Pharma Deutschland recommends that the final Regulation should:
establish a harmonised European governance framework for regulatory sandboxes;
encourage cross-border participation by innovators and competent authorities;
ensure that experience gained within regulatory sandboxes systematically informs future
guidance and legislative development;
explicitly include AI-supported development, Digital Twins and advanced manufacturing
technologies among the priority areas eligible for participation.
Strategic biotechnology projects
The Biotech Act rightly recognises that biotechnology manufacturing is a strategic asset for Europe's
health security, economic resilience and global competitiveness. Maintaining and expanding
manufacturing capacity within the European Union is essential not only for innovation but also for
ensuring secure supply chains, rapid response capabilities and long-term strategic autonomy.
Pharma Deutschland strongly supports the Commission's objective of strengthening European
biomanufacturing. However, regulatory simplification alone will not be sufficient to attract long-term
investment. Companies make investment decisions based on the overall predictability of the
regulatory environment, the speed of regulatory procedures and the availability of a coherent
European innovation ecosystem.
The Biotech Act should therefore establish a framework that creates confidence for long-term
investments across the entire biotechnology value chain—from early research and clinical
development to commercial manufacturing.
The proposed framework for High-Impact Strategic Projects represents an important opportunity to
accelerate Europe's biotechnology capabilities.
Pharma Deutschland welcomes the intention to prioritise projects with significant societal and
economic impact, particularly those contributing to innovative medicines, advanced therapies,
vaccine development, biomanufacturing and preparedness for future health emergencies.
To maximise the effectiveness of this instrument, the designation of Strategic Projects should provide
tangible regulatory advantages.
Projects receiving this designation should benefit from:
accelerated regulatory procedures;
coordinated scientific advice across relevant EU authorities;
prioritised interactions with competent authorities;
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simplified administrative requirements where appropriate;
predictable timelines throughout development.
The designation should represent more than a political label; it should deliver measurable regulatory
benefits that encourage companies to locate strategic biotechnology investments within the
European Union.
A predictable regulatory environment for investment
Global competition for biotechnology investment is intensifying.
While Europe continues to produce world-leading scientific research, many innovative companies
increasingly choose to conduct late-stage development, scale-up manufacturing or
commercialisation outside the Union.
The Biotech Act should therefore contribute to improving Europe's attractiveness by providing a
stable, predictable and innovation-friendly regulatory framework.
Regulatory predictability should become a strategic objective in itself. Frequent legislative changes,
overlapping requirements and inconsistent implementation across policy areas create uncertainty
that discourages investment.
The Commission should therefore ensure that future implementing measures under the Biotech Act
remain proportionate, science-based and developed in close dialogue with stakeholders.
Strengthening Europe's Biosimilar Ecosystem
The Biotech Act rightly recognises that Europe's biotechnology ecosystem encompasses both
innovative biological medicines and biosimilars. A competitive European biosimilar sector contributes
significantly to resilient supply chains, strategic autonomy, sustainable healthcare systems and
timely patient access to biological therapies.
Pharma Deutschland therefore welcomes the recognition of biosimilars within the scope of the
Biotech Act. Measures designed to strengthen European biotechnology and biomanufacturing
should explicitly benefit both innovative biologics and biosimilars, recognising their complementary
contribution to Europe's life sciences ecosystem.
While the European Medicines Agency provides a single scientific assessment for biosimilars across
the Union, important elements affecting market uptake continue to differ considerably between
Member States. Divergent approaches to interchangeability, substitution and procurement create
fragmentation within the internal market and may weaken incentives for investment in European
biosimilar development and manufacturing.
Although these issues remain largely within Member State competence, the Biotech Act should
promote greater regulatory convergence by encouraging the exchange of best practices and
supporting the consistent implementation of the EMA's scientific conclusions across the Union.
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A stronger and more harmonised European framework for biosimilars would contribute not only to
patient access but also to Europe's competitiveness, resilience and long-term security of supply.
Effective Governance and Regulatory Coherence
The Biotech Act introduces several new governance structures designed to strengthen coordination
across the European biotechnology ecosystem. Pharma Deutschland welcomes these initiatives and
recognises their potential to improve strategic foresight and regulatory cooperation.
In particular, the establishment of the Foresight Panel for Emerging Health Innovation and the
EU Health Biotechnology Support Network can make an important contribution to identifying
emerging technologies, supporting innovators and improving regulatory preparedness.
However, the creation of additional governance bodies should not increase institutional complexity.
Clear responsibilities
The final legislation should clearly define the respective roles of all newly established bodies and
ensure close coordination with existing European institutions, particularly:
the European Medicines Agency (EMA);
the European Commission;
relevant scientific expert groups;
existing coordination mechanisms established under pharmaceutical legislation.
Companies should experience a coherent regulatory landscape rather than multiple overlapping
interfaces.
A coordinated European innovation ecosystem
The Biotech Act should actively strengthen coordination across European legislation affecting
biotechnology.
In particular, implementation should be closely aligned with:
the revised EU pharmaceutical legislation;
the AI Act;
the European Health Data Space;
relevant data legislation;
legislation governing advanced therapies and clinical research.
Avoiding inconsistent requirements across these legislative instruments will reduce regulatory
burden and increase legal certainty for innovators.
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Continuous regulatory dialogue
Scientific innovation develops considerably faster than legislation.
Pharma Deutschland therefore encourages the Commission to strengthen mechanisms for
continuous dialogue between regulators, industry, academia and patients throughout the
implementation of the Biotech Act.
Beyond formal scientific advice procedures, the newly established governance structures should
facilitate ongoing exchanges on emerging technologies, novel development methodologies and
evolving regulatory needs.
Such continuous interaction would improve regulatory learning while increasing Europe's
responsiveness to scientific progress.
Recommendations
Pharma Deutschland recommends that the final Regulation should:
clarify the respective responsibilities of the newly established governance bodies under
Articles 37 and 39 and their interaction with existing European agencies, particularly the
European Medicines Agency;
avoid overlapping mandates and administrative duplication;
establish mechanisms for continuous dialogue between regulators, industry, academia and
patients throughout implementation of the Biotech Act.
Supplementary Protection Certificates (SPCs)
Pharma Deutschland welcomes the Commission's intention to strengthen incentives for
biotechnology innovation through the proposed extension of Supplementary Protection Certificates
(SPCs). Appropriate intellectual property incentives remain essential for maintaining Europe's
competitiveness in research-intensive biotechnology sectors.
However, the proposed eligibility criteria require further clarification to ensure legal certainty and
practical applicability.
Clarifying the eligibility criteria
The proposal requires that the medicinal product contains a new active substance that is "distinctly
different" from previously authorised products.
The concept of "distinctly different" is currently undefined and introduces significant legal
uncertainty.
European pharmaceutical legislation has traditionally relied on clearly established concepts such as
novelty and new active substance status. Introducing an undefined qualitative threshold risks
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inconsistent interpretation across Member States and could reduce the predictability of the proposed
incentive.
Pharma Deutschland therefore recommends replacing this terminology with objective and legally
established criteria.
Removing unnecessary cumulative requirements
The proposal additionally requires that the medicinal product demonstrates both:
a distinctly different active substance; and
a distinctly different mechanism of action.
The rationale for requiring both criteria cumulatively remains unclear.
Many important biotechnology innovations are based on new molecular approaches while acting on
established biological pathways. Such innovations can provide substantial therapeutic benefits
without necessarily fulfilling both conditions simultaneously.
The Commission should therefore reconsider whether both cumulative requirements are necessary
to achieve the intended policy objectives.
Practical feasibility of comparative evidence
The proposal further requires demonstration that the medicinal product is at least equally safe and
effective compared with all authorised medicinal products for the same indication.
In practice, this requirement is unlikely to be feasible.
Clinical development programmes are designed around predefined comparators and do not
generate direct comparative evidence against every authorised treatment available within the Union.
Maintaining this requirement could therefore unintentionally exclude genuinely innovative products
from the incentive scheme.
Pharma Deutschland recommends revising this provision to ensure that eligibility criteria remain
scientifically robust while reflecting established principles of pharmaceutical development.
Recommendations
Pharma Deutschland recommends that Article 27(1) (and the corresponding provisions in Article
59 for veterinary medicinal products) be amended as follows:
Article 27(1)(a): Replace the undefined criterion "distinctly different" with legally
established terminology, in order to ensure legal certainty, consistent interpretation and
predictable application across the Union.
Article 27(1)(b): Reconsider the cumulative requirement that an eligible medicinal product
must demonstrate both a distinctly different mechanism of action and at least
equivalent safety and efficacy compared with authorised medicinal products. The current
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formulation risks excluding important incremental and platform innovations that provide
significant clinical value.
Article 27(1)(b): Revise the requirement to demonstrate safety and efficacy in comparison
with any authorised medicinal product in the Union for the same disease, as such
comparative evidence is generally not generated during pharmaceutical development
programmes and is therefore unlikely to be feasible in practice. A more proportionate
criterion aligned with established regulatory principles would provide greater legal certainty
while preserving the intended innovation incentive.
Article 27(1)(c): Clarify the requirement that clinical trials must be conducted in more than
two Member States. The Regulation should specify whether this refers to pivotal clinical
trials only or to the overall clinical development programme, in order to avoid legal
uncertainty during implementation.
Article 27(1)(d): Clarify the definition of "at least one manufacturing step" performed
within the Union. More precise guidance on the qualifying manufacturing activities would
improve predictability for investment decisions and reduce divergent interpretation across
Member States.
Concluding Remarks
Pharma Deutschland strongly supports the objectives of the European Biotech Act and welcomes
the Commission's ambition to strengthen Europe's biotechnology ecosystem.
The proposal represents an important opportunity to improve Europe's competitiveness across
research, clinical development, manufacturing and regulatory science. At the same time, the final
legislation should ensure that these ambitions translate into practical improvements for innovators
operating within the European regulatory framework.
To maximise its impact, the Biotech Act should:
further simplify and accelerate clinical research across the European Union;
establish a coherent framework for the responsible use of Artificial Intelligence in
biotechnology;
strengthen the interaction with the European Health Data Space;
create effective and harmonised regulatory sandboxes;
provide meaningful regulatory incentives for Strategic Biotechnology Projects;
improve coordination between newly established governance structures and existing
European institutions;
ensure legal certainty regarding Supplementary Protection Certificates;
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maintain coherence with the revised pharmaceutical legislation and other horizontal EU
legislation.
The Biotech Act has the potential to become a cornerstone of Europe's future life sciences strategy.
By combining scientific excellence with a predictable, innovation-friendly regulatory framework, the
European Union can strengthen its global competitiveness while ensuring that patients gain faster
access to innovative therapies.
06.08.2026
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