Ref. Ares(2021)1400307 - 22/02/2021
Roche feedback to the European Commission Trade Policy
Review
Roche welcomes the opportunity to provide feedback to the European Commission’s review of the European
Union’s trade policy (the “Review”). The Commission’s objective is to build a consensus around a fresh
medium-term direction for EU trade policy, responding to a variety of new global chal enges and taking into account
the lessons learned from the coronavirus crisis.
Context for Roche feedback:
Recognising that the Review is relevant to the life-sciences sector in many aspects, in this feedback, we have
focused on digital trade elements and in particular data policy related aspects, such as cross-border dataflows.
General considerations:
In the light of the central role of data in the context of digital trade, data policies wil strongly define the future trade
landscape. An effective digital trade policy framework should be aligned with the data policy elements of the future
European Data Strategy and as such refer to agreed concepts, models and processes and consistently apply a
governance framework for data access, sharing and use, recognising and visualizing the value to individuals and
societies of translating data into actionable information.
Policy frameworks should address data transfer and market access issues, including expectations on transparency
and protection of personal data and data security while al owing for necessary flexibility to accommodate multiple
data access and sharing models (e.g. transactional, partnership, federated) and contexts of data use and consider in
particular:
(i) GDPR is leveraged as a baseline approach to protection of personal data that considers practical aspects of
compliance and enforcement
(i ) recognition of data partners prerogative to protect commercial y or general y sensitive information (also
considering competition laws)
(i i) value exchange within data ecosystems is agreed upon
(iv) data standards for quality and interoperability
(v) processes are sufficiently rapid, agile and flexible
(vi) an effective framework for fair (non-discriminatory) competition
(vi ) whenever possible, a cross-border approach/commitment to development of scalable ecosystems
In particular in the field of healthcare, the current Covid-19 crisis shows the importance of cross-border exchange of
high-quality health data.
Question 10: How can digital trade rules benefit EU businesses, including SMEs? How could the
digital transition, within the EU but also in developing country trade partners, be supported by trade policy, in
particular when it comes to key digital technologies and major developments (e.g. block chain, artificial
intel igence, big data flows)?
Data used in the context of for example artificial Intel igence (AI) has the potential to contribute to earlier disease
detection, more accurate diagnosis, further understanding of human physiology and the development of
personalised medicines and diagnostics. Examples of practical AI applications can be found in data mining to
identify drug targets and molecule interactions, clinical trial design and recruitment, supply chain planning, adverse
event recognition, patient support platforms and physician decision support accelerate research for example
through better target identification, trial execution, improving regulatory procedures and identification of novel
scientific insight generation.
Health data is unique. In contrast to industrial data in other sectors, health data is personal and sensitive, and
requires special y strict protection, yet regulating and enabling the access and processing promises to yield
enormous and invaluable insights and benefits for citizens, patients and society. In the healthcare sector, the right
to access and control individual data needs to be balanced against the responsibility of healthcare professionals
and manufacturers of medical technologies to deliver safe and high-quality care and the opportunity to address
unmet needs and deliver better care for people.
Personal data protection is among the local/regional objectives that are most likely to involve a data transfer
restriction, however, much of the friction currently experienced in the attempts to establish dataflows is based on
apparent misperceptions such as data being better protected in one location or that data localization maximises
value for local populations. In fact, disruptions in dataflows may rather limit access to new technologies / therapies
for the local population. In this context, it should be noted that also conservative interpretations of GDPR to ensure
data stays local have been prohibitive. It should be a priority to ensure a uniform approach to interpretation of the
GDPR among EU Member States prior to leveraging GDPR instruments in the context of frameworks for third
country dataflows.
We strongly agree with the baseline in the Consultation Note that stability and predictability, including legal
certainty, is paramount to improve market access. To ful y unlock the value and growth potential inherent in data,
any measures to improve market access should in particular address interoperable personal data protection and
data security provisions and data standard definitions in line with the principles expressed in the
European Data
Strategy. Whereas regulatory differences across countries are to some extent necessary and appropriate, there is
a clear need for regulatory cooperation to achieve interoperable frameworks that include mechanisms to reduce
regulatory overload. A report by the World Economic Forum (WEF)
Exploring International Data Flow Governance
from 2019, further provides examples on how trade policy, incl. regulatory cooperation can play a critical role in
helping achieve the required balance between data transfer and other policy objectives.
Digital trade rules and trade policy can play a major role in addressing regulatory and standards differences and
incompatibilities for example in the areas of protection of personal data and data security provisions and data
quality standards as barriers to trade and promote harmonised governance frameworks. Existing provisions in
regional free trade agreements that prohibit unnecessary and discriminatory restrictions on data flows provide
governments with examples of tools to enable the flow of data across borders. We provide more detailed
feedback to various digital trade barriers below in our response to Question 11.
Question 11: What are the biggest barriers and opportunities for European businesses engaging in
digital trade in third countries or for consumers when engaging in e-commerce? How important are the
international transfers of data for EU business activity?
The Consultation Note recognises that it wil , perhaps now in the aftermath of the Covid-19 crisis more than ever,
be essential for the EU economy to benefit from growth opportunities abroad. In the digital technologies’ context,
data is the central commodity which hosts enormous potential for innovation also in the health field. According to
the WEF platform initiative
Shaping the Future of Technology Governance: Data Policy, it is predicted that the
global volume of data wil double between 2018 and 2022, and double again between 2022 and 2025 but “much of
the data needed to tackle the world’s most pressing chal enges lies siloed in both public and private sources, with
an array of regulatory, commercial and social risks preventing the sharing of data, even for social good”. According
to the WEF report
Exploring International Data Flow Governance, “limited services access and higher data
processing costs could end up broadly affecting countries’ ability to compete in the Fourth Industrial Revolution,
within which growth wil be driven by technology deployment”.
In the field of digital and sustainable technologies, incl. AI and Internet of Things, the innovative industry in Europe
has the potential to be global leaders and a major contributor to the future competitiveness of Europe. Roche, as a
global y active innovative R&D company largely relies on international data transfers (incl. the internal distribution
to its centers of excel ence for the particular research) for the purpose of leveraging the potential of digital
technologies, such as AI, to accelerate research through better target identification, clinical trial execution and
general y for the identification of novel scientific insight generation to the benefit of citizens, patients and society.
As stated earlier Roche's access and use of data has the potential to contribute to the development of
personalised medicines and diagnostics. AI, as an enabler of personalised medicine, relies heavily on access to
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datasets on which the system has been trained. The higher the quality of data that goes into the system, the better
the outcome of the AI specific task. Without access to high quality data the potential of AI wil not be realized in
healthcare. Cloud computing and AI can provide a technology platform that is able to meet the real data security
and personal data protection needs of nations without geographical limitations as long as the right legal
framework, policies and standards are agreed to on a global/regional basis.
To increase the value of European data and further strengthen Europe’s role in the emerging data economy as set
out in the
European Data Strategy, it is essential to establish and implement international y acceptable personal
data protection, security, interoperability and quality standards. FAIR Principles1 offer a strong foundation to
enabling this and the reusable principle in particular benefits patients and society. Regulatory cooperation and
standards harmonisation are key for enabling increased col aboration, insights generation and exchange at scale
across borders (note potential e.g. in pandemic scenario) and sectors, where applicable. Increased international
and cross-sector exchange and col aboration can accelerate recognition of the value to individuals and societies of
translating data into actionable information. Increased consistency, or at least interoperability, between national /
regional frameworks especial y in the field of protection of personal data, data security and quality standards and
certifications helps avoid overregulation and the related legal uncertainty consequences (see especial y AI
governance context). A governance framework, including FTAs and WTO initiatives, should therefore prioritize
regulatory cooperation on personal data protection and security measures and standardization needs to support
data quality and interoperability.
To the extent possible, it should be a natural extension of existing structures and take into account the existing
global standardisation arena to avoid duplication and leverage systems already implemented within sectors. In
particular, there should be a link to al relevant European and international health IT standards development
organisations but also include industry consortia that deliver interoperability profiles, with due stakeholder
engagement. In the context of any standardisation, harmonisation or coordination efforts, Roche believes
meaningful sharing of data is enabled by high quality data and interoperability. Quality data and interoperability set
the foundation for delivery of personalised healthcare. We encourage the aspiration of GAIA-X, as the potential
infrastructure for the EU Common Data Spaces, to define international y acceptable interoperability and data
quality standards. We strongly encourage leveraging existing standards to avoid additional adoption cost and time
to achieve this objective.
In the context of protection of personal data, it is important to consider the different data flows and forms of data
(ie. anonymized, pseudonymized, aggregated data and personal data) when considering governance frameworks.
Variation in interpretation of GDPR and other regional/local frameworks for protection of personal data and
inconsistent country practices including differing expectations of anonymization, pseudonymization and
aggregation processes are a barrier to market access to companies offering innovative services.
1Wilkinson, M. D. et al. The FAIR Guiding Principles for scientific data management and stewardship. Scientific Data 2016 3:160018 (2016)
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