Data and Biotechnology at the Crossroads
The debate around data privacy, data sharing and data research has been raging for decades. The rise of artificial intelligence and an ever increasing interconnected world has brought it to a pinnacle in recent years. How do we regulate data? What is personal data? Who owns data? Countries everywhere are grappling with these questions, and in some cases are putting in policies that may be detrimental to innovation.
And yes, while for the most part the focus of this debate has been the tech sector, biotech has not been unscathed. Let's face it, data is data and every sector has its version of data and biotech is no different.
Let me elaborate.
Research and development in the biotech sector, in general, begins in research institutions (though well financed companies also fund their own research too). Most of these institutions are publicly funded with a goal to disseminate the resulting fruit of their research for public benefit. Institutions carry out this goal through technology transfer. Scientists at institutions might discover a gene or a protein for example, that appears commercially promising (which they patent), and work with their tech transfer offices to find a partner to further develop the promising research. This is generally done by licensing the patented technology to someone who will develop it.
After many years, significant financial investment and numerous failures, the result of that research might be a novel life saving therapeutic, or an environmentally applicable enzyme, or a seed that will yield a novel crop. Keep in mind that these collaborations and partnerships are becoming increasingly global in nature and often are driven by pre-commercial companies, accounting for over 70% of the early-stage clinical developments.
It is also the case that the healthcare sector is experiencing a paradigm shift from traditional one-size-fits-all medical care to personalized medicine tailored to the genomic, molecular, and lifestyle characteristics of individual patients. Companies are realizing that unlocking the power of healthcare data, including human genomic resource materials as well as digital and other related type of biomedical information, to fuel innovation in medical research is at the heart of today’s paradigm shift. To put it simply, medicine today is increasingly a collaboration between the realms of data science and clinical science.
Harnessing data offers biotechnology researchers deeper understanding of disease pathways and ultimately helps develop targeted treatments with improved efficacy and safety. The pipeline of biotechnological innovation is rich with these transformative therapies that would not exist were it not for this remarkable convergence of modern biotechnology and the data sciences.
We're not overstating it when we say that data drives innovation in biotech. And that the convergence of big data across the spectrum of biotechnology, is unleashing a new wave of innovations not only in healthcare but also in food security and our ability to deal with climate change. This may sound lofty, but it is within reach and achievable in the right policy environment. Or, it can be stymied before it even takes off.
India understands the potential of biotechnology.
Over the past decade, India has invested significant resources towards the creation and nurturing of its biotechnology sector. Last year alone the Department of Biotechnology (DBT) invested the equivalent of 500 million USD into biotech science clusters and international partnerships and more than 1.5 billion in the life sciences sector. In 2020 the COVID pandemic prompted global collaboration in the race for a cure and India took part in that effort. The decades long US India Vaccine Action Program has resulted in many cross-border collaborations that have yielded tremendous success. In his recent address to the US India Business Council, Prime Minister Modi touted India as being open for business and invited US companies to collaborate in all business sectors in India.
This is all good and well, and will likely (hopefully) result in beneficial products not only for the Indian people, but perhaps the world over. Then why is India stymieing its own efforts?
On July 13, 2020, a Committee of Experts within India’s Ministry of Electronics and Information Technology ("the Committee”) published the first draft of a Non-Personal Data Governance Framework for India for public consultation.
In its proposed framework, the Committee alludes to various issues relating to non-personal data and puts forward recommendations for consideration by the Indian Government on the regulation of said data. In one of its recommendations, the Committee states that non-personal data may be transferred outside India, but shall continue to be stored within India; and that “critical” non-personal data can only be stored and processed in India.
If India is truly serious about the goal of collaboration, it needs to understand the collaborative nature of biotechnology and that a forced data localization requirement (which is what the recommended policies amount to) is the antithesis of that goal. Indeed, in the biotechnology sector which is already prone to great risk, such policies would discourage scientific collaboration. As attractive as India is with respect to its research capabilities, there are many other countries with less restrictive, or no localization requirements that are waiting in the wings to do business. Companies will simply look elsewhere.
However, this isn't only bad for India, but in addition, unreasonable restrictions on the flow of data out of India pose significant barriers to global R&D collaboration. Without the ability to transfer data out of India, the ability to drive global research and development projects would be significantly undermined.
In this regard, India should also be careful of how it regulates access to anonymized and aggregated data which it has classified as "sensitive", or the Committee's recommendation which compels the sharing of data for “social/public/or economic benefits.” The Framework explicitly lists science and healthcare as core public interest purposes that would justify a compelled sharing of data.
Such a situation where data sharing could be compelled by a government authority would discourage biotechnology companies from engaging in research and development endeavors with local Indian companies in the first place thereby frustrating global R&D collaboration initiatives in India. But again, these obstacles are not only problematic for India, they would undermine scientific advancement and, more importantly, do a disservice to global public health and the development of treatments to benefit all of mankind.
Clearly privacy of data should be protected and this article is not intended to suggest otherwise. Countries are right to protect the privacy of their citizens. But such a goal need not stand in the way of scientific and economic progress. Any restrictions of data for life sciences research can and should be crafted in such a way as to balance privacy public policy objectives while still enabling cross-border research and development to occur.
Ultimately, to realize the potential of promising biotech innovations and address unmet medical and societal needs, life sciences researchers around the world require a robust and reliable global ecosystem for data. They require an ecosystem that allows for timely access to a wide range of data sets and where any restrictions on international data flows are transparent, limited in scope and the least trade restrictive to achieve a legitimate public policy objective.
India would be wise to consider the global implications of such policies... and so should other countries.
