• A review by more than 40 experts recently found that precision medicine's key barriers exist in policy and governance, not science and technology.
  • Unlocking data, prioritizing inclusivity and rethinking pricing models are key to maximizing precision medicine's full potential.

Could precision medicine see a resurgence in the post-COVID era? Not without fixing longstanding policy and governance challenges like cross-border data access, ethical technology development, genomic data policies and viability of diagnostics development.

That was the message from more than 40 global experts from across the healthcare ecosystem recently. They took a hard look at the barriers standing in the way of precision medicine approaches over the last 12 months part of the World Economic Forum’s Global Fourth Industrial Revolution Councils. The barriers they identified were not in science and technology but in policy and governance, ranging from laws to standards that set the “rules of the road” for corporations, governments and international organizations.

Health and healthcare

How is the World Economic Forum bringing data-driven healthcare to life?

The application of “precision medicine” to save and improve lives relies on good-quality, easily-accessible data on everything from our DNA to lifestyle and environmental factors. The opposite to a one-size-fits-all healthcare system, it has vast, untapped potential to transform the treatment and prediction of rare diseases—and disease in general.

But there is no global governance framework for such data and no common data portal. This is a problem that contributes to the premature deaths of hundreds of millions of rare-disease patients worldwide.

The World Economic Forum’s Breaking Barriers to Health Data Governance initiative is focused on creating, testing and growing a framework to support effective and responsible access – across borders – to sensitive health data for the treatment and diagnosis of rare diseases.

The data will be shared via a “federated data system”: a decentralized approach that allows different institutions to access each other’s data without that data ever leaving the organization it originated from. This is done via an application programming interface and strikes a balance between simply pooling data (posing security concerns) and limiting access completely.

The project is a collaboration between entities in the UK (Genomics England), Australia (Australian Genomics Health Alliance), Canada (Genomics4RD), and the US (Intermountain Healthcare).

As a result of their review, these expert Council Members had some tough words for the healthcare systems and the policymakers who need to adapt - and quickly - to accelerate healthcare systems’ movement toward precision medicine and better address a range of health issues from cancer to the current COVID-19 crisis.

“Unfortunately, more than half of the world’s population still has no access to precision medicine and is unable to reap the benefits," wrote the Council in the Precision Medicine Vision Statement, released this week. "We must be ever vigilant about increasing the capabilities of many countries and populations to join this global movement towards more personalized and targeted ways of screening, preventing, diagnosing, treating and curing patients with disease.”

1. Unlock the data

The lack of data interoperability is a key barrier to achieving precision medicine’s potential. Data interoperability is the capability of different programs to exchange data via a common set of formats. Without international data standards on genomic data, for example, we won’t be able to integrate data on genetic markers (specific sequences in our genetic blueprint that make us unique) into patient records so researchers can understand why one patient or population may be particularly susceptible to COVID-19. The lack of data interoperability is currently standing in the way of enabling large-scale data analytics to track and understand the spread of COVID-19 and tailoring patient treatments to fight the pandemic.

Such genomic data standards are being developed to help with interoperability, along with ways of federating data to ask questions of patient records across different countries. Still, the deployment of these standards needs to be greatly accelerated. For example, 475 million people are affected by rare disease worldwide, and only 5% of people with a rare disease receive treatment. Accelerating our ability to share data globally could provide benefits to diagnosis, disease management and treatment, clinical trials and personal well-being.

2. Ethical inclusion of vulnerable populations

COVID-19 is highlighting the need for ethical guidelines to guide inclusive technology development and deployment. The World Health Organization makes it clear that even in public health emergencies, research like clinical trials for new drugs to treat COVID-19 should be done in a way that protects but does not exclude vulnerable groups like pregnant women, minorities, and children.

We know that research studies often do not engage under-represented populations and if they do, often the results are not broken down by gender or ethnicity. For instance, we have some evidence that women recover from COVID-19 at a higher rate than men, but if we lump together all genders in when reporting research results of new treatments, we may be unable to understand why. If we do not prioritize including minorities (who are disproportionately impacted by COVID-19) in studies, we will not know which treatments work best for these vulnerable populations.

Furthermore, representativeness and inclusivity in medical research must be addressed for precision medicine advances to be applicable to populations outside of Europe and North America. The Council’s Members worry, rightly so, that many precision medicine treatments and diagnostics will not work very well when applied in other populations around the world who are in desperate need of high quality, value-based healthcare.

healthcare

What is the World Economic Forum doing about healthcare value and spending?

Each year, $3.2 trillion is spent on global healthcare making little or no impact on good health outcomes.

To address this issue, the World Economic Forum created the Global Coalition for Value in Healthcare to accelerate value-based health systems transformation.

This council partners with governments, leading companies, academia, and experts from around the world to co-design and pilot innovative new approaches to person-centered healthcare.

3. Pay a fair price for diagnostics

The diagnostics space has been chronically underfunded, subject to regulatory confusion, and boom-and-bust cycles. The current business models for diagnostics development do not support sustainable investment in science and technology or the capacity for building infrastructure needed to scale, particularly in emerging economies. This uncertainty plagues companies developing genetic tests to diagnose people with conditions such as kidney disease that can then be targeted by precision treatments. For this reason, diagnostics drive 70% of healthcare decisions, but only account for 2% of healthcare spending in the United States.

We need a shift in the value proposition and pricing models that accurately reflect the role of diagnostics in the entire healthcare journey. Instead of viewing diagnostics as a small step at the beginning of a healthcare journey, we need to consider the true value of knowing up front which treatment will be right for a specific person. Right now, without reimbursing the diagnostic test for what it is – a “sign post” that guides the next steps of prevention or treatment and cure – we will continue to suffer from a lack of cutting edge and widely available diagnostic tools.

"With guidance in place, the global community can continue to come together to build new solutions and reset how we look at healthcare from a precision perspective."

—Genya Dana

The Global Precision Medicine Council’s Vision Statement for Precision Medicine provides case studies to illustrate how to bridge these key governance gaps. The document includes models that offer guidance in a variety of areas including: building trust and engagement for direct-to-consumer genetic testing, increasing access to precision therapeutics in fast track situations, and structuring regulatory systems to innovate around genomic data privacy and ownership.

The Council's work to date is a first step towards developing the robust international collaborative environment needed to understand the many challenges that exist and to test solutions that bridge policy and governance gaps. These same governance gaps also stand in the way of treating COVID-19 in an ethical, timely, and coordinated way. With guidance in place, the global community can continue to come together to build new solutions and reset how we look at healthcare from a precision perspective.