In the six years to 2021, 20% of all EMA authorised products were classified as combination products, i.e. drug/device or drug/diagnostic¹, a trend that is set to continue.

The current pace of advancements in health-technology and biotechnology innovation is as diverse and dynamic as it has ever been, and set to intensify further over the coming years. In healthcare, medicines will increasingly be complemented and augmented by multiple possibilities to better manage, recover, and sustain health. 

Such interventions, right across the patient journey from diagnosis to post treatment care, promise to unlock not only a more holistic joined-up care for patients but also valuable efficiencies for health systems. The use of new technologies in medical research and clinical practice offers unprecedented opportunities to support the care pathway and eventually also to change the means by which we deliver care to individual patients. Such technologies, taken together and known as integrated healthcare solutions, also add complexity and regulatory challenges.

Early cancer detection and diagnosis is arguably the most impactful way to turn the tide against cancer: Survival rates are 5 to 10 times greater when cancer is detected at an early stage

(Aravanis, 20172). And early detection also brings a significant productivity benefit from enabling people to move beyond their illness and return to productive life and work, while also saving many years of lost life (Ezell, 20213). Conversely, when cancer diagnosis and care is

delayed or inaccessible, patient outcomes are compromised, with a lower chance of survival, greater problems associated with treatment, and higher costs of care.

Today’s integrated healthcare solutions combine two or more dimensions along the continuum of patient care including for example, a drug, and a device, such as a companion diagnostic; next-generation sequencing (NGS) or a drug delivery system; prognostic / predictive biomarkers; and digital health technologies (DHTs), including clinical decision support tools, remote patient monitoring, apps, or wearables.

Emergent solutions to meet the challenge of cancer offer health systems ever more precise and timely means of understanding the genomic alterations that underlie a patient’s cancer. And with this to fit the therapy to the patient’s exact need, through personalised healthcare.

Companion diagnostics (CDx) are available for an increasing number of medicines: They allow clarity, for example, on a cancer’s genomic profile and for treatment decisions that focus therapy on the patients who will benefit. Examples include tests for gene alterations such as BRAF in metastatic melanoma, ALK in lung cancer, and HER2 in breast cancer. Companion diagnostics contribute to significantly improving treatment outcomes, and lowering trial and error approaches and related resources.

Emergent circulating tumor DNA tests (ctDNA), known as liquid biopsies, hold strong potential to screen early for a variety of cancers. The benefits extend right across the patient’s care journey, from earlier detection to any recurrence, earlier and more frequent monitoring of the medicine’s effects, and most of all, a much less invasive alternative to follow up tissue biopsies. They can also inform treatment options, especially in situations where there is no tumor tissue or only minimal tumor tissue available.

Not only are new technologies set to transform the risk management of diseases such as cancer and Alzheimer’s through next generation diagnostic possibilities, but also later in the patient journey, in post treatment care through science-based software that offers real time, real life digital measures and signals that monitor therapeutic response and help manage illness.

One of the most eyecatching areas in which digital technologies can help health systems get ahead of cancer is in radiology. Radiographic imaging is essential right across the oncology patient journey, and also in drug clinical trials, to establish the stage of the disease, to evaluate treatment effectiveness, to determine success of treatment, and to detect potential relapse. As manual readings of radiology images are resource-intensive at 15-60 minutes per CT/ PET scan, with up to 40% reader-to-reader variability and risk of observational oversights, there are significant limitations to manual reads of oncology imaging.

AI-based CT & PET/CT imaging solutions aim to significantly improve the quality and speed of disease diagnosis and treatment and also guide more accurate patient screening and monitoring at point of care. They may also accelerate and improve evidence generation in drug development. Such technology interventions at a system level offer enormous potential for precisioning medicine as well as greater peace of mind to patients at risk of over/ under diagnosis.

As integrated healthcare solutions proliferate, combined with the still accelerating pace of innovation, their regulation can often be as yet undefined and potentially unpredictable. The assessment of such solutions is going to bring new complexities to regulation, and a need to build capabilities and capacities to meet the challenge.

Today, developers must navigate a fragmented and overly complex system when developing and seeking regulatory review for these products. Each component of an integrated solution may fall under a different regulatory definition, framework or procedure with oversight by different public and private bodies. To date navigating regulatory requirements has been a discovery through dialogue process. This inevitably extends the time it takes for the benefits of innovation to be adopted by health systems and reach patients.

Clarity on regulatory pathways for today and tomorrow’s products is crucial for patients waiting on solutions to their unmet needs. The European Medicines Agency (EMA) is the key actor in the assessment of medicines in the European Union (EU). To harness the potential of integrated solutions and to keep pace with the rapid advancement of science and technology, it is crucial EMA plays a leading role in orchestrating modern, streamlined regulatory approaches and procedures with all relevant authorities, notified bodies4, and stakeholders necessary in order to deliver these innovations to patients more quickly.

In the context of the current once-in-a-generation revision of the European pharmaceutical legislation, while Roche welcomes the introduction of a sandbox mechanism to test highly innovative products, we believe that to enable the full potential of the sandbox concept for integrated solutions, it needs to expand beyond pharmaceuticals towards devices and in-vitro diagnostics as well.

At the same time, we call on the European Commission to be more ambitious, and have the role of the EMA be a true orchestrator between highly complex, siloed and multi-governance-based EU regulatory frameworks, e.g. the medicinal products and IVDR/MDR regulatory frameworks.

The components in healthcare solutions are likely to diversify as the convergence of medical research and digital technology continues its dynamic evolution. It is fundamental to the healthcare innovation competitiveness of Europe that regulation keeps pace with what becomes increasingly possible in digital data and analytics driven, learning healthcare systems. We cannot extend the waiting time for patients due to the zig-zagging or challenges in traversing regulatory bodies to define the path.


  1. EFPIA, Evidence MIX (Measures, Insights, and eXamples): Evaluating the EU Regulatory System

  2. Alexander M. Aravanis, Mark Lee, Richard D. Klausner, Next-Generation Sequencing of Circulating Tumor DNA for Early Cancer Detection, Cell, 9 February 2017, Pages 571-574

  3. Stephen Ezell, Seizing the Transformative Opportunity of Multi-cancer Early Detection, ITIF webinar, April 19, 2021

  4. Notified bodies are government accredited, mostly private companies, that take over sovereign tasks on behalf of national authorities.

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