Improving diagnosis for patient safety – Get it right, make it safe!

Our mission of the European Medicines Agency is to ensure that medicines in the European Union are safe, effective and of high quality. But even with the best medicines at hand, treatments can only benefit patients if their disease has been diagnosed accurately and on time. In public health, as with any other aspect of our life, to come up with best solutions, we first need to identify and understand the problem we are facing.

I welcome the theme set by the WHO for this year’s World Patient Safety Day, focused on improving diagnosis for patient safety under the slogan?“Get it right, make it safe!”. This important campaign raises awareness of diagnostic errors, which “account for 16% of preventable patient harm and are common in all health care settings.” Missed, incorrect, delayed, or poorly communicated diagnoses can negatively impact patient outcomes. They may lead to prolonged or more severe illness, disability, or even death, while also contributing to higher healthcare costs.

On this World Patient Safety Day, I want to raise awareness of the importance of point-of-care (POC) diagnostics – conducted at the time and place of patient care, and not in a laboratory.

Let’s take the example of hepatitis C, a viral infection that affects the liver and can lead to serious complications like liver cirrhosis and liver cancer if untreated. When the first medicines against hepatitis C virus (HCV) were approved by EMA around ten years ago, they were potential game changers: curing the disease actually came possible. But effective treatment and patient safety depends on rapid and accurate diagnosis. More and more Member States can now rely on POC testing for hepatitis C in routine clinical use to make this diagnosis, according to a 2022 ECDC report.

This is just one example that illustrates how important POC diagnostics can be. It is time to see more such tests developed and rolled-out in Europe. The pharmaceutical sector must act now - embrace innovative approaches and invest in research and development so more point-of-care diagnostics become available to patients who need them.

Those quick tests already out there are still not used enough, with issues ranging from lack of funding and resources, poor healthcare infrastructure and lack of training for healthcare providers, amongst others. We need more funding programmes available to fill these gaps. EU4Health, the largest programme of the European Commission to boost health around the EU, will soon close a 2024 call for accessible and affordable tests to advance early detection of heritable cancers in European regions. I would like to see more initiatives like this.

Let’s prioritise reliable point-of-care diagnostics! Medicines can really work and the healing of patients can properly start with the right and timely diagnosis.

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