Goodbye 2023: when optimism came back

When you smell the Glühwein on the air and the radio station plays Chris Rea’s Driving Home for Christmas you know the festive season is here and it is time to reflect on another eventful year.

In 2023, optimism returned to our lives with the official end of the COVID-19 public health emergency. The last three years tested our regulatory system to its limits, but we have come out stronger, more coordinated both at European Union (EU) and international level, and better prepared for future crises. Today, we continue to learn its lessons while remembering that for many people life has not returned to normal.

The key crisis lesson for our network is that collaboration is king; if you do not have a culture of close collaboration with your partners, it can be incredibly difficult to address challenges when they emerge. Last year, the EU faced a crippling shortage of basic medicines: patients struggled to get access to simple antibiotics. As part of our extended mandate, we built new tools and structures to improve our ability to respond to medicines shortages by closely monitoring supply and demand. And while this problem continued in 2023, we were able to be proactive and are much better prepared to ensure patients have the medicines they need.

Among the other big stories in 2023, I would highlight the role of innovation in our work. Firstly, we had the launch of the proposed new EU pharmaceutical legislation. This is a big deal. We will use the concepts to future-proof our medicines regulation network to drive innovation putting patients at the centre. Secondly, we felt the full presence of artificial intelligence (AI) in medicines regulation. As we need to be fully prepared for the regulatory challenges ahead of us, EMA acted timely and launched a draft AI reflection paper for consultation in July. I am an optimist by nature and I see AI as an enabler of a smarter, more data-driven regulatory network. It is good news for patients and animals but there is much work ahead of us to ensure appropriate safeguards are in place.

The third innovation I want to highlight is in the medical device area. We witnessed a milestone in the support for innovation and availability of safe and effective high-risk medical devices. For the first time ever, the expert panels at EMA granted scientific advice to three manufacturers of novel or breakthrough devices under a pilot that was launched earlier this year.

As I wave goodbye to 2023, I would like to thank those who continue to champion science and collaboration to support patients and animals in the EU. Medicines regulation is good science combined with good collaboration (between people, countries, and institutions). Despite everything and as already stated by Hippocrates 2,400 years ago: science is the father of knowledge, and we should never take its value to society for granted. Without it, we would be nowhere. As medicines regulators we have a responsibility to shout it from the rooftops: good science underpins everything we do and every decision we make.

Our best work, I believe, comes from the trust we place in science and the trust we place in each other. So, let us continue to build on the trust and collaboration as we move into 2024. And on behalf of my team at EMA, I wish you and all your loved ones a wonderful festive season and a happy and prosperous new year!