The unprecedented disruption caused by the pandemic has brought healthcare back to the forefront of public policy. In Europe, it is now clearer than ever that when it comes to protecting the health of citizens, the EU is strongest when we act together.
It is precisely this lesson that gave birth to the European Health Union, a work in progress since 2020 and a project built on the opportunities provided by the crisis to address the long-standing challenges and shortcomings that affect healthcare systems across our Union.
Medicines is a strong case in point. Access to medicines is one of the most powerful symbols of an efficient healthcare system.
The reality today is that medicines are not reaching all patients quickly enough as innovative and promising medicines that go on the market are not always available in all member states equally. Too many diseases also still remain with no prevention or treatment options at all. At the same time, many patients and healthcare systems cannot afford certain medicines due to their high prices and medicines shortages are a chronic problem that can leave patients without the therapies they need.
Geopolitical tensions have also highlighted the vulnerabilities and dependencies in our healthcare systems, which expose us to the whims of third countries. Meanwhile, pressing priorities such as the rise of antibiotic-resistant bacteria are not being addressed with the speed and efficiency required.
Europe needs a step change on medicines.
Since the current EU rules were put in place more than 20 years ago, new scientific and technological megatrends have revolutionised the health and pharmaceutical landscape. Our regulatory system cannot afford to lag behind.
A modern pharmaceutical system that is crisis-resilient and can deliver for citizens every day is a key part of the strong European Health Union that we are building with COVID-19 as a backdrop. Whether it is to stop a headache, treat an allergy, vaccinate a child or treat a cancer patient with the latest innovative medicine, these are essential products that citizens must have access to.
In 2019, 42 per cent of people in Malta were prescribed medicines.
Yet, while patients in some Western and bigger member states have access to 90 per cent of newly approved medicines, in some Eastern and smaller member states the number is as low as 10 per cent. The waiting time for access also differs a lot, with patients having to wait several years in some member states and only a few months in others.
Concretely, this means that some patients are left without effective treatment options for their disease. That is why it is so crucial to ensure that patients have access to both innovative and affordable medicines and that, at the same time, our world-leading pharmaceutical industry remains strong and internationally competitive.
Antimicrobial resistance needs to be tackled head-on before this ‘silent pandemic’ becomes our next global crisis
Our one-size-fits-all rules and fragmented single market for medicines are part of the problem. Incentives ought to be provided for our innovative industry but they should be more closely linked to responding to the needs of patients and health systems. Ensuring access for patients in all 27 member states is for us essential.
That is why we will, as a first order of priority, promote rules to ensure medicines reach all patients in the EU and to do so while enabling competition which, in turn, reduces prices and ensures the sustainability of healthcare systems across member states. We need to create a single market for medicines.
Second, but equally essential, is to support innovation with rules that stimulate research and slashing red tape from the system. Our approach will save €300 million in unnecessary administration.
To prevent shortages, it is also necessary to improve oversight of medicine supply chains, in particular to determine the need to boost EU strategic autonomy when it comes to medicine manufacturing and to identify the need to require contingency stocks of certain medicines.
Finally, antimicrobial resistance needs to be tackled head-on before this ‘silent pandemic’ becomes our next global crisis. Today, 35,000 people in the EU lose their life every year to drug-resistant bacteria.
We will propose bold instruments, including transferable exclusivity vouchers for novel antimicrobials, procurement mechanisms and prudent-use measures, to address the issue and to stimulate a product pipeline that has been dry for decades.
The key to this reform’s success can be found in one word: ‘balance’. The European pharmaceuticals industry must stay at the cutting edge of innovation; at the same time we must ensure that EU rules play their part to support bringing this innovation to citizens and patients across the EU.
Margaritis Schinas is vice president of the European Commission in charge of promoting our European Way of Life. Stella Kyriakides is European Commissioner for Health and Food Safety.