Drug shortages are an old problem, but over the past few years they have hit record levels.
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00:00Hi, I'm Stefan Grubbe. Drug shortages have been an old problem, but over the past few
00:18years they have hit record levels. A consistent stream of supply issues has disrupted the
00:24deliveries of vital medicines, from hormone replacement therapy to cancer chemotherapies
00:30to medicines used to the treatment of the newest set of diabetes. Some of those shortages
00:35are now subsiding, others are persisting. That's why on top of the EU health policy
00:40agenda is the Critical Medicines Act. Aiming to address shortages experienced during the
00:47Covid-19 crisis, EU production, distribution, stockpiling and joint procurement, and improving
00:55cooperation between national administrations, pharma, civil society and the scientific
01:00community. We're talking about essential medicines such as painkillers, insulin and
01:05antibiotics, but the list could easily be much longer. We wanted to know from citizens
01:12in Europe which medicines should be on such a list. Medicines against which diseases?
01:18No, I think I'm healthy, I rarely take medicine, so I don't have any problem with that.
01:28You know, remembering the issues we had also during Covid, so I think that stockpiling
01:34medicines is very important and definitely to become independent of third countries in
01:40that respect is super important. I just was with a doctor, a special doctor, and he prescribed
01:45me something, I was kind of shocked because I didn't expect anything, I should start immediately
01:48and I went to the pharmacy and the pharmacist said no, it's out of stock. So I went to another
01:54pharmacy, they would say yes, it's confirmed, it's out of stock. I'm personally not a fan
01:59of the fact that you keep everything so secluded because, for instance, I go often to Asia
02:05and in Asia they have other things that we don't have in Europe. Sometimes we have to
02:09choose between some medicines, we have to choose that one instead of this one because
02:14it's not refounded by the healthcare.
02:19Let's bring in Gerardo Fortuna now, who has followed very closely the development of the
02:24Critical Medicines Act for Euronews. Gerardo, good to see you. So, tell us about the origins
02:31of this legislative initiative. Who had the idea?
02:35Of course, there have always been shortages in the EU. There was one in particular that
02:40started this discussion between the Commission and Member States, that was the one in 2022
02:47on amoxicillin, which is an antibiotic, and then there were some initiatives like a critical
02:53medicine list at the EU level that was drafted by the European Medicine Agency with the help
02:59of the Commission, of course, and in the end also this Critical Medicine Alliance, which
03:03is a cooperation platform between industry and also Member States.
03:10So, although Ursula von der Leyen initially had suggested some urgency, the whole matter
03:16is not on the list that you just described of the to-do list until the end of March.
03:23What's going on?
03:24To be fair, it's always been Oliver Varelli, the Health Commissioner, who presented this
03:30initiative as something to present in the first 100 days. It was a bit of a decision
03:38by the Commission and the current Commissioner to prioritise this one because it was a bit
03:42of a low-hanging fruit, because the other big topic, the Biotech Act at the EU level,
03:48it seems a bit too far in terms of the development stage.
03:53I want you to look into your crystal ball anyway. Will the Critical Medicines Act see
03:59the light of day in 2025?
04:01I'd say that 2025, if this is our timeline, yes, there will be a Critical Medicines Act
04:07by that time.
04:08Why do drug shortages happen? There are multiple reasons. Geopolitical factors like the COVID
04:15pandemic, the Ukraine-Russia war or Brexit, a sudden spike in demand due to a rapid increase
04:22of a particular disease, or a sudden drop in supply because of recalls or quality problems.
04:31Whatever the reasons for a shortage, it puts patients in a very uncomfortable position
04:36because medical supply issues can be distressing and frustrating. And that's why policymakers
04:42decided to act. Joining me now is Belgian Health Minister Frank van den Broeke, one
04:48of the driving forces in Europe in favor of the Critical Medicines Act. Welcome to
04:53the program, Minister. You led the EU charge against drug shortages after the COVID era.
05:00Tell us how that experience shaped your political thinking.
05:04The trigger for us was an experience that was really very bad, one of the worst shortages
05:10we ever had with thrombolytics. And at a certain moment, we were even afraid that patients
05:15would die because of the shortage of that medicine. And we saw the same thing happening
05:20in other countries. Production that disappeared, impossibility to act by governments. And so
05:29indeed we called for an EU initiative in May 2023, and 23 EU member states joined us, which
05:37shows that this was a structural problem present everywhere.
05:42And what should the new Critical Medicines Act focus on?
05:46Well, the first is that you should have a good insight in your real vulnerabilities,
05:52which medicines are vulnerable to shortages and why. And this means that you have to screen
05:59critical medicines to examine the vulnerabilities and to better understand the supply chains
06:06and the supply chain problems. That's the first thing. Secondly, obviously, you need
06:12solutions in terms of production in Europe, which means that you should think about how
06:17for some basic critical medicines where the supply chains are very vulnerable, how can
06:22you reshore to Europe production? And finally, we should try to help each other and not try
06:30to make life of other member states more difficult. And this means that you should be cautious
06:36with national stockpiling. When one member state tries to protect itself by a national
06:42stockpile, that may be causing a problem for another member state. And so coordination
06:50of how you go about national stockpiles and national protective measures is very important.
06:56Will the Act also tackle the issue of too much dependence from countries like China
07:00and India?
07:01Yes. I think the fact that 70 to 80 percent of our pharmaceuticals are dependent on production
07:08in countries like China and India is a problem. Certainly, if you look at the geopolitical
07:13situation, one of the solutions is a diversification of international partnerships. Maybe if you
07:20have, let's say, a layer of third countries that can come to help you, you're better protected.
07:27So the idea is not to isolate yourself from the world. The idea of the country is to have
07:33secure provision by interesting partnerships and by not being too dependent on countries
07:40like China or India.
07:41The question for the future will be, can the EU achieve drug supply sovereignty? The Critical
07:47Medicines Act will be designed to come as close as possible to this goal, to the benefit
07:52of millions of patients in Europe.