Der Mangel an Arzneimitteln ist ein altbekanntes Problem, aber in den letzten Jahren hat er ein Rekordniveau erreicht.
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00:00Hi, I'm Stefan Grubbe.
00:15Drug shortages have been an old problem, but over the past few years they have hit record
00:20levels.
00:21A consistent stream of supply issues has disrupted the deliveries of vital medicines.
00:26From hormone replacement therapy to cancer chemotherapies to medicines used to the treatment
00:32of the newest set of diabetes.
00:34Some of those shortages are now subsiding, others are persisting.
00:39That's why on top of the EU health policy agenda is the Critical Medicines Act.
00:44Aiming to address shortages experienced during the COVID-19 crisis, EU production, distribution,
00:51stockpiling and joint procurement.
00:54And improving cooperation between national administrations, pharma, civil society and
01:00the scientific community.
01:01We're talking about essential medicines such as painkillers, insulin and antibiotics.
01:07But the list could easily be much longer.
01:11We wanted to know from citizens in Europe which medicines should be on such a list.
01:16Medicines against which diseases?
01:21No, 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.
01:42I just was with the doctor, a special doctor, and he prescribed me something, I was kind
01:45of shocked because I didn't expect anything, I should start immediately and I went to the
01:49pharmacy and the pharmacist said, no, it's out of stock.
01:53So I went to another pharmacy, they would say, yes, it's confirmed, it's out of stock.
01:58I'm personally not a fan of the fact that you keep everything so secluded because, for
02:04instance, I go often to Asia and in Asia they have other things that we don't have in Europe.
02:09Sometimes we have to choose between some medicines, we have to choose that one instead of this
02:13one because it'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.
02:27Gerardo, good to see you.
02:29So tell us about the origins of this legislative initiative, who had the idea?
02:35Of course there have always been shortages in the EU.
02:38There was one in particular that started this discussion between the Commission and Member
02:43States.
02:44That was the one in 2022 on amoxicillin, which is an antibiotic.
02:50And then there were some initiatives like Critical Medicine List at EU level that was
02:55drafted by the European Medicine Agency with the help of the Commission, of course.
03:00And in the end also this Critical Medicine Alliance, which is a cooperation platform
03:05between 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.
03:36It was a bit of a decision by the Commission and the current Commissioner to prioritize
03:41this one because it was a bit of a low-hanging fruit.
03:44Because the other big topic, the Biotech Act at EU level, it seems a bit too far in terms
03:51of the development stage.
03:53I want you to look into your crystal ball anyway.
03:57Will the Critical Medicines Act see the light of day in 2025?
04:01I'd say that 2025, this is our timeline.
04:05Yes, there will be a Critical Medicine Act by that time.
04:08Why do drug shortages happen?
04:11There are multiple reasons.
04:12Geopolitical factors like the Covid pandemic, the Ukraine-Russia war or Brexit.
04:18A sudden spike in demand due to a rapid increase of a particular disease.
04:24Or 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.
04:41And that's why policymakers decided to act.
04:44Joining me now is Belgian Health Minister Frank van den Broeck, one of the driving forces
04:49in Europe in favor of the Critical Medicines Act.
04:52Welcome to the program, Minister.
04:54You 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.
05:09One of the worst shortages we ever had with thrombolytics.
05:12And at a certain moment, we were even afraid that patients would die because of the shortage
05:17of that medicine.
05:19And we saw the same thing happening in other countries.
05:23Production that disappeared, impossibility to act by governments.
05:29And so indeed, we called for an EU initiative in May 2023 and 23 EU member states joined
05:36us, which shows 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?
05:57And this means that you have to screen critical medicines to examine the vulnerabilities and
06:04to better understand the supply chains and the supply chain problems.
06:08That's the first thing.
06:09Secondly, obviously, you need solutions in terms of production in Europe, which means
06:15that you should think about how for some basic critical medicines where the supply chains
06:21are very vulnerable, how can you reach to Europe production?
06:26And finally, we should try to help each other and not try to make life of other member
06:33states more difficult.
06:34And this means that you should be cautious with national stockpiling.
06:39When one member state tries to protect itself by a national stockpile, that may be causing
06:45a problem for another member state.
06:48And so coordination of how you go about national stockpiles and national protective measures
06:55is very important.
06:56Will the Act also tackle the issue of too much dependence from countries like China and 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.
07:11Certainly, if you look at the geopolitical situation, one of the solutions is a diversification
07:16of international partnerships.
07:19Maybe if you have, let's say, a layer of third countries that can come to help you,
07:26to better protect it.
07:27So the idea is not to isolate yourself from the world.
07:31The idea of the country is to have secure provision by interesting partnerships and
07:36by not being too dependent on countries like China or India.
07:41The question for the future will be, can the EU achieve drug supply sovereignty?
07:46The Critical Medicines Act will be designed to come as close as possible to this goal,
07:51to the benefit of millions of patients in Europe.