The German government rejected claims by U.S. Health Secretary Robert F. Kennedy Jr. that Berlin prosecuted doctors and patients for refusing Covid-19 vaccinations or mask mandates. “The statements made by the U.S. Secretary of Health are completely unfounded, factually incorrect, and must be rejected,” German Health Minister Nina Warken said in a statement late Saturday. “I can happily explain this to him personally,” she said. “At no time during the coronavirus pandemic was there any obligation for doctors to carry out vaccines against Covid-19,” Warken added. “Anyone who did not wish to offer vaccines for medical, ethical or personal reasons were not criminally liable and did not have to fear penalties,” she said. Warken added that “criminal prosecution took place only in cases of fraud and forgery of documents, such as the issuing of false vaccine certificates” or exemption certificates for masks.  “Doctors [in Germany] decide independently and autonomously on the treatment of patients,” the minister stressed, adding that “patients are also free to decide which treatment they wish to receive.” Kennedy said in a video post on Saturday that he had written to Warken after receiving reports that Germany was restricting “people’s abilities to act on their own convictions” in medical decisions. He claimed that “more than a thousand German physicians and thousands of their patients” faced prosecution for issuing exemptions from mask-wearing or Covid-19 vaccination requirements during the pandemic. Kennedy did not provide specific examples or identify the reports he cited, but he said Germany was “targeting physicians who put their patients first” and was “punishing citizens for making their own medical choices.” He accused Berlin of undermining the doctor–patient relationship and replacing it with “a dangerous system that makes physicians enforcers of state policies.” Former German Health Minister Karl Lauterbach also pushed back on the claims, telling Kennedy on X to “take care of health problems in his own country.”

President Donald Trump has told his health secretary, Robert F. Kennedy Jr., to consider aligning the U.S. vaccination schedule with those in Europe, where many countries recommend fewer vaccines. Kennedy has taken up the charge with gusto and is considering advising parents to follow Denmark’s childhood schedule rather than America’s. Many who specialize in vaccination and public health say that would be a mistake. While wealthy European countries do health care comparatively well, they say, there are lots of reasons Americans are recommended more shots than Europeans, ranging from different levels of access to health care to different levels of disease. “If [Kennedy] would like to get us universal health care, then maybe we can have a conversation about having the schedule adjusted,” Demetre Daskalakis, who led the Centers for Disease Control and Prevention’s National Center for Immunization and Respiratory Diseases before resigning in protest in August, told POLITICO. Children, especially those who live in poor and rural areas, would be at greater risk for severe disease and death if the U.S. were to drop shots from its schedule, Daskalakis said. Denmark, for instance, advises immunizing against only 10 of the 18 diseases American children were historically recommended immunizations against. It excludes shots for potentially serious infections, including hepatitis A and B, meningitis and respiratory syncytial virus. Under Kennedy, the government has already changed its hepatitis B vaccine recommendations for newborns this year, even as critics warned the new advice could lead to more chronic infections, liver problems and cancer. The health department points out that the new guidance on hepatitis B — that mothers who test negative for the virus may skip giving their newborn a shot in the hospital — now align more closely with most countries in Europe. Public health experts and others critical of the move say slimmer European vaccine schedules are a cost-saving measure and a privilege afforded to healthier societies, not a tactic to protect kids from vaccine injuries. Kennedy’s interest in modeling the U.S. vaccine schedule after Europe, they point out, is underpinned by his belief that some childhood vaccines are unsafe and that American kids get too many too young. Kennedy’s safety concerns don’t align with the rationale underpinning the approach in Europe, where the consensus is that childhood vaccines are safe. Wealthy European countries in many cases eschew vaccines based on a risk-benefit calculus that doesn’t hold in America. European kids often don’t get certain shots because it would prevent a very small number of cases — like hepatitis B — or because the disease is rarely serious for them, such as Covid-19 and chickenpox. But since the U.S. doesn’t have universal access to care, vaccinating provides more return on investment, experts say. “We just have a tradition to wait a little bit” before adding vaccines to government programs, said Johanna Rubin, a pediatrician and vaccine expert for Sweden’s health agency. Swedish children are advised to get vaccines for 11 diseases before they turn 18. Rubin cited the need to verify the shots’ efficacy and the high cost of new vaccines as reasons Sweden moves slowly to add to its schedule. “It has to go through the health economical model,” she said. VACCINE SAFETY’S NOT THE ISSUE Martin Kulldorff, a Swedish native and former Harvard Medical School professor who led Kennedy’s vaccine advisory panel until this month, pointed to that country’s approach to vaccination and public health in an interview with POLITICO earlier this year. Before the Centers for Disease Control and Prevention this month dropped its recommendation that children of mothers who test negative for hepatitis B receive a vaccine within a day of birth, Kulldorff cited Sweden’s policy. “In Sweden, the recommendation is that you only do that if the mother has the infection. That’s the case in most European countries,” he said. “You could have a discussion whether one or the other is more reasonable.” The U.S. policy, as of Dec. 16, more closely resembles Sweden’s, with hepatitis B-negative mothers no longer urged to vaccinate their newborns against the virus at birth. But Sweden’s public health agency recommends that all infants be vaccinated, and the country’s regional governments subsidize those doses, which are administered as combination shots targeting six diseases starting at 3 months. Public health experts warn that even children of hepatitis B-negative mothers could catch the virus from others via contact with caregivers who are positive or shared household items. The prevalence of chronic hepatitis B in the U.S. is 6.1 percent compared to 0.3 percent in Sweden, according to the Coalition for Global Hepatitis Elimination, a Georgia-based nonprofit which receives funding from pharmaceutical companies, the CDC and the National Institutes of Health, among others. Michael Osterholm, the director of the Center for Infectious Disease Research and Policy at the University of Minnesota, said the U.S. has taken a more comprehensive approach to vaccination, in part because its population is sicker than that of some Western European countries, and the impact of contracting a disease could be more detrimental. Osterholm pointed to the Covid pandemic as an example. By May 2022, the U.S. had seen more than 1 million people die. Other high-income countries — though much smaller — had more success controlling mortality, he said. “People tried to attribute [the disparity] to social, political issues, but no, it was because [peer nations] had so many more people who were actually in low-risk categories for serious illness,” Osterholm said. Kennedy and his advisers also cited European views on Covid vaccination in the spring when the CDC dropped its universal recommendation, instead advising individuals to talk to their providers about whether to get the shot. Last month, the Food and Drug Administration’s top vaccine regulator, Vinay Prasad, linked the deaths of 10 children to Covid vaccination without providing more detailed information about the data behind his assertion. European countries years ago stopped recommending repeat Covid vaccination for children and other groups not considered at risk of becoming severely sick. Covid shots have been linked to rare heart conditions, primarily among young men. European vaccine experts say Covid boosters were not recommended routinely for healthy children in many countries — not because of safety concerns, but because it’s more cost-effective to give them to high-risk groups, such as elderly people or those with health conditions that Covid could make severely sick and put in the hospital. In the U.K., Covid-related hospitalizations and deaths declined significantly after the pandemic, and now are “mostly in the most frail in the population, which has led to more restricted use of the vaccines following the cost-effectiveness principles,” said Andrew Pollard, the director of the Oxford Vaccine Group in the United Kingdom, which works on developing vaccines and was behind AstraZeneca’s Covid-19 shot. Pollard led the Joint Committee on Vaccination and Immunization, which advises the U.K. government, for 12 years before stepping down in September. In the U.S., more moves to follow Europe are likely. At a meeting of Kennedy’s vaccine advisers earlier this month, Tracy Beth Høeg, now acting as the FDA’s top drug regulator, pointed to Denmark’s pediatric schedule, which vaccinates for 10 diseases, while questioning whether healthy American children should be subject to more vaccines than their Danish counterparts. Danish kids typically don’t get shots for chickenpox, the flu, hepatitis A and B, meningitis, respiratory syncytial virus and rotavirus, like American children do, though parents can privately pay for at least some of those vaccines. The country offers free Covid and flu vaccines to high-risk kids. After the vaccine advisory meeting wrapped, Trump said he was on board, directing Kennedy to “fast track” a review of the U.S. vaccine schedule and potentially align it with other developed nations. He cited Denmark, Germany and Japan as countries that recommend fewer shots. Last week, Kennedy came within hours of publicly promoting Denmark’s childhood vaccine schedule as an option for American parents. The announcement was canceled at the last minute after the HHS Office of the General Counsel said it would invite a lawsuit the administration could lose, a senior department official told POLITICO. The notion that the U.S. would drop its vaccine schedule in favor of a European one struck health experts there as odd. Each country’s schedule is based on “the local situation, so the local epidemiology, structure of health care services, available resources, and inevitably, there’s a little bit of political aspect to it as well,” said Erika Duffell, a principal expert on communicable disease prevention and control at the European Centre for Disease Prevention and Control, an EU agency that monitors vaccine schedules across 30 European countries. Vaccine safety isn’t the issue, she said. For example, even though most Europeans don’t get a hepatitis B shot within 24 hours of birth, the previous U.S. recommendation, “there is a consensus that the effectiveness and safety of the vaccine has been confirmed through decades of research” and continuous monitoring, she said. European nations like Denmark and the U.K. have kept new cases of hepatitis B low. Denmark recorded no cases of mother-to-child transmission in 2023, and Britain’s rate of such spread is less than 0.1 percent — though the latter does routinely recommend vaccinating low-risk infants beginning at 2 months of age. European experts point to high levels of testing of pregnant women for hepatitis B and most women having access to prenatal care as the reasons for success in keeping cases low while not vaccinating all newborns. The major differences between the U.S. and the U.K. in their approach to hepatitis B vaccination are lower infection rates and high screening uptake in Britain, plus “a national health system which is able to identify and deliver vaccines to almost all affected pregnancies selectively,” Pollard said. The CDC, when explaining the change in the universal birth dose recommendation, argued the U.S. has the ability to identify nearly all hepatitis B infections during pregnancy because of ”high reliability of prenatal hepatitis B screening,” which some European experts doubt. “If we change a program, we need to prepare the public, we need to prepare the parents and the health care providers, and say where the evidence comes from,” said Pierre Van Damme, the director of the Centre for the Evaluation of Vaccination at the University of Antwerp in Belgium. He suggested that, if there was convincing evidence, U.S. health authorities could have run a pilot study before changing the recommendation to evaluate screening and the availability of testing at birth in one U.S. state, for example. WHERE EUROPEANS HAVE MORE DISEASE In some cases, European vaccination policies have, despite universal health care, led to more disease. France, Germany and Italy moved from recommending to requiring measles vaccination over the last decade after outbreaks on the continent. The U.S., until recently, had all but eradicated measles through a universal recommendation and school requirements. That’s starting to change. The U.S. is at risk of losing its “measles-elimination” status due to around 2,000 cases this year that originated in a Texas religious community where vaccine uptake is low. The 30 countries in the European Union and the European Economic Area, which have a population of some 450 million people combined, reported more than 35,000 measles cases last year, concentrated in Romania, Austria, Belgium and Ireland. Europe’s comparatively high rate is linked to lower vaccination coverage than the level needed to prevent outbreaks: Only four of the 30 countries reached the 95-percent threshold for the second measles dose in 2024, according to the European Centre for Disease Prevention and Control. Kennedy touted the U.S.’s lower measles rate as a successful effort at containing the sometimes-deadly disease, but experts say the country could soon see a resurgence of infectious diseases due to the vaccine skepticism that grew during the pandemic and that they say Kennedy has fomented. Among kindergarteners, measles vaccine coverage is down 2.7 percentage points as of the 2024-2025 school year, from a peak of 95.2 percent prior to the pandemic, according to CDC data. That drop occurred before Kennedy became health secretary. Kennedy and his advisers blame it on distrust engendered by Covid vaccine mandates imposed by states and President Joe Biden. But Kennedy led an anti-vaccine movement for years before joining the Trump administration, linking shots to autism and other conditions despite scientific evidence to the contrary, and he has continued to question vaccine safety as secretary. In some EU nations, vaccines aren’t compulsory for school entry. Swedish law guarantees the right to education and promotes close consultation between providers and patients. Some governments fear mandates could push away vaccine-hesitant parents who want to talk the recommended shots over with their doctor before giving the vaccines to their children, Rubin explained. In the U.S., states, which have the authority to implement vaccine mandates for school entry, rely on the CDC’s guidance to decide which to require. Vaccine skeptics have pushed the agency to relax some of its recommendations with an eye toward making it easier for American parents to opt out of routine shots. Scandinavian nations maintain high vaccine uptake without mandates thanks to “high trust” in public health systems, Rubin said. In Sweden, she added, nurses typically vaccinate young children at local clinics and provide care for them until they reach school age, which helps build trust among parents. CHICKENPOX Another example of where the U.S. and Europe differ is the chickenpox vaccine. The U.S. was the first country to begin universal vaccination against the common childhood illness in 1995; meanwhile, 13 EU nations broadly recommend the shot. Denmark doesn’t officially track chickenpox — the vaccine isn’t included on its schedule — but estimates 60,000 cases annually in its population of 6 million. The vastly larger U.S. sees fewer than 150,000 cases per year, according to the CDC. Many European countries perceive chickenpox as a benign disease, Van Damme said. “If you have a limited budget for prevention, you will spend usually the money in other preventative interventions, other vaccines than varicella,” he said, referring to the scientific term for chickenpox. But there’s another risk if countries decide to recommend chickenpox vaccination, he explained. If the vaccination level is low, people remain susceptible to the disease, which poses serious risks to unborn babies. If it’s contracted in early pregnancy, chickenpox could trigger congenital varicella syndrome, a rare disorder that causes birth defects. If children aren’t vaccinated against chickenpox, almost all would get the disease by age 10, Van Damme explained. If countries opt for vaccination, they have to ensure robust uptake: vaccinate virtually all children by 10, or risk having big pockets of unvaccinated kids who could contract higher-risk infections later. Europe’s stance toward chickenpox could change soon. Several countries are calculating that widely offering chickenpox vaccines would provide both public health and economic benefits. Britain is adding the shot to its childhood schedule next month. Sweden is expected to green-light it as part of its national program in the coming months. While the public doesn’t see it as a serious disease, pediatricians who see serious cases of chickenpox are advocating for the vaccine, Rubin told POLITICO. “It is very contagious,” she said. “It fulfills all our criteria.” The U.K. change comes after its vaccine advisory committee reviewed new data on disease burden and cost-effectiveness — including a 2022 CDC study of the U.S. program’s first 25 years that also examined the vaccine’s impact on shingles, a painful rash that can occur when the chickenpox virus reactivates years later. Scientists had theorized for years that limiting the virus’ circulation among children could increase the incidence of shingles in older adults by eliminating the “booster” effect of natural exposure, but the U.S. study found that real-world evidence didn’t support that hypothesis.

HOW DO BULGARIANS FEEL ABOUT JOINING THE EURO? The Balkan nation is sharply divided about bidding farewell to the lev.  Text by BORYANA DZHAMBAZOVA Photos by DOBRIN KASHAVELOV in Pernik, Bulgaria Bulgaria is set to adopt the EU’s single currency on Jan. 1, but polling shows the Balkan nation is sharply divided on whether it’s a good thing. POLITICO spoke to some Bulgarians about their fears and hopes, as they say goodbye to their national currency, the lev. Their comments have been edited for length. ANTON TEOFILOV, 73 Vendor at the open-air market in Pernik, a small city 100 kilometers from Sofia What do you think about Bulgaria joining the eurozone? We are a different generation, but we support the euro. We’ll benefit hugely from joining the eurozone. It will make paying anywhere in the EU easy and hassle-free. It would be great for both the economy and the nation. You can travel, do business, do whatever you want using a single currency — no more hassle or currency exchanges. You can go to Greece and buy a bottle of ouzo with the same currency. What do you think will change in your everyday life once the euro replaces the lev? I don’t expect any turbulence — from January on we would just pay in euros. No one is complaining about the price tags in euros, and in lev at the moment. Are you more hopeful or worried about the economic impact of switching to the euro? Why? The lev is a wonderful thing, but its time has passed; that’s just how life works. It will be much better for the economy to adopt the euro. It will be so much easier to share a common currency with the other EU countries. Now, if you go to Greece, as many Bulgarians do, you need to exchange money. After January – wherever you need to make a payment – either going to the store, or to buy produce for our business, it would be one and the same. What would you like politicians and institutions to do to make the transition easier for ordinary people? The state needs to explain things more clearly to those who are confused. We are a people who often need a lot of convincing, and on top of that, we’re a divided nation. If you ask me, we need to get rid of half the MPs in Parliament – they receive hefty salaries and are a burden to taxpayers, like parasites, without doing any meaningful work. Do you think joining the eurozone will bring Bulgaria closer to Europe culturally or politically? There are 27 member states, and we will become one with them. There will be no difference between Germany and us—we’ll be much closer to Europe. I remember the 1990s, when you needed to fill out endless paperwork just to travel, let alone to work abroad. I spent a year working in construction in Germany, and getting all the permits and visas was a major headache. Now things are completely different, and joining the eurozone is another step toward that openness. Advertisement PETYA SPASOVA, 55 Orthopedic doctor in Sofia What do you think about Bulgaria joining the eurozone? It worries me a lot. I don’t think this is the right moment for Bulgaria to join the eurozone. First, the country is politically very unstable, and the eurozone itself faces serious problems. As the poorest EU member state, we won’t be immune to those issues. On the contrary, they will only deepen the crisis here. The war in Ukraine, the growing debt in Germany and France … now we’d be sharing the debts of the whole of Europe. We are adopting the euro at a time when economies are strained, and that will lead to serious disruptions and a higher cost of living. I don’t understand why the state insists so strongly on joining the eurozone. I don’t think we’re ready. What do you think will change in your everyday life once the euro replaces the lev? Even now, when you go to the store and look at the price of bread or other basic foods, we see prices climbing. I’m afraid many people will end up living in extreme poverty. We barely produce anything; we’re a country built on services. When people get poorer, they naturally start consuming less. I’m not worried about myself or my family. We live in Sofia, where there are more job opportunities and higher salaries. I’m worried about people in general. Every day I see patients who can’t even afford the travel costs to come to Sofia for medical check-ups. Are you more hopeful or worried about the economic impact of switching to the euro? Why? I’m extremely worried. I don’t want to relive the economic crisis of the 90s, when the country was on the verge of bankruptcy. What would you like politicians and institutions to do to make the transition easier for ordinary people? No one cares what people think. Many countries held referendums and decided not to join the eurozone. I don’t believe our politicians can do anything at this point. I’m not even sure they know what needs to be done. Do you think joining the eurozone will bring Bulgaria closer to Europe culturally or politically? I feel offended when I hear this question. We’ve been part of Europe for a very long time, long before many others. We can exchange best practices in culture, science, education, and more, but that has nothing to do with the eurozone. Joining can only bring trouble. I remember years ago when I actually hoped Bulgaria would enter the eurozone. But that was a different Europe. Now things are deteriorating; the spirit of a united Europe is gone. I don’t want to be part of this Europe. Advertisement SVETOSLAV BONINSKI, 53 Truck driver from Gabrovo, a small city in central Bulgaria What do you think about Bulgaria joining the eurozone? I’m against Bulgaria joining the eurozone. We saw how Croatia and Greece sank into debt once they adopted the euro. I don’t want Bulgaria to go down the same path. Greece had to take a huge loan to bail out its economy. When they still had the drachma, their economy was strong and stable. After entering the eurozone, many big companies were forced to shut down and inflation went through the roof. Even the German economy is experiencing a downturn.. What do you think will change in your everyday life once the euro replaces the lev? I worry that there will be speculation and rising inflation. Five years ago, I used to buy cigarettes in Slovakia at prices similar to Bulgaria. Now I can’t find anything cheaper than €5 per pack. They saw their prices rise after the introduction of the euro. We’ll repeat the Slovakia scenario. Are you more hopeful or worried about the economic impact of switching to the euro? Why? We can already feel that things won’t end well — prices have gone up significantly, just like in Croatia. I’m afraid that even in the first year wages won’t be able to compensate for the rise in prices, and people will become even more impoverished. I expect the financial situation to worsen. Our government isn’t taking any responsibility for that. What would you like politicians and institutions to do to make the transition easier for ordinary people? I hope they will make an effort. We are completely ill-equipped to adopt the euro—all the stats and figures the government presents are lies. We must wait until the country is ready to manage the euro as a currency. We’re doing fine with the lev. We should wait for the economy to grow and for wages to catch up with the rest of Europe. The only thing the state could do to ease the process is to step down. The current government is interested in entering the eurozone only to receive large amounts of funding, most of which they will probably pocket themselves. The Bulgarian lev is very stable, unlike the euro, which is quite an unstable currency. All the eurozone countries are burdened with trillions in debt, while those outside it are doing quite well. Do you think joining the eurozone will bring Bulgaria closer to Europe culturally or politically? I don’t think so. We’ve been part of Europe for a long time. The only difference now will be that Brussels will tell us what to do and will control our budget and spending. Brussels will be in charge from now on. No good awaits us. Elderly people won’t receive decent pensions and will work until we drop dead. Advertisement NATALI ILIEVA, 20 Political science student from Pernik What do you think about Bulgaria joining the eurozone? I see it as a step forward for us. It’s a positive development for both society and the country. I expect that joining the eurozone will help the economy grow and position Bulgaria more firmly within Europe. For ordinary people, it will make things easier, especially when traveling, since we’ll be using the same currency. What do you think will change in your everyday life once the euro replaces the lev? The transition period might be difficult at first. I don’t think the change of currency will dramatically affect people’s daily lives – after all, under the currency board, the lev has been pegged to the euro for years. Some people are worried that prices might rise, and this is where the state must step in to monitor the situation, prevent abuse, and make the transition as smooth as possible. As part of my job at the youth center, I travel a lot in Europe. Being part of the eurozone would make travel much more convenient. My life would be so much easier! I wouldn’t have to worry about carrying euros in cash or paying additional fees when withdrawing money abroad, or wondering: Did I take the right debit card in euros? Are you more hopeful or worried about the economic impact of switching to the euro? Why? I’m more concerned that the issue will be politicized by certain parties to further polarize society. Joining the eurozone is a logical next step – we agreed to it by default when we joined the bloc in 2007. There is so much disinformation circulating on social media that it’s hard for some people to see the real facts and distinguish what’s true from what’s not. What would you like politicians and institutions to do to make the transition easier for ordinary people? The state needs to launch an information campaign to make the transition as smooth as possible. Authorities should explain what the change of currency means for people in a clear and accessible way. You don’t need elaborate language to communicate what’s coming, especially when some radical parties are aggressively spreading anti-euro and anti-EU rhetoric. Do you think joining the eurozone will bring Bulgaria closer to Europe culturally or politically? Yes, I think it will help the country become better integrated into Europe. In the end, I believe people will realize that joining the eurozone will be worth it. Advertisement YANA TANKOVSKA, 47 Jewelry artist based in Sofia What do you think about Bulgaria joining the eurozone? If you ask me, the eurozone is on the verge of collapse, and now we have decided to join? I don’t think it’s a good idea. In theory, just like communism, the idea of a common currency union might sound good, but in practice it doesn’t really work out. I have friends working and living abroad [in eurozone countries], and things are not looking up for regular people, even in Germany. We all thought we would live happily as members of the bloc, but that’s not the reality. What do you think will change in your everyday life once the euro replaces the lev? I expect the first half of next year to be turbulent. But we are used to surviving, so we will adapt yet again. Personally, we might have to trim some expenses, go out less, and make sure the family budget holds. I make jewelry, so I’m afraid I’ll have fewer clients, since they will also have to cut back. Are you more hopeful or worried about the economic impact of switching to the euro? Why? I’m terribly worried. The state promises there won’t be a jump in prices and that joining the eurozone won’t negatively affect the economy. But over the past two years the cost of living has risen significantly, and I don’t see that trend reversing. For example, in the last three years real estate prices have doubled. There isn’t a single person who isn’t complaining about rising costs. What would you like politicians and institutions to do to make the transition easier for ordinary people? There is nothing they can do at this point. Politicians do not really protect Bulgaria’s interests on this matter. The issue is not only about joining the eurozone but about protecting our national interests. I just want them to have people’s well-being at heart. Maybe we need to hit rock bottom to finally see meaningful change. Do you think joining the eurozone will bring Bulgaria closer to Europe culturally or politically? Not really. That’s up to us, not to Europe. I just want Bulgarian politicians to finally start creating policies for the sake of society, not just enriching themselves, to act in a way that would improve life for everyone. Advertisement KATARINA NIKOLIC, 49, AND METODI METODIEV, 53 Business partners at a ‘gelateria’ in Sofia What do you think about Bulgaria joining the eurozone? Metodi: For a small business like ours, I don’t think it will make much difference, as long as the transition to the new currency is managed smoothly. I can only see a positive impact on the economy if things are done right. I’m a bit saddened to say farewell to the Bulgarian lev — it’s an old currency with its own history — but times are changing, and this is a natural step for an EU member. Katarina: I have lived in Italy which adopted the euro a long time ago. Based on my experience there, I don’t expect any worrying developments related to price increases or inflation. On the contrary, joining the eurozone in January can only be interpreted as a sign of trust from the European Commission and could bring more economic stability to Bulgaria. I also think it will increase transparency, improve financial supervision, and provide access to cheaper loans. What do you think will change in your everyday life once the euro replaces the lev? Metodi:  I don’t think there will be any difference for our business whether we’re paying in euros or in leva. We’ve been an EU member state for a while now and we’re used to working with both local and international suppliers. It will just take some getting used to switching to one currency for another. But we are already veterans — Bulgarian businesses are very adaptive — from dealing with renominations and all sorts of economic reforms. I’m just concerned that it might be challenging for some elderly people to adapt to the new currency and they might need some support and more information. Katarina: For many people, it will take time to get used to seeing a new currency, but they will adapt. For me, it’s nothing new. Since I lived in Italy, where the euro is used, I automatically convert to euros whenever Metodi and I discuss business. Are you more hopeful or worried about the economic impact of switching to the euro? Why? Metodi: The decision has already been taken, so let’s make the best of it and ensure a smooth transition. I haven’t exchanged money when traveling in at least 10 years. I just use my bank card to pay or withdraw cash if I need any. Katarina: I remember that some people in Italy also predicted disaster when the euro was introduced, and many were nostalgic about the lira. But years later, Italy is still a stable economy. I think our international partners will look at us differently once we are part of the eurozone. Advertisement What would you like politicians and institutions to do to make the transition easier for ordinary people? Metodi: I think the authorities are already taking measures to make sure prices don’t rise and that businesses don’t round conversions upward unfairly. For example, we may have to slightly increase the price of our ice cream in January. I feel a bit awkward about it because I don’t want people to say, “Look, they’re taking advantage of the euro adoption to raise prices.” But honestly, we haven’t adjusted our prices since we opened three years ago. I’m actually very impressed by how quickly and smoothly small businesses and market sellers have adopted double pricing [marking prices in lev and euros]. I know how much work that requires, especially if you’re a small business owner. Katarina: It’s crucial that the state doesn’t choke small businesses with excessive demands but instead supports them. I believe that helping small businesses grow should be a key focus of the government, not just supervising the currency swap. My hope is that the euro will help the Bulgarian economy thrive. I love Bulgaria and want to see it flourish. I’m a bit more optimistic than Metodi, I think the best is yet to come. Do you think joining the eurozone will bring Bulgaria closer to Europe culturally or politically? Metodi: I think so. Despite some criticism, good things are happening in the country, no matter who is in power. We need this closeness to truly feel part of Europe. Katarina: The euro is a financial and economic instrument. Adopting it won’t change national cultural identity, Bulgarians will keep their culture. I’m a true believer in Europe, and I think it’s more important than ever to have a united continent. As an Italian and Serbian citizen, I really appreciate that borders are open and that our children can choose where to study and work. In fact, our gelateria is a great example of international collaboration: we have people from several different countries in the team.

Disclaimer POLITICAL ADVERTISEMENT * This is sponsored content from AstraZeneca. * The advertisement is linked to public policy debates on the future of cancer care in the EU. More information here. Europe has made huge strides in the fight against cancer.[1] Survival rates have climbed, detection has improved and the continent has become home to some of the world’s most respected research hubs.[2],[3] None of that progress came easy — it was built on years of political attention and cooperation across borders. However, as we look to 2026 and beyond, that progress stands at a crossroads. Budget pressures and tougher global competition threaten to push cancer and health care down the EU agenda. Europe’s Beating Cancer Plan — a flagship initiative aimed at expanding screening, improving early detection and boosting collaboration — is set to expire in 2027, with no clear plan to secure or extend its gains.[4],[5] “My [hope is that we can continue] the work started with Europe’s Beating Cancer Plan and make it sustainable… [and] build on the lessons learned, [for other disease areas] ” says Antonella Cardone, CEO of Cancer Patients Europe. A new era in cancer treatment Concern about the lapsing initiative is compounded by two significant shifts in health care: declining investment and increasing scientific advancement. Firstly, Europe has seen the increased adoption of cost-containment policies by some member states. Under-investment in Europe in cancer medicines has been a challenge — specifically with late and uneven funding, and at lower levels than international peers such as the US — potentially leaving patients with slower and more limited access to life-saving therapies.[6],[7],[8] Meanwhile, the U.S., which pays on average double for medicines per capita than the EU,[9] is actively working to rebalance its relationship with pharmaceuticals to secure better pricing (“fair market value”) through policies across consecutive administrations.[10] All the while, China is rapidly scaling investment in biotech and clinical research, determined to capture the trials, talent, and capital that once flowed naturally to Europe.[11] The rebalancing of health and life-science investment can have significant consequences. If Europe does not stay attractive for life-sciences investment, the impact will extend beyond cancer patient outcomes. Jobs, tax revenues, advanced manufacturing, and Europe’s leadership in strategic industries are all at stake.[12] Secondly, medical science has never looked more promising.[7] Artificial intelligence is accelerating drug discovery, clinical trials, and diagnostics, and the number of approved medicines for patients across Europe has jumped from an average of one per year between 1995 and 2000 to 14 per year between 2021 and 2024.[13],[14],[15], [7] Digital health tools and innovative medtech startups are multiplying, increasing competitiveness and lowering costs — guiding care toward a future that is more personalized and precise.[16],[17] Europe stands at the threshold of a new era in cancer treatment. But if policymakers ease up now, progress could stall — and other regions, especially the U.S. and China, are more than ready to widen the innovation gap. Recognizing the strategic investment Health spending is generally treated as a budget item to be contained. Yet investment in cancer care has been one of Europe’s smartest economic bets.[18],[19] The sector anchors millions of high-skilled jobs (it employs around 29 million people in the EU[11]) and attracts global life sciences investment. According to the European Commission, the sector contributes nearly €1.5 trillion to the EU economy.[12] Studies from the Institute of Health Economics confirm that money put into research directly translates into better survival outcomes.[20] The same report shows that although the overall spend on cancer is increasing, the cost per patient has actually decreased since 1995, suggesting that innovative treatments are increasing efficiency.[20] Those gains matter not only to patients and families, but to Europe’s long-term stability: healthier populations mean fewer costs down the line, stronger productivity, and more sustainable public finances.[20] Fixing Europe’s access gap Cancer medicines bring transformative value — to patients, to society and to the wider economy. [21] However, even as oncology therapies advance, patients across Europe are not benefiting equally. EFPIA’s 2024 Patients W.A.I.T. indicator shows that, on average, just 46 percent of innovative medicines approved between 2020 and 2023 were available to patients in 2024.[22] On average, it takes 578 days for a new oncology medicine to reach European patients, and only 29 percent of drugs are fully available in all member states.[23] This is not caused by a lack of breakthrough medicines, but by national policy mechanisms that undervalue innovation. OECD and the Institute for Health Economics data show that divergent HTA requirements, rigid cost-effectiveness thresholds, price-volume clawbacks, ad hoc taxes on pharmaceutical revenues and slow national reimbursement decisions collectively suppress timely access to new cancer medicines across the EU.[24] These disparities cut against Europe’s long-standing reputation as a collection of societies that values equitable, high-quality care for all of its citizens. It risks eroding one of the EU’s defining strengths: the commitment to fairness and collective progress. Cancer policy solutions for the EU Although this is ultimately a matter for member states, embedding cancer as a permanent EU priority — backed by funding, coordination, and accountability — could give national systems the incentives and strategic direction to buck these trends. These actions will reassure pharmaceutical companies that Europe is serious about attracting clinical trials and the launch of new medicines, ensuring that its citizens, societies and economies enjoy the benefits this brings. Europe’s Beating Cancer Plan delivered progress, but its expiry presents a pivotal moment. 2026 and beyond bring a significant opportunity for the EU to build on this by ensuring that member states implement National Cancer Control Plans and have clear targets and accountability on their national performance, including on investment and access. To do this, EU policymakers should consider three actions as an immediate priority with lasting impact: * Embed cancer and investment within EU governance. Build it into the European Semester on health with mandatory indicators, regular reviews, and accountability frameworks to ensure continuity. This model worked well during Covid-19 and should be adapted for non-communicable diseases starting with cancer as a pilot. * Secure stable and sufficient funding. The Multiannual Financial Framework must ensure adequate funding for health and cancer to encourage coordinated initiatives across member states. * Strengthen EU-level coordination. Ensure that pan-EU structures such as the Comprehensive Cancer Centres and Cancer Mission Hubs are adequately funded and empowered. These are the building blocks of a lasting European commitment to cancer. With action, Europe can secure a sustainable foundation for patients, resilience and continued scientific excellence. -------------------------------------------------------------------------------- [1] European Commission, OECD/European Observatory on Health Systems and Policies. 2023. State of Health in the EU: Synthesis Report 2023. Available at: https://health.ec.europa.eu/system/files/2023-12/state_2023_synthesis-report_en.pdf [Accessed December 2025] [2] Efpia. 2025. Cancer care 2025: an overview of cancer outcomes data across Europe. Available at: https://www.efpia.eu/news-events/the-efpia-view/statements-press-releases/ihe-cancer-comparator-report-2025/ [Accessed December 2025] [3] Cancer Core Europe. 2024. Cancer Core Europe: Advancing Cancer Care Through Collaboration. Available at: https://www.cancercoreeurope.eu/cce-advancing-cancer-care-collaboration/ [Accessed December 2025] [4] European Commission. 2021. Europe’s Beating Cancer Plan. Available at:https://health.ec.europa.eu/system/files/2022-02/eu_cancer-plan_en_0.pdf [Accessed December 2025] [5] European Parliament. 2025. Europe’s Beating Cancer Plan: Implementation findings. https://www.europarl.europa.eu/RegData/etudes/STUD/2025/765809/EPRS_STU(2025)765809_EN.pdf [Accessed December 2025] [6] Hofmarcher, T., et al. 2024. Access to Oncology Medicines in EU and OECD Countries (OECD Health Working Papers, No.170). OECD Publishing. Available at: https://www.oecd.org/content/dam/oecd/en/publications/reports/2024/09/access-to-oncology-medicines-in-eu-and-oecd-countries_6cf189fe/c263c014-en.pdf [Accessed December 2025] [7] Manzano, A., et al. 2025. Comparator Report on Cancer in Europe 2025 – Disease Burden, Costs and Access to Medicines and Molecular Diagnostics (IHE). Available at: https://ihe.se/app/uploads/2025/03/IHE-REPORT-2025_2_.pdf [Accessed December 2025] [8] Efpia. [no date]. Europe’s choice. Available at: https://www.efpia.eu/europes-choice/ [Accessed December 2025] [9] OECD. 2024. Prescription Drug Expenditure per Capita. https://data-explorer.oecd.org/vis?lc=en&pg=0&snb=1&vw=tb&df[ds]=dsDisseminateFinalDMZ&df[id]=DSD_SHA%40DF_SHA&df[ag]=OECD.ELS.HD&df[vs]=&pd=2015%2C&dq=.A.EXP_HEALTH.USD_PPP_PS%2BPT_EXP_HLTH._T..HC51%2BHC3.._T…&to[TIME_PERIOD]=false&lb=bt [Accessed December 2025] [10] The White House. 2025. Delivering most favored-nation prescription drug pricing to American patients. Available at: https://www.whitehouse.gov/presidential-actions/2025/05/delivering-most-favored-nation-prescription-drug-pricing-to-american-patients/ [Accessed December 2025] [11] Eleanor Olcott, Haohsiang Ko and William Sandlund. 2025. The relentless rise of China’s Biotechs. Financial Times. Available at: https://www.ft.com/content/c0a1b15b-84ee-4549-85eb-ed3341112ce5 [Accessed December 2025] [12] European Commission, Directorate-General for Communication. 2025. Making Europe a Global Leader in Life Sciences. Available at: https://commission.europa.eu/news-and-media/news/making-europe-global-leader-life-sciences-2025-07-02_en [Accessed December 2025] [13] Financial Times. 2025. How AI is reshaping drug discovery. Available at: https://www.ft.com/content/8c8f3c10-9c26-4e27-bc1a-b7c3defb3d95 [Accessed December 2025] [14] Seedblink. 2025. Europe’s HealthTech investment landscape in 2025: A deep dive. https://seedblink.com/blog/2025-05-30-europes-healthtech-investment-landscape-in-2025-a-deep-dive [15] European Commission. [No date]. Artificial Intelligence in healthcare. Available at: https://health.ec.europa.eu/ehealth-digital-health-and-care/artificial-intelligence-healthcare_en [Accessed December 2025] [16] Codina, O. 2025. Code meets care: 20 European HealthTech startups to watch in 2025 and beyond. EU-Startups. Available at: https://www.eu-startups.com/2025/06/code-meets-care-20-european-healthtech-startups-to-watch-in-2025-and-beyond [Accessed December 2025] [17] Protogiros et al. 2025. Achieving digital transformation in cancer care across Europe: Practical recommendations from the TRANSiTION project. Journal of Cancer Policy. Available at: https://www.sciencedirect.com/science/article/pii/S2213538325000281 [Accessed December 2025] [18] R-Health Consult. [no date]. The case for investing in a healthier future for the European Union. EFPIA. Available at: https://www.efpia.eu/media/xpkbiap5/the-case-for-investing-in-a-healthier-future-for-the-european-union.pdf [Accessed December 2025] [19] Pousette A., Hofmarcher T. 2024.Tackling inequalities in cancer care in the European Union. Available at: https://ihe.se/en/rapport/tackling-inequalities-in-cancer-care-in-the-european-union-2/ [Accessed December 2025] [20] Efpia. 2025. Comparator Report Cancer in Europe 2025. Available at: https://www.efpia.eu/media/0fbdi3hh/infographic-comparator-report-cancer-in-europe.pdf [Accessed December 2025] [21] Garau, E. et al. 2025. The Transformative Value of Cancer Medicines in Europe. Dolon Ltd. Available at: https://dolon.com/wp-content/uploads/2025/09/EOP_Investment-Value-of-Oncology-Medicines-White-Paper_2025-09-19-vF.pdf?x16809 [Accessed December 2025] [22] IQVIA. 2025. EFPIA Patients W.A.I.T. Indicator 2024 Survey. Available at: https://www.efpia.eu/media/oeganukm/efpia-patients-wait-indicator-2024-final-110425.pdf [Accessed December 2025] [23] Visentin M. 2025. Improving equitable access to medicines in Europe must remain a priority. The Parliament. Available at: https://www.theparliamentmagazine.eu/partner/article/improving-equitable-access-to-medicines-in-europe-must-remain-a-priority [Accessed December 2025] [24] Hofmarcher, T. et al. 2025. Access to novel cancer medicines in Europe: inequities across countries and their drivers. ESMO Open. Available at: https://www.esmoopen.com/action/showPdf?pii=S2059-7029%2825%2901679-5 [Accessed December 2025]

Thirty-six million Europeans — including more than one million in the Nordics[1] — live with a rare disease.[2] For patients and their families, this is not just a medical challenge; it is a human rights issue. Diagnostic delays mean years of worsening health and needless suffering. Where treatments exist, access is far from guaranteed. Meanwhile, breakthroughs in genomics, AI and targeted therapies are transforming what is possible in health care. But without streamlined systems, innovations risk piling up at the gates of regulators, leaving patients waiting. Even the Nordics, which have some of the strongest health systems in the world, struggle to provide fair and consistent access for rare-disease patients. Expectations should be higher. THE BURDEN OF DELAY The toll of rare diseases is profound. People living with them report health-related quality-of-life scores 32 percent lower than those without. Economically, the annual cost per patient in Europe — including caregivers — is around €121,900.[3] > Across Europe, the average time for diagnosis is six to eight years, and > patients continue to face long waits and uneven access to medications. In Sweden, the figure is slightly lower at €118,000, but this is still six times higher than for patients without a rare disease. Most of this burden (65 percent) is direct medical costs, although non-medical expenses and lost productivity also weigh heavily. Caregivers, for instance, lose almost 10 times more work hours than peers supporting patients without a rare disease.[4] This burden can be reduced. European patients with access to an approved medicine face average annual costs of €107,000.[5] Yet delays remain the norm. Across Europe, the average time for diagnosis is six to eight years, and patients continue to face long waits and uneven access to medications. With health innovation accelerating, each new therapy risks compounding inequity unless access pathways are modernized. PROGRESS AND REMAINING BARRIERS Patients today have a better chance than ever of receiving a diagnosis — and in some cases, life-changing therapies. The Nordics in particular are leaders in integrated research and clinical models, building world-class diagnostics and centers of excellence. > Without reform, patients risk being left behind. But advances are not reaching everyone who needs them. Systemic barriers persist: * Disparities across Europe: Less than 10 percent of rare-disease patients have access to an approved treatment.[6] According to the Patients W.A.I.T. Indicator (2025), there are stark differences in access to new orphan medicines (or drugs that target rare diseases).[7] Of the 66 orphan medicines approved between 2020 and 2023, the average number available across Europe was 28. Among the Nordics, only Denmark exceeded this with 34. * Fragmented decision-making: Lengthy health technology assessments, regional variation and shifting political priorities often delay or restrict access. Across Europe, patients wait a median of 531 days from marketing authorization to actual availability. For many orphan drugs, the wait is even longer. In some countries, such as Norway and Poland, reimbursement decisions take more than two years, leaving patients without treatment while the burden of disease grows.[8] * Funding gaps: Despite more therapies on the market and greater technology to develop them, orphan medicines account for just 6.6 percent of pharmaceutical budgets and 1.2 percent of health budgets in Europe. Nordic countries — Sweden, Norway and Finland — spend a smaller share than peers such as France or Belgium. This reflects policy choices, not financial capacity.[9] If Europe struggles with access today, it risks being overwhelmed tomorrow. Rare-disease patients — already facing some of the longest delays — cannot afford for systems to fall farther behind. EASING THE BOTTLENECKS Policymakers, clinicians and patient advocates across the Nordics agree: the science is moving faster than the systems built to deliver it. Without reform, patients risk being left behind just as innovation is finally catching up to their needs. So what’s required? * Governance and reforms: Across the Nordics, rare-disease policy remains fragmented and time-limited. National strategies often expire before implementation, and responsibilities are divided among ministries, agencies and regional authorities. Experts stress that governments must move beyond pilot projects to create permanent frameworks — with ring-fenced funding, transparent accountability and clear leadership within ministries of health — to ensure sustained progress. * Patient organizations: Patient groups remain a driving force behind awareness, diagnosis and access, yet most operate on short-term or volunteer-based funding. Advocates argue that stable, structural support — including inclusion in formal policy processes and predictable financing — is critical to ensure patient perspectives shape decision-making on access, research and care pathways. * Health care pathways: Ann Nordgren, chair of the Rare Disease Fund and professor at Karolinska Institutet, notes that although Sweden has built a strong foundation — including Centers for Rare Diseases, Advanced Therapy (ATMP) and Precision Medicine Centers, and membership in all European Reference Networks — front-line capacity remains underfunded. “Government and hospital managements are not providing  resources to enable health care professionals to work hands-on with diagnostics, care and education,” she explains. “This is a big problem.” She adds that comprehensive rare-disease centers, where paid patient representatives collaborate directly with clinicians and researchers, would help bridge the gap between care and lived experience. * Research and diagnostics: Nordgren also points to the need for better long-term investment in genomic medicine and data infrastructure. Sweden is a leader in diagnostics through Genomic Medicine Sweden and SciLifeLab, but funding for advanced genomic testing, especially for adults, remains limited. “Many rare diseases still lack sufficient funding for basic and translational research,” she says, leading to delays in identifying genetic causes and developing targeted therapies. She argues for a national health care data platform integrating electronic records, omics (biological) data and patient-reported outcomes — built with semantic standards such as openEHR and SNOMED CT — to enable secure sharing, AI-driven discovery and patient access to their own data DELIVERING BREAKTHROUGHS Breakthroughs are coming. The question is whether Europe will be ready to deliver them equitably and at speed, or whether patients will continue to wait while therapies sit on the shelf. There is reason for optimism. The Nordic region has the talent, infrastructure and tradition of fairness to set the European benchmark on rare-disease care. But leadership requires urgency, and collaboration across the EU will be essential to ensure solutions are shared and implemented across borders. The need for action is clear: * Establish long-term governance and funding for rare-disease infrastructure. * Provide stable, structural support for patient organizations. * Create clearer, better-coordinated care pathways. * Invest more in research, diagnostics and equitable access to innovative treatments. Early access is not only fair — it is cost-saving. Patients treated earlier incur lower indirect and non-medical costs over time.[10] Inaction, by contrast, compounds the burden for patients, families and health systems alike. Science will forge ahead. The task now is to sustain momentum and reform systems so that no rare-disease patient in the Nordics, or anywhere in Europe, is left waiting. -------------------------------------------------------------------------------- [1] https://nordicrarediseasesummit.org/wp-content/uploads/2025/02/25.02-Nordic-Roadmap-for-Rare-Diseases.pdf [2] https://nordicrarediseasesummit.org/wp-content/uploads/2025/02/25.02-Nordic-Roadmap-for-Rare-Diseases.pdf [3] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [4] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [5] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf [6] https://www.theparliamentmagazine.eu/partner/article/a-competitive-and-innovationled-europe-starts-with-rare-diseases? [7] https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/efpia-patients-wait-indicator-2024.pdf [8] https://www.iqvia.com/-/media/iqvia/pdfs/library/publications/efpia-patients-wait-indicator-2024.pdf [9] https://copenhageneconomics.com/wp-content/uploads/2025/09/Copenhagen-Economics_Spending-on-OMPs-across-Europe.pdf [10] https://media.crai.com/wp-content/uploads/2024/10/28114611/CRA-Alexion-Quantifying-the-Burden-of-RD-in-Europe-Full-report-October2024.pdf Disclaimer POLITICAL ADVERTISEMENT * The sponsor is Alexion Pharmaceuticals * The entity ultimately controlling the sponsor: AstraZeneca plc * The political advertisement is linked to policy advocacy around rare disease governance, funding, and equitable access to diagnosis and treatment across Europe More information here.

This article is presented by EFPIA with the support of AbbVie I made a trip back to Europe recently, where I spent the vast majority of my pharmaceutical career, to share my perspectives on competitiveness at the European Health Summit. Now that I work in a role responsible for supporting patient access to medicine globally, I view Europe, and how it compares internationally, through a new lens, and I have been reflecting further on why the choices made today will have such a critical impact on where medicines are developed tomorrow. Today, many patients around the world benefit from medicines built on European science and breakthroughs of the last 20 years. Europeans, like me, can be proud of this contribution. As I look forward, my concern is that we may not be able to make the same claim in the next 20 years. It’s clear that Europe has a choice. Investing in sustainable medicines growth and other enabling policies will, I believe, bring significant benefits. Not doing so risks diminishing global influence. > Today, many patients around the world benefit from medicines built on European > science and breakthroughs of the last 20 years I reflect on three important points: 1) investment in healthcare benefits individuals, healthcare and society, but the scale of this benefit remains underappreciated; 2) connected to this, the underpinning science for future innovation is increasingly happening elsewhere; and 3) this means the choices we make today must address both of these trends. First, let’s use the example of migraine. As I have heard a patient say, “Migraine will not kill you but neither [will they] let you live.”[1] Individuals can face being under a migraine attack for more than half of every month, unable to leave home, maintain a job and engage in society.[2] It is the second biggest cause of disability globally and the first among young women.[3] It affects the quality of life of millions of Europeans.[4] From 2011-21 the economic burden of migraine in Europe due to the loss of working days ranged from €35-557 billion, depending on the country, representing 1-2 percent of gross domestic product (GDP).[5]   Overall socioeconomic burden of migraine as percentage of the country’s GDP in 2021 Source: WifOR, The socioeconomic burden of migraine. The case of 6 European Countries.5 Access to effective therapies could radically improve individuals’ lives and their ability to return to work.[6] Yet, despite the staggering economic and personal impacts, in some member states the latest medicines are either not reimbursed or only available after several treatment failures.[7] Imagine if Europe shifted its perspective on these conditions, investing to improve not only health but unlocking the potential for workforce and economic productivity? Moving to my second point, against this backdrop of underinvestment, where are scientific advances now happening in our sector? In recent years it is impressive to see China has become the second-largest drug developer in the world,[8] and within five years it may lead the innovative antibodies therapeutics sector,[9] which is particularly promising for complex areas like oncology. Cancer is projected to become the leading cause of death in Europe by 2035,[10] yet the continent’s share of the number of oncology trials dropped from 41 percent in 2013 to 21 percent in 2023.10 Today, antibody-drug conjugates are bringing new hope in hard-to-treat tumor types,[11] like ovarian,[12] lung[13] and colorectal[14] cancer, and we hope to see more of these advances in the future. Unfortunately, Europe is no longer at the forefront of the development of these innovations. This geographical shift could impact high-quality jobs, the vitality of Europe’s biotech sector and, most importantly, patients’ outcomes. [15] > This is why I encourage choices to be made that clearly signal the value > Europe attaches to medicines This is why I encourage choices to be made that clearly signal the value Europe attaches to medicines. This can be done by removing national cost-containment measures, like clawbacks, that are increasingly eroding the ability of companies to invest in European R&D. To provide a sense of their impact, between 2012 and 2023, clawbacks and price controls reduced manufacturer revenues by over €1.2 billion across five major EU markets, corresponding to a loss of 4.7 percent in countries like Spain.[16] Moreover, we should address health technology assessment approaches in Europe, or mandatory discount policies, which are simply not adequately accounting for the wider societal value of medicines, such as in the migraine example, and promoting a short-term approach to investment. By broadening horizons and choosing a long-term investment strategy for medicines and the life science sector, Europe will not only enable this strategic industry to drive global competitiveness but, more importantly, bring hope to Europeans suffering from health conditions. AbbVie SA/NV – BE-ABBV-250177 (V1.0) – December 2025 -------------------------------------------------------------------------------- [1] The Parliament Magazine, https://www.theparliamentmagazine.eu/partner/article/unmet-medical-needs-and-migraine-assessing-the-added-value-for-patients-and-society, Last accessed December 2025. [2] The Migraine Trust; https://migrainetrust.org/understand-migraine/types-of-migraine/chronic-migraine/, Last accessed December 2025. [3] Steiner TJ, et al; Lifting The Burden: the Global Campaign against Headache. Migraine remains second among the world’s causes of disability, and first among young women: findings from GBD2019. J Headache Pain. 2020 Dec 2;21(1):137 [4] Coppola G, Brown JD, Mercadante AR, Drakeley S, Sternbach N, Jenkins A, Blakeman KH, Gendolla A. The epidemiology and unmet need of migraine in five european countries: results from the national health and wellness survey. BMC Public Health. 2025 Jan 21;25(1):254. doi: 10.1186/s12889-024-21244-8. [5] WifOR. Calculating the Socioeconomic Burden of Migraine: The Case of 6 European Countries. Available at: [https://www.wifor.com/en/download/the-socioeconomic-burden-of-migraine-the-case-of-6-eu­ropean-countries/?wpdmdl=358249&refresh=687823f915e751752703993]. Accessed June 2025. [6] Seddik AH, Schiener C, Ostwald DA, Schramm S, Huels J, Katsarava Z. Social Impact of Prophylactic Migraine Treatments in Germany: A State-Transition and Open Cohort Approach. Value Health. 2021 Oct;24(10):1446-1453. doi: 10.1016/j.jval.2021.04.1281 [7] Moisset X, Demarquay G, et al., Migraine treatment: Position paper of the French Headache Society. Rev Neurol (Paris). 2024 Dec;180(10):1087-1099. doi: 10.1016/j.neurol.2024.09.008. [8] The Economist, https://www.economist.com/china/2025/11/23/chinese-pharma-is-on-the-cusp-of-going-global, Last accessed December 2025. [9] Crescioli S, Reichert JM. Innovative antibody therapeutic development in China compared with the USA and Europe. Nat Rev Drug Discov. Published online November 7, 2025. [10] Manzano A., Svedman C., Hofmarcher T., Wilking N.. Comparator Report on Cancer in Europe 2025 – Disease Burden, Costs and Access to Medicines and Molecular Diagnostics. EFPIA, 2025. [IHE REPORT 2025:2, page 20] [11] Armstrong GB, Graham H, Cheung A, Montaseri H, Burley GA, Karagiannis SN, Rattray Z. Antibody-drug conjugates as multimodal therapies against hard-to-treat cancers. Adv Drug Deliv Rev. 2025 Sep;224:115648. doi: 10.1016/j.addr.2025.115648. Epub 2025 Jul 11. PMID: 40653109.. [12] Narayana, R.V.L., Gupta, R. Exploring the therapeutic use and outcome of antibody-drug conjugates in ovarian cancer treatment. Oncogene 44, 2343–2356 (2025). https://doi.org/10.1038/s41388-025-03448-3 [13] Coleman, N., Yap, T.A., Heymach, J.V. et al. Antibody-drug conjugates in lung cancer: dawn of a new era?. npj Precis. Onc. 7, 5 (2023). https://doi.org/10.1038/s41698-022-00338-9 [14] Wang Y, Lu K, Xu Y, Xu S, Chu H, Fang X. Antibody-drug conjugates as immuno-oncology agents in colorectal cancer: targets, payloads, and therapeutic synergies. Front Immunol. 2025 Nov 3;16:1678907. doi: 10.3389/fimmu.2025.1678907. PMID: 41256852; PMCID: PMC12620403. [15] EFPIA, Improving EU Clinical Trials: Proposals to Overcome Current Challenges and Strengthen the Ecosystem, efpias-list-of-proposals-clinical-trials-15-apr-2025.pdf, Last accessed December 2025. [16] The EU General Pharmaceutical Legislation & Clawbacks, © Vital Transformation BVBA, 2024.

After more than three decades in the pharmaceutical industry, I know one thing: science transforms lives, but policy determines whether innovation thrives or stalls. That reality shapes outcomes for patients — and for Europe’s competitiveness. Today, Europeans stand at a defining moment. The choices we make now will determine whether Europe remains a global leader in life sciences or we watch that leadership slip away. It’s worth reminding ourselves of the true value of Europe’s life sciences industry and the power we have as a united bloc to protect it as a European good. Europe has an illustrious track record in medical discovery, from the first antibiotics to the discovery of DNA and today’s advanced biologics. Still today, our region remains an engine of medical breakthroughs, powered by an extraordinary ecosystem of innovators in the form of start-ups, small and medium-sized enterprises, academic labs, and university hospitals. This strength benefits patients through access to clinical trials and cutting-edge treatments. It also makes life sciences a strategic pillar of Europe’s economy. The economic stakes Life sciences is not just another industry for Europe. It’s a growth engine, a source of resilience and a driver of scientific sovereignty. The EU is already home to some of the world’s most talented scientists, thriving academic institutions and research clusters, and a social model built on universal access to healthcare. These assets are powerful, yet they only translate into future success if supported by a legislative environment that rewards innovation. > Life sciences is not just another industry for Europe. It’s a growth engine, a > source of resilience and a driver of scientific sovereignty. This is also an industry that supports 2.3 million jobs and contributes over €200 billion to the EU economy each year — more than any other sector. EU pharmaceutical research and development spending grew from €27.8 billion in 2010 to €46.2 billion in 2022, an average annual increase of 4.4 percent. A success story, yes — but one under pressure. While Europe debates, others act Over the past two decades, Europe has lost a quarter of its share of global investment to other regions. This year — for the first time — China overtook both the United States and Europe in the number of new molecules discovered. China has doubled its share of industry sponsored clinical trials, while Europe’s share has halved, leaving 60,000 European patients without the opportunity to participate in trials of the next generation of treatments. Why does this matter? Because every clinical trial site that moves elsewhere means a patient in Europe waits longer for the next treatment — and an ecosystem slowly loses competitiveness. Policy determines whether innovation can take root. The United States and Asia are streamlining regulation, accelerating approvals and attracting capital at unprecedented scale. While Europe debates these matters, others act. A world moving faster And now, global dynamics are shifting in unprecedented ways. The United States’ administration’s renewed push for a Most Favored Nation drug pricing policy — designed to tie domestic prices to the lowest paid in developed markets — combined with the potential removal of long-standing tariff exemptions for medicines exported from Europe, marks a historic turning point. A fundamental reordering of the pharmaceutical landscape is underway. The message is clear: innovation competitiveness is now a geopolitical priority. Europe must treat it as such. A once-in-a-generation reset The timing couldn’t be better. As we speak, Europe is rewriting the pharmaceutical legislation that will define the next 20 years of innovation. This is a rare opportunity, but only if reforms strengthen, rather than weaken, Europe’s ability to compete in life sciences. To lead globally, Europe must make choices and act decisively. A triple A framework — attract, accelerate, access — makes the priorities clear: * Attract global investment by ensuring strong intellectual property protection, predictable regulation and competitive incentives — the foundations of a world-class innovation ecosystem. * Accelerate the path from science to patients. Europe’s regulatory system must match the speed of scientific progress, ensuring that breakthroughs reach patients sooner. * Ensure equitable and timely access for all European patients. No innovation should remain inaccessible because of administrative delays or fragmented decision-making across 27 systems. These priorities reinforce each other, creating a virtuous cycle that strengthens competitiveness, improves health outcomes and drives sustainable growth. > Europe has everything required to shape the future of medicine: world-class > science, exceptional talent, a 500-million-strong market and one of the most > sophisticated pharmaceutical manufacturing bases in the world. Despite flat or declining public investment in new medicines across most member states over the past 20 years, the research-based pharmaceutical industry has stepped up, doubling its contributions to public pharmaceutical expenditure from 12 percent to 24 percent between 2018 and 2023. In effect, we have financed our own innovation. No other sector has done this at such scale. But this model is not sustainable. Pharmaceutical innovation must be treated not as a cost to contain, but as a strategic investment in Europe’s future. The choice before us Europe has everything required to shape the future of medicine: world-class science, exceptional talent, a 500-million-strong market and one of the most sophisticated pharmaceutical manufacturing bases in the world. What we need now is an ambition equal to those assets. If we choose innovation, we secure Europe’s jobs, research and competitiveness — and ensure European patients benefit first from the next generation of medical breakthroughs. A wrong call will be felt for decades. The next chapter for Europe is being written now. Let us choose the path that keeps Europe leading, competing and innovating: for our economies, our societies and, above all, our patients. Choose Europe. -------------------------------------------------------------------------------- Disclaimer POLITICAL ADVERTISEMENT * The sponsor is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The ultimate controlling entity is European Federation of Pharmaceutical Industries and Associations (EFPIA) * The political advertisement is linked to the Critical Medicines Act. More information here.

Rick Pazdur, the FDA’s top drug regulator, told staff Tuesday he submitted his resignation to the agency, an abrupt departure weeks after he was convinced by Commissioner Marty Makary to take the post to help bring stability to an agency reeling from months of upheaval, according to four people familiar with the decision granted anonymity to discuss the move. The decision — which comes days after top vaccine regulator Vinay Prasad said the agency would ratchet up regulatory requirements for new vaccines — is almost certain to raise new questions about Makary’s leadership of the FDA. Pazdur in recent weeks clashed with Makary over the Commissioner’s National Priority Voucher program, according to media reports. That program — which aims to speed final review of drugs that address health priorities, pose a transformative innovative impact, address an unmet medical need, help onshoring efforts or increase affordability — was also criticized by Pazdur’s predecessor, George Tidmarsh. FDA experts have worried the involvement of political appointees in the process of choosing which firms receive a voucher could raise questions about the program’s integrity. STAT first reported the news of Pazdur’s decision to retire. It is unclear if the decision is final — one person familiar with the decision said the longtime cancer drug regulator has 30 days to change his decision. “We respect Dr. Pazdur’s decision to retire and honor his 26 years of distinguished service at the FDA,” an FDA spokesperson said in a statement. “As the founding director of the Oncology Center of Excellence, he leaves a legacy of cross-center regulatory innovation that strengthened the agency and advanced care for countless patients. His leadership, vision, and dedication will continue to shape the FDA for years to come.” The White House and Pazdur did not immediately respond to requests for comment. Pazdur, a 26-year agency veteran, initially rebuffed efforts by Makary to convince him to assume leadership of the FDA’s Center for Drug Evaluation and Research — but ultimately agreed to take the job after being assured he would be given autonomy in the role free from political influence and the ability to rehire staff.

LONDON — The U.K. has agreed to raise how much its National Health Service spends on new drugs, in a concession made under pressure from the Trump administration in return for tariff-free access to the U.S. market. “Today’s agreement is a major win for American workers and our innovation economy,” U.S. Commerce Secretary Howard Lutnick said in a statement on Monday. “This deal doesn’t just deepen our economic partnership with the United Kingdom — it ensures that the breakthroughs of tomorrow will be built, tested, and produced on American soil.”  The deal will see Britain increase the National Institute for Health and Care Excellence (NICE) cost-effectiveness threshold by 25 percent, as POLITICO first reported in October, and slash the cap on revenue the NHS can reclaim from drugmakers to no more than 15 percent.  The new NICE threshold will be £25,000 to £35,000 per quality adjusted life year gained over and above current treatments. The U.S. said the combined changes would increase the net price the NHS pays for new medicines by 25 percent. In exchange, the administration will grant an exemption for U.K.-made pharmaceuticals, ingredients and medical technology from U.S. tariffs for the remainder of President Donald Trump’s term.  U.K. Business and Trade Secretary Peter Kyle said: “This deal guarantees that UK pharmaceutical exports – worth at least £5 billion a year – will enter the US tariff free, protecting jobs, boosting investment and paving the way for the UK to become a global hub for life sciences. “We will continue to build on the UK-US Economic Prosperity Deal, and the record-breaking investments we secured during the US State Visit, to create jobs and raise living standards as part of our Plan for Change.” The breakthrough comes after months of back-and-forth between both sides, with the sector not covered in the Economic Prosperity Deal and Washington demanding a “preferential environment” to lift the threat of steep import duties. The administration had threatened to impose up to 100 percent tariffs on drugs.  In July, the President issued a letter to 17 drugmakers, demanding they offer their drugs to Medicaid at most-favored-nation prices, prices tied to lower prices abroad, and shift manufacturing to U.S. soil.  Update: This story has been updated following confirmation from the U.S. and U.K. governments.