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13 June 2024
Nico Schmidt
Harald Schumann
Alarming gaps in availability of innovative drugs across the EU
Alexia Barakou
Alarming gaps in availability of innovative drugs across the EU
13 June 2024Where a cancer patient lives determines whether they have access to life-saving drugs. Investigate Europe research reveals how several EU countries do not have direct access to a number of critical medicines.
In January 2023, Kadri Tennosaar had already been battling cancer for three years. First the doctors cut the tumour out of her breast, then the treatment began. But now, four chemotherapy sessions later, the doctor had the black-and-white CT image of Tennosaar's lungs. Like tiny raindrops, white dots were clustered together. The cancer was growing in both lungs. The treatment had not worked. "I burst into tears," recalls Tennosaar. At 53, she didn't want to die. "The doctor acted as if I didn't even exist.”
But another doctor gave Tennosaar hope. There was a drug that could help her. The drug was called Enhertu. "Suddenly I felt hope again," Tennosaar says today. The problem is that treatment with the drug costs €20,000 for three months. Patients normally have to take Enhertu for over a year. Money that Tennosaar, who until the illness stopped her was in charge of a sports field in the Mustamäe district of the Estonian capital Tallinn, cannot afford.
Where in the EU a patient like Kadri Tennosaar lives, largely determines whether they get the drugs that can prolong or even save their lives. Investigate Europe analysis, published as part of its Deadly prices investigation, reveals how many critical medicines are not available through general reimbursement to thousands across the bloc, with patients in central and eastern EU states often most acutely affected by the lack of access.
But another doctor gave Tennosaar hope. There was a drug that could help her. The drug was called Enhertu. "Suddenly I felt hope again," Tennosaar says today. The problem is that treatment with the drug costs €20,000 for three months. Patients normally have to take Enhertu for over a year. Money that Tennosaar, who until the illness stopped her was in charge of a sports field in the Mustamäe district of the Estonian capital Tallinn, cannot afford.
Where in the EU a patient like Kadri Tennosaar lives, largely determines whether they get the drugs that can prolong or even save their lives. Investigate Europe analysis, published as part of its Deadly prices investigation, reveals how many critical medicines are not available through general reimbursement to thousands across the bloc, with patients in central and eastern EU states often most acutely affected by the lack of access.
In Estonia, cancer patient Kadri Tennosaar had the support of a charity to get access to a critical drug.Priit Simson/Delfi Media
The renowned German research institute IQWiG compiled a list of 32 outstanding medicines for Investigate Europe and its German partners NDR, WDR and Süddeutsche Zeitung which, the scientists assessed between 2019 and 2023 as having a "significant" or "considerable" additional benefit to existing therapies. This means that a drug can prolong or improve patients' lives and may also have fewer side effects. The drugs selected included treatments for conditions such as breast cancer, leukaemia and cystic fibrosis.
The investigation reveals that in six EU countries one in four important medicines is missing. Without purchasing agreements between countries and companies, which are the basis for reimbursement, health authorities have to resort to other costly methods to obtain a drug, or miss out on access altogether.
The situation is particularly dramatic in Hungary, where 25 out of 32 medicines are not generally reimbursed, and in Malta and Cyprus, where 19 and 15 medicines respectively are simiary unavailable. Patients in Cyprus and Hungary can get some drugs by applying for individual access - but often at extortionate costs to the state. In the Baltic states and Romania, a high number of important medicines are also unavailable.
For almost a decade, Paul Fehlner headed the patent department of Swiss drugmaker Novartis. He is now head of intellectual property at US biotech company Revision Therapeutics. Fehlner explains the strategy of drug firms today: "Normally, pharmaceutical companies go for the biggest markets first, which makes sense. So Germany, France, Spain, Italy and other markets get access to the product, but [other countries] will be deprioritised because they are not that big.”
The investigation reveals that in six EU countries one in four important medicines is missing. Without purchasing agreements between countries and companies, which are the basis for reimbursement, health authorities have to resort to other costly methods to obtain a drug, or miss out on access altogether.
The situation is particularly dramatic in Hungary, where 25 out of 32 medicines are not generally reimbursed, and in Malta and Cyprus, where 19 and 15 medicines respectively are simiary unavailable. Patients in Cyprus and Hungary can get some drugs by applying for individual access - but often at extortionate costs to the state. In the Baltic states and Romania, a high number of important medicines are also unavailable.
For almost a decade, Paul Fehlner headed the patent department of Swiss drugmaker Novartis. He is now head of intellectual property at US biotech company Revision Therapeutics. Fehlner explains the strategy of drug firms today: "Normally, pharmaceutical companies go for the biggest markets first, which makes sense. So Germany, France, Spain, Italy and other markets get access to the product, but [other countries] will be deprioritised because they are not that big.”
For patients, this means that they are often left to fend for themselves when faced with a serious illness. They have to rely on the goodwill of charities or donors to pay for life-saving treatments or apply for individual access through the state. In some cases, patients even have to sue their governments to gain access to the expensive medicines.
In Europe, the European Medicines Agency (EMA) makes the initial, central decision as to which medicines are allowed on the EU market and which are not. If a manufacturer wins approval for its product, the EU grants it an exclusive monopoly on its active ingredient for at least eight years. Having this exclusivity means that no other drug manufacturer can put a medicine with the same active agent on the market. Consequently, there is no competition between producers.
After that, pharmaceutical companies will be free to decide whether and in which EU countries they want to market their medicines. Until now, health authorities have negotiated almost always individually with companies.
"In principle, everyone in the EU should benefit from the single market," says lawyer Ellen 't Hoen, who campaigns for fair access to medicines. "But medicines are not equally accessible to everyone in the single market." This is partly the fault of pharmaceutical companies, which first market their products in countries that are "tolerant of high prices".
In Europe, the European Medicines Agency (EMA) makes the initial, central decision as to which medicines are allowed on the EU market and which are not. If a manufacturer wins approval for its product, the EU grants it an exclusive monopoly on its active ingredient for at least eight years. Having this exclusivity means that no other drug manufacturer can put a medicine with the same active agent on the market. Consequently, there is no competition between producers.
After that, pharmaceutical companies will be free to decide whether and in which EU countries they want to market their medicines. Until now, health authorities have negotiated almost always individually with companies.
"In principle, everyone in the EU should benefit from the single market," says lawyer Ellen 't Hoen, who campaigns for fair access to medicines. "But medicines are not equally accessible to everyone in the single market." This is partly the fault of pharmaceutical companies, which first market their products in countries that are "tolerant of high prices".
“In principle, everyone in the EU should benefit from the single market. But medicines are not equally accessible to everyone.”
— Ellen 't Hoen, lawyer
Efpia, the European Federation of Pharmaceutical Industries and Associations, rejects any blame on the companies. It says there is a “broad consensus” that drug prices “should” be based on a country's ability to pay. The association cites "slow regulatory processes", "delays in starting national health technology assessments" and "local formulary decisions by healthcare providers" as reasons for the unavailability of medicines.
Pharmaceutical companies use their market power to force countries to keep negotiated prices secret. National negotiators must sign confidentiality agreements. In this way, companies can hide what discounts they give to states against the official price of a drug. States negotiate blindly. This means that in some cases, companies can charge much more for their drugs in countries with smaller markets than in richer western Europe.
The lack of essential medicines in less populous or lower income states is also the result of the pharmaceutical companies' corporate policy. A pharmacist working for a Hungarian subsidiary of a multinational drug manufacturer explains: "For a company like Novartis or Pfizer, the Hungarian market is a rounding error.” In the country, patients have no access to 25 out of 32 medicines through reimbursement. "I wouldn't want to be a cancer patient in Hungary these days," the pharmacist says.
Pharmaceutical companies use their market power to force countries to keep negotiated prices secret. National negotiators must sign confidentiality agreements. In this way, companies can hide what discounts they give to states against the official price of a drug. States negotiate blindly. This means that in some cases, companies can charge much more for their drugs in countries with smaller markets than in richer western Europe.
The lack of essential medicines in less populous or lower income states is also the result of the pharmaceutical companies' corporate policy. A pharmacist working for a Hungarian subsidiary of a multinational drug manufacturer explains: "For a company like Novartis or Pfizer, the Hungarian market is a rounding error.” In the country, patients have no access to 25 out of 32 medicines through reimbursement. "I wouldn't want to be a cancer patient in Hungary these days," the pharmacist says.
The Hungarian state exploits a mechanism which was introduced for solving unique cases, whereby individual patients can apply for reimbursement of their treatment costs. If the application is approved, the social insurance will cover the entire cost of treatment. Between 2013 and 2022, the number of applications increased eightfold. Of more than 25,000 applications in 2022, nine out of 10 were approved. Without official reimbursement approval, the price of these drugs skyrockets. "There is no room for bargaining," says a Hungarian official. On the patient side, the major problem in this scheme is the uncertainty of receiving treatment.
In Tallinn at the beginning of 2023, breast cancer patient Kadri Tennosaar's hopes were fading. The government would not pay for the drug that could help her. Despite the verdict from Germany's IQWiG Institute stating: "There is evidence of a significant additional benefit for the endpoint of overall survival.” In other words, Enhertu helped patients live significantly longer. And although the drug was approved by the EMA in January 2021, negotiations with Estonia are still ongoing today. It can take years for patients in poorer countries to get access to the drug if pharmaceutical companies only launch their products in richer nations.
This is time that seriously ill people often do not have. The average time from EMA approval to a pharmaceutical company contacting the Estonian authorities in 2021-2023 was 680 days, almost two years. Erki Laidmäe, head of pharmaceuticals and medical devices department at the Estonian Health Insurance Fund, told Investigate Europe that "an acceptable price level has not yet been reached" with Enhertu's manufacturer, Daiichi Sankyo.
In Tallinn at the beginning of 2023, breast cancer patient Kadri Tennosaar's hopes were fading. The government would not pay for the drug that could help her. Despite the verdict from Germany's IQWiG Institute stating: "There is evidence of a significant additional benefit for the endpoint of overall survival.” In other words, Enhertu helped patients live significantly longer. And although the drug was approved by the EMA in January 2021, negotiations with Estonia are still ongoing today. It can take years for patients in poorer countries to get access to the drug if pharmaceutical companies only launch their products in richer nations.
This is time that seriously ill people often do not have. The average time from EMA approval to a pharmaceutical company contacting the Estonian authorities in 2021-2023 was 680 days, almost two years. Erki Laidmäe, head of pharmaceuticals and medical devices department at the Estonian Health Insurance Fund, told Investigate Europe that "an acceptable price level has not yet been reached" with Enhertu's manufacturer, Daiichi Sankyo.
In six EU countries one in four of the 32 important medicines analysed by Investigate Europe is missing.Shutterstock
Laidmäe added that in other cases, “medicines are missing from our market because an alternative is already available. Patients are not untreated. Our market is very tiny and manufacturers will not penetrate it if market share promises to remain small. Whoever comes first often gets the whole market and there is no room for the others.”
In its analysis of the 32 drugs, Investigate Europe accounted for cases where alternative medicines are available when calculating overall country totals. Daiichi Sankyo said it works with authorities to ensure eligible patients can "access the medicine as quickly as possible." The firm said it was unable to comment further while negotiations are ongoing.
In contrast in Germany, legislation guarantees pharmaceutical manufacturers that health insurance companies will reimburse any drug approved by the EMA. This means that they are immediately available to patients - unlike in Estonia.
In some European countries, charities have long had to fill the gap left by reluctant pharmaceutical companies and cash-strapped governments. In Estonia, the charity Kingitud Ule, Gifted Life, has helped more than 2,000 patients since it was established 10 years ago.
In its analysis of the 32 drugs, Investigate Europe accounted for cases where alternative medicines are available when calculating overall country totals. Daiichi Sankyo said it works with authorities to ensure eligible patients can "access the medicine as quickly as possible." The firm said it was unable to comment further while negotiations are ongoing.
In contrast in Germany, legislation guarantees pharmaceutical manufacturers that health insurance companies will reimburse any drug approved by the EMA. This means that they are immediately available to patients - unlike in Estonia.
In some European countries, charities have long had to fill the gap left by reluctant pharmaceutical companies and cash-strapped governments. In Estonia, the charity Kingitud Ule, Gifted Life, has helped more than 2,000 patients since it was established 10 years ago.
Kadri Tennosaar and her new doctor submitted an application in early 2023 asking for support from the charity. "I was afraid that the committee would reject my application," recalls Tennosaar. "But my doctor said there was a good chance it would be accepted." The fund did indeed approve the treatment. In March last year, Tennosaar saw the drug that could save her life for the first time. The medicine looked "transparent like water". When she was given it, it initially felt like her earlier chemotherapy. Tennosaar later said of the days that followed: "I was weak. It took the strength out of my body.”
Less than four hours' drive from Tallinn, at the Eastern Hospital in the Latvian capital Riga, oncologist Alinta Hegmane regularly treats cancer patients for whom innovative drugs have long been available. "But the cost of certain treatment is not covered," she says. "This is everyday life here." According to Investigate Europe's research, 11 of the 32 important drugs are not reimbursed. The drugs cost thousands of euros and treatment usually takes years. "Few people can afford that," says Hegmane.
That's why her patients register from their hospital beds on the crowdfunding platform Ziedot. There they publicise their case. They write a text about themselves and their illness. They compete for readers' money, which they can donate directly by clicking a button. Viola from Riga, for example, says in her post that she used to be an "active woman" before she got cancer. Now she is on the platform asking for "the chance to live another year". She also needs Enhertu for her treatment. Like the Estonian health system, the Latvian health system does not cover the cost of treatment. So far, donors have helped Viola with €590 of the €45,212 needed for her treatment.
Less than four hours' drive from Tallinn, at the Eastern Hospital in the Latvian capital Riga, oncologist Alinta Hegmane regularly treats cancer patients for whom innovative drugs have long been available. "But the cost of certain treatment is not covered," she says. "This is everyday life here." According to Investigate Europe's research, 11 of the 32 important drugs are not reimbursed. The drugs cost thousands of euros and treatment usually takes years. "Few people can afford that," says Hegmane.
That's why her patients register from their hospital beds on the crowdfunding platform Ziedot. There they publicise their case. They write a text about themselves and their illness. They compete for readers' money, which they can donate directly by clicking a button. Viola from Riga, for example, says in her post that she used to be an "active woman" before she got cancer. Now she is on the platform asking for "the chance to live another year". She also needs Enhertu for her treatment. Like the Estonian health system, the Latvian health system does not cover the cost of treatment. So far, donors have helped Viola with €590 of the €45,212 needed for her treatment.
“The cost of certain treatment is not covered. This is everyday life here.”
— Latvian oncologist Alinta Hegmane
In other countries, patients are forced to go to even greater lengths to access a drug.
In the western Romanian city of Lugoj, breast cancer patient Andreea Crăciun had to take her own health system to court. She was diagnosed with breast cancer at the end of November last year. "Then everything happened very quickly," Crăciun recalls. She started chemotherapy within two weeks.
"The cancer was very aggressive. It was my only option. The second shock came when she found out that the state would not pay for her treatment with the drug she needed, Keytruda. Many EU countries cover the cost of the drug for breast cancer patients – but not Romania. One treatment costs €5,000. She can still pay for the first three treatments herself. "Then I didn't know what to do," she recalls today. In desperation, the mother of two schoolchildren turned to a lawyer. On 2 February this year, her lawyer filed a lawsuit against the Romanian state. Ten days later, the court ruled in her favour. Today, the national health fund is paying for her treatment.
In 2023, more than 1,000 patients in Romania were given the cancer medication they needed at the state's expense by court orders, according to oncologist Michael Schenker, head of the country's national cancer commission. The country lacks resources to pay for innovative drugs and the head of the national health insurance has urged authorities to double the budget for drugs, Schenker said. The state refused.
Romania does not have access to six of the 32 innovative drugs. The government said that in multiple cases, the manufacturer chose not to market their product there.
In the western Romanian city of Lugoj, breast cancer patient Andreea Crăciun had to take her own health system to court. She was diagnosed with breast cancer at the end of November last year. "Then everything happened very quickly," Crăciun recalls. She started chemotherapy within two weeks.
"The cancer was very aggressive. It was my only option. The second shock came when she found out that the state would not pay for her treatment with the drug she needed, Keytruda. Many EU countries cover the cost of the drug for breast cancer patients – but not Romania. One treatment costs €5,000. She can still pay for the first three treatments herself. "Then I didn't know what to do," she recalls today. In desperation, the mother of two schoolchildren turned to a lawyer. On 2 February this year, her lawyer filed a lawsuit against the Romanian state. Ten days later, the court ruled in her favour. Today, the national health fund is paying for her treatment.
In 2023, more than 1,000 patients in Romania were given the cancer medication they needed at the state's expense by court orders, according to oncologist Michael Schenker, head of the country's national cancer commission. The country lacks resources to pay for innovative drugs and the head of the national health insurance has urged authorities to double the budget for drugs, Schenker said. The state refused.
Romania does not have access to six of the 32 innovative drugs. The government said that in multiple cases, the manufacturer chose not to market their product there.
In 2023, more than 1,000 patients in Romania received the cancer medication they needed at the state's expense by court orders.Shutterstock
Across the EU, only Germany and Austria have access to all 32 drugs. Wealthy nations also have gaps in availability, including the Netherlands, where five drugs are missing, as well as Ireland (4) and France (3). Mayeul Charoy, a French official who works closely on drug reimbursements, told Investigate Europe at a recent industry conference: “Yes, these medicines [from our list] are not yet reimbursed because the manufacturers have not yet submitted an acceptable offer.”
To change this, several projects have tried to foster joint negotiations between member states. "We wanted to ensure that more patients had access to essential medicines," recalls former Belgian health minister Maggie De Block. Together with her colleagues from the Netherlands and Luxembourg, she set up a joint procurement initiative, Beneluxa, in 2015. "We are small countries and together we hoped to be able to negotiate better," says De Block. Ireland and Austria have also joined Beneluxa.
Over the past nine years, the five countries have only managed to achieve joint procurement for three medicines. Clemens Auer, former secretary general in Austria's health ministry calls Beneluxa a "political signal to the industry" , although he acknowledges that it cannot, under the current circumstances, grow and encompass the whole European Union. So the inequity in access persists.” It is a scandal, says Auer, that there are first, second and third class citizens in Europe when it comes to access to new medicines.
To change this, several projects have tried to foster joint negotiations between member states. "We wanted to ensure that more patients had access to essential medicines," recalls former Belgian health minister Maggie De Block. Together with her colleagues from the Netherlands and Luxembourg, she set up a joint procurement initiative, Beneluxa, in 2015. "We are small countries and together we hoped to be able to negotiate better," says De Block. Ireland and Austria have also joined Beneluxa.
Over the past nine years, the five countries have only managed to achieve joint procurement for three medicines. Clemens Auer, former secretary general in Austria's health ministry calls Beneluxa a "political signal to the industry" , although he acknowledges that it cannot, under the current circumstances, grow and encompass the whole European Union. So the inequity in access persists.” It is a scandal, says Auer, that there are first, second and third class citizens in Europe when it comes to access to new medicines.
Pembrolizumab, sold under the Pembrolizumab brand, is not reimbursed everywhere in Europe.Shutterstock
The problem is felt across Europe. In an interview with Investigate Europe, a former health official in Ireland complains: "The 27 member states negotiating for themselves is astonishingly inefficient and leads to inequality for European citizens."
In 2016, then-Cypriot health minister George Pamborides wrote to then-EU health commissioner Vytenis Andriukaitis, complaining that his country was getting access to innovative medicines "very late". The letter has been obtained by Investigate Europe. Pamborides therefore proposed that the EU set up a mechanism to bring small member states to the negotiating table with pharmaceutical companies "to secure preferential prices for the procurement of innovative medicines". The letter disappeared into a drawer, and with it the idea.
At a meeting of EU health ministers last November, Greece and Malta again put a central purchasing mechanism for innovative medicines on the agenda. But Germany quickly brushed the proposal aside. "Joint purchasing should only be used for cross-border health threats," said the German representative in the plenary session.
In 2016, then-Cypriot health minister George Pamborides wrote to then-EU health commissioner Vytenis Andriukaitis, complaining that his country was getting access to innovative medicines "very late". The letter has been obtained by Investigate Europe. Pamborides therefore proposed that the EU set up a mechanism to bring small member states to the negotiating table with pharmaceutical companies "to secure preferential prices for the procurement of innovative medicines". The letter disappeared into a drawer, and with it the idea.
At a meeting of EU health ministers last November, Greece and Malta again put a central purchasing mechanism for innovative medicines on the agenda. But Germany quickly brushed the proposal aside. "Joint purchasing should only be used for cross-border health threats," said the German representative in the plenary session.
“The 27 member states negotiating for themselves is astonishingly inefficient and leads to inequality for European citizens.”
— Former heath official in Ireland
The European Commission has also recognised the problem. In 2020, it announced that it would revise its pharmaceutical strategy. Three years later, in April 2023, it presented its new legislative proposal, the Pharma Package. At the presentation, health commissioner Stella Kyriakides said: “Where you live should not determine whether you live or whether you die.” The Commission told Investigate Europe that the package “would enable an additional 60-70 million patients to have access to innovative medicines in the EU annually.” Despite lengthy negotiations, no result has yet been achieved.
As in the case of Estonian breast cancer patient Kadri Tennosaar, who only gained access to the potentially life-saving drug Enhertu thanks to a charity organisation. By March this year, after years of illness, it was already a familiar procedure for Tennosaar when she lay down on the cold bed and glided through the CT scanner with a loud roar. Always a little nervous, she waits for the result – has the cancer in her body grown? A few weeks later, she hears from her doctor. This time the news is good. "It was a small miracle," Tennosaar says today, describing the moment in which she learned that she had entered remission. The new drug, Enhertu, has worked. The cancer is gone from her lungs.
Additional reporting: Sarmīte Gaidule, Attila Kalman, Alexandra Nistoroiu, Piret Reiljan, Iulia Rosu
Data collection: Mašenjka Bačić, Eurydice Bersi, Lorenzo Buzzoni, Wojciech Cieśla, Anuška Delić, Lukas Diko, Sarmīte Gaidule, Vellu Hämäläinen, Pascal Hansens, Attila Kalman, Miglė Krancevičiūtė, Ida Mažutaitienė, Leïla Minano, Maxence Peigné, Paulo Pena, Andrei Petre, Bettina Pfluger, Manuel Rico, Marta Portocarrero, Leonard Scharfenberg, Nico Schmidt, Zuzana Šotová, Amund Trellevik, Ingeborg Eliassen, Eurydice Bersi
Editor: Chris Matthews
As in the case of Estonian breast cancer patient Kadri Tennosaar, who only gained access to the potentially life-saving drug Enhertu thanks to a charity organisation. By March this year, after years of illness, it was already a familiar procedure for Tennosaar when she lay down on the cold bed and glided through the CT scanner with a loud roar. Always a little nervous, she waits for the result – has the cancer in her body grown? A few weeks later, she hears from her doctor. This time the news is good. "It was a small miracle," Tennosaar says today, describing the moment in which she learned that she had entered remission. The new drug, Enhertu, has worked. The cancer is gone from her lungs.
Additional reporting: Sarmīte Gaidule, Attila Kalman, Alexandra Nistoroiu, Piret Reiljan, Iulia Rosu
Data collection: Mašenjka Bačić, Eurydice Bersi, Lorenzo Buzzoni, Wojciech Cieśla, Anuška Delić, Lukas Diko, Sarmīte Gaidule, Vellu Hämäläinen, Pascal Hansens, Attila Kalman, Miglė Krancevičiūtė, Ida Mažutaitienė, Leïla Minano, Maxence Peigné, Paulo Pena, Andrei Petre, Bettina Pfluger, Manuel Rico, Marta Portocarrero, Leonard Scharfenberg, Nico Schmidt, Zuzana Šotová, Amund Trellevik, Ingeborg Eliassen, Eurydice Bersi
Editor: Chris Matthews