Is an expensive medicine a violation of human rights? The judge will speak about this on Wednesday

Can a pharmaceutical company with retroactive effect be called back for the price it has asked for a patented medicine for years? That question is all about a lawsuit against drug manufacturer Abbvie. The Farma Foundation for accountability in 2023, the manufacturer of the Rheumamedicijn Adalimumab, brand name HUMIRA, has taken the Amsterdam District Court. The judge is expected to make a decision this Wednesday.

Abbvie is said to have made a billion euros in ‘excessive profit’ in the Netherlands in the period 2004-2018, when there was a patent on Humira. Farma argues that money, as accountable, could also have been spent on other patients who need care.

Lawyers, healthcare providers and health economists at home and abroad keep a close eye on the matter. The medical journal The Lancet mentioned the expected statement “Potentially groundbreaking.” Farma for accountability was founded in 2018 by chairman Wilbert Bannenberg (72), a former doctor of public health who is committed to affordable medicines.

Bannenberg does not have to punish Abbvie, or a fine, he says to NRC. “I hope for judicial recognition of the principle that profit on medicines – even if that profit is legally permitted – still has legal limits.”

Most sold medicine

Humira is the showpiece of Abbvie. The turnover of only this medicine worldwide was $ 21.6 billion in 2021. When the drug was admitted to the American market in 2002, that was a breakthrough in the treatment of rheumatism. Later the inflammatory also proved to be an effective remedy for numerous other inflammatory diseases, such as Crohn’s disease (inflammation of the small intestine), ulcerative colitis (inflammation of the colon) and psoriasis (a skin condition). For example, Humira grew into the most sold medicine in the world.

Humira was also the best -selling and profitable medicine in the Netherlands for years. Until 2018, when the patent ended, the treatment cost 460 euros per injection, around twelve thousand euros per patient annually. ABBVIE Nederland yielded 2.1 billion euros. In 2023, five years after the patent on Humira had expired, the price had fallen by almost 90 percent. Other parties were able to put it on the market as a generic remedy by that time.

According to Bannenberg, this price drop proves that Humira was unnecessarily expensive for years. “Patients depend on that one medicine as long as it is still under patent,” he says. Humira is in the basic package and is therefore reimbursed by health insurers. Through premiums and income -related contributions, all Dutch people therefore contribute to a reimbursed medicine. “Every euro that we as a society spend too much on Humira, we cannot spend on other care,” says Bannenberg.

Zorgstituut Nederland determines the amount we as a society are willing to pay for one extra year in good health. Bannenberg left based on that calculate That of the 1 billion euros from Abbvie 14,000 people could have been living in good health a year longer. He calls it a “displacement of our collective right to health.”

The Shell case

That emphasis on the violation of human rights makes this matter special and important, says Brigit Toebes, professor of health law in an international perspective at the University of Groningen. She is a member of the Pharma Advisory Council for accountability, the foundation of Bannenberg.

Toebes makes a comparison with the case in 2024 against Shell, in which Milieudefensie is halving the CO₂-Tuight. The court in The Hague equalized Shell. _{But what remained intact, she says, was more important: “The recognition of the judge that in addition to governments, companies also bear a human rights responsibility.”}

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The Universal Declaration for Human Rights of the United Nations states that non-state actors, including companies, are responsible for this. That principle was later worked out in a number of ‘principles for companies and human rights’, also known as the Ruggie Principles named. “Those are not rules that were laid down by law, but the frameworks that Milieudefensie relied on,” says Toebes. “And now also pharma to account.”

With this difference that is a more concrete calculation under the case against Abbvie, says Toebes. “In the Shell case, speculating how much climate damage the company will cause in the future.” The damage caused by Abbvie can be calculated, she says.

More expensive and more expensive

The story of pharmaceuticals who charge gigantic prices for their medicines is not new, nor their defense. The high research and development costs of a medicine must be recovered. Only part of the research results in a safe and effective medicine.

But something has changed in recent years, Rianne van den Ham sees. She is a pharmaco epidemiologist at Utrecht University and expert in the field of equal access to medicines. “Treatments are becoming increasingly complex and therefore more expensive. As a result, there are more and more innovations in complex illnesses such as cancer and rare disorders.” Van den Ham saw the high prices of patented medicines rise in rapidly in the last twenty years.

The boundaries are coming, it turned out last month. Then the Healthcare Institute decided not to reimburse a number of breast cancer treatments, because it did not lead to a longer survival for all patient groups. “That decision was based on disappointing research results, but it also shows that as a country we can no longer compensate for all treatments,” says Van den Ham. “Simply because we can no longer pay it all.”

It is not her style, Van den Ham admits, a complex discussion like this fighting in court. “But we do need people like Wilbert Bannenberg to shake up the system. He is not afraid to make enemies and he says what it says.”

Bernie Sanders

At Bannenberg the idea of ​​starting a ‘principle case’ against the pharmaceutical industry. It was not yet clear that Abbvie would be the target. “We were looking for a means with a price that everyone can immediately imagine: this should not be possible,” says Bannenberg.

It became Humira, thanks to help from unexpected corner. The US Senator Bernie Sanders got angry in 2022 About the Humira prize in the US, which was there rise to 80,000 dollars per patient, compared to around 12,000 euros in the Netherlands. Abbvie had to explain in the Congress under Ede how much it had spent on research and development costs of the medicine, and how much profit it had made with it. For the first time, such sensitive information became public. “So we were able to make a real calculation about the excessive profit of Humira, with figures from the pharmaceutical company himself, the most unexpected source you can have,” says Bannenberg. “That makes this case much stronger than when you have to count with your own estimates.”

Risky Industries

But how did Farma account for the conclusion that 1 billion euros was made ‘excessive profit’? “There is no definition of that,” says Bannenberg. “But we have tried to turn it by calculating a socially acceptable price. We dare to call what remains.” The foundation extrapolated the figures that ABBVIE released in the US to the Dutch context and thus established that the company made around 2.1 billion euros with Humira with Humira in the patent period. 29 percent of that amount, around 600 million euros, eight pharma for accountability a ‘reasonable profit’. That percentage is based on all kinds of calculation models about fair winnings in the pharmaceutical industry. If you still deduct the estimated costs for the research and development of Humira, estimated at around 440 million euros, then 1 billion euros in excessive profit remains.

Van den Ham calls the calculation method “Elegant”. “Logically, Abbvie defended himself in court by saying that the assumptions under this calculation model are incorrect, but they also give no insight into what those figures should be.” She finds it logical that a company “does not want to give such sensitive information, it affects the competitive position. But it is not clear which amount a pharmaceutical company actually invests in research and development. What part of that amount has been paid with public money, and can we see something in the price that the pharmaceuticalist asks for?”

If the judge rules in favor of Pharma to account on Wednesday, it is still unclear which consequences that will have. Do not expect the judge to make a decision about how many To have made too much profit Abbvie, says Bannenberg: “In the best case, it is established that Abbvie has taken too much profit from the system in a general sense, and other pharmaceuticals know that they can also be tapped for that.”

Professor Toebes hopes that “pharmaceutical companies through this case will think about their policy and become more aware of their social responsibility.”

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