Today, 9 May 2025, is an important day in court for the Dutch Pharmaceutical Accountability Foundation (PAF). In February 2023, PAF started a court case against AbbVie, over AbbVie’s excessive profits on the sales of its rheumatoid arthritis medicine Humira (adalimumab). PAF is alleging that the company acted unlawfully in extracting excessive profits from the sales of Humira in the Netherlands, and in doing so causing displacement of care in the country. After all, each health care euro can only be spent once.
In the Netherlands, Humira sales accounted for €2.1 billion from 2004-2018. As much as €1 billion amounted to excess profits earned through unfair pricing practices according to PAF. (Between 2003-2024 the global turnover for the product was US$231 billion.) The excessive profits on Humira in the Netherlands translated to the loss of close to 14.000 years of healthy life. The figures which underpin the case can be found in the economics study by Zorgvuldig Advies carried out upon request by PAF. The diagram below taken from this study, shows the relation between cost, reasonable profits and excess profits. Excess profits account for 49% of the sales. This profit level was sustained over the years of market exclusivity, despite the fact that sales increased because of the expanded indications for the product. Normally when the sales volume of a product increases, the price drops.
The 90% price drop of Humira once the market exclusivities expired in 2018 and generic competition kicked in offers further evidence of AbbVie’s excessive pricing. The Dutch Healthcare Authority (NZa) noted in its report “From Patent to Competition”, released in April, that spending per patient per year in the Netherlands on adalimumab fell nearly 90%, from €10,400 during the patent period to €1,300 once generic competition was introduced. This provides further evidence that the high price of Humira was due to AbbVie taking advantage of its monopoly position in the market.
AbbVie’ s response to PAF’s allegations is available here (in Dutch). Today, in responses to the media AbbVie has commented that the action by PAF may harm innovation for Dutch patients. This is a much heard argument used by the pharmaceutical industry to counter any measure they do not like with the prediction that the industry will abandon innovation efforts. The threat that innovation may be at stake often impresses policy makers. But in this case, it is hard to maintain considering that the global turnover for the product was US$231 billion.
It is not the first time AbbVie is being scrutinized for its pricing of Humira. In 2019 the Dutch competition authority, Authority for Consumers and Markets (ACM), launched an investigation into the discounts AbbVie offered hospitals. By the end of 2018, AbbVie had lost its market monopoly because of patent expiry and sought to obstruct market entry by biosimilars through exclusive contracts with hospitals by which hospitals would only retain discounts if they did not switch any of their patients to a biosimilar. The investigation was closed in 2020 after AbbVie stated it would no longer force hospitals to purchase exclusively from AbbVie.
In May, 2021 AbbVie was investigated by the US Congress as part of in-depth investigations into the pharmaceutical industry’s pricing practices, including the pricing of Humira. AbbVie had increased the price of Humira by 470% since its introduction in 2003 in the US. US patients paid US$ 77,586 for a year’s supply. AbbVie has used monopoly rights to sustain its high prices beyond what is reasonable. The Initiative for Medicines, Access & Knowledge (I-Mak) had found that AbbVie filed for 257 patents for Humira. Ninety percent of these patents were filed after the drug was first approved in 2002, so they had little relation to developing the product and were mainly used for strategic marketing purposes. I-Mak called this AbbVie’s “wall of patents”, meant to keep more affordable biosimilar versions of its product out of the market. And it worked: Biosimilars of Humira became available on the US market only in 2023 after which prices started to fall.
PAF’s case will be heard at the Amsterdam District Court before a panel of judges on 9 May 2025. By coincidence, in the United States, AbbVie will be holding its annual meeting of shareholders at 15:00 CET. A decision by the Court on the merits of this case is expected within 6-12 weeks.
Disclosure: Ellen ‘t Hoen is a member of the PAF advisory board.
Ellen ‘t Hoen, LLM PhD, is a lawyer and public health advocate with over 30 years of experience working on pharmaceutical and intellectual property policies.