AMSTERDAM, THE NETHERLANDS: In February 2023, the Pharmaceutical Accountability Foundation (PAF) filed a lawsuit against AbbVie Netherlands and AbbVie Inc (globally), alleging that the company acted unlawfully in extracting excessive profits from its rheumatoid arthritis drug, adalimumab (Humira). The company made a staggering turnover of $231 billion globally between 2003-2024. In the Netherlands alone, they netted €2.1 billion from 2004-2018; as much as €1 billion amounts to excess profits earned through unfair pricing practices, PAF’s lawsuit contends. Now, judges will be asked to decide whether AbbVie was acting unlawfully.
“A person’s health is priceless; unfortunately, health systems have limits,” said Wilbert Bannenberg, PAF’s Chairperson. “Companies are acting unlawfully when they keep prices so high that it leads to excessive profits and displacement of care. We estimate that the excessive profits on Humira in the Netherlands translate to the loss of 13,950 years of healthy life. This infringes on the human right to health.”
Adalimumab (Humira, known as ‘Swiss army knife’ of medicines), is an effective treatment for rheumatoid arthritis, psoriasis, and several other inflammatory conditions. It was for many years the most widely sold and profitable drug in both the Netherlands and the world. The Dutch Healthcare Authority (NZa) in April released a report on inflated medicines prices during patent monopolies, and noted 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.
PAF’s case alleges that AbbVie abused its dominant position in the market to make excessive profits. An excessive profit was calculated by subtracting from AbbVie’s turnover R&D costs (11%) and production and distribution costs (11%) (both figures as disclosed by AbbVie to the US Congress), and a ‘fair’ 29% profit from the drug’s turnover, leaving the remaining 49%, or €1 billion, in excessive profit. This is based on a report by health economists.
At the heart of this case is the question of whether there are limits to what a company can charge for innovative new medicines; PAF is asking for the court to declare that AbbVie’s excessive extraction of profits from the Dutch healthcare system was unlawful. Pharmaceutical companies violate their duty of care when they exploit market exclusivities—granted as incentives to spur innovation on needed medicines—not to serve public health, but to extract excessive profits. PAF’s litigation is based on tort (Unlawful act: breach of social duty of care and Human Rights Law (violation of the Right to Health) and competition law (abuse of a dominant position). If granted, this would be the world’s first successful litigation on the Right to Health and excessive profits.
PAF has published Abbvie’s defence transparently on our website.
PAF’s long-term goals are to establish that there be legally enforceable regulations that ensure medicines are fairly and socially acceptable priced; these should oblige pharmaceutical companies to provide transparency on research and development costs, the share of public funding and profit margins.
PAF’s case will be heard at the Amsterdam District Court before a panel of judges 9 May 2025 from 9:30 -12:30. By coincidence, in the United States, AbbVie executives will be holding their annual meeting of stockholders at 15:00 CET. A decision by the Court on the merits of this case expected within 6-12 weeks.
Further resources:
- Background and further info on the case
- Video explaining the case
- Dutch Healthcare Authority (Nederlandse Zorgautoriteit, NZa) report: From patent to competition – Analysis of expenditure and use of 7 expensive medicines
- Zorgvuldig Advies’ “In-depth analysis: high profits made with Humira”: Follow-up to Zorgvuldig Advies’ first report in response to AbbVie’s ‘Statement of Defence’
- Letters from Dutch authorities relevant to the case:
- NZa position on expensive medicines and displacement: Dutch original; English machine translation
- Dutch National Healthcare Institute (Zorginstituut Nederland, ZIN): Letter in connection with the PAF v AbbVie lawsuit regarding Humira: Dutch original; English machine translation
- Netherlands Authority for Consumers and Markets (Autoriteit Consument & Markt, ACM): Letter answering questions from the Pharmaceutical Accountability Foundation: Dutch original
About the Pharmaceutical Accountability Foundation
The Pharmaceutical Accountability Foundation is an independent, public good foundation under Dutch law, which works to ensure equitable, affordable access to medicines for all. In particular, we attach a value to fair pricing for health products, in accordance with European and international legal and human rights standards. We therefore take issue when pharmaceutical companies abuse their market position to overcharge for medicines. We try to prevent this by providing advice and information to governments and other stakeholders. If that does not help, we may consider legal action as a means to achieve our objectives.
About PAF’s previous case
This is PAF’s second case. PAF’s first case concerned the pharmaceutical company Leadiant, which made a 50-year-old drug, CDCA, 500 times more expensive after monopolising sources of raw materials, buying up competing products, and obtaining “orphan drug” status which provided for 10 years market exclusivity. This case resulted in a €19.5 million fine from the Dutch competition authority ACM in 2021, later reduced to €17 million and confirmed by the Rotterdam District Court. The Dutch PAF case inspired follow-on cases and fines in Italy and Spain.
This case demonstrates that PAF’s strategy of holding pharmaceutical companies to account for specific market abuses is not only workable but can act as a model in other jurisdictions.
About Humira
Humira is a prescription drug for rheumatoid arthritis and 7 other diseases that was first brought to the market in 2003. Humira became the largest selling pharmaceutical product in the world.
Globally, AbbVie made $231 billion turnover on Humira until 2024, largely due to prices being extremely high in the USA ($80,000/patient/year), where the patents only ended in 2023. Using a similar calculation, AbbVie could have made globally up to $120 billion in excessive profits. In May 2021, the USA Congress called AbbVie and 5 other pharmaceutical companies to account for ‘unsustainable’ pricing.