On 21 February, the Dutch Pharmaceutical Accountability Foundation (PAF) took the bold step to take AbbVie to court, claiming the company’s pricing policy had harmed the Dutch healthcare system and the people who make use of it. The Foundation has calculated that AbbVie overcharged the health care system by as much as € 1.2 billion for its blockbuster medicine Humira (adalimumab). An English translation of the subpoena is available here.
Humira is a prescription medicine for rheumatoid arthritis and seven other diseases that was first brought to the market in 2003. Humira became the largest selling pharmaceutical product in the world. Until 2022, AbbVie earned US$ 208 billion with Humira globally.
In the Netherlands, in 2003 AbbVie’s price for Humira was € 10,000-12,000 per patient per year. AbbVie maintained this high price even though the number of patients increased more than tenfold, and the number of indications for use was expanded from one (rheumatism) to eight.
AbbVie sold € 2.3 billion worth of Humira in the Netherlands during its market monopoly, which ran from 2004 until 2018. PAF calculated that € 1.2 billion of the € 2.3 billion was excessive profit. This amounts to € 68 per Dutch citizen, according to PAF. The excessive profit was calculated by subtracting all R&D costs, as claimed by AbbVie, production and distribution costs (as disclosed in US Congress), and by adding a 25% profit from the drug’s turnover. After patent protection expired, the price of adalimumab dropped by 80%.
Health economists, with whom the Foundation collaborates, have calculated that AbbVie’s excessive profit could have ensured up to 16,300 extra years of healthy life for Dutch citizens.
PAF is bringing civil litigation based on tort (Unlawful act: breach of social duty of care), Human Rights Law (violation of the Right to Life and the Right to Health) and competition law (abuse of a dominant position). The Foundation claims that AbbVie made excessive profits at the health care system’s and its users’ expense and, consequently, violated the Dutch Civil Code (art 6:162). The Foundation is seeking a declaratory judgement that AbbVie acted unlawfully and is not asking for financial damages directly. However, a positive outcome will open the way for others, such as health insurers, to seek compensation.
This is not the first time AbbVie’s Humira pricing and marketing behaviour has been scrutinised.
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. The price of Humira took centre stage. 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. Like in the Netherlands, in the US 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 to do with developing the product but were mainly used for strategic marketing purposes. AbbVie obtained 130 granted patents and 39 years of protection. 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. Only this year, biosimilars of Humira became available on the US market and prices started to fall.
PAF has successfully taken legal action against a pharmaceutical company’s pricing behaviour. In 2018 PAF submitted an enforcement request with the Dutch competition authority, Authority for Consumers and Markets (ACM) to investigate the pricing by Leadiant Biosciences’ of its product chenodeoxycholic acid (CDCA) a treatment for cerebrotendinous xanthomatosis (CTX), a rare metabolic disease. The company had increased the price of chenodeoxycholic acid (CDCA) 500-fold after it obtained market exclusivity after the European Medicines Agency approved it as an orphan drug. Three years later, in July 2021, the ACM imposed a fine on the company of € 19,5 million. PAF’s action sparked similar cases elsewhere in Europe. Leadiant has also been fined for excessive pricing and abuse of its dominant position in the market in Spain, Israel and Italy against the company. A similar case brought by the consumer group Test-Aankoop in Belgium is still pending.
Ellen ‘t Hoen is a member of the Expert Advisory Board of the Foundation for Pharmaceutical Accountability.