Version 15 November 2023
About Adalimumab/Humira and pricing issues
- AbbVie’s blockbuster drug Adalimumab (brand name: Humira) for the treatment of rheumatoid arthritis is one of the best selling pharmaceutical products in history.
- Between 2003 and 2022, it netted AbbVie $208 billion globally, and €2.3 billion in the Netherlands from 2004-2018.
- Humira was the most sold drug worldwide between 2012-2020.
- AbbVie tried to fight off the entry of biosimilar versions of Humira (made by third parties) into its profitable market by filing 247 patents on the medicine in the US. Generic drug makers entered into agreements with AbbVie to open the European market in 2018 in exchange for them guarding the American market until 2023.
- When biosimilars entered the European market in October 2018, AbbVie promptly dropped the price of Humira by 80%, an indication of how much it was overpriced during the length of its patent protection.
About the court case
- At the Pharmaceutical Accountability Foundation, we believe that companies should be called to account when they make excessive profits through excessive pricing.
- AbbVie overcharged the Dutch healthcare system by up to €1.2 billion during its monopoly period through excessive pricing.
- This was calculated by subtracting research and development costs, production costs as well as a ‘fair’ profit of 25% from Humira’s turnover. The remaining 53% is considered excessive profit.
- The Foundation contends that AbbVie acted contrary to fundamental human rights, including the right to life and the highest attainable standard of health, which includes access to essential medicines
- On 21 February 2023, the Foundation brought a lawsuit against AbbVie to hold it to account. The lawsuit makes claims against AbbVie for:
- Abuse of a dominant market position: Under the Dutch Competition Act (DCA) companies that hold a monopoly (i.e. via a patent) cannot use that monopoly to engage in unfair practices. AbbVie’s excessive pricing as well as its gaming of the patent system to extend its monopoly are, the Foundation contends, breaches of this law.
- Displacement of care: National health plans have limited financing, and health authorities set priorities about what medicines can be made available. When medicines prices exceed what a health system can afford, health authorities may attempt to negotiate lower prices or an increased budget. But if this does not work they will need to ration care to only specific patients, or to make trade-offs for more cost-effective care. This is known as ‘care displacement’ – making tough choices when the cost of treatments puts pressure on budgets. Some medicines are costly to produce and/or costly to administer; others are inexpensive to produce but have excessive prices due to abuse of a monopoly position in the market. It is the Foundation’s contention that AbbVie is guilty of the latter.
- Violation of human rights principles: Pharmaceutical companies are not selling luxury goods, but lifesaving medicines. They are given temporary monopolies over these medicines to help them recoup costs associated with research and development, but in return they have a duty of care not to abuse those monopoly rights. Human rights law guarantees the rights to life and to the highest attainable standard of health. The UN also has Guiding Principles on Business and Human Rights that sets forward obligations of private companies to respect human rights. In charging excessive prices, AbbVie infringes these rights, and neglects its duties toward socially responsible behaviour.
- Outside the Netherlands, AbbVie has been called before the US Congress in May 2021 to answer for its pricing strategy and gaming of the US patent system.
- A win for the Foundation in this case would establish that there are limits to how high pharmaceutical companies can push prices on medicines.