Dutch lawsuit on Humira assesses whether its price was ‘excessive’

In a unique legal challenge, the Dutch pharmaceutical accountability is foundation contract The Humira manufacturer (Adalimumab), Abbvie, today in a Dutch court, May 9, due to alleged excessive profit. The foundation is not looking for financial damage. Rather, a panel of judges makes a decision about the principle of what a reasonable profit is. The core of the matter is the question of whether there should be limits to what a company can charge for medicines.

The foundation accuses ABBVIE of ‘abusing’ its dominant position in the market as a monopoly to make excessive profit, hereby also certain ‘human rights’, such as the ‘right to health’ of people. In deze context berekende de eiser dergelijke winst door af te trekken van de inkomsten – Abbvie’s Humira -omzet in Nederland waren € 2,1 ($ 2,36) miljard van 2004 tot toen het patent van het product in 2018 afliep – onderzoek en ontwikkeling, productie en distributiekosten en wat de stichting heeft geopend, een “fair” winst, een “beurs”, een “fair” winst, een “beurs”, een “fair” winst, A “fair”, a “fair” profit, € 1 ($ 1.13) bill.

The Pharmaceutical Accountability Foundation is an independent, public good basis under Dutch law that says it works to “ensure fair, affordable access to medicines for everyone.”

Humira has been a blockbuster medication worldwide for two decades. The biological has several indications, including rheumatoid arthritis, Crohn’s disease and psoriasis. Humira still has billions of dollars in sales in the United States, where biosimilar traction has been slow, initially due to a lawsuit, which caused biosimilars to enter the market until 2023 and then a sub -optimal operational supply chain of medicines. Humira’s market share remains quite high at 70% despite the competition. Moreover, biosimilar discounts are not as steep as they are outside the US, including the Netherlands.

The Dutch Healthcare Authority, an agency of the Dutch Ministry of Health, Welfare and Sport a report released Last month, which noted that the annual expenditure per patient on products based on adalimumab in the Netherlands in 2018 decreased almost 90%, from € 10,400 ($ 11,713) during the Humira patent period to € 1,300 ($ 1,464) as soon as biosimilar competition was introduced.

Biosimilars are very close to the molecular structure and function for them to which you are referred, brand name inrider biological medicines. There are also no clinically meaningful differences in effectiveness. Humira is an originator with countless referred biosimilars.

In the first legal proceedings in 2023, the ABBVIE Foundation accused Van concern “unfair, excessive price practices. “It called on the importance of considering opportunities costs when evaluating expenditure for Humira:” The Dutch government has set a maximum budget for healthcare. That means you have to make choices. You can only spend every euro once. And we see that because drug manufacturers charge a too high price, other medicines or services cannot be delivered. In addition, the foundation suggests that ordinary Dutch citizens are financially negatively influenced, because they “pay for the [excessive profit]by higher and higher [health insurance] premiums. “

The long -term goals of the foundation are the establishment of legally enforceable instructions that ensure that medicines are reasonably priced on “socially acceptable” levels. Moreover, the organization is looking for a way to oblige more transparency of pharmaceutical companies with regard to research and development costs, the share of public financing and profit margins.

In response to the legal complaint, ABBVIE has said that it acts in accordance with all Dutch laws and regulations. The company categorically rejects the allegations of the foundation. Moreover, Abbvie says that the costs of failed development projects, expansion of indications and related studies are not adequately justified in the claimant’s argument. According to Abbvie, no suitable discounts were negotiated with care providers who are included in the calculations.

Defendant also attracts problems with accusations that the price of Humira was ‘too high’. In the Netherlands, when a medicine is launched, manufacturers are confronted with multiple entities, including the National Health Care Institute and the Ministry of Health, Welfare and Sport, with whom they negotiate the prices and reimbursement of medication. Probably, the moment Humira was launched, Abbvie negotiated an acceptable price with the relevant authorities.

In general, profitable or price guts is considered the practice of increasing the prices of goods to a level “much higher”, then is considered “reasonable or fair”. More often than not, the term is associated with sellers use circumstances that reduce the offer. This would include emergency situations that cause serious limitations on the supply side. Although Humira did enjoy a period in which it was a monopoly, which lasted until 2018 in Europe, there were no supply restrictions that ABBVIE would have exploited. This in turn raises questions about whether the foundation of the foundation with regard to ‘excessive profit’ will be accepted before the court.

Nevertheless, the umbrella problem of increasing spending on what the government calls ‘expensive drugs’ has recently deteriorated. In the eyes of the foundation, this can be exacerbated by “unreasonable prices” that make it more difficult to maintain a sustainable health care system in which there is universal access to an essential package of benefits.

If the challenge of the foundation is successful, this could establish a precedent in the Netherlands, and perhaps Europe, over price and profit limits. A decision by a panel from judges about whether ABVIE has acted illegally is expected in six to 12 weeks.