ACM launches investigation into Biogen over a possible abuse of dominance in connection with MS drugs

The Netherlands Authority for Consumers and Markets (ACM) has launched an investigation into prescription drug manufacturer Biogen over a possible abuse of a dominant position in connection with multiple sclerosis (MS) drugs and thereto-associated blood tests. ACM assesses the manner in which Biogen makes its anti-JCV blood test Stratify available in the Netherlands. This test is exclusively available for patients who are being treated with the Biogen drug Tysabri or are considering treatment with it. As a result, Biogen’s anti-JCV blood test is currently not available to patients who are being treated with other MS drugs. As such, Biogen may impede effective competition from potential new and existing providers of natalizumab-based MS drugs. That can affect price, supply, and freedom of choice for health care providers and patients.

The Stratify test is used in MS patients that are treated with Tysabri. Tysabri contains the active ingredient natalizumab. When using drugs containing natalizumab, patients run the risk of developing a life-threatening brain infection. That risk can be estimated using a special anti-JCV blood test, such as the Stratify test.

Businesses cannot abuse their dominant positions

A business has a dominant position if it is able to act independently of buyers and competitors, for example because it is not easy for buyers to switch providers. Businesses can have dominant positions, but they cannot abuse them. That is prohibited under the competition rules. Abuse may include the use of unfair conditions vis-à-vis buyers. That can lead to higher costs for businesses, and, ultimately, also to higher prices and less innovation for consumers.

Next steps

The ACM will assess whether Biogen has indeed violated the competition rules. In this process, ACM may also come to the conclusion that the law has not been violated.

Do you have any relevant information regarding Tysabri and/or the Stratify test, and the way in which these are made available? If so, please consider filing a report with ACM.

Earlier this year, the Italian competition authority (AGCM) launched a similar investigation into Biogen. Where the investigations overlap, ACM and the AGCM work together.

Health care sector

ACM ensures that markets remain fair and open, so that businesses are able to compete with each other on price, quality, and innovation. If it receives any indications that a business abuses its dominant position, ACM can take action. The prescription drug sector is one of ACM’s key priorities. This investigation fits in with ACM’s efforts to ensure health care is accessible and affordable.