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Spain: Novartis before the Court for not publishing its criteria for drug approval



Novartis and Spain have been adventurous, according to international press reports on a treatment for leukemia,

At the end of 2018, the Spanish government announced the approval of an innovative therapist covered by the so-called cellular immunotherapy ( CART) and utilizes the ability of our immune system to recognize and attack tumors. This treatment, called Kymriah, was initiated by Novartis.

However, members of the No es Sano campaign and the Spanish Consumer Agency asked the Ministry of Health to be informed of its value and the therapeutic and financial criteria used to treat it. to justify their approval. In January 201

9, the Spanish Government sent a letter to the Campaign containing information only about the cost of for treatment which amounted to EUR 320,000 . However, it did not provide information on its approval criteria except for something "general and incomplete"

The result was the campaign and the Spanish Consumer Agency to resort to the Spanish Central Transparency Council, an independent authority responsible for ensuring transparency. of public activity. The Transparency Council decided that the Ministry would provide the necessary information in the public interest.

Novartis has, for its part, brought proceedings before the courts to delay the procedure. In other words, to prevent the public service from sharing this information and therefore publishing it. The goal is pending.

See related publications

https://saludporderecho.org/en/novartis-goes-to-court-to-try-to-prevent-the-go Government-from-making-information-public-about- the-approval-of-one-of-its-most-innovative-treatments /

https://spainsnews.com/novartis-turns-to-the-courts-to-keep- secret-data- on a publicly funded drug society /

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