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Price increases for cancer drugs up to 1500%: the ICA imposes a 5 million Euro fine on the multinational Aspen

The ICA imposed a fine of more than 5 million Euros on the multinational pharmaceutical company Aspen for infringing art. 102, letter a) of the Treaty on the Functioning of the European Union. In fact, the company had fixed unfair prices with increases up to 1500% for life-saving and irreplaceable drugs in the treatment of oncohematological patients, especially children and elderly people.

After purchasing the antitumor drug package from GlaxoSmithKline - whose patent expired decades ago - Aspen started negotiations with the Italian Medicines Agency (Agenzia Italiana del Farmaco - AIFA) with the sole aim to obtain a high increase in prices, even in the absence of any necessary economic justifications. The negotiation strategy adopted by Aspen was so aggressive as to reach the credible threat of interrupting the direct supply of the drugs to the Italian market. The mentioned products are based on the following active ingredients: chlorambucil, melphalan, mercaptopurine and tioguanine, in which only Aspen is present with the so-called Cosmos drugs, that is the medical products Leukeran (chlorambucil), Alkeran – both injectable and in tablets – (melphalan), Purinethol (mercaptopurine) and Tioguanine (tioguanine).

Through this negotiation strategy, Aspen obtained an extremely high increase in prices, ranging between 300% and 1500% of the initial prices.

The ICA’s investigation on the unfair practice was carried out through a two-phase test that measured the disproportion between prices and costs.

The unreasonableness of the mentioned disproportion resulted indicative of unfair prices also in the light of specific context and behavioural factors, such as: the inter-temporal comparison of prices, the absence of economic justifications for the increase, the absence of any extra-economic benefits for patients, the nature of Comos’s drugs, the characteristics of the group Aspen and the damage caused to the National Health System (Sistema Sanitario Nazionale – SSN).

Rome, 14 October 2016