The European Commission accepts commitments from the manufacturer, Aspen.

On 15 May 2017, the EC opened an investigation into Aspen, a South African-based global pharmaceutical company, to ascertain whether it is abusing its dominant position. Following consultations with stakeholders held during the 2020 summer about the commitments offered by the manufacturer, the EC was able to accept these commitments on 10 February 2021.

Dominant position

Aspen, a pharmaceutical company, acquired the rights to several medicinal products and another company prior to 2012. Aspen won a dominant position in the market for certain therapies through acquiring the rights to medicinal products used mainly for the treatment of leukaemia and other haematological cancers.

Due to the frequent lack of suitable alternatives for treating cancer, Aspen has been able to push through price increases for specific cancer medicines within the Member States, where the products are marketed. The medicinal products in question include those sold under the Alkeran, Leukeran and Purinethol brand names.

Commission investigation of pricing and distribution policies

The EC's study of the revenue data revealed that the revenue from the sale of these medicinal products within the European Economic Area was "very high" in absolute terms and in comparison with the revenue of similar companies in the sector. Prices were on average around 300 percent above the relevant costs after a reasonable return was taken into account.

The associated high profits and subsequent excessive burden on health and social systems in Europe could not be explained. As the patent protection for the Aspen medicaments concerned expired 50 years ago, it can now be assumed that the R&D costs have been fully amortised.

Aspen also used its dominant market position against the national authorities, which tried to oppose the price increases. The company threatened to have the medicines removed from national lists of reimbursable medicinal products and it also expressed a willingness to withdraw the medicines from sale in the Member States concerned.

This pricing and distribution policy prompted the EC to investigate the matter as a breach of EU antitrust regulations.

EC accepts commitments from the manufacturer

The antitrust regulations provide that companies subject to an investigation by the EC may offer commitments in order to meet the Commission's concerns. The corresponding undertaking made in July 2020 was published in the Official Journal of the European Union.

At that time, the National Association of Statutory Health Insurance Funds took a stand and advocated that the EC take up the abuse of a dominant position in the pharmaceutical market. However, the price reduction would have to include compensation for the damage caused in the past due to the excessive prices.

On 10 February 2021, the EC accepted the undertaking provided by the manufacturer. Accordingly, the Commission accepts the reduction of the prices for six unpatented cancer medicines by 73 percent as well as a longer-term supply commitment with these unpatented medicaments.