JSE-listed pharmaceutical group Aspen Pharmacare Holdings has agreed to various commitments to address competition concerns raised by the European Commission after it opened an investigation into Aspen and some of its European subsidiaries.

The commission believes Aspen may have abused its dominant position by imposing unfair prices on molecules – or products, including chlorambucil, melphalan, mercaptopurine, tioguanine and busulfan, sold in the European Economic Area (EEA).

These products generated about €28-million in revenue for the financial year ended June 30 in the EEA.

More than 80% of the revenue is generated by solid dose form products that are currently sold at an average price of less than €2 per tablet and about €3 per patient per day, despite the products’ low volumes, says Aspen.

Aspen explains in a statement that each product treats, on average, about 200 patients a year per EEA member State, with one product having an average as low as eight patients.

“The average prices are well below those of certain other post-patent originator oncology drugs that face generic competition in the EEA. Additionally, in a number of EEA member States, certain of the products faced higher priced generic equivalents,” the company states.

Aspen therefore disagrees with a preliminary assessment made by the European Commission, but has nonetheless proposed commitments to address the commission’s competition concerns.

The company reports that the commission has responded positively to the proposed commitments and intends to accept it, subject to market testing whereby third parties will submit their observations regarding the proposed commitments.

Aspen proposes to implement average price reductions per product across the EEA of between 27% and 79%, which equates to an overall average of 73%, which it will maintain for ten years and guarantee supply for at least five years.

After five years, should Aspen wish to cease commercialising any of the products, it will make them available for sale to a third party or, absent an interested buyer, maintain the marketing authorisations and make a one-time payment to the relevant entities responsible for reimbursement of medicines and other beneficiaries as appropriate to bridge the implementation of the price reductions.

The company says it will continue to cooperate with the commission to prioritise the needs of patients.