Amid rising concern over antibiotic resistance, a battle is brewing in Europe over a proposal to offer vouchers to companies as an incentive to develop new treatments, a controversial idea has already raised objections from more than a dozen members of the European Union.
The basic premise is straightforward. A company that wins regulatory approval for a novel antibiotic gets a voucher that can then be used to extend for one year the exclusive rights to the results of clinical trial data for another of its medicines. As an alternative, the drug maker could sell the voucher to another pharmaceutical company.
The concept has existed for more than a decade in the U.S., where a drug company can win a voucher for developing treatments for rare pediatric diseases, neglected tropical diseases, and public health emergencies. The trade-off is different from what is being proposed in Europe, though. In exchange for a needed therapy, in the U.S., a drugmaker can win expedited approval for another medicine being developed.
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