Public health-friendly options for protecting pharmaceutical registration data

Abstract

To gain marketing approval, generic firms typically rely on the clinical safety and efficacy testing data that brand-name pharmaceutical companies previously submitted ("registration data"). Big Pharma and the US government are pushing developing countries to provide brand-name companies with a minimum of five years exclusive rights to registration data. But restrictions on use of registration data delay the introduction of price-lowering generic competition. This paper considers public-health friendly alternatives, emphasising a cost-sharing approach, in which generic firms have an absolute right to use registration data, but must pay a proportionate share of the cost of generating the data.