Would cost recovery unduly stifle competition and industry innovation (for example, through “free rider” effects)?
Pre-market approval of an IVD will permit the sponsor to supply products in Australia. The benefits of market approval are limited to the applicant – none of the assessment work will benefit other sponsors. As costs can be identified for the activities undertaken, fees are considered to be an appropriate cost recovery mechanism. The calculation of the fee ensures all applicants are treated equitably and does not confer advantage on one applicant over another. That is, by imposing the charge on the IVD industry, this should not stifle competition in the industry’s delivery of its end product. The cost recovery arrangements, therefore, will not impact on industry competition.
Related Questions
- Under the guise of cost recovery, industry is actually paying to get their products approved. How can the government claim to be objective in its decisions?
- Does the ServiceNOW™ disaster recovery program cover the cost of replacing a defective switch?
- How can employers and consumers leverage competition to lower cost and improve quality?
