On Monday, 11 December 2017, KEI delivered the following statement in response to WIPO’s publication of a Draft Reference Document on Exception Regarding Acts for Obtaining Regulatory Approval from Authorities.
KEI commends the work of the WIPO secretariat in preparing Draft Reference Document (SCP27/3) on Exception Regarding Acts for Obtaining Regulatory Approval from Authorities. The document provides a detailed overview of the policy objectives that engendered the creation of the regulatory review exception and a comprehensive insight into its application in 65 countries. Importantly, it also describes the challenges faced by countries in its implementation.
With respect to impact of the exception, the report provides the results of an impact assessment conducted by the United Kingdom “in conjunction with Section 60(5)(b) of Patents Act. The impact assessment estimated that the regulatory review exception “would reduce the cost of undertaking trials (for example, by eliminating cost of freedom-to-operate investigations which would save companies between £3,000 to £135,000 per trial) and would make the UK a more attractive place for companies to undertake research and development.”
As a follow up to the Secretariat’s work on the draft reference document, we request that the Office of the Chief Economist to conduct an impact assessment of the regulatory review exception in at least 7 countries. The terms of reference of this impact assessment could include:
1 . An examination of the effects of the regulatory review exception, if any, on the costs of undertaking clinical trials.
2. A study of how the regulatory review exception affected the entry of generic medicines into the market.