Author : Daria Kim
The article addresses the problem of restricted access to industry-sponsored clinical trial data. In particular, it analyses the intersection of the competing claims that mandatory disclosure of pharmaceutical test data impedes innovation incentives, and that access facilitates new drug development.
These claims are characterised in terms of public-good and common-resource dilemmas. The analysis finds that confidentiality protection of primary research data plays an ambiguous role.
While secrecy, as such, does not solve the public-good problem in pharmaceutical innovation (in the presence of regulatory instruments that protect the originator drug against generic competition), it is likely to exacerbate the common-resource problem, in view of data as a source of verified and new knowledge.
It is argued that the claim of the research-based industry that disclosure of clinical data impedes innovation incentives is misplaced and should not be leveraged against the pro-access policies. The analysis proposes that regulation should adhere to the principle that protection should be confined to competition by imitation.
This implies that the rules of access should be designed in such a way that third-party use of data does not interfere with protection against generic competition. At the same time, the long-term collective benefit can be maximised when the ‘cooperative choice’ – i.e. when everyone shares data – becomes the ‘dominant strategy’.
This can be achieved only when access is not subject to the authorisation of the initial trial sponsors, and when primary data is aggregated, refined and managed on the collective basis.