E-DRUG: Data exclusivity and trials data disclosure - collision? (2)
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Andy Gray asks an important question about the effect of the new push for
transparency about clinical trials (including voluntary and mandated
publication of results on both public and private websites) on data
exclusivity either under the TRIPS Agreement or under data exclusivity
rules as currently drafted.
As a preliminary matter, we know that Art. 39.3 of the TRIPS Agreement only
provides data protection, not exclusivity, and that it requires protection
only for "undisclosed data." Thus, the argument would be that any
disclosure, whether mandated by government or offered voluntarily by
manufacturers, would defeat any claim for TRIPS-mandated data protection.
Unlike Art. 39.3, most data exclusivity rules do not directly reference the
issue of confidentiality or non-disclosure. Instead, they ordinarily
preclude the use of, and/or reliance on, previously submitted data or on
the fact of prior registration, domestically or elsewhere, as the basis for
establishing the safety and efficacy of a generic equivalent during the
period of exclusivity.
Andy's question is more subtle: Even though you can't use or rely on the
data and even though you can't rely on the fact of prior registration
domestically or elsewhere, can the regulators rely on the information
published in the government-required, or better yet, industry-sponsored
websites? At present, there doesn't seem to be any direct prohibition
against such use, even in draft FTA language. But, I guess the question
ultimately will be whether the disclosures will contain enough detailed
information about quality studies/GMP and safety/efficacy clinical trials
to justify marketing approval. Most of the proposals to date in the U.S.
are that only summaries of late stage clinical trials be published. Thus,
the question becomes: would or should those summaries be sufficient to
satisfy regulators?
Professor Brook K. Baker, Health GAP
Northestern University School of Law
400 Huntington Ave.
Boston, MA 02115 USA
617-373-3217
b.baker@neu.edu