David Guest wrote:
I am interested in the legal basis for suppressing the report.
The "reasoning" given by Justice Greenwood for granting an interlocutory
injunction under s 52 of the Trade Practices Act 1974 (Cth) is publicly
available at:
http://www.austlii.edu.au/au/cases/cth/federal_ct/2006/868.html
My "lay" understanding of the main points of his "reasoning" is as follows:
1. Because the non-commercial web site set up to publish the report had
links to a site that accepted paid sponsorship the judge accepted the
argument that the former site was, "operating in trade or commerce" and
the Trade Practices Act applied (this was disputed by our legal team).
2. Because a draft report was sent to the regulators (Therapeutic Goods
Administration, Therapeutic Goods Advertising Code Council and the
Complementary Health Care Council, etc.) for comment, as well as to the
company, the judge believed the process failed to provide the company
with, "any opportunity to put its position and influence the measured,
balanced and proportional evaluation of the evidence and the literature
leading to a final report" and this constituted "misleading conduct".
Our legal team argued that it was appropriate to send the draft report
to the regulators as the draft report criticised the regulatory process
as well as the claims made by the company about their product. The final
report (now suppressed) had considerable changes in response to
pertinent comments made by both the regulators and the company. We also
argued it was common academic practice to send a draft report to expert
colleagues for peer review (e.g. it was also sent to the NPS for
comment) but this was also judged "misleading conduct".
3. The judge accepted the argument (of the company's in-house medical
expert) that the report failed to adequately distinguish clinical trials
performed on Ginkgo biloba in general from trials conducted using their
unique proprietary extract (EGb 761®). We disputed this view.
4. The judge believed that the public interest was served by allowing
the regulatory complaint process to take its course.
However, Catch 22 is THERAPEUTIC GOODS REGULATIONS 1990 - REG 42ZCAJ
which states that a complaint cannot be heard if a proceeding has begun
in a court about the subject matter of the complaint and the proceeding
has not been finally disposed of. See:
http://www.austlii.edu.au/au/legis/cth/consol_reg/tgr1990300/s42zcaj.html
Leaving the matter to the regulators also ignored the prime reason for
wanting to publish the report on the Internet; the time taken by the
current co-regulatory system to deal with complaints about inappropriate
promotion. In particular, by the time a complaint has been heard,
appeals have been lodged, and a decision reached, promotional campaigns
have usually run their course.
Once again, I must stress that the above is only my "lay" understanding
of the main issues involved; other issues were also raised (and
disputed), a lawyer is needed to give a proper answer to David's
seemingly simple question!
In conclusion, our legal team noted that the outcome of applying law,
like medicine, is never certain. Our legal team was confident that they
would successfully oppose the injunction, but they didn't! Just as we
don't always save our patients!
Cheers
Ken
--
Dr. Ken Harvey
Adjunct Senior Research Fellow
School of Public Health, La Trobe University
http://www.medreach.com.au
VOIP: +61 (03) 9029 0634; Mobile +61 (04) 1918 1910
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