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The secrecy of drug regulatory information |
Key words: drug evaluation, cost-effectiveness.
(Aust Prescr 2002;25:78-9)
Recent Australian legislation has reinforced the communityâ⚬➢s desire to
preserve the privacy of personal information, as far as this is compatible with
the public good. Yet the community has a desire for more â⚬ƹÅ-openâ⚬➢ government
and demands increased public access to information held by government. However,
some of this information may have been supplied to the government in confidence.
Can a satisfactory balance be found between these sometimes competing desires?
Government decisions on the marketing and subsidy of drugs depend on the assessment
of data provided by the pharmaceutical industry. These data are largely â⚬ƹÅ-commercial-in-confidenceâ⚬➢.
Clinical trials and other data are evaluated within the Therapeutic Goods Administration
(TGA), or externally, before a new drug can be approved in Australia. The evaluations,
and the TGAâ⚬➢s recommendation based on them, are assessed by the Australian
Drug Evaluation Committee (ADEC) which then recommends to the Minister for Health
which drug should be approved. Unlike the situation which applies for regulatory
bodies in certain overseas countries*, virtually none of
the information held by the TGA is currently made available publicly. Much of
it will also never appear in the medical literature. The cost-effectiveness
data considered by the Pharmaceutical Benefits Advisory Committee (PBAC), when
recommending that a drug be listed on the Pharmaceutical Benefits Scheme (PBS),
are also secret.1
Would there be advantages for the community if the drug regulatory information
held by government was more widely available? The evaluations, the TGAâ⚬➢s
recommendation, and the ADEC and PBAC assessments would provide an extensive
and balanced source of information about a new drug. Their availability should
ultimately result in better therapeutic practice, and the Australian drug regulatory
process would be more transparent. Scientifically valid information concerning
trials with unfavourable outcomes would be available. These negative studies
currently rarely reach the public domain. Toxicological data about drugs which
have been rejected for marketing would provide a valuable additional resource
for predicting, on the basis of analogy, potential problems with similar drugs.
Additionally, there is an ethical consideration. Should information be allowed
to remain secret, when its wider availability could prevent the unnecessary
repetition of studies that are likely to have negative or otherwise unfavourable
outcomes? Resources would be saved and animals and human participants would
be spared pointless and perhaps hazardous procedures.
Would there be disadvantages for those who currently expect that the information
will remain secret? Some disadvantages for the pharmaceutical industry are obvious.
The knowledge would put competitors in a stronger position, and at an earlier
stage. Some item of knowledge, missed or ignored by the original owners of the
information, might spark an idea which is ultimately of great commercial advantage
to someone else. The original investigators who produced the pharmaceutical
industryâ⚬➢s data may find that the information was in the public domain
before they had published it in the scientific literature. This might deter
the better investigators from working in drug development. Evaluators of drug
regulatory data, if identified, could be exposed to various external pressures.
The staff of the TGA and members of ADEC and PBAC might also face increased
public criticism of their recommendations.
Can some reconciliation be achieved between the potential public benefit available
from the release of currently confidential drug regulatory information, and
the understandable commercial and possibly individual wish for continued secrecy
of this information? The names of the ADEC members are already public knowledge
and the identity of evaluators could be concealed when their evaluations were
released. It would be no bad thing if investigators, and the pharmaceutical
industry, expedited the publication of original data in the scientific literature.
From the commercial-in-confidence standpoint, the timing of the public availability
of governmental-held information would be critical. The pharmaceutical industry
might have relatively little problem with information becoming publicly available
20 to 30 years after it was lodged with government, yet its immediate public
availability appears to be unacceptable to the industry in Australia. Some mutually
agreed intermediate position might be achieved. Perhaps pharmacological and
clinical data could be released after PBS listing (a drug in Australia is unlikely
to be widely used without such listing), or a certain time after ADEC has recommended
its approval. The release of formulation data could be deferred until expiry
of the drugâ⚬➢s patent, or later, so that generic manufacturers were not
advantaged. In all such matters, Australia would need to act in co-ordination
with other nations.
Surely there is a case that the potential community benefit, and also ethical
considerations, require that better use should be made of the treasure trove
of drug information that government and industry in Australia currently keep
secret?
* New drug information is available from the web sites of the US Food and Drug Administration (www.fda.gov) and the European Medicines Evaluation Agency (www.emea.eu.int)
Reference
1. Marley J. Cost-effectiveness:
the need to know. Aust Prescr 1996;19:58-9.
Professor Eadie was chairman of ADEC from 1985
to 1993.
