The secrecy of drug regulatory information
- M.J. Eadie
- Aust Prescr 2002;25:78-9
- 1 July 2002
- DOI: 10.18773/austprescr.2002.067
Recent Australian legislation has reinforced the community'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 'open' 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 'commercial-in-confidence'. 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 TGA'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 TGA'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 industry'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 drug'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?
Professor Eadie was chairman of ADEC from 1985 to 1993.
Emeritus Professor, Department of Medicine, University of Queensland
Former chairman, Australian Drug Evaluation Committee