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The Royal Commission on Genetic Modification - submissionsAgcarmLAW & LEGISLATION — SECTIONS B(f), B(n)Submission This submission concentrated on the protection of data given during the HSNO Act application procedure. Agcarm noted that applicants must supply ERMA with detailed data packages, of considerable commercial value, during the application procedures. There is a need, therefore, to protect these packages against unfair use by competitors. Hazardous Substances and New Organisms Act (HSNO) Agcarm observed that there is provision for the protection of commercially sensitive information associated with approvals for pharmaceuticals and agricultural compounds (animal remedies and pesticides). This protection does not extend, however, to applications in respect to GM research or GMOs. Agcarm recommended amendment of the HSNO Act in order to extend protection these types of applications. This could take the form of a provision similar to that for hazardous substances or, in the interests of harmonisation of Australasian law, follow the example of the Gene Technology Bill 2000. Under clause 45 of this bill the Regulator cannot use certain information in considering licence applications. Of note is clause 45(c) where it states that if the information is commercially sensitive, the Regulator must not take information from previous applications into account for the purpose of considering an application by another person for a GMO licence, unless the first person has given consent for the information to be so taken into account. This means other applicants must provide their own data package in order to prevent an unfair competitive advantage. Official Information Act (OIA) 1982 Section 57 of the HSNO Act allows for requests for the release of information held by ERMA. In particular, it allows for release of information provided by applicants for HSNO Act approvals. Where the applicant has declared the information sought commercially sensitive, ERMA may decline to provide that information under section 9(2)(b) of the OIA. This decision can be appealed to the Ombudsman who is required to balance the competing demands in their deliberations. Should he or she decide that release of the information is appropriate, then the applicant has the option of withdrawing the application. Agcarm submitted that this decision making process is opaque and uncertain. While the possibility of release of information may be considered a business risk, it is Agcarm’s opinion that the dimensions of the risks are such as to provided significant disincentive to doing business. It was further noted that the option to withdraw the application is costly for the applicant (for further information, see the Monsanto submission where this point was also raised). Agcarm then stated that a better balance needs to be struck between the competing interests. They noted that it would be a significant time before adequate case law is established to provide a working enunciation of what information has a reasonable chance of surviving requests for release. In the interests of clarity and certainty, Agcarm suggested the provision of a protocol setting out guidelines for the handling of such information requests that also describes information that may be kept confidential as of right. |