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Local councils, medical trials and GMOs
Local councils, medical trials and GMOs
- Expert
Q&A
2 September 2016
Medical trials
involving genetically modified vaccines and other GM
treatments will still be allowed under planning changes
Auckland and three other local councils are
making.
Auckland councillors this week agreed to a ban on the general release of genetically modified organisms under the city's Unitary Plan.
That has led to concerns that a medical trial involving genetically modified organisms would be stopped in its tracks.
Environment Minister Dr Nick Smith said today that the Government would review the "appropriateness of councils being involved in regulating genetically modified organisms".
“A trial for liver cancer vaccine Pexa-Vec is being conducted at Auckland Hospital which involves a GMO. The new Auckland Unitary Plan prohibits the release of any GMO and would not allow any such future medical treatments,” Dr Smith said in apress release.
The
SMC put together the following Expert Q&A with Dr Kerry
Grundy, Team Leader (Futures Planning), Whangarei District
Council. (Contact Dr Grundy on 09 430 4200) Dr Grundy is
convenor of the Inter-council Working party on GMO Risk
Evaluation and Management Options (comprising Auckland
Council, Whangarei District Council, Far North District
Council, and Northland Regional Council).*
1: Will existing and/or future medical trials involving GMOs be banned in these regions as a result of the plan changes?
"I can confirm that the GMO provisions in all planning documents do not affect medical applications involving GMOs including present and future applications. These are permitted.
"The plan provisions apply only to outdoor use of GMOs, i.e. GMOs released to the environment or outdoor field trial of GMOs. They do not apply to indoor use in contained facilities, laboratories, hospitals or to medical applications or most veterinary applications."
2. As part of the plan provisions, do the Councils require any additional notification of, or approval for, GM-related trials (medical or otherwise) than is currently required through the likes of the Environmental Protection Authority?
"The councils’ plan provisions make outdoor field trials of GMOs a discretionary activity under the RMA. This means they need a resource consent from council to conduct a field trial in addition to approval from the EPA.
"The resource consent will require strict liability from the party conducting the trial for any environmental or economic damage that may occur as a result of the trial together with a bond to cover any costs should they arise (HSNO does not require this).
"This does not apply to medical trials as medical applications are specifically excluded from council provisions. In addition, the definition of field trials in the plan provisions refers only to 'outdoor' field trials."
3. Are there any specific provisions relating to patients involved in medical trials who are being treated with GM therapies - such as the Pexa-Vec liver cancer vaccine? For instance, relating to where the vaccines can be administered, or where patients are housed while receiving treatment?
"There are no specific provisions relating to patients involved in medical trials who are being treated with GM therapies presently or in the future. Medical applications are not subject to the plan provisions. They are treated as permitted activities under the RMA. They require no consent from council. Council has no role in relation to them."
4. Are there currently any outdoor trials of GMOs underway in any of the regions governed by the four Councils that have contributed to the plan?
"There are no outdoor field trials that I am aware of underway in any of the jurisdictions covered by the councils in Auckland and Northland who have or are in the process of putting GMO provisions in their planning documents."
5. What provisions have the Councils made for the possible future introduction of new genetic technologies, such as gene-editing techniques, and their evaluation and classification as GM according to the plan?
"Councils have made no specific provisions for possible future introduction of new genetic techniques and their classification as GM according to the plans. Councils only regulate GMOs as defined in the HSNO Act.
"The plans’ definition of a GMO is the same as the HSNO definition. If an organism produced by a new technique is included as a GMO under the HSNO Act it will be treated as such by the plans. If an organism produced by a new technique is not defined as a GMO under HSNO it will not be caught by the plan provisions."
*The GMO plan provisions that are in the Auckland Unitary Plan and in plan changes to the WDC and FNDC GMO plan changes are based on research and documentation produced by the Working Party.
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