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Local councils, medical trials and GMOs – Expert Q&A

Posted in Briefings on September 2nd, 2016.

UPDATED: 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.

gmAuckland councillors this week agreed to a ban on the general release of genetically modified organisms under the city’s Unitary Plan.

*See new comments below on the legal aspects of the plan changes and download legal documents related to the issue here.

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. 

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. Dr Kerry Grundy was involved in the development of the provisions.

Helen Atkins, Partner at Atkins, Holm, Majurey, provided the following legal opinion to Federated Farmers on the implications of changes to the Auckland Unitary Plan for medical trails involving GMOs:

“The implications of the IHP* recommendations for the Pexa-Vec vaccine are obvious. As this vaccine has been approved for release it is by definition (both under HSNO and the PAUP) a genetically modified organism release and therefore a prohibited activity under the PAUP.

“Even if clinical trials have begun they are ongoing and in that respect every time the vaccine it taken out of containment and released into the environment into the trial members it is, by definition, a genetically modified organism release.

“Further the rules in the PAUP will prohibit therapeutic use of Pexa-Vec in the Auckland region beyond the clinical trial and will also prevent the use of other similar therapeutic agents which are genetically modified organisms in clinical trials or for treatment of patients.

“Prohibition of these therapeutics will stymie the use of new therapeutic technologies and may put patients’ lives at risk.”

*IHP = Independent Hearings Panel
HSNO Act = Hazardous Substances and New Organisms Act
PAUP = Proposed Auckland Unitary Plan

Legal documents: Follow this link to access a series of submissions relating to the treatment of GMOs under Auckland’s Unitary Plan, including from the University of Auckland and Auckland District Health Board.

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