Research delayed by court battles.
Scientists in New Zealand whose work with genetically modified (GM) animals had been threatened by a High Court ruling have been given a reprieve. But they say that the case highlights the legislative challenges their research faces.
The case involves a series of applications made by the state-owned science company AgResearch to the Environmental Risk Management Authority (ERMA), a government regulatory agency. The 2008 submissions seek permission to use and develop up to 18 different species of GM livestock in a contained outdoor facility, without specifying which genes may be modified, as well as a broad range of related laboratory research. The Hazardous Substances and New Organisms (HSNO) Act, under which ERMA was established, designates such applications to be of "significant public interest" and thus gives interested parties an opportunity to play a role in the decision-making process.
The campaigning group GE Free New Zealand, based in Nelson, challenged ERMA's right to assess the applications, arguing in court that "the applications are too generic to constitute proper applications under HSNO". The case went to the High Court, with ERMA as the first defendant and AgResearch the second. Justice Clifford of the High Court agreed with the plaintiff and ruled on 5 June 2009 that ERMA must cease processing the four applications.
But AgResearch appealed the High Court ruling, and on 24 March 2010, New Zealand's Court of Appeal lifted the ban, pointing out that merely accepting and processing the applications did not give them a seal of approval.
"ERMA is pleased to have clarity around the law relating to our receipt of applications," says Geoff Ridley, ERMA's acting general manager of its new organisms group.
AgResearch currently holds two approvals to develop and test GM cattle in containment. The first was obtained 11 years ago. Both applications have been amended and extended a number of times as the work has progressed, but they are now at the point in which new approvals are required to enable further development and breeding of the cattle.
AgResearch had hoped to transfer their herd of 100 GM cows to the 4 new linked applications, but the legal action and subsequent delays forced them to make more specific interim applications.
The original approvals were amended on 11 March to allow existing GM cattle to escape a threatened cull. A further application that will enable AgResearch to resume breeding the cows is under consideration, with a decision expected from ERMA in mid-April.
Despite the recent Court of Appeal ruling in AgResearch's favour, Barry Scott, head of the Institute of Molecular Biosciences at Massey University in Palmerston North, New Zealand, and former ERMA board member, says these sorts of legal challenges can stifle business development. Jimmy Suttie, science and technology general manager for AgResearch's applied biotechnologies group, acknowledges this possibility. "The impact is twofold: it makes NZ companies themselves reluctant to invest and, because of the way the international media may view the actions of GE Free NZ, it can suggest that the anti-GM attitude in New Zealand is more extreme than it really is," he says.
New Zealand researchers say they need to partner with international commercial companies to obtain venture capital and market access. AgResearch currently has two biopharmaceutical partners: Pharming NV in Leiden, the Netherlands, and GTC Biotherapeutics in Framingham, Massachusetts, who produced ATryn, the first FDA-approved biopharmaceutical (a human anticoagulant protein) from a transgenic animal.
Although ERMA will now resume processing the four AgResearch applications, issues brought up during the legal battle remain relevant. Much of the argument centred on the generic nature of the documents and whether they contain enough information to evaluate risks and benefits. Indeed, some opponents of genetic modification believe AgResearch is testing the system to see how broad their applications can be.
But Scott argues that such broadly-worded applications are valid. "Many of the risks and controls associated with genetically modifying animals will be the same," he says. "The process is costly and you don't want to be forever going back to ERMA."
This may not be the end of the story. GE Free New Zealand says that it might take the matter to the country's Supreme Court, the highest judicial body in the country.