Paul Hutchison: Biotechnology developers face formidable hurdles

COMMENT

Given the increasing level of public concern over the possible release of genetically modified organisms into the environment, it is important to understand the reality of the legislation that the Government is putting in place before the moratorium comes off at the end of the month.

Fundamental to the debate is that there will be no release of GM crops unless the evidence is compelling and passes through some of the toughest scrutiny in the world.

Under the New Organisms and Other Matters Bill - the new GM legislation - the commercial release of GM crops is highly unlikely to be permitted in the foreseeable future; some would say less likely than the possibility of unintentional GM crops or pirated GM crops being established here.

Before the moratorium was imposed in 2000, despite the law allowing commercial release, no application was made. The cholera vaccine orochol berna, which had an interim Medsafe approval, was withdrawn from chemists' shelves when it was found to be in breach of the voluntary moratorium.

The new bill increases substantially the hurdles for a successful application. Not only is each applicant subject to extremely rigorous scrutiny, case by case. It is also subject to full public consultation, as well as widened call-in powers by the Minister for the Environment.

Those powers include:

* Significant cultural, economic, environmental, ethical, health, international or spiritual effects.

* Significant effects in an area in which the Environmental Risk Management Authority lacks sufficient knowledge or experience.

Given the above, the authority is only likely to pass an application for commercial release if there is a compelling reason, such as a guaranteed environmentally friendly GM solution for our possum problem, a proven-safe GM pharmaco crop that would bring in very substantial export dollars, or a GM vaccine to prevent a life-threatening epidemic confronting the population.

The fact that the rabbit calici virus was pirated into New Zealand demonstrates what can happen when the rules are too tough, or there are perceived commercial imperatives.

Because GM is such an important issue, it is appropriate to have legislation that is very tough but reflects the realities of a modern interconnected world.

Though many New Zealanders would like us to be GM-free, the royal commission rejected the concept because it was "impractical in light of all the evidence".

The new category conditional release may see some applications in the foreseeable future, but the hurdles are formidable. Each application must pass the steps above and also include:

* Control of the extent and purposes for which organisms can be used.

* The imposition of any obligation to comply with relevant codes of practice * A requirement for the disposal of any organism or genetic material.

The royal commission said continuation of research is critical to our future, and most New Zealanders seem comfortable with GM confined to the laboratory. The new bill has provisions to help streamline low-risk research, which in many instances has been strangled by excessive compliance costs and long timelines from application.

A major criticism of the GM bill is that it does not go far enough in cutting compliance costs, especially for medium and high-risk research. It may become the biotechnology equivalent of the Resource Management Act.

Scientists and ethics committees wrestling with all the cultural, spiritual, ethical aspects of applications could become a nightmare for researchers.

Environmental Risk Management Authority officials have remarked that processing the science may take six weeks, but addressing the ethical issues could take six months to infinity.

If we want to achieve sustainable economic growth to afford higher standards of education, health and environmental protection, we must seek ways to add value to our primary agriculture and horticulture commodities.

The Government in its growth and innovation strategy has focused on biotechnology as one of three key areas. The biotechnology strategy paper and biotechnology task force both recommend that transparency, predictability and best regulation practice are essential. The GM bill needs improving in that respect.

Moratoriums are very blunt instruments. The lost opportunities that would have occurred in medicine, science and industry if they were imposed, rather than allowing the world's best-practice risk analysis, should not be underestimated.

The reality is that commercial release in New Zealand of GM crops in the near future is extremely unlikely. We should follow a cautious evidenced-based scientific approach to GM, consistent with the recommendations of the royal commission and consistent with a knowledge economy.

* Dr Paul Hutchison is National's science spokesman.