Submission to MoRST on the NZ Biotechnology Strategy

Submission to the Ministry of Research, Science and Technology on the New Zealand Biotechnology Strategy - November 2002

NZORD has a network of over 70 rare disease support groups. Since our establishment two years ago, we have communicated regularly with our network about many issues closely related to improved diagnosis and treatment for rare disorders.

We can say with confidence that despite some diverse views, there is widespread support among patients and their families for the central theme of the Biotechnology Strategy - biotechnology responsibly applied for our collective benefit.

But more than that, we are aware of the great significance that the combination of greater genome knowledge to identify causes, and biotechnological advances in providing solutions, have for rare diseases. We know this brings the first real hope that we can control greater numbers of these diseases, rather than just be the victims of them. We have a strong and very direct interest in seeing this strategy is implemented, but suggest the addition of a particular focus in the health research area.

Growing New Zealand's Biotechnology Sector

Our comments under this heading in the discussion document address only the application of biotechnology to health generally, and to rare diseases in particular. We think this needs a particular focus in the strategy, beyond the largely economic issues and general health benefits addressed in the draft. The context for these comments is:

1. Improved primary and secondary health services, and the reduction of infections and epidemics through sanitation, vaccination, etc, exposes rare and genetic disorders as a growing proportion of society's total burden of disease.

2. As with all past gains (hygiene, cross-infection control, vaccines, antibiotics, etc) there is a critical point when knowledge of the causes of the disease, and the technology to prevent or control them, come together to make dramatic health gains achievable.

3. Knowledge of the genome, and advances in biotechnology for testing, screening, and treating, means the time is right for a planned approach to minimise the incidence and reduce the burden of genetic and rare conditions.

4. Specific and targeted action is needed to make the possibility a reality.

5. In both the USA and Europe, public policy now recognises the combined incidence and impact of rare diseases, as significant public health issues that needs particular attention, and specific additional resources are allocated for that.

New Zealand scientists will be able to make significant contributions to the control of rare diseases but there will need to be planned additional investment in the basic research, and development of therapies. It is partly about playing our part in a bigger global effort, for the benefit of all, but such a commitment would also give many good research and economic/intellectual property opportunities here in New Zealand.

The strategy should ensure that key agencies like the Health Research Council, Universities and Crown Research Institutes, are mandated and resourced to give some particular focus to outcomes for rare conditions specifically, while still making progress on more common diseases and other economic objectives.

Additional comments:

We support the three principles of community understanding and connection, effective regulation, and growth. Our comments below address aspects of these principles and are cross-referenced to the discussion questions where relevant, but some of them take a broader view.

The Community and Biotechnology (Q 1 to Q4)

1. It would be wrong to assume the notion of one "community" view or set of values in relation to the biotechnology sector. The community is diverse and includes views that support as well as oppose biotechnology, as well as those who don't know enough about it. Consensus is unlikely in the short to medium term on this issue.

2. There is risk of a false assumption that community views opposed to biotechnology somehow represent the voice of the wider community. (Q2, Q3). We think that is an unfortunate tendency. Many who support caution also support progress. And many with ideological opposition will never be convinced. The lowest common denominator should not be a basis for policy making and community input or oversight. (Q1, Q3).

3. There is ample opportunity now, for community input into policy and decision making, whether in support on in opposition. The balance is about right and we do not think any extension of these opportunities is warranted. Such input also acts as an inherent brake on progress and the costs and risks of this would not justify extended opportunities for input. (Q3, Q6, Q7).

4. More objective information on biotechnology from government and other independent sources would certainly assist community knowledge and acceptance, and more study of the topic in schools would be highly desirable. (Q1, Q2).

5. Views on biotechnology among Maori seem as diverse as they do in the rest of the community. It appears there is plenty of opportunity at present for these views to be incorporated into the decision-making process. (Q4).

Regulating Biotechnology (Q5 to Q10)

1. The current regulatory system is thorough and comprehensive. When decisions are made there can be confidence of thorough examination of risks and benefits. (Q5, Q6).

2. There is some argument the controls are excessive, though amendments to the low risk regulations should solve many difficulties. NZORD does not believe there is any justification for added controls. (Q6, Q7).

3. There should be contingency plans to relax the regulatory system as time and experience give better knowledge of risks. (Q5, Q7).

John Forman
Executive Director