Biotechnology strategy

Backgrounder for the Council of the Royal Society

June 2003

ALERT Comment by CEO, Dr Steve Thompson

Last October, Government asked for feedback to its discussion paper on Biotechnology. Its vision then dealt mainly with process issues such as increased Maori, educational, and community understanding, trust and dialogue; a 'Futurewatch' process to anticipate trends; and a one-stop website for biotechnology. The paper asked for feedback, and the results have been digested into this week's new Biotechnology Strategy.

Meanwhile, the Government's Biotechnology Task Force reported on 6 May, followed by Budget news on 15 May. The Task Force report saw New Zealand growing from 40 to 200 core biotechnology companies, employing 18,000 people over the next 10 years. Its main recommendations for government were:

• Establish a $200m Biotechnology Investment Fund.
• Review compliance costs and tax structure.
• Improve relations with the pharmaceutical industry.
• Consolidate networks into one strong industry body.
• Streamline practices under the HSNO Act; bring in line with Australian and US practice.
• Extend the effective patent life for biotechnology.

This week's strategy has responded to the main points with its vision to grow the industry, regulate it, and build public understanding, including a 'Futurewatch', and encouraging school science studies. Government will also move to extend patent life beyond the current 20 years.

Falling a little short of the $200m suggested, the Venture Investment Fund will invest at least $15m of seed funds in biotechnology, and FRST has announced $16m in new research funding. Much of the $8.8m new NERF money announced in the Budget will also go to biotechnology. The strategy lays out a complex diagram of the current (and expensive) approval process, and ERMA will move to streamline these processes.

The tenor of the strategy is an enabling one, helping to get things moving, but leaving the industry to decide its own future. Biotechnology firms have already welcomed the report, though others are concerned at the "proceed with caution" message.

New Zealand Biotechnology Strategy

A plethora of key actions is laid down in the strategy, as listed below:

Make information available on different aspects of biotechnology (science, research, the market sector, regulation and ethics) through a range of government and non-government sources, using a variety of media. Sources are numerous and include government agencies, research institutes, the Royal Society of New Zealand (RSNZ), sector bodies such as BIOTENZ and specialist groups. Recent initiatives include the BiosphereNZ website and the Royal Society’s DNA50 website. (See Annex Three for a list of websites.) Consideration will also be given to the appropriateness of establishing a New Zealand biotechnology portal website.

Support school biotechnology education with resources. The technology curriculum specifies biotechnology as one of the areas in which students will be expected to carry out activities. The science curriculum strand “Making Sense of Science and its Relationship to Technology” can use exemplars from biotechnology. Support will be given to produce resources to meet these curriculum needs, including addressing ethical issues. Companies will be encouraged to develop programmes that involve students in biotechnology activities, such as Genesis Research and Development’s Harakeke project

Implement biotechnology futurewatch activities, to be funded through Vote Research, Science and Technology (RS&T). Futurewatch will scan for emerging biotechnologies and develop early assessments of issues and opportunities. These scans and assessments will feed into the work of the Bioethics Council, policy ministries and other relevant forums.

Implementation of the Bioethics Council work programme. The Bioethics Council will provide independent advice to the Government on biotechnological issues that have significant cultural, ethical and spiritual dimensions. It will also provide information and be involved in public dialogue on cultural, ethical and spiritual aspects of biotechnology.

Enact amendments to HSNO that support the consideration of cultural, ethical and spiritual matters. The ministerial call-in powers have been extended to include these matters. As well, amendments to reflect better the Treaty of Waitangi include adding knowledge and experience of the Treaty and tikanga Maori to the knowledge and experience that the Minister for the Environment considers when appointing members of the Environmental Risk Management Authority (ERMA) Board.

Support research into areas of socio-economic and ethical aspects of biotechnology. Over the past two years there has been a significant increase in funding for social research aspects of biotechnology. This includes projects such as “incorporating tangata whenua values into scientific decision-making”, “ethical impacts of genetic technologies” and research on community dialogue models.

Support and facilitate dialogue initiatives through instruments such as the Science and Technology Dialogue Fund (in Vote RS&T). This fund has been set up to pilot new ways of engaging New Zealanders over scientific developments. The effectiveness of these approaches will be evaluated and reported back to the science community.

Fund outreach activities. These activities highlight what is behind key scientific developments, e.g. through Science Centres, Royal Society activities and science outreach organised by community groups through the Science and Technology Promotion Fund.

Support the development of Maori initiatives to develop effective communication models and resources that will foster constructive interaction with Maori communities on science and research generally, as well as specifically on biotechnology. This involves support for initiatives by organisations such as Nga Kaihautu Tikanga Taiao, the Maori Advisory Committee to ERMA and the network of Maori members of Institutional Biological Safety Committees; the Crown Research Institute (CRI) Maori Managers’ network; the National Association of Maori Mathematicians, Scientists and Technologists; and iwi-based science and technology groups.

Toi te Taiao: The Bioethics Council. A key aim of the Council is to promote and participate in public dialogue, particularly on cultural, ethical and spiritual aspects of biotechnology.

Enhance science and technology education at all levels Lifting general skill levels in science requires a focus on both participation and achievement. Since 1999 the New Zealand school system has introduced a new technology curriculum that is compulsory from Years 1 to 10 and includes biotechnology as an area of focus. Successfully implementing this curriculum is the current challenge, with a need for supporting material, teachers qualified to teach biotechnology and stronger links between the science and technology teachers. The National Certificate of Educational Achievement now makes it possible to study biotechnology through to Year 13, providing a broader pathway to tertiary study. The Government’s Tertiary Education Strategy provides a sound framework for supporting this objective in the tertiary sector.

Recruit and retain scientists and science entrepreneurs, working with industry on an industry-initiated programme of active recruitment and repatriation of science and entrepreneurial talent. This may include tapping into the New Zealand diaspora through programmes such as “World-class New Zealanders”, and greater use of scholarships and fellowships.

Foster and draw on Maori biological knowledge and innovative capacity Consultation has shown a clear need to foster and use Maori strengths in the areas of natural resources, their beneficial uses and ecological management. Work programmes in this area include:

MoRST work on fostering the creative potential of Maori as innovators, researchers and thinkers. This will involve developing RS&T policies targeted towards a stronger emphasis on Maori creative potential while maintaining an appreciation of social justice and Treaty issues;

the work of Maori research units at universities and wananga, including the work of Nga Pae o te Maramatanga, The Natioinal Institute for Maori Development and Advancement;

Develop commercial skills and experience New Zealand needs to have ‘commercially savvy’ scientists and ‘scientifically savvy’ industry managers. This calls for:

implementing cross-disciplinary links at tertiary institutions;

greater exposure to best international practices, e.g. Industry NZ working with industry to promote best practice, especially in intellectual property management.

Invest in excellent fundamental research Consultation also reinforced the need to maintain a strong base of fundamental research as the foundation for innovation. Excellence in fundamental research has been a strength and hallmark of New Zealand biotechnology and we must ensure this continues to be the case. The Government is a key player here and has in recent years steadily lifted the level of investment in biotechnology research.

Strengthen strategic approaches to biotechnology research funding. As the major research funder, the Foundation for Research, Science and Technology (FRST), working with the sector, is increasingly developing strategic approaches to research funding that will build on strengths and enhance critical mass and collaborative links. This approach also must be co-ordinated with biotechnology-related research funding through the Marsden Fund, CoREs and the HRC. International peer review will be an integral part of benchmarking excellence and strategic focus.

Co-ordinate planning for major infrastructure investment in capital equipment and platform technologies. This also requires close co-ordination between research institutions and government funding agencies (FRST, the HRC, the Tertiary Education Commission (TEC), RSNZ, and Industry NZ). Examples of such infrastructure include next-generation Internet links and bioinformatics databases.

Support clustering and developing effective collaboration and alliances. This support is currently provided by Industry NZ, through its Biotechnology Directorate. This will be further enhanced through the newly merging agency, New Zealand Trade and Enterprise (NZTE) combining industry, investment and trade support.

Provide funding to increase the rate of commercialisation, particularly at the early stages of commercial development, including:

supporting the public funding mechanisms already available to foster commercialisation, including Technology for Business Grants, Grants for Private Sector Research and Development and Industry NZ funding grants; and the New Zealand Venture Investment Fund;

implementing a new pre-seed accelerator fund;

providing more flexibility in FRST funding of experimental development so projects can be funded up to the pre-seed stage of commercialisation.

The Government will also consider the Biotechnology Taskforce recommendation for a private-public funding mechanism, specifically targeted to biotechnology development, with flexibility to span all stages of commercialisation.

Stimulate market-led research, especially through the development of a best practice programme jointly developed by industry, CRIs and tertiary research providers for achieving effective connections between industry and science.

Encourage early collaboration between research providers and businesses, especially through funding instruments that provide incentives to link. Examples include FRST’s Research for Industry funding, Research Consortia and TechNZ funding.

Promote the enabling aspects of biotechnology to a wide range of industry sectors, especially building on the synergies between the biotechnology and the primary sectors. Government agencies, such as the Ministry of Agriculture and Forestry (MAF) and NZTE can facilitate through communicating biotechnology market information and demonstration projects that promote the integration of biotechnology into industries.

Promote New Zealand biotechnology with integrated profiling and national branding. A start has been made with the BiosphereNZ website set up by Industry NZ and the sector, joint industry-government participation in major international conferences, such as Bio2002 and Bio2003 and showcasing missions in Australia. The Government is committed to further joint international showcasing including hosting high-profile events in New Zealand, such as the APEC innovation showcase.

Build focused country and regional links. Focused country partnerships and regional links can enable greater traction through joint development and showcasing. Industry and government will need to work together to achieve these partnerships in ways that support New Zealand’s major trading interests and provide mutual benefit for all partners. Building stronger biotechnology links with Australia is a priority and discussions and exchanges are already underway. The United States of America and East Asian economies, principally Korea and Singapore, are also important partners for scientist-to-scientist links and for the commercial development of biotechnology.

Represent New Zealand’s interests in and contribute to the multilateral policy arena for the debate and development of international biotechnology protocols. Themes of interest for international harmonisation include privacy and security, protection of information, food safety, biological diversity, regulation, standards and ethics. Relevant international fora include Asia Pacific Economic Co-operation (APEC), Organisation for Economic Co-operation and Development (OECD), United Nations Educational, Scientific and Cultural Organisation (UNESCO) (bioethics), World Health Organisation (WHO), World Trade Organisation (WTO) and UN Food and Agricultural Organisation (FAO), the Codex Alimentarius Commission, and the World Intellectual Property Organisation.

Fund Centres of Research Excellence. Two of the CoREs; the Allan Wilson Centre for Molecular Ecology and Evolution and the National Centre for Advanced Bio-Protection Technologies are world-class research centres addressing these matters. They have significant government funding to enhance their capacity and extend their research programmes.

Fund specific sustainability and bioprotection research projects – through the FRST ‘Sustainablity’ research category.

Fund biotechnology impacts research – through the FRST ‘Sustainable Biotechnology’ portfolio.

FRST, in conjunction with the Ministry for the Environment (MfE), the Department of Conservation (DoC), and MAF is to develop a research strategy for environmental biotechnology.

Enact and implement the changes to HSNO, including:

streamlining the approval process for laboratory research involving the development or import of low-risk GMOs;

addressing some regulatory gaps relating to new technologies and human cells;

streamlining the approval process for medicines and veterinary medicines that are or contain new organisms;

fast-tracking approvals of medicines and veterinary medicines for use in emergencies;

strengthening incentives to comply with HSNO by establishing liability for harm caused by non-complying activities and a civil penalty regime for breaches of HSNO or approvals granted under the Act;

extending the ministerial call-in powers to include cultural, spiritual and ethical matters;

including provision for ERMA to impose conditions on the release of new organisms – a new conditional release category;

extending the existing regulation-making powers relating to the impacts of hazardous substances, to also cover conditionally released new organisms;

establishing MAF as the primary enforcement agency for conditional release, new organisms in containment and unauthorised releases of new organisms;

clarifying ERMA’s responsibilities regarding the protection of releasing confidential information that is included with an application to ERMA;

removing the requirement for contained fermentations of more than 10 litres of new organisms to be considered as field tests and instead to be considered as a development;

measures to more appropriately reflect the Treaty of Waitangi relationship in the administration of the Act.

Enact the Human Assisted Reproduction Technology Bill - to regulate the use of human reproductive technology. The Bill establishes a three-tier framework for ethical decision making consisting of:

prohibitions on fundamentally unacceptable practices, such as reproductive cloning;

a Ministerial Advisory Committee which will be established to provide advice and develop guidelines for those operating in this area;

mandatory ethical approval for non-established procedures, such as newly developed techniques to aid fertility, and for all research.

Update the Human Tissue Act in light of new social and technological developments in relation to the use of human cells and tissues.

Implement biotechnology futurewatch activity to help early identification of and work on potential regulatory issues from emerging biotechnologies.

Pursue introducing amendments arising from the reviews of the Patent and Plant Variety Rights Acts, during the 2003 parliamentary term.

Complete, by December 2003, the review of New Zealand’s regulation of bioprospecting activities to establish an overarching policy framework.

Hold best regulatory practice workshops – led by sector groups and supported by government agencies.

Provide targeted industry advice on biotechnology-related legislation – to be led by relevant government agencies working jointly with the sector.

Develop an Intellectual Property Management Manual specifically for biotechnology – to be led by NZTE working jointly with the sector.

Assign MoRST an overview role in relation to biotechnology-related regulation, in liaison with key agencies and sector bodies.

Conduct periodic independently contracted system audits to assess whether the regulatory regime and its operation are achieving an appropriate balance between assurance and innovation.

See http://www.morst.govt.nz/?CHANNEL=BIOTECHNOLOGY+STRATEGY&PAGE=Biotechnology+Strategy