towards a bioeconomy? opportunities and challenges for policy biotechnologydivision
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Towards a Bioeconomy? Opportunities and
Challenges for Policy
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The OECD
Unique structure: about 200 committees, working groups and expert groups
Attended by some 40,000 senior officials from national administrations
Supported by OECD Secretariat (about 1600 people), committees and working groups discuss wide range of policy areas (economic, scientific, health, education, trade, agriculture, development, etc.)
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Main Aims of Organisation
• Help create conditions for sustainable economic growth in member countries
• Seek to facilitate sustainable economic growth in non-member countries
• Champion free trade and liberal market economics.
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What Do We Do?
(i) Develop and agree international indicators
(ii) Collection and analysis of data
(iii) Policy analysis
(iv) Provide a forum for broad debate
(v) Agree international policy recommendations
(vi) Develop best practice guidelines – “Rules of the Game”
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OECD Activities - Biotechnology
Internal Coordination Group on Biotechnology(ICGB)
STI ENV AGR
BiotechnologyDivision
Health
Industry & Sustainability
Infrastructure
IPR
Biological Resources & Biosecurity
Environmental Health & Safety
Biosafety
Agriculture and Environment
Biomasss
Novel Food and Feed
Statistics and Indicators
International Futures ProgrammeBIOECONOMYBIOSECURITY
“Bioeconomy”
“an economy in which the latent value incumbent in biological products and processes is captured through economic, health, environmental and other gains”.
Mandate (2004) from OECD S&T Ministers to take steps to manage the transition to a
bioeconomy.
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Health
Key Drivers• quality, safety, efficacy and efficiency of products.• demographics, life style, economic/ cost issues• business competition and consolidation –structural change• Asian market expansion • Genetics & genomics, biomarkers, EBM Focus of effort• Incremental change• Cost containment• Health technology assessment
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Health
Major Policy Issues
• Increase quality & efficacy as well as efficiency of research and innovation enterprise
• Reduce R&D time scales and raise npvs or lose opportunities• Overcome market failure – win the npv game! • Move to more evidence based medicine• Regulatory developments around access, use and linkability
of data and on whether public/ private policies can co-develop.
• Value based reimbursement
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OECD Ministerial Priorities
• Create a match between demand and supply side measures to deliver health innovation that meets needs.
• Deliver a policy environment that captures the potential health benefits from genetics and genomics in line with expectations of society.
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Policy Challenges in Genetics and Genomics
• Development of high quality, trusted clinical genetics services.
• The balance between access to and rights over genetic data and inventions.
• Ownership of genetic data and inventions• Establishment, management and governance
of genetic databases
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Increase access to IPR protected products and processes
• System seems to function mainly as intended, but needs to be monitored.
• OECD principles for licensing genetic inventions. International soft law (target December 2005).
• Role of cooperative mechanisms (patent pools etc) and impact on markets and competition legislation (with ESRC Genomics Forum)
• Experimental use/ research exemptions
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Genetic Databases
• Fundamental tension between research and privacy• Range of issues around consent (opt outs, blanket
consents, making right to withdraw work, repeat consents)
• Limits to which the paradigms of the 20th century fit the new genetics in the information age.
• Need for transparent framework for governance that deals with and reconciles different interests (LEC, regional, national, international
• Engender public trust and engagement
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Biotechnology, Innovation & Health Policy
• Decision making in health technology – how to take account of biomedicines. Challenge of polymorphisms.
• Negotiating the opportunities and challenges from pharmacogenetics and EBM.
• Understand new research models that integrate across the innovation cycle.
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What is considered by technology assessment (top 5)
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0%
20%
40%
60%
80%
100%
Effectiveness Quality/Safety Cost-effectiveness
Professionalimplications
Additionalcosts/savings
What is considered by technology assessment? (bottom 5)
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0%
5%
10%
15%
20%
25%
30%
35%
40%
45%
Waiting times Equity Patientperspectives
Lack of alternativetreatment
Industry/R&D
Who is involved in decisions?
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0%
20%
40%
60%
80%
100%
Funding
Investment
Facilitating and Impeding conditions
• Facilitating conditions:– Trust in the evidence.– Additional funding.– Flexibility in shifting resources (away from silo).
• Impeding conditions:– Lack of additional funding.– Inflexibility of budget.– Payment mechanisms. Policy alignment.
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Challenges to Decision Making from the New Genetics
• value of genetic testing• assessing pharmacogenetics/ selective approvals• addressing uncertainty (data and investment)• high cost/ high benefits• avoiding stagnation through policy vacuums • capturing and diffusing innovation for better
outcomes
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Pharmacogenetics – opportunity or hype?
• PGX is here now – one manifestation of biomarkers• Pharmacokinetics impacts probably less far reaching than
pharmacodynamics• Clinical practice adopting slowly, impact on dosing, cohorts
and drug design• Genotyping v. phenotyping – clinical effectiveness case by
case• Clinical utility uncertain in scope• Delivery and Uptake rates uncertain• Investment situation uncertain• No regrets policy making
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Policy Priorities for Pharmacogenetics
1 - Address how to meet specific regulatory challenges from pharmacogenetics (trials, reviews, tandem/ selective approvals,
2 – Integration of Regulatory Developments (with biobanks, accreditation, development of databases)
3 – Cooperation and Capacity (data sharing, rare diseases, education, national capacity)
4 – Broader policy lacking
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Getting Regulation “Right”
• Crowded set of actors• Application of outdated paradigms to new
genetics in information age• Need to reconcile regulations/
operationalization of policy within and between nations
• How to develop meaningful engagement of society
• Create policy instruments/ environment that able to deal with increasing use of genetic data.
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DEVELOPMENT
IDENTIFICATION of NEED
DIFFUSION
DELIVERY
Research Policy-Guidelines-eghuman subjects, consent, privacy.-Research Ethics Boards
RESEARCH
Industry Policy-Feasibility-Trials-Formulation-IPR
Healthcare Policy-Accessible-Affordable-Cost-effective
Regulatory/LegislativePolicy-Patient safety-Standards-Medical guidelines
Decisions
Match innovation and health needs
Enabling environment?Making Demand and Supply Work Together
COMMERCIALISATION
Industry and EnvironmentKey Drivers/Opportunities
• advances in the science (enzymology, pathway engineering, gene shuffling, metabolomics),
• desire to move to ecoefficiency and decouple growth from environmental degradation
Focus of Effort
• Policy action to leverage transition. Micro-level policies focused on supply or procurement.
Major Policy Issues
• Broader scope analysis with focus on key barriers.
• Development of indicators and metrics
• Meet the supply side challenges
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Industrial BiotechnologyRange of Activities
Biobased Products Manufacturing Nanotechnology
Bioenergy and Synthesis Biotech Interface
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Pollution
(e.g., CO2 , toxic chemicals)
Economic Growth (e.g., employment, GDP)
Conventional technology
Sustainability via the biobased economy
Eco-efficiency &
renewable feedstock
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Measuring the Bioeconomy
Country strategies: visions, roadmaps, foresight. Goal setting
Measuring activity: eg investment, jobs, numbers of firms, churning, patents. Definitions, methodology and comparability.
Measuring impact: productivity, sustainability, demand and acceptability. Small impacts so far, pervasive sector.
Measuring cause and effect: Activity or Policy? Do we need to know.
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Conclusions• Broad medium- long term perspective of opportunities
offered by biotechnology and the biosciences – and the challenges to ensuring these are captured – is necessary and by and large missing.
• Particular focus needed on opportunties for sustainable growth, innovation, valuation and access to intellectual assets, globalisation and regulation.
• Implications for policy beyond so-called biotechnology policy, and the trade offs involved, need to be thought through and articulated.
• Solid metrics and indicators are necessary to underpin progress and any emerging roadmap.
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Towards a Bioeconomy?
• Growing strategic interest in the bioeconomy in (OECD and non-OECD areas)
• Potential for significant global economic, social and environmental benefits
• Considerable uncertainties facing both public and private actors
• Need for a broad-based forward-looking policy-oriented review of future developments in the sector
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Policy RequirementsIndustrial and R&D policies – what rules should apply so as to ensure that
public support is fully effective without distorting competition
Business and value chain models – what is needed to ensure the financial viability and market success of new applications
Legal and regulatory framework – what changes should be made to existing legal and regulatory provisions both at the national and international levels so as to facilitate the future development of the bioeconomy
Institutional arrangements – is there a need at the international level to change institutional arrangements impacting on the bioeconomy? At the domestic level, what institutional arrangements might be appropriate for ensuring that national policy fully takes into account the interest of all stakeholders?
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Project Objectives
• Building scenarios for the development of the bioeconomy
• Identifying technical, financial, human capital, regulatory bottlenecks
• Providing as much as possible a quantifiable benefit analysis of the main segments
• Providing a road map of necessary policy choices ahead
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