Towards a Bioeconomy?
Challenges for Policy
Unique structure: about 200 committees, working
groups and expert groups
Attended by some 40,000 senior officials from national
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.)
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
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
OECD Activities - Biotechnology
Internal Coordination Group on Biotechnology
STI ENV AGR
Biotechnology Environmental Health
Agriculture and Environment
Division & Safety
Health Biosafety Biomasss
Industry & Sustainability Novel Food and Feed
International Futures Programme
Statistics and Indicators
“an economy in which the latent value incumbent in
biological products and processes is captured
through economic, health, environmental and
Mandate (2004) from OECD S&T Ministers to
take steps to manage the transition to a
• 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
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-
• Value based reimbursement
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.
Policy Challenges in Genetics and
• Development of high quality, trusted clinical
• 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
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
• Fundamental tension between research and privacy
• Range of issues around consent (opt outs, blanket
consents, making right to withdraw work, repeat
• 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
Biotechnology, Innovation &
• Decision making in health technology –
how to take account of biomedicines.
Challenge of polymorphisms.
• Negotiating the opportunities and
challenges from pharmacogenetics and
• Understand new research models that
integrate across the innovation cycle.
What is considered by technology
assessment (top 5)
Effectiveness Quality/Safety Cost- Professional Additional
effectiveness implications costs/savings
What is considered by technology
assessment? (bottom 5)
Waiting times Equity Patient Lack of alternative Industry/R&D
tie Pr ta
nt id es
Ac ea ps
ad li t
em ca ic
Who is involved in decisions?
Facilitating and Impeding
• 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.
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
opportunity or hype?
• PGX is here now – one manifestation of biomarkers
• Pharmacokinetics impacts probably less far reaching than
• 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
Policy Priorities for
1 - Address how to meet specific regulatory challenges
from pharmacogenetics (trials, reviews, tandem/
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
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
• How to develop meaningful engagement of
• Create policy instruments/ environment that
able to deal with increasing use of genetic
Making Demand and Supply Work Together
Match innovation and
IDENTIFICATION of -Accessible
consent, privacy. NEED -Affordable
-Formulation DEVELOPMENT Policy
-IPR -Patient safety
Industry and Environment
• advances in the science (enzymology, pathway engineering, gene
• desire to move to ecoefficiency and decouple growth from environmental
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
Range of Activities
Biobased Products Manufacturing Nanotechnology
Bioenergy and Synthesis Biotech Interface
(e.g., CO2 , toxic
Sustainability via the
Economic Growth (e.g., employment, GDP)
Measuring the Bioeconomy
Country strategies: visions, roadmaps, foresight.
Measuring activity: eg investment, jobs, numbers of
firms, churning, patents. Definitions, methodology
Measuring impact: productivity, sustainability,
demand and acceptability. Small impacts so far,
Measuring cause and effect: Activity or Policy? Do
we need to know.
• 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.
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
Industrial 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
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
• Building scenarios for the development of the
• 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
“…… on the road to globalisation ……OECD
member countries need to take their share of
responsibility…..and provide the engine for the
train of sustainability……..”
Donald J Johnston
OECD Secretary General
World Summit on