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Biotechnology at OECD

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					Towards a Bioeconomy?
  Opportunities and
 Challenges for Policy


                   BIOTECHNOLOGY
                       DIVISION
                   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.)



                                                 BIOTECHNOLOGY
                                                     DIVISION
   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.

                                       BIOTECHNOLOGY
                                           DIVISION
                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”

                                                 BIOTECHNOLOGY
                                                     DIVISION
                  OECD Activities - Biotechnology

                                    Internal Coordination Group on Biotechnology
                                                     (ICGB)

                   STI                                          ENV                                    AGR

                          Biotechnology                  Environmental Health
                                                                                             Agriculture and Environment
                             Division                          & Safety


                Health                                         Biosafety                              Biomasss


                 Industry & Sustainability                Novel Food and Feed


             Infrastructure

                                                           International Futures Programme
                              IPR                                   BIOECONOMY
                                                                    BIOSECURITY

Biological Resources
    & Biosecurity


                   Statistics and Indicators



                                                                                                             BIOTECHNOLOGY
                                                                                                                 DIVISION
             “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.


                                          BIOTECHNOLOGY
                                              DIVISION
                        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

                                                   BIOTECHNOLOGY
                                                       DIVISION
                        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
                                                   BIOTECHNOLOGY
                                                       DIVISION
 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.
                                    BIOTECHNOLOGY
                                        DIVISION
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

                                          BIOTECHNOLOGY
                                              DIVISION
www.oecd.org/biotechnology




                             BIOTECHNOLOGY
                                 DIVISION
   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


                                             BIOTECHNOLOGY
                                                 DIVISION
          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

                                                BIOTECHNOLOGY
                                                    DIVISION
  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.
                                    BIOTECHNOLOGY
                                        DIVISION
        What is considered by technology
               assessment (top 5)
100%




80%




60%




40%




20%




 0%

       Effectiveness   Quality/Safety       Cost-       Professional     Additional
                                        effectiveness   implications   costs/savings

                                                                          BIOTECHNOLOGY
                                                                              DIVISION
          What is considered by technology
             assessment? (bottom 5)
45%

40%

35%

30%

25%

20%

15%

10%

5%

0%
      Waiting times   Equity      Patient     Lack of alternative   Industry/R&D
                               perspectives       treatment

                                                                      BIOTECHNOLOGY
                                                                          DIVISION
                         G
                          ov
                              er
                  In             nm
                     du
                         st          en
                            ry           to




                                                            0%
                                                                 20%
                                                                                    40%
                                                                                          60%
                                                                                                    80%
                                                                                                          100%
                               re             ffi
                                  pr              ci
                                                     al
                                     es
                                        en              s
              Pa
                  tie          Pr            ta
                                  ov              tiv
                      nt             id               es
                         s/            er
                             co             gr
                                ns
                                   um oup
                                        er              s
                                            gr
                     H                           ou
            Ac          ea                            ps
                           lth         Po
               ad                          li t
                  em            ca              ic
                                   re              ia
                       ic              m
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                                      ca                s
                                         le
                                              xp
                                                    er
                                                       ts
                                            O
                                                 th
                                                     er
                                                        s
                                                                                                                 Who is involved in decisions?




    DIVISION
                                                                                          Funding




BIOTECHNOLOGY
                                                                       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.
                                                        BIOTECHNOLOGY
                                                            DIVISION
    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

                                                  BIOTECHNOLOGY
                                                      DIVISION
            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



                                                            BIOTECHNOLOGY
                                                                DIVISION
            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


                                                 BIOTECHNOLOGY
                                                     DIVISION
  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.
                                        BIOTECHNOLOGY
                                            DIVISION
   Making Demand and Supply Work Together
                                                            Enabling environment?
                                   Match innovation and
                                   health needs
Research
                                                                        Healthcare
Policy
-Guidelines-eg                                                          Policy
human subjects,
                               IDENTIFICATION of                        -Accessible
consent, privacy.              NEED                                     -Affordable
-Research                                                               -Cost-effective
Ethics Boards
                                                           DIFFUSION
                    RESEARCH



    Industry
    Policy                                                              Regulatory/
    -Feasibility                                           DELIVERY
    -Trials                                                             Legislative
    -Formulation     DEVELOPMENT                                        Policy
    -IPR                                                                -Patient safety
                                       COMMERCIALISATION                -Standards
                                                                        -Medical
                                                                        guidelines



                                           Decisions
          Industry and Environment
Key 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

                                                           BIOTECHNOLOGY
                                                               DIVISION
          Industrial Biotechnology
             Range of Activities
Biobased Products   Manufacturing   Nanotechnology
   Bioenergy        and Synthesis   Biotech Interface




                                         BIOTECHNOLOGY
                                             DIVISION
                                                                  BIOTECHNOLOGY
                                                                      DIVISION




                     Conventional
                      technology
 Pollution
(e.g., CO2 , toxic
   chemicals)

                                               Sustainability via the
                                                biobased economy




                            Economic Growth   (e.g., employment, GDP)
   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.
                                            BIOTECHNOLOGY
                                                DIVISION
                   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.
                                                 BIOTECHNOLOGY
                                                     DIVISION
         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
                                       BIOTECHNOLOGY
                                           DIVISION
                 Policy Requirements
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
   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?

                                                                BIOTECHNOLOGY
                                                                    DIVISION
            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

                                       BIOTECHNOLOGY
                                           DIVISION
           OECD’s Role

“…… 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
                         Sustainable Development

                                     BIOTECHNOLOGY DIVISION

				
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posted:10/16/2012
language:English
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