VIEWS: 3 PAGES: 32 POSTED ON: 10/16/2012
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 ns s/ te an ch ag ni er 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
"Biotechnology at OECD"