Biomedicine And Health Innovation - OECD
Biomedicine andHealth InnovationSYNTHESIS REPORT Industrial Biotechnology Green Growth Bio-based Products Measuring PerformanceOECD Innovation StrategyJune 2010
Biomedicine and Health InnovationSynthesis ReportNovember 2010
2BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORTTable of contentsBIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORT . 3I. Introduction.3II. The changing nature of health innovation .4III. Lessons and policy recommendations .7IV. New policy challenges from advances in biomedicine .14Annex. Summary of OECD reports on biomedicine and health innovation .19OECD 2010
BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORTBIOMEDICINE AND HEALTH INNOVATIONSYNTHESIS REPORTI. IntroductionOver the past few years, the OECD has done important work in a number ofareas related to innovation in biomedicine, including on: genetics and genomics,intellectual property rights and collaborative mechanisms and knowledge markets,health research infrastructures, translational research, regulatory policies thataffect the approval and uptake of new technologies, and new business models forbringing health products to market, etc. This synthesis report presents the mainlessons and policy messages that emerge from this significant body of work andIt was developed as a thematic contribution to the OECD Innovation Strategy, acomprehensive policy strategy to harness innovation for stronger and moresustainable growth and development, and to address the key societal challenges ofstthe 21 century. The recommendations in this report aim, therefore, to serve asuseful reference and resource to those governments, member or non-member,interested in fostering health innovation and improving the economic and healthimpacts of their biomedical research sector. As innovation is increasinglyacknowledged as the main driver of sustainable growth, productivity, and wealthcreation, governments have a strong stake in setting up conditions that encourage it.The recent economic crisis and ongoing efforts to bring about a sustainablerecovery bring many of the points made into this document into even sharperrelief. The crisis has caused civil society and the governments that serve them toplace renewed focus on the social welfare benefits of investment in innovation.Nowhere is innovation more relevant than in the context than human health.Thus, the recent economic worries have done much to bring the issues set out inthis document even further up the political agenda and have placed healthprovision solidly in the cross-hairs of public scrutiny and expectation. Governmentsmust more than ever ensure they harness innovation in health technology in anefficient and effective manner.OECD 20103
4BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORTII. The changing nature of health innovationGeneral innovation trendsThe health innovation ecosystem is in flux. A number of key drivers are pushingresearch organisations to think creatively about the way they manage and capturevalue from existing knowledge, be it in-house or external. Some of the majorengines of change are identified in this paper. However, whilst most experts agreeon what the drivers are, there is no consensus as to how innovators, funders, orgovernments are strategically positioning themselves, on what the future structureof the sector is likely to be or on what an appropriate future governance systemlooks like. These uncertainties need to be addressed.Science and technologyThe biomedical research system is under enormous pressure as it has becomefar more diverse, has accommodated many new players globally, has distributedits knowledge intensive resources widely, is awash in information, and hasbecome increasingly costly to maintain. Biomedical research institutions arelooking for new ways of working. The organisation of research is changingdriven by informatics and the relatively new notion that collaboration and sharingof knowledge can be more than a zero sum game. Of particular note are: Convergence of technologies and fieldsbiology, engineering, IT, syntheticbiology, nanotechnology. Digitisation of biomedical and health data, information and knowledge andthe increased importance of large databases for biomedical research andhealth decision-making. The need to access multiple sources of data and to make these interoperable. The shift towards knowledge-driven, evidence based innovation in medicineand biology. Development of platform technologies/standards as globalisation accelerates.What is especially new is the ease of communication amongst a very broadscope of distributed, virtual and diverse knowledge resources. Sophisticated useof information technologies enables users flexibly to interconnect these resourcesand to deliver research efficiencies.But the explosion of promising new fields of research and technologicalopportunities will not translate into broad based improvements in health carewithout some sound policy work and a high level of consensus amongst the OECDcountries.Industry organisationThe system of health innovation the very process by which new medicines,vaccines, and diagnostics are produced is suffering from declining productivityand escalating costs. The failure or attrition rate in medicines development hasstayed high, despite the promise of new technology. The market perceives apipeline problem in several of the large pharmaceutical companies and is reflectingthat in the way it values businesses. This is leading to a number of mergers andOECD 2010
BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORTacquisitions and alliances creating some structural flux. In short, there isuncertainty over the future structure of the health biotechnology and pharmaceutical (biopharmaceutical) industry. Some drivers of change in business strategiesfor knowledge management in the industry include: The productivity decline in pharmaceutical R&D. Technology, including the increasing role of biotechnologies in healthinnovation. The entrance of new players as research capacity globalises and the growthin competitive firms from the emerging economies. Uncertainty over new developments such as how personalised medicinewill be delivered, and the role of diagnostics in delivery. The changing nature of demand and outcome expectations, particularly thegrowing role played by health consumers and patient advocacy groups.The future organisational structure of the biopharmaceutical industry is ahotly debated topic. Some see the rise of outsourcing and knowledge management services as part of the move away from fully integrated pharmaceuticalcompanies to a more networked pharmaceutical industry ecology. Others, onthe contrary, believe that the complexity and difficult capital investmentdecisions in the health sector portend well for a return to a more verticallyintegrated structure.Financial constraintsThe search for funding in early stages of research and translation, the highcosts of product development and regulatory approvals, the financial pressuresdue to valuation of biotechnology and pharmaceutical firms, as well asconstraints on the public purse have been a constant in this sector. Particularissues are: Escalating costs of development and higher regulatory risks. Growing constraints on public health expenditures. Funding gaps, e.g. the soresearch, but also gaps in available funding for diseases/approaches, etc. Efforts to improve valuation of assets and enterprises based on theknowledge they hold.What are some of the specificities of the health sector and healthinnovation?Health innovation is an interactive and distributed process which involvesfive main phases: i) identification of need, ii) research and development,iii) commercialization, iv) delivery, and v) diffusion. These stages are increasinglyunderstood to be circular, iterative and highly interconnected-unlike thetraditional notion of a linear step-by-step process, as so often inbred in policy.Health innovation is tightly connected to the provision, uptake and use of newtreatments: feedback from purchasers, providers and patients is essential inshaping the innovation process. Feedback mechanisms are built in throughoutthe innovation cycle, and are the source of modifications that improveOECD 20105
6BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORTindividual products and enhance innovative capacity as a whole as well asoftentimes the focus of research.Health innovation is a notoriously complex and expensive undertaking whichinvolves multiple actors from the public and private sectors. At each stage of theinnovation cycle, many social and economic factors can affect the development,uptake or diffusion of new health technologies. Across the OECD, a number ofstudies have identified major health innovation bottlenecks in the cycle strategiesfor removing them. While the details vary, the roadblocks share similar characteristics across countries. Innovation in health care relies on (uncertain) technicaland scientific advances; involves multiple players; requires large financial commitments, high risks and long time-frames; and is highly regulated.Moreover, the provision of health care is considered a public good and in somecountries a right. The government has an important role in funding both basicand clinical research; regulating safety and efficacy; determining availability,equity and access; and often pricing and/or reimbursement of health productsand services.Finally, public opinion matters greatly and there are numerous examples ofpublic pressure on government health policies (to provide greater access, tomaintain affordability of products/services, to increase/relax the burden ofregulation).Changing role of government policyIn 2004 the OECD held two consecutive Ministerial meetings, on Science andTechnology and on Health, which both concluded that the OECD needs to helpdeliver on the vision that the remarkable advances in the biosciences shouldcontribute fully to improving the health of society and to sustainable growth.Since, OECD Member countries, in close cooperation with a number of nonmembers, have been interested in exploring what can be done to re-invent theprocess of health innovation so that both the efficiency and effectiveness of theprocess is improved.Government policies are deemed important in: communicating a vision ofwhat are the public policy objectives in health and innovation and developing aroadmap for the future; creating incentives for R&D; providing sustainablefinancing for shared research infrastructures; fostering translation of publicresearch; in fostering openness, cooperation and networking; educating researchersfor an interdisciplinary scientific future; updating the regulatory environment;building dialogue and public trust; ensuring privacy and security of personal dataand samples; promoting the development of standards.Governments may be the only voices that can take a leadership role inchampioning the opportunity to deliver, over the course of the next couple ofdecades, innovative health products and services that are evidence based,personalized, and safer and more effective. Governments should create aroadmap for delivering such health innovations. Philanthropies, government andregulatory agencies (e.g. US FDA, US NIH, EMEA) and some non-governmentalorganisations and patient groups have been at the forefront of identifying what amore efficient route to market for health products could look like. The challengeis delivering the institutions, the industrial capacity, the financing and theregulatory environment needed for a more effective innovation system.OECD 2010
BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORTIn short, there is a need to articulate a vision of what is possible, a roadmapthat identifies the individual steps that will make the vision reality, and adialogue amongst stakeholders to agree how to go forward together. There is asignificant level of OECD consensus on the steps that need to be taken,presented in the following section on Lessons and Policy Recommendations.III. Lessons and policy recommendationsA. The future of biomedical innovation requires accessing and managingdistributed networks of knowledge providers A more open architecture for innovation in health is emerging. Collaborations, public-private partnerships, consortia, innovation networks, brokeragefacilities, prizes, and data sharing/exchange platforms are increasingly usedto access dispersed sources of data, information, know-how, materials,compounds, software, methodologies, expertise, and patented innovations. User-driven and user-centric innovation is a new trend in biomedicine andhealth innovation. Formal networks of doctors and surgeons and otherhealth professionals help provide data and feedback to innovators. Improved access to and exchange of biological samples and data is criticallyimportant to advancing the global scientific and medical knowledge base.The fusion and use of diverse sources of data, knowledge and technologiesmay require that both technical (e.g. for interoperability) and legal (e.g.intellectual property) solutions be found. As many knowledge assets are externally distributed, organisations derivevalue from the ability to access, manage and exploit knowledge frommultiple sources. Open or networked health innovation requires organisation, frameworks, financing, good information and asset management andvision. These are important for both public and private research organisations. New research and business models more efficiently exploit such distributednetworks of knowledge. However, there is no single model of firm or interfirm organisation which has emerged as a clear success. Governmentsshould tolerate and encourage experimentation and search for emergingbest practices. Regulations have an impact on the incentives to participate in networksand consortia. There is a need to reduce bureaucracy and red tape, to makesure conflict of interest rules are reasonable, and to clarify anti-trustconsiderations.B. Biomedical research infrastructures need to be accessible, high qualityand sustainably financed High-quality biomedical research increasingly relies on biological andhealth-related infrastructures where large and diverse sources of biological,health and personal data and samples are stored, made interoperable andmade accessible to a range of potential scientific users globally.OECD 20107
8BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORT In the life sciences, governments have a strong policy interest in developingand making accessible data, information, and knowledge to accelerate innovation. The circulation of knowledge is essential to innovation performance.New ideas emerge from the combination of existing knowledge from varioussources. For example, within the scientific community, there is consensusthat given the vast complexity of the human genome, progress in understanding disease will depend on the establishment, harmonisation and broaduse of human biobanks and genetic research databases and in maintainingthese scientific resources over the long term. But open or networked healthtechnology innovation requires organisation, frameworks, financing, qualityinformation, asset management and vision. Governments need to providesignificant financial and human capital investments to assure the sustainability of research infrastructures. Lean economic times are when more notless attention needs to be paid to such infrastructure. IT infrastructures are the backbone that allow the networking of disparatedatabases and repositories. When building IT infrastructures and databases,t limit the future scope of research or collaborations. Quality assurance/management of the materials and data contained inresearch infrastructures is a prerequisite for high quality research and forfacilitating exchange of data and samples. International guidelines orstandards help establish good practices that can raise the quality of thematerials and data and build trust and reputation locally and globally.Governments should work to ensure adherence to international guidelinessuch as the OECD Guidelines for Human Biobanks and Genetic ResearchDatabases that facilitate wide access to data and materials for biomedicaladvances while ensuring that research is conducted in a manner respectfulof participants, and that upholds human dignity, fundamental freedomsand human rights. They should endeavour to develop further guidance orstandards where needed.C. The intellectual property landscape is evolving to better leveragestrategic intangible assets Intellectual assets, including in the form of intellectual property, arestrategically key for the successful commercialisation of products andservices in the health sector. The focus for governments should be oncreating conditions that better leverage such assets to deliver optimalbenefits both for health and for wealth. evolving graduresearch organisations make portions of their IP freely accessible in order toaccess collaborative networks, external sources of data, information andknow-how. There is growing recognition that such shifts towards open innovation isresulting in more flexible IP management. Interest is accruing in the moreefficient utilisation, valorisation and diffusion of intellectual property,knowledge and intellectual assets.OECD 2010
BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORT New mechanisms for collaboration have emerged within this evolvingintellectual property landscape. In order to create greater efficiencies in theuse and exploitation of intellectual property, consideration has been givenclearinghouses, exchanges, auctions, and brokerages; patent pools; model agreementsand frameworks for intellectual property sharing; collaborative innovationarrangements; etc. are some of the approaches that have increasingly garneredattention. These mechanisms are used as means to improve efficiencies in thetransaction of intellectual property and knowledge in order to stimulateinnovation, foster R&D and promote the commercialisation of products andservices. The establishment of such collaborative mechanisms raises a number ofchallenges as they normally involve very diverse areas. They may involveareas of intellectual property law and practice, competition and anti-trustlaw, business acumen, life sciences, and research and development in thelife sciences. Often these mechanisms are put in place by a multi-disciplinary team covering these diverse areas. Governments may want tobetter understand the types of collaborative mechanisms available and todevelop frameworks to aid in their establishment and governance. In their own collaborative research and consortia participation, publicresearch organisations and universities should carefully consider the divisionbetween precompetitive and proprietary research outcomes to reflect thisnew reality. The management of IP in an open innovation contextasopposed to the traditional technology transfer approach of licensing outpatents in one-to-one deals remains a challenge. Universities may tend toovervalue or undervalue their IP, which can lead to difficulties incollaborating with industry as well as unnecessary costs and/or foregone rentbenefits. New policies may be needed to help universities determine whereon the value chain different strategies for sharing and/or licensing IP aremost effective. Governments can encourage a spirit of exchange and co-operativeresearch which leads to improved access to biomedical technologiesthrough a number of mechanisms. These include legislation, regulation,policies, guideline development, and conditions for funding or forproviding
4 BIOMEDICINE AND HEALTH INNOVATION: SYNTHESIS REPORT OECD 2010 II. The changing nature of health innovation General innovation trends The health innovation ecosystem is in flux. A number of key drivers are pushing research organisations to think creatively about the way they manage and capture
user-friendly format. 2003: Launch of OECD Health Care Quality Indicators (HCQI) project to develop a set of indicators measuring and comparing quality of care across countries. 2004: First OECD Health Ministerial Meeting in Paris to discuss the main findings from the OECD Health Project. Release of publication Towards High-Performing Health .
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