OECD countries agree Guidelines on licensing of healthcare genetics

March 6, 2006

Paris, 1 March 2006

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PREFACE

  • These Guidelines offer principles and best practices for the licensing of genetic inventions used in human health care. They are targeted at all those involved with innovation and the provision of services in health, and particularly at those involved in the licensing of such inventions. The Guidelines are intended to assist both OECD and non-OECD governments in the development of governmental policies as well as in their efforts to encourage appropriate behaviour in the licensing and transferring of genetic inventions. Overall, the Guidelines seek to foster the development and delivery to the market of products and services based on genetic inventions, such as therapeutics and diagnostics, in order to more effectively and efficiently address health care needs in both OECD member and non-member countries.

  • These Guidelines apply to the licensing of intellectual property rights2 that relate to genetic inventions used for the purpose of human health care. Within these Guidelines, the term "Genetic Invention" includes nucleic acids, nucleotide sequences and their expression products; transformed cell lines; vectors; as well as methods, technologies and materials for making, using or analysing such nucleic acids, nucleotide sequences, cell lines or vectors. This definition is intended to be forward looking to encompass highly related future developments.

    Genetic Innovation and Human Health Care

  • . Advances in biotechnology and genetics offer much promise for sustainable growth and development of economies and for society more broadly. Genetic innovations already play an important role in meeting health needs. Future advances will provide a better understanding of the interaction between environmental factors and genetic heritage, will lead to the development of new products and services, including diagnostic tests, therapeutics, and medications, and will contribute to more effective and efficient delivery of high quality health care more generally. Efforts need to be made to ensure that these advances deriving from a better understanding of genetics are made available to those who stand to benefit, both in developing and developed countries.

  • Progress in genetics and health-related biotechnology is not only increasingly valuable to health care, but also represents a significant and growing portion of OECD member countries' economies. Developments in the field of genetics may also provide society with important results that may be transferred and may stimulate knowledge spillover effects of importance to the economy at large, both in developing and developed countries.

  • The genetics and genomics revolution and the development of products and services that has happened in its wake have been due to the work both of the public and private sectors, individually and in collaboration. Research thrives on collaboration and getting the most out of the genetics revolution will rely increasingly on efficient and effective exchange between those researching and developing new innovations – as well as with those that would use these innovations. It is this spirit of exchange and co-operative effort that lies at the core of these Guidelines.

    Balanced Intellectual Property System

  • Innovations, in the field of genetics as in others, are typically protected via various forms of intellectual property rights, including patents. Innovations may also be protected through laws preventing the unauthorised transfer of undisclosed information, and through contractual provisions, such as those in material transfer agreements.

  • Generally, the patent system and other forms of intellectual property aim to encourage the development and dissemination of knowledge and innovations with a view to fostering scientific, technical and social progress for the betterment of society. While a rights holder may choose to exploit or commercialise such innovations directly, often these are also exploited or commercialised via licensing agreements, joint development activities or through material transfer agreements. Such agreements or activities allow the operation of the intellectual property system as they not only promote the commercialisation of and access to innovations, but also provide rights holders with the ability, if they wish, to achieve a return on their investment. All of these functions constitute an integral part of a balanced intellectual property system.

  • While there is no single model for the licensing or transferring of genetic innovations, the manner in which rights holders choose to carry out such activities has and will increasingly have implications for future research and development, especially involving fundamental or new technologies, as well as for access to the latest medical innovations. These Guidelines aim to provide parameters so as to ensure that licensing and material transfer agreements as well as joint development activities are based on economically-rational practices that help eliminate high transactions costs while complying with competition law and that serve the interests of society, shareholders and other stakeholders.

    Nature and Structure of the Document

  • These Guidelines cover a broad reach of activities and are intended to be interpreted as appropriate to the circumstances. Moreover, these Guidelines are not intended to cover exhaustively all aspects of licensing practices in the field of biotechnology, including genetics. The Recommendation on the Licensing of Genetic Inventions was adopted by the Council of the OECD on February 23rd, 2006 (see C(2005)149/Rev1). 3

  • The Guidelines are intended to be evolutionary in nature and should be reviewed in light of developments in genetic innovations, changes in business practices, and the needs of society. Thus, there will be a need for these Guidelines to be assessed, four years after adoption at the latest, and periodically thereafter, in order to ensure that they are fostering the desired objectives of stimulating genetic research and innovation while maintaining appropriate access to health products and services. They should at all times be read and applied in a purposive manner.

  • Part One sets out the Principles applicable to the licensing of genetic inventions together with the related Best Practices that were adopted as an OECD Council Recommendation. The Principles provide a framework within which to conceive of voluntary, market-oriented licensing arrangements with respect to genetic inventions used for the purpose of research and human health care. The Best Practices are practical means for putting into place that framework. Part Two contains explanatory Annotations which elaborate on the Principles and Best Practices in Part One.

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    Press release in English

    In French: Les pays de l'OCDE adoptent des Lignes directrices relatives aux licences en génétique médicale

    Organisation for Economic Co-operation and Development
    http://www.oecd.org
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