The business model of Concept Foundation is based on access to, and its ability to leverage, intellectual property (IP). It was established in 1989 through PATH by a grant from WHO's Special Programme of Research, Training and Research Development (WHO/HRP) to ensure the availability of Cyclofem®. This agreement gave Concept access to preclinical, toxicological and clinical trial data that would allow the development of a regulatory dossier for submission to drug regulatory agencies worldwide. It is data like these that Concept Foundation uses as its intellectual property (IP) and allows it to work with pharmaceutical companies in lower and middle income countries and implement its business model.

Concept has not, as yet, been involved in the development of patents from product R&D. However, it is, through funding from the Rockefeller Foundation and MIHR-USA, working on the continuing development of the highly successful and widely utilized MIHR/PIPRA IP Management Resource. Sadly, the initiator, the Centre for Management of Intellectual Property in Health Care and Development (MIHR), no longer exists but the continuation and development of the online version of the IP Management Resource represents a continuing achievement and legacyof MIHR.

MIHR/PIPRA IP Management Resource

The Resource consists of a Handbook, an Executive Guide, a CD-ROM and an Online version, developed with support principally from the Rockefeller Foundation. While distribution of printed materials to developing countries has been extremely successful, on a longer term and more sustainable basis it is more appropriate to move towards using the Online version of the Resource on www.iphandbook.org as the principal medium for updating information and information sharing.  

“Pragmatic IP management is building bridges between the world’s islands, be they economic, institutional, or geographic. The choice of this metaphor is not accidental. It affirms a key claim that reverberates within the resource: the global IP system and innovation management are not about changing islands. Rather, it is about building bridges between them” Anatole Krattiger, the Handbook’s Editor-in-Chief

Prepared by and for policy-makers, leaders of public and private sector research, licensing executives, and scientists, the online resource of the ipHandbook offers up-to-date information and strategies for utilizing the power of both intellectual property (IP) and the public domain. Emphasis is placed on the integration of IP strategies in a health and agricultural innovation setting; intellectual property is thus seen as a tool in accelerating product development and delivery, particularly in relation to meeting socio-economic goals.

For Concept Foundation, for Product-Development Partnerships in health, and indeed for anyone engaged in the development and delivery of health products, one of the key challenges is to reduce costs and increase “global access”. Costs can be reduced by re-engineering the product development process to reduce risk, by leveraging investments and contributions from multiple stakeholders, and by capitalizing on the comparative advantages of various institutions. Risk can be reduced by attending to the principal factors determining innovation, one of which is authoritative IP management.

The innovation of health products can be depicted as a stepwise process that begins with basic research and proceeds to candidate identification, animal testing, scale up, clinical testing, registration, introduction, and distribution. For each of these steps, however, attention should be paid to all factors determining innovation and should not be understood as simply a series of steps as success in one is facilitated by and dependent upon success in the others. For example, important decisions about the choice of technologies for scale-up, the location of production, investment requirements, and other issues should also be made during the R&D process. Just as important, attention should be paid to the regulations, to manufacturing, to distribution, and to IP management.

The online resource is based on the comprehensive Handbook and Executive Guide that provide substantive discussions and analysis of the opportunities awaiting anyone in the field who wants to put intellectual property to work. The printed version includes 153 chapters on a full range of IP topics and over 50 case studies, composed by over 200 authors from North, South, East, and West. This overall effort was led by Anatole Krattiger who continues to serve as Editor-in-Chief supported by a global Editorial Board.

Through its WHO intellectual property out-licensing programme Concept currently supports the global introduction of the once a month contraceptive injection Cyclofem® and the Medabon® combination product for early termination of pregnancy. Research and development for a range of additional products under this agreement are currently underway. More information on Cyclofem® and Medabon®  can be found under “Access to hormonal contraception” and “Access to medical abortion” sections of this site, or by visiting www.medabon.info