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2008 Feb 30
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2008 Feb 16
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2008 Jan 10
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2008 Jan 06
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corecompetencies

monthly injectable contraceptive

emergency contraception

HIV speciment bank

What we do

Our business model - collaborating with industry, governments and NGOs

Concept Foundation has a unique competence in, and knowledge of, developing access-to-medicines programmes for drugs for reproductive health and in ensuring their appropriate use in developing countries. We are not aware of another not-for-profit organization that is working in this area to ensure that products of assured quality are made available to the public sector of lower and middle income countries at a controlled cost plus price.

Concept Foundation’s business model achieves maximum public sector benefits through the focused management of intellectual property (IP) for pharmaceuticals and support to manufacturers to provide products that otherwise would not be available to the public sector at affordable cost and of assured quality. It develops and manages intellectual property for reproductive health products, manages technology transfer into the developing world, and out-licenses manufacturing and distribution of pharmaceuticals to avoid marginalization of the poor, especially in small countries, where no attractive markets exist for pharmaceutical companies. Concept Foundation does this by:
  • reating Public-Private Partnerships (PPPs) with pharmaceutical companies in developing countries; and
  • supporting systematic, coordinated product introduction in priority countries.
To achieve a functional PPP, Concept Foundation partners with pharmaceutical manufacturers. Concept controls and manages product quality and its provision at a preferential public sector price through a bilateral contractual arrangement with the manufacturer. Since most commercial manufacturers are uninterested, unwilling or unable to meet such an agreement, Concept has to provide the incentive for the company to make the investment necessary to produce the product under international current Good Manufacturing Practice (cGMP) and to meet the contractual requirements of such an agreement. It achieves this by: providing the intellectual property to allow the registration of the product with stringent drug regulatory agencies, including conduct of toxicology and bioequivalence studies, if required; compiling drug regulatory dossiers that comply with International Conference on Harmonization (ICH) requirements; and by identifying distributors and meeting regulatory requirements in developing countries. Concept Foundation works with the manufacturer as the “guardian” of product quality and affordable public sector access. This bilateral arrangement ensures that these issues are controlled, based on specific agreements on quality, availability and pricing between Concept Foundation and the manufacturer. Furthermore, Concept Foundation monitors implementation of the public sector price by the distributor in country.

With regard to medical abortion, Concept Foundation has applied its experience and expertise to ensure the physical access to medicines and in creating the necessary environment for its introduction in developing countries. Because of the nature of abortion and the medical, social and religious issues linked to it, Concept Foundation believes that care must be exercised in making drugs for medical abortion available and in ensuring their appropriate use. It considers it necessary to go beyond normal Access-to-Medicines programmes designed to ensure that a product is available to all those who require them at an affordable price by working with governments and national and international NGOs to underpin its availability with a supportive health system.

Concept Foundation has achieved this in Cambodia and Nepal, working closely with governmental and those national and international partners that government has determined should be involved in the introduction of medical abortion. The method of development of a national introductory strategy for drugs for medical abortion and synchronization of the activities required to implement it, has been catalyzed by Concept, to ensure the appropriate use of the product it is making available. This approach is planned in other countries and we consider is a unique contribution that Concept Foundation has made with governments and NGO partners in countries in the developing world.