FIGO Initiative on Unsafe Abortion Regional meetings, 2011 Concept Foundation: Making Medabon® Available Helena von Hertzen MD Senior Advisor

FIGO Initiative on Unsafe Abortion Regional meetings, 2011 What is Concept Foundation? Concept Foundation was established as an international, charitable, not-for-profit organization in Thailand in 1989, through a grant to HRP/WHO (PATH, UNFPA, the World Bank and several foundations ) to “make various reproductive health and family planning products available to public sector of low and middle income countries at affordable, or at least preferential prices, for their safe and effective use.”

FIGO Initiative on Unsafe Abortion Regional meetings 2011 Concept Foundation - WHO Concept Foundation has a general collaboration agreement with WHO in reproductive health, which allows it to translate the research work of WHO into products for commercialization for the benefit of people who access their medicines through the public sector in developing countries worldwide.

FIGO Initiative on Unsafe Abortion Regional meetings, 2011 Goals of Concept Foundation Concept Foundation is pursueing the following goals Goal 1Access to Safe Medical Abortion 2Access to High Quality Drugs for Maternal Health – misoprostol (Gynuity); - prequalification programme (WHO) 3Access to Hormonal Contraception 4Access to other Reproductive Health products 5Supporting PDPs on IP & access to markets

FIGO initiative on unsafe abortion Concept is making available a co-packaged mifepristone (1x200mg tablet) & misoprostol (4x200μg tablets) = Medabon® through its pharmaceutical partner, Sun Pharma, Mumbai, India. Activities are ongoing, or planned, to register it in 26 developing countries or countries in transition; and introduce it in 11 countries. Concept’s PPP on Medabon®

Product availability BUT, -What is the quality of the products that are available? -Do mifepristone and misoprostol manufacturers meet international quality and safety requirements? -What do we know about the stability of misoprostol formulations in tropical climates or even in 25°C after production ? Concept Foundation is undertaking a study with the support of Gynuity Health Projects to investigate the quality of medical abortion drugs on the market.

Where is Medabon being registered? RegisteredIn processPlanned... NepalEthiopiaViet NamCuba IndiaMongoliaColombiaGeorgia CambodiaMozambiqueBeninGuyana ZambiaMoldovaBurkina FasoKazakhstan GhanaSouth AfricaMexico CityTajikistan TunisiaBrazilUzbekistan TurkeyMacedoniaArmenia >1 million women used Medabon 12 countries in EU CameroonKyrgyzstan Iceland Norway BangladeshMarocco Thailand

FIGO Initiative on Unsafe Abortion Regional meetings, 2011 Medical abortion regimen up to 63 days Day 1 Day 2 Day h 48h Mifepristone 200 mg orally and hours later 800 µg misoprostol either vaginally or sublingually

FIGO Initiative on Unsafe Abortion Regional meetings, 2011 Need for information PATH, Ipas, Concept and WHO/HRP developed materials for health care providers and programme managers who are working to introduce Medabon®. This material is also intended to reach policy makers and the media and include: Medabon®: Medical & Service Delivery Guidelines Medical Abortion & Medabon®: Key Talking Points Medabon®: Frequently Asked Questions (FAQ) Medabon®: What You Need to Know (sample patient brochure) Medabon®: Background for Providers of Emergency Care Medabon®: A Framework for Introduction Medical Abortion: Selected References On site:

FIGO Initiative on Unsafe Abortion Regional meetings, July-August 2009

FIGO Initiative on Unsafe Abortion Regional meetings, health/publications/ medical_abortion/index.html The need for information - providers/policy makers WHO organized a meeting of experienced researchers and clinicians working on medical abortion. They responded to a list of the most frequently asked questions about medical abortion from health-care personnel providing abortion services. They reviewed those questions and compiled answers based on scientific literature and their own experience.

FIGO Initiative on Unsafe Abortion Regional meetings, 2011 Who provides product, where and when? supportive health system provided through pharmacies or community distribution provided by all levels of medical providers provided and monitored by trained medical providers When can these levels of service be implemented? How and when can be shift to basic provision?

FIGO Initiative on Unsafe Abortion Regional meetings, 2011 Objectives of an introductory strategy Provision of medical abortion in the context of CAC in all facilities meeting the requirements of the national guidelines. In the initial phase this will be undertaken in selected healthcare facilities. Development of a training curriculum for the provision of comprehensive abortion care, in particular of MVA and medical abortion and including values clarification. Development of IEC materials for professionals and users. Development of an advocacy strategy for CAC. Implementation of operations research to allow planning for scaling up to other health care facilities.

FIGO Initiative on Unsafe Abortion Regional meetings, 2011 An optimal approach to product introduction To achieve the stated objectives, it is necessary to develop and implement an appropriately designed introductory process. This requires: a systematic and incremental approach; and coordination and collaboration between the public health system and all key stakeholders - synchronization of activities is the key to building an appropriate and supportive health system for the provision of medical abortion. This is ongoing in Nepal, Cambodia and Zambia, and starting in Ghana.

FIGO Initiative on Unsafe Abortion Regional meetings 2011 Project management TCIC Policy Advocacy Material development Training Service delivery Product availability Operations Research Sun Pharma Concept NHTC/DHS All listed CAC service providers Public & private FHD/MOH TCIC/Ipas NESOG NHIECC TCIC/Ipas TCIC/Ipas FHD/MOH MSI FPAN PSI CREHPA NESOG Ipas NESOG Nursing Council Medical Council PSI CREHPA partners Training curriculum development TCIC/Ipas NHTC/DHS NESOG Nursing Council Medical Council Regional/district health authorities Nepal