Public Private Partnership for the Development of Heat-Stable Oxytocin

The lion’s share of maternal deaths is often due to direct causes or consequences of pregnancy related complications, or causes by interventions, omissions, incorrect treatment or event that result from these complications. The major direct cause of maternal death in developing countries is severe bleeding (postpartum haemorrhage). Oxytocine has been described by the WHO as first choice medication for treatment of postpartum haemorrhage. The WHO Department of Essential Drugs and Medicines Policy has listed and reported ‘Priority Medicines for Europe and the World’ (November 2004, WHO/EDM/PAR/2004.7). In this report they state that ‘maternal death, often due to postpartum haemorrhage, is almost entirely limited to developing countries. One of the major contributing factors to this mortality is the absence of heat stable oxytocin that could be administered to the mother to prevent severe blood loss. Despite research in the early 1990s to demonstrate this stability problem, nothing has been done to develop heat stable oxytocin’.

Thus, although postpartum haemorrhage (PPH) is known to be a major cause of maternal mortality, no heat stable oxytocin that is the most important intervention used to treat PPH is available.
The report mentioned above concludes and recommends therapeutic improvement through improved pharmaceutical delivery mechanisms, particularly those that can withstand extremes of climate.

Purpose
The overall objective of the project is the development and provision of a heat stable oxytocin, and the distribution of the medication within the developing countries up to the individual patient, thereby contributing to reaching MDG5, namely improving maternal health.

Partners within the project
The Oxytocin consortium exists of the following organizations: World Health Organization (WHO), Kinesis Pharma B.V., BioConnection B.V., Schering-Plough, GlaxoSmithKline, Center for Human Emergence (CHE), Cordaid Memisa, Royal Tropical Institute (KIT), TNO Quality of Life, TNO Built Environment and Geosciences, Royal Dutch Organization of Midwives (KNOV) and the International Confederation of Midwives (ICM). All of the organizations have unique qualities and this diverse mix of traditional and non-traditional partners have an added value for collaboration.

Results
The project (PPP) expects to achieve that a heat stable oxytocine medication can be made available to the developing countries and brought to the child-bearing women, and ultimately contribute to reduce the maternal mortality rate.

Activities
In order to achieve these results, the partnership will undertake the following activities:

1. Meshworking
a. (Re)create and maintain the climate for the Project (PPP) Oxytocin, and safeguard the commitment to the common purpose among the MDG5 Meshwork partners.
b. Roadmap for large-scale change.

2. Oxytocin
a. Pharmaceutical technological development of heat stable oxytocin. This development includes the production of three batches of heat stable product.
b. Identification of the market segments that need to be focused on for the heat stable oxytocin.
c. Identification of 20 developing countries where heat stable oxytocin will be introduced.
d. To obtain marketing authorization of heat stable oxytocin in the 20 developing countries.
e. Transfer of production to a manufacturing site in a developing country for global supply to the developing world.
f. Transfer of production to a second a third manufacturing site in a developing country, partly for local supply.
g. Operational research (‘field trials’) according to WHO guidelines and preparation of WHO User Guideline for heat stable oxytocin.
h. Pricing of heat stable oxytocin and creation of financial system for purchase and supply.
i. Distribution of heat sable oxytocin to local users.
j. Monitoring systems to improve delivery of maternal health.
k. Impact measurement in select countries.
l. Definition of a business model for sustainable heat stabile oxytocin supply