New beginnings @ConceptFNDN
When I started working on the heat stable carbetocin project in 2012 at the Special Programme of Research on Human Reproduction (HRP), a public private partnership between WHO/HRP, Ferring Pharmaceuticals and MSD for Mothers I was surprised how little end-to-end thinking existed in terms of generating the evidence, issuing the normative guidance and then following through planned manufacturing, quality assurance, procurement, market shaping and introduction of a new technology in maternal health across the global health stakeholders.
Prevention and management of postpartum haemorrhage (PPH) encompass complex interactions between medicines, devices and other aspects of quality of care such as timely recognition and action. For these reasons, I believe Concept Foundation can make a meaningful contribution to end-to-end thinking and contributing to specific points such as quality assurance, regulatory processes and knowledge sharing in low and middle-income countries. I am particularly excited to join Concept Foundation and work towards improving access to quality assured essential sexual and reproductive health (SRHR) technologies in some areas that receive less attention.
WHO Model List of Essential Medicines 2019 update published
On July 9, WHO published the 21st update of the Model List of Essential Medicines. Of particular relevance to Concept Foundation’s work, the co-packaged mifepristone-misoprostol regimen for safe medical abortion was moved from the complementary to the main list with removal of the requirement of close medical supervision; heat-stable carbetocin was included in the list for the first time for prevention of PPH and tranexamic acid (TXA) had the PPH treatment indication added in addition to its trauma related use. All three changes are important and should contribute to improving access to quality assured essential sexual and reproductive health technologies.
Maternal Health Supplies Caucus starts Tranexamic Acid Working Group
The maternal health community is increasingly focusing on tranexamic acid (TXA) for PPH management following the release of the WHO Guideline in 2017 and the PPH indication inclusion in the WHO 2019 EML. In July, the Maternal Health Caucus of the Reproductive Health Supplies Coalition established a “TXA Working Group” chaired by myself, representing Concept Foundation. While research projects on TXA’s role in PPH prevention are ongoing, several organizations are looking into assessing access barriers at the country level with a view to overcoming some key challenges. Updating national essential medicine lists, national guidelines and treatment protocols are probably the most urgent priorities.
Procurement challenges for health commodities in low and lower middle-income countries need action
Dr Kalipso Chalkidou and colleagues from the Centre for Global Development published an elegant report in June. Featured on the BBC News website, “Tackling the Triple Transition in Global Health Procurement” brings a different yet important angle to the need for capacity strengthening for efficient procurement. In South Africa and Zambia a single generic manufacturer had a contraceptives and hormones market share of 72% and 99% respectively. As one-firm concentration increases, the possibility of competition diminishes with one manufacturer dictating the price. The report also found that unbranded generics, usually the least expensive options, have only 5 percent of the market by volume and 3 percent by value in low and lower-middle income countries, whereas in the United States and the United Kingdom, unbranded quality-assured generics account for 85 percent of the pharmaceutical market by volume, but only about a third by cost.
Self-injection of contraceptives is a central feature in WHO’s first ever self-care guideline
On 24 June, WHO released its first Consolidated Guideline on Self-Care Interventions for Health, focusing on SRHR. Release of these guidelines mirror a global shift in health services being more accessible at home in addition to healthcare facilities, a major step towards improving access to and affordability of healthcare. In the case of contraception, since the introduction of Sayana Press (self-injectable DMPA) in 2014, we are seeing this shift in the SRHR community in the form of women and girls self-administering their injectable contraception at home – a promising and exciting approach to increasing access to quality and affordable contraception. It is expected that this practice is going to increase over time as it becomes more widely accepted, leading to an increase in demand for self-injectable contraception. With the support of Bill and Melinda Gates Foundation and Children’s Investment Fund Foundation, Concept Foundation is working on the development of a generic self-injectable DMPA with a selected manufacturing partner, to ensure the future market is equipped to meet increasing demand.