What Women Want: Accelerating Access to Microbicides

Commitment to Action

What Women Want: Accelerating Access to Microbicides

Commitment by

International Partnership for Microbicides

The International Partnership for Microbicides conducted the second annual Microbicide Access Forum (MAF) in partnership with WHO and the Population Council. IPM then developed a mathematical model for microbicide introduction strategies in partnership with the London School of Hygiene and Tropical Medicine, and initiated a product acceptability study for three microbicide formulations in partnership with U.S. and Africa-based researchers. A 'Review on Access to Medicines in the Developing World: Lessons Learned from the Pharmaceutical Industry,' was conducted, along with an investigation of vaginal practices of African women and their implications for microbicide use, in partnership with the University of Bern.

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Tabs

Overview

Summary

Commitment

What Women Want: Accelerating Access to Microbicides

Launched

2006

Est. Duration

1 year

Estimated Total Value

$3,000,000

Region

Asia

Countries

Africa, Asia, Latin America & Caribbean

Commitment by

International Partnership for Microbicides

Partner(s) of the Commitment Maker(s)

Harvard Medical School, Françios-Xavier Bagnoud Ctr, Harvard School of Public Health, Harvard Business School, Partners In Health, Fxb (Francois-Xavier Bagnoud) International

Details

IPM is committed to providing women with an affordable and self-initiated HIV-prevention strategy to reduce the cycle of infection which has led to the deaths of more than 25 million people worldwide and orphaned more than 15 million children since 1981. To achieve this commitment, IPM will partner with Harvard's Schools of Business and Medicine, the Fran?ois-Xavier Bagnoud Center for Health and Human Rights at the Harvard School of Public Health, and Partners In Health to establish an interdisciplinary collaboration to consider new ways to ensure widespread access to lifesaving health technologies.

Background

The spread of HIV across the world, particularly in developing countries, continues to devastate the lives of individuals and communities and is constraining and, in the worst affected countries, reversing development gains. Women increasingly bear the brunt of the global AIDS epidemic. Pervasive gender inequality often places women at higher risk of exposure to HIV, while biological factors make them more susceptible to transmission. By providing a female-initiated HIV prevention technology, a microbicide could expand the range of options available to women. But a microbicide will only achieve its lifesaving potential if substantial work is done in advance to ensure that it is acceptable and widely available to the women who need it most. Microbicides present a unique challenge because they are being specifically developed for resource-poor countries and may not be widely marketed in developed economies, at least initially. To maximize impact, strategies must be developed in advance that can accelerate microbicide introduction by overcoming potential obstacles including the lack of efficient regulatory pathways for product approval, poor distribution networks for reaching many vulnerable communities, and potential socio-cultural barriers to microbicide uptake and use.
Partners in Health and Harvard University spearheaded the delivery of antiretroviral therapy in resource-poor settings. The Clinton Global Initiative has played a vital role in fostering this partnership by bringing together IPM, Partners In Health, and Harvard University in a forum focused on developing innovative solutions to some of the world's most pressing problems. Preparing the way for microbicides requires urgent action from leaders in science, public health, and the policy community - exactly the type of collaboration the Clinton Global Initiative is designed to support.
July 16, 2008
Implementation Period: July 1, 2007 - June 30, 2008
IPM has developed an important partnership with the pharmaceutical industry that allows IPM to obtain royalty-free license of several ARV drugs. This allow IPM to distribute the microbicides and determine product prices without obtaining further approvals..
IPM has investigated the acceptability of different gel viscosities in a sample of women and men partners. IPM has made large efforts towards selecting and preparing research centers for clinical trials to measure the efficacy of microbicide candidates. IPM is studying the regulatory requirements and procedures in countries that are likely to pioneer microbicide introduction programs.

Partnership Opportunities

SEEKING: financial resources, implementing partners, best practices information, media and marketing assistance.
OFFERING: implementing partners, best practices information.

Progress Reports

April 2009
- Conducted the second annual Microbicide Access Forum (MAF) in partnership with WHO and the Population Council. This conference convened in August, preceding the International AIDS Conference in Mexico City, and provided an opportunity for donors, microbicide developers, and NGOs to coordinate efforts to facilitate access to safe and effective microbicides. Presentations examined lessons learned from the introduction of related health products. Participants identified key 'next steps' to strengthen preparation for microbicide access.
- Developed a mathematical model for microbicide introduction strategies, in partnership with the London School of Hygiene and Tropical Medicine: The model estimates the impact of a microbicide on the number of new HIV infections in two contrasting settings in Southern India and South Africa. Introduction scenarios take into account efficacy and use, introduction strategy, uptake, speed of approval, and potential restrictions on product delivery. The model estimates the cost-effectiveness of the scenarios in both settings and assesses whether the scenarios with the highest impact are also the most cost-effective.
- Initiated a product acceptability study for three microbicide formulations in partnership with U.S. and Africa-based researchers. The acceptability study investigates women's preferences for placebo vaginal tablets, gel capsules, and films. The study is planned in four African countries: Burkina Faso, Mozambique, Tanzania, and Zambia. Study results will inform the research and development efforts regarding microbicide formulations that women and their male partners prefer, and hence should be considered for future microbicide delivery.
- Conducted a 'Review on Access to Medicines in the Developing World: Lessons Learned from the Pharmaceutical Industry.' IPM is partnering with selected pharmaceutical companies to assess the implications for microbicide introduction of experience in scaling up access to antiretrovirals (ARVs), the HPV vaccine and anti-malarials in developing countries. Lessons learned will be analyzed and shared with IPM, and if agreeable, to the pharmaceutical companies, as well as other stakeholders in microbicide development.
- Investigated vaginal practices of African women and their implications for microbicides use, in partnership with the University of Bern. The University of Bern has investigated vaginal practices in diverse settings over the past six years. Through the WHO-sponsored Multi-country Study on Gender, Sexuality and Vaginal Practices (GSVP Study), the university has documented reported behaviors and preferences, created a measurement and classification framework for vaginal practices, and surveyed and reported on the prevalence of specific practices. IPM is partnering with the University of Bern to develop a document that synthesizes the results of the vaginal practices studies and assesses the implications for use of microbicides by African women.
December 2006
- Plans to establish formal collaboration between partners; agree on roles and responsibilities; and develop research and policy programs.
Milestones Reached:
- IPM has obtained licenses from Pfizer to develop maraviroc and from Merck to develop L'644. Both are HIV entry inhibitors.
- To create a supportive political environment for microbicide development, IPM has participated in international, regional, and national events with donors, decision-makers, and stakeholders, including community leaders and non-governmental organizations.
- In collaboration with international partners such as the World Health Organization and the Population Council, IPM organized a Microbicides Access Forum in August 2008.