File 027071

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Call to Action!
The impact of funding decline on female empowerment through the FC2 female
condom and the increase of HIV/AIDS
Facts
36.7 million
People living with HIV/AIDS worldwide 2015
1 in 25 Adults
Are living with HIV in Sub Saharan Africa
1.1 million
People died of AIDS-related illnesses worldwide
2015
70%
Of people living with HIV worldwide are found in
Sub-Saharan Africa
51% are women
More than half of people living with HIV/AIDS are women
Since the beginning of the epidemic, more than 70 million people have been infected with the
HIV virus and about 35 million people have died of HIV. Globally, 36.7 million [34.0–39.8
million] people were living with HIV at the end of 2015. An estimated 0.8% [0.7-0.9%] of
adults aged 15–49 years worldwide are living with HIV, although the burden of the epidemic
continues to vary considerably between countries and regions. Sub-Saharan Africa
remains most severely affected, with nearly 1 in every 25 adults (4.4%) living with HIV
and accounting for nearly 70% of the people living with HIV worldwide (WHO, GHO Data).
Problem
Male and female condoms remain the only dual protection devices in the world that protect men
and women from both STIs, such as HIV, as well as unplanned pregnancy. The FC2 female
condom remains the only dual protection device in the world that is both WHO and USFDA
approved and is under the full control of women. Research shows that when a male
and female condom are both available in the same market the overall number of protected sex
acts goes up with as much as 13% (2006: Hatzell, Feldblum & Van Damme).
Historically, the FC2 female condom has been procured by UNFPA (United Nations Population
Fund) and USAID (United States Agency for International Development). Recently, UNFPA
has had a 50% decrease in available funding for all their commodity procurement, and the
USAID procurement budget is being slashed under the Trump administration leading to a major
decline of female condom procurement in Africa:
2016 2015 2014 2013 2012
UNFPA 10,60 11,21 17,14 34,15 24,55
USAID 9,96 10,02 7,32 4,5 15,63
On a per country example this has led to, for instance, an annual need for 3 million
FC2 female condoms in Uganda, and no funding to procure. A need of 1 million
female condoms annually in Kenya, and funding for only 230,000. A need of 6 million female
condoms annually in Zimbabwe and funding for only 3 million. And these are just some
examples of the many countries who do not receive their actual FC2 female condom need on
the continent of Africa.
Solution
Female Health Company would like to propose a partnership with new donors
in order to ensure that the need for the FC2 female condom is met in Africa to ensure
prevention of HIV/AIDS among the target groups that need it. FHC is committed to
providing the training and technical support to the countries and target groups to ensure correct
and safe usage of the FC2 female condom, if donors are willing to procure the female condoms
that are necessary in these countries. We could even create a specific donor brand for the
FC2 female condom, to increase brand recognition for the donor in the region while
saving lives together.
On Female Health Company
The Female Health Company manufactures, markets and sells the FC2 Female Condom. FC2 is the only currently
available female-controlled product approved by the U.S. Food and Drug Administration (FDA) and cleared by
the World Health Organization (WHO) for purchase by U.N. agencies that provides dual protection against
unintended pregnancy and sexually transmitted infections (STIs), including HIV/AIDS. The Company's first
generation product was the FC1 Female Condom, a Class III medical device approved by FDA in 1993. The
Company's second generation product, FC2, has been available globally since 2007, and in the U.S. since 2009
after it was approved by the FDA as a Class III medical device. To date, FHC has shipped its female condom to
over 140 countries worldwide.
Currently, there are only two FDA approved and marketed products that prevent the transmission of HIV/AIDS
through sexual intercourse: the male condom and FC2. FC2 is currently the only FDA approved and marketed
female-controlled product that prevents STIs, including HIV/AIDS. Used consistently and correctly, FC2 provides
women dual protection against STIs, including HIV/AIDS, and unintended pregnancy. When used correctly the
protection rates against unintended pregnancies are 95 percent for female condoms compared to 98 percent for
male condoms according to the FDA. FC2 is not seen as directly competing with the male condom; it provides an
alternative to either unprotected sex or male condom usage.
An economic analysis of the cost effectiveness of an FC2 HIV/AIDS prevention program conducted by Dr. David
Holtgrave, the chairman of the Department of Health Behavior and Society at the Johns Hopkins Bloomberg
School of Public Health, was featured in the March 26, 2012 issue of AIDS and Behavior. The study showed that
the Washington, D.C. FC2 prevention program, a public-private partnership to provide and promote FC2,
prevented enough HIV infections in the first year alone to save over $8 million in avoided future medical care
costs (over and above the cost of approximately $445,000 for the program). This means that for every dollar spent
on the program, there was a cost savings of nearly $20. In the article Dr. Holtgrave concluded, "These results
clearly indicate that delivery of, and education about, Female Condoms is an effective HIV prevention intervention
and an outstanding public health investment." Washington, D.C. began its program in 2010 to fight a disease that
is at epidemic levels. At least 3 percent of Washington, D.C. residents have HIV or AIDS, a prevalence rate that
is the highest of any U.S. city.
In May 2014, a business case was published by Global Health Visions, LLC, commissioned by Rutgers WPF, the
advocacy partner of the Universal Access to Female Condoms (UAFC) Joint Programme. Part of the publication
was a study comparing total expected costs with total estimated economic benefits and it determined there was an
excellent return on investment for female condoms in sub-Saharan Africa. For example, in Nigeria an investment
of $1 offers a $3.20 return on investment to the country's economy.
Numerous clinical and behavioral studies have been conducted regarding use of the female condom. Studies show
that in many cultures, the female condom is found acceptable by women and their partners. Importantly, studies
also show that when the female condom is made available as an option along with male condoms there is a
significant increase in protected sex acts with a concurrent decrease in STIs. The increase in protected sex acts
varies by country and averages between 10 percent and 35 percent.
FC2 consists of a soft, loose fitting sheath and two rings: an external ring of rolled nitrile and a loose internal ring
made of flexible polyurethane. FC2's soft sheath lines the vagina, preventing skin-to-skin contact during
intercourse. Its external ring remains outside the vagina, partially covering the external genitalia. The internal ring
is used for insertion and helps keep the device in place during use.
FC2's primary raw material, a nitrile polymer, offers a number of benefits over natural rubber latex, the raw
material most commonly used in male condoms. FC2's nitrile polymer is stronger than latex, reducing the
probability that the female condom sheath will tear during use. Unlike latex, FC2's nitrile polymer quickly transfers
heat. FC2 can warm to body temperature immediately upon insertion, which may enhance the user's sensation and
pleasure. Unlike the male condom, FC2 may be inserted in advance of arousal, eliminating disruption during sexual
intimacy. FC2 is also an alternative to latex sensitive users who are unable to use latex male or female condoms
without irritation. To the Company's knowledge, there is no reported allergy to the nitrile polymer. FC2 is prelubricated,
disposable, and recommended for use during a single sex act. FC2 is not reusable.
The first clinical evidence of AIDS was noted more than thirty years ago. Since then, HIV/AIDS has become the
most devastating pandemic facing humankind in recorded history. In November 2009, WHO released statistics
indicating that on a world-wide basis, HIV/AIDS is now the leading cause of death in women 15 to 44 years of
age. According to WHO, in 2012 worldwide women comprised 50 percent of all the adults living with HIV and
approximately 58 percent of all new adult cases of HIV/AIDS in Sub-Saharan Africa. In the United States the
Centers for Disease Control and Prevention (CDC) and FDA both list heterosexual sex as the most common
method of HIV transmission in women.
For sexually active couples, male condoms and FC2 are the only barrier methods approved by the FDA for
preventing sexual transmission of HIV/AIDS. In recent years, scientists have sought to develop alternative means
of preventing HIV/AIDS. Based on the complexities of such research, a viable prevention alternative is unlikely
to be available in the foreseeable future. To date, it is clear that condoms, male and female, continue to play a key
role in the prevention of STIs, including HIV/AIDS. The United Nations Joint Programme on HIV/AIDS
(UNAIDS) has reported that, since the beginning of the HIV/AIDS epidemic, it is estimated that condoms have
averted approximately 50 million new cases. FC2, when used consistently and correctly, gives a woman control
over her sexual health by providing dual protection against STIs, including HIV/AIDS, and unintended pregnancy.
The feminization of HIV/AIDS has increased the relevance of FC2 for the prevention of unintended pregnancies
as well as disease prevention. Unintended pregnancy may result in maternal and infant death, babies with
HIV/AIDS, AIDS orphans, and increased health care costs.