Wednesday, 22 February 2012

Development of Infertility-Related Health Policy

Governmentally mandated health policy has a significant role to play in the recognition and treatment of infertility. The inclusion or exclusion of infertility in national reproductive health guidelines and the decision to publicly fund or mandate private insurance coverage for treatment affects the lives and health of infertile
individuals and society as a whole. In 2001, the WHO held a meeting on the medical, ethical, and social aspects of assisted reproduction. A set of recommendations for responsible health policies, clinical practices and research issues was developed, however the multiple issues raised by infertility and its treatment are far from resolved.

While ARTs are not easily accessible throughout the world, governments have the responsibility to ensure that public and private services are safe and effective where they are available. The lack of guidelines and regulations for treatment of infertility is a serious drawback to ensuring the safety and efficacy of services as well as improving their quality. In 1992 the federal Fertility Clinic Success Rate and Certification Act was enacted requiring each ART program in the United States to report success rates to the CDC in order to provide the public with information on the effectiveness of services. While the federal government is involved in this much-needed surveillance of high-tech infertility treatment procedures, there is no formal monitoring process or mandated reporting for low-tech treatments.

In 1999 the CDC developed a model program for the certification of embryo labs to be carried out voluntarily by interested states. This program included detailed standards on consistent performance of ART procedures, quality assurance and control, maintenance of records and staffing personnel qualifications. However, this certification was voluntary and many important issues were not dealt with. There are currently no federal or state guidelines on informed consent for fertility patients or gamete donors, payment to gamete donors or surrogates, number of embryos to be transferred to a woman's uterus per ART cycle, treatment eligibility restrictions regarding age, marital status or sexual orientation; or assorted other ethical issues such as the use of donor eggs from human fetuses or sperm harvested from human cadavers. The American Society of Reproductive Medicine has issued guidelines on a range of issues related to assisted reproduction but they do not have the force of regulation. There is little consensus on the type of regulation which would suit the needs of the United States, but there is a growing consensus that some regulation may be necessary given the medical, ethical and social issues involved in the practice of ARTs.

Any activity which creates human embryos engenders significant controversy. In order to address this, issues such as embryo storage and the health of children born resulting from the use of ARTs merit public discussion and governmental policy. In the United States there has been no federal funding given for embryo research since 1974 therefore, most embryo research is conducted in private clinical settings where the progress is driven largely by competition among clinics to increase their success rates. This research is generally not subject to the scientific rigor and oversight common to federally funded investigations. Hundreds of thousands of embryos are being currently in cryopreservation in the United States without standardized policies regarding how long they can be kept. Potential health risks for children born from these embryos are unknown. Additionally, there are no mandates for informed consent on the use of embryos in case of parental divorce or death.

In the developing world the creation of health policy relating to infertility continues at a slow pace. Providers of ARTs in Africa operate in a virtual legal and ethical vacuum. The legal system is far outpaced by developments in reproductive health and a real danger of abuse and unregulated experimentation exists. In Latin America there is conflict between scientific interests, civil society, and perceived religious restrictions regarding infertility treatments, with a lack of open discussion between society and the church regarding legislation. ARTs are not widely regulated in Latin America, legislation or regulation exists only in Mexico, Brazil, and Argentina and there are frequently no national quality control or clinic licensing systems. This lack of policy, combined with the power of the Catholic Church puts pressures on providers who, in absence of formal regulations, make ethical and treatment decisions on a case-by-case basis. Legislation is not generally sought however, for fear of the enactment of restrictive laws due to the powerful lobby of the Church. Lack of regulation regarding storage and use of embryos in Latin America can also endanger women's health due to a cultural preference to protect any embryos resulting from ARTs at the expense of a woman's health.

It could be argued that because public health professionals are presently involved in infertility assessment, prevention, treatment and policy development, infertility is already a public health concern. However, this is not explicitly expressed. Infertile individuals, their families, and society as a whole could benefit from the application of public health skills to additional problems surrounding infertility and its treatment. There is a particular need for the discipline of public health to be involved in the collection and surveillance of health data, generation of informed public debate, and development health policy.

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