The last 25 years has witnessed a growing interest in and demand for technology-driven reproductive interventions, such as Assisted Reproduction Technologies (ART), particularly within Europe. In fact, Europe is the world leader in ART services, performing over half of all reported treatment cycles worldwide. Between 1997 and 2002, the number of cycles has increased by 59%, from approximately 204,000 to 324,000, respectively, with In vitro fertilisation (IVF) and Intracytoplasmic sperm injection (ICSI) being the most prevalent treatments. As a result of the total cycles of ART in 2002, approximately 49,000 births occurred across 25 European countries. The EU represents a complex, highly differentiated landscape of ART treatment. Across countries, there is considerable diversity in regulatory and funding schemes for infertility. While some countries place strict prohibitions on particular techniques (e.g., egg donation, handling of embryos) and the intensity of services in terms of the number of cycles, others allow a wide choice of treatments with minimal regulatory oversight and restrictions on access to and reimbursement of care. Moreover, while the majority of Member States regulate many issues related to reproductive cell donation (e.g., compensatory schemes, donor consent) via statutory mandates, there is notable divergence on particular requirements, as well as on key issues such as the use of donors and surrogates and the importation/exportation of cells. Most EU Member States have deemed infertility a medical condition and have made provisions within their national policies to fund all or some portion of infertility treatment. However, there are varying restrictions among countries on access to ART treatments, including the type of ART treatment used, age of eligibility, number of allowable treatment cycles or embryo transfers, marital status, previous children, and place of treatment provision (i.e., public or private clinic). As a result of such restrictions, many couples decide to fully or partially self-fund infertility treatments. Other individuals may elect to seek private treatment even if public funding is available in attempts to gain more expedient access to care. A movement toward private sector treatment raises important regulatory issues for governments in terms of quality and safety considerations. Moreover, it introduces complex equity and ethical issues, as the eligibility criteria and costs of ART render treatment unattainable for many individuals. Several studies have assessed the costs of a successful pregnancy resulting from IVF treatment. The available estimates vary widely, ranging from £4,202 to £90,112 (€6,139 to €131,651), depending on the number of cycles, use of combination regimens, age at time of treatment, and inclusion of the cost of complications, obstetrics, and neonatal care. One factor that affects the cost burden (and safety) of ART is the number of embryos transferred, as the number of transfers increases the risk for higher order pregnancies. Although there is a clear trend towards transfers with fewer embryos, multiple pregnancy still remains an issue for many countries, with significant health and economic implications. The EU could play an important role in coordinating a consensus forum(s) to facilitate the exchange of information on ART treatment and debate important issues related to the regulation, financing, cost-effectiveness, and associated equity and ethical considerations of infertility services among Member States. Moreover, in order to promote policy decisions and guidelines based on sound evidence, there is a need for more robust and systematic economic evaluation on ART treatment. To enhance the relevancy and efficiency of such assessments, there should be increased collaboration between expert groups, namely the scientific and Health Technology Assessment (HTA) communities. Given the complexity and evolving nature of ART treatment, additional research is required on issues such as medical tourism, reimbursement, recent policy and regulatory developments, and multiple births. Furthermore, there is a need for improved data collection and monitoring of ART treatment within the EU, particularly with regards to the new Member States and the private sector. To that end, as private sector treatment and reproductive tourism becomes more pervasive, it will be of increasing significance for governments to address important regulatory issues related to the quality and safety of such treatment provision
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