How can we improve access to Assisted Reproductive Technology Globally

1. How can we improve access to Assisted Reproductive Technology Globally G. I. Serour, FRCOG, FRCS, FACOG, FSOGC, FJSOG, FSIGO, FIFFS, FEBCOG (Hon.) Professor of Obstetrics and Gynaecology, Director, International Islamic Center for Population Studies and Research, Al-Azhar University Clinical Director, The Egyptian IVF-ET Center, Maadi, Cairo, Egypt FIGO Past President 25th EBCOG/ 15th TSOG Joint Congress, Antalya, 17th – 21st May 2017

2. Conflict of interest I declare I have no conflict of interest in this presentation.

3. Items Addressed • Had there been an increasing demand for ART globally? • Current Global need and access to ART. • Barriers in Access to ART. • How can we improve Access to ART.

4. Had there been an increasing demand for ARTglobally?

5. Mean age of women at the birth of the first child (2008)UN Statistics, July 2011

6. Psychological and Social Consequences of Infertility in DCs 1. Fear, guilt, self blame. 2. Depression and helplessness. 3. Social violence and Isolation. 4. Economic deprivation. 5. Total loss of social status. 6. ST1 and HIV. 7. Starvation/disease/suicide. 8. IPV (2015)**. Ombelet W., Cooke I., Dyer S., Serour G., Devroey P. , 2008. Hum Reprod Update: 14(6):605-21 ** 32nd STAG meeting report HRP/WHO 18-20 Feb. 2015, Geneva

7. Human Rights Issue The modern evolution of human rights no longer requires legal marriage as a condition of family foundation, but outside more conservative societies, recognizes non traditional families and their participant’s rights to access ART. Serour GI. and Dickens B., 2016. Ethical and legal issues arising from Complications of ART. Cambridge University Press. In Complications and Outcomes of Assisted Reproduction . 2017 (editor B. Rizk and J. Gerris)

8. Why increasing demand? • Changing life style. • Changing definition of the family. • Infertility is a socio cultural problem with gender based sufferings. • High prevalence of STI/ HIV • High rate of tubal and ♂ factor infertility particularly in DCs. • Oncofertility. Socio-cultural, economic consequences of infertility.

9. Current Global Need for ART

10. Model on the outcome in Specific types of Infertility Treatment 10,000 typical couples - Overall live birth rate after conventional treatment 37% - Couples would need ART 63% - Collins JA and Van Steirteghem A, 2004 Hum. Reprod. Update 10:309-316.

11. Global Need for ART Assuming that 50% of ART eligible couples would choose ART, it is estimated that the global need for ART would be at least 1500 cycle/pmpy. Collins J Hum Reprod Update 8 (3) 265-77, 2000 ESHRE Capri Workshop Group, 2001 Hum. Reprod. 16:1518-1526.

12. 2012 ART babies born globally reached 6.5 million in 2012, mostly in the developed world, based on an estimated 1.9-2.2 million cycles being performed and the delivery of around 480.000 babies each year. Adamson D 2016. Focus on Reproduction, ESHRE Sept. 2016, 18.

13. 2013 In Europe, Belgium and Denmark each has the highest provision of ART in 2013 with more than 2000 cycles of ART/mppy. Leading countries such as France, the Netherlands and the UK were each below 1000 cycles/mppy. C. Calhaz-Jorge, 2016. Focus on Reproduction, ESHRE Sept. 2016, 17-19

14. In countries where ART is not sponsored or subsidized by the State or health insurance, as is the case in most of the countries particularly LICs and LMICs, most patients will not be able to have access or a complete access to ART and having ART involves a huge financial burden for the couple. Serour GI et al, 1991. Int. J Gynecol & Obstet, 36, 1991,49-53

15. A large percentage of couples paying for ART out of their pocket will stop after having the first or second ART cycles and before they succeed to have a baby. B. Fauser and GI Serour 2013. Fertil & Steril 100(2) 2013, 297-298

16. IVF/ICSI cycle Cost - Serour GI et al., 1991. Int. JGO. 36:49-53 - Shahin A 2007, Reprod. Biomed Online 15:51-56

17. Inavailability of ART The IFFS surveillance 2016 showed data on ART from only 74 countries of the 194 member states of WHO. Oray SJ. 2016. 7th edition IFFS September 2016 ,Vol. 1, Issue 1.

18. Availability and Access Despite massive global expansion of ART services over the past decade (2005-2014) ART remains inaccessible in many parts of the world, particularly in Sub-Saharan Africa, Eastern Europe, mid-central and Southern Asia and Latin America. • Ory SJ et al Fertil & Steril 2014, 101:1582-1583. • Jones HW et al 2010, 2011 www.iffs

19. Barriers in Access to ARTEpidemiological Lack of population level database that accurately defines the burden of infertility, need for ART and difficulties in access to ART service.

20. Geographic Barrier Disparity of ART services available in different countries exists between the rich and the poor countries, and between urban and rural regions in the same country.

21. Financial Barrier Lack of financial coverage of ART service by the States or the private insurance in many countries results in substantial out– of – pocket expenses in the private sector.

22. Socio-Cultural and religious Barrier Cultural, religious and societal perception of the diagnosis of infertility and acceptance of ART as an effective line of treatment of infertility, is a barrier to access ART in many countries.

23. Health Education Barrier Limited knowledge of the public, patients and even HCPs of the magnitude of the problem of infertility, impact of female age on infertility and its impact on health, quality of life, and its treatment including ART.

24. A recent survey of 1000 young people from across UK by RCOG & BFS revealed worrying gaps in their knowledge of RH and decline of fertility with age. RCOG, 2016. The membership magazine Sept. 2016, pp. 8

25. Data from the USA suggests that disparities exist in access to ART treatment based on ethnicity, education level and income. Chambers GM et al. Hum Reprod. 2013 Nov.; Vol. 28, Issue (11), pp.:3111-7.

26. Restrictive Health Policy Barrier Many governments do not recognize reproduction and treatment of infertility as a disease and a cause of disability. Frequently resources are not allocated for establishing and sponsoring infertility centers including ART services particularly in LICs and LMICs .

27. Health Workforce Shortage Barrier Establishing ART centers needs expensive equipment and highly trained personnels including reproductive endocrinologists, embryologists, and researchers. Such qualified HCPs are usually either not available in LICs and LMICs or migrate to HICs for a better professional career.

28. Cross Border Reproductive Care BarrierAlthough in principle, the care of foreign and local patients should be the same, and fit the best possible standards, there is evidence that this is not always the case. Shenfield F. et al, 2011. Hum. Reprod, Vol.26, No.7 pp. 1625–27. doi:10.1093/humrep/der090

29. How can we Improve Access to ART.

30. Throughout the world, the availability of and access to ART is the result of available health resources, health care systems, public health policies and regulations, socio-economic, cultural, religious and ethical influences. -Serour GI 2002, Current practices and controversies ART, WHO 41-49 - Serour GI. Hum. Reprod., ESHRE Monographs 2008 , Issue 1; Pp. 34-41

31. Resources, Justice, Utility If limited health service resources are utilised to provide expensive ART service, the opportunity is lost for using these resources to provide basic health care needs to the greatest sector of population of the country. 31 Serour G I, 2008 Hum Reprod, ESHRE Monographs July 2008, 34-42doi:doi10.1093/humrep/den143.

32. Reducing ART cost However, not providing such service to the infertile couples would be unjust and unethical. Every effort should be made to reduce ART cost. Serour G I, and A. G. Serour 2017. Ethical issues in infertility. Best Practice & Research Clinical Obstetrics & Gynaecology 31-MAR-2017 DOI information: 10.1016/j.bpobgyn.2017.02.008. (in Press) 32

33. The service to the needy may be provided through donation, charitable projects, companies, research projects, health insurance, establishing public ART centers, applying low cost or natural IVF cycles and satellite clinics. Serour G I, and A. G. Serour 2017. Ethical issues in infertility. Best Practice & Research Clinical Obstetrics & Gynaecology 31-MAR-2017 DOI information: 10.1016/j.bpobgyn.2017.02.008. (in Press) 33

34. Policies that substantially decrease out-of-pocket cost for ART treatment reduce financial barriers to access ART and result in an overall maximization in utilization. 

35. In the 12 months after the introduction of a policy that increased out-of-pocket costs from ∼$1500 Australian dollars (€1000) to ∼$2500 (€1670) for a fresh IVF cycle, there was a 21-25% reduction in fresh ART cycles across all SES quintiles. Chambers GM et al. Hum Reprod. 2013 Nov.; Vol. 28, Issue (11), pp.: 3111-7.

36. Prevention of Infertility In LICs and LMICs it is important to prevent infertility by preventing and early treatment of PPI, PAI, unsafe abortion , Iatrogenic infertility, tuberculosis, schistosomiasis and STDs which are among the prevailing causes of infertility in LICs and LMICs • Serour GI and Hefnawi, 1982. Int. J Gynecol & Obstet, 20, 1982,19-22. • Serour G I, and A. G. Serour 2017. Ethical Issues in Infertility. Best Practice & Research Clinical Obstetrics & Gynaecology 31-MAR-2017 DOI information: 10.1016/j.bpobgyn.2017.02.008. (in Press) 36

37. Streamline Infertility Perception Political leadership, societies and HCPs should give up the misperception that access to infertility care is a life style choice rather than a Human Right issue. Infertility and its treatment is an intrinsic Human Right as it is defined by WHO and WB as a disease and a cause of disability. Mehta A et al, 2016. Limitations and Barriers in Access to care for male factor infertility. Fertil & Steril 2016. Vol 105 No. 5, pp.:1128-37

38. Health Education Health education of the public and HCPs on the impact of age, delayed childbirth and life style on fertility will reduce the need for ART.

39. Male Infertility treatment Improved access to, and utilization of, male reproductive medicine services may have a positive effect on wider utilization of ART particularly in DCs. -Serour GI 2002, Current practices and controversies ART, WHO 41-49

40. Empowerment of women Women should be empowered to protect themselves from unsafe abortion, PPI, STDs and HIV. When infertility occurs they are not to suffer from its medical, social or economic consequences.

41. Political Commitments Policymakers should be convinced that health is not merely the absence of disease or infirmity, (WHO constitution). Infertility sufferings negatively affect population control policy and its treatment should be integrated in Reproductive health programs. -Fathalla MF 2001, Current Practices and Controversies in ART. WHO – Geneva. • Serour G. I, 2001. Current practices and Controversies in ART, WHO-Geneva • Serour G. I, 2008, Hum Reprod. Medical And Socio – Cultural Aspects Of Infertility In The Middle East. Hum. Reprod., ESHRE Monographs 2008(1):34-41; doi:10.1093/humrep/den143

42. Capacity building of DCs FIGO RMC developed infertility tool box to identify a structured programme of advocacy, health education, prevention of infertility, individual and societal support and access to specialized health professionals to encourage appropriate lifestyle, evidence based treatment and referral system for infertility treatment. FIGO, RMC, 2015. http//:www.arc fertility.com/figo, accessed February 2015

43. The FIGO Fertility Tool Box ™ • Levels FIGO, RMC, 2015. http//:www.arc fertility.com/figo, accessed February 2015

44. Continuous Education in DC’s Environment Al-Azhar Univ. Workshop: Basic & Advanced Clinical and Laboratory Training Course in Infertility including ART for Developing Countries “, November 26-30, 2016

45. Cross border ART Regulation When for some reasons, treatment at home is not possible or not available, CBRC is a solution that enhances patient’s autonomy. Furthermore, it fits with the principle of freedom of movement of patients within Europe (EU proposal directive, 2008). Commission of the European Communities. Proposal for a directive of the European parliament and of the council on the application of patients’ rights in cross-border healthcare, Presented by the European Commission on 2 July 2008, European Communities, 2008; Directorate-General for Health and Consumers, European Commission, Brussels. http://ec.europa.eu/dgs/health_consumer/index_en.htm

46. Conclusion Infertility is a health problem of considerable socio-cultural and economic impact. It needs to be alleviated by several measures including health education, prevention, early diagnosis, and EB cost effective treatment including ART.

47. Conclusion ART as practiced today is very complex and expensive and coincides with much patient discomfort and increased chances for complications resulting in considerable rates of discontinuation and reduction of proportions of couples achieving pregnancy. B. Fauser and GI Serour 2013. Fertil & Steril 100(2) 2013, 297-298

48. Conclusion Establishing an enabling environment of political commitments, health education, capacity building, low cost ART, empowerment of women and international collaboration of all stakeholders including the private sector are essential to improve global access to ART.

49. 30th November – 1st December 2017 Cairo- Marriott hotel Zamalek For more info. Please contact Conference Secretariat. 10 Al Mesaha St. Dokki-Giza E-mail: efsociety1@hotmail.com - website: www.efss-egypt.com