China’s population development trend
In recent years, China has been sliding into a “low fertility trap”. From 1990 to 2021, China’s birth rate dropped from 21.06 to 7.52‰, and the population growth rate dropped from 14.39 to 0.34‰. At the same time, the ageing rate of the population over the age of 65 years rose from 5.6 to 14.2%. Aware of the seriousness of this problem, the Chinese government has made several policy adjustments in the past decade to stimulate fertility. However, the effect of these policies seems to be limited. In 2021, there were 10.62 million births, with a birth rate of 7.52‰, with both being the lowest since 1978. The population crisis has become one of the hottest topics. At the National People’s Congress (NPC) and the Chinese People’s Political Consultative Conference (CPPCC) in 2022, a total of 9 proposals, the most ever, were aimed at raising the fertility rate.
Infertility rate and number in China
At present, there is no unified opinion on the definition of infertility. In different studies, the denominator of the infertility rate is also inconsistent5. It was difficult for us to accurately estimate the number of infertile couples in China. Therefore, we tried to solve this problem through meta-analysis. The infertility rate of all couples was 0.015–0.042, and that of couples at risk was 0.089–0.153. A review reported that the one-year infertility rate of married and voluntary women aged 20–44 years is approximately 9% worldwide20, which seemed to be consistent with our conclusion. From the 1970s to the 1980s, the two-year infertility rate of newly married women in China was 6.89%21, which was lower than the current rate of 8.9%. We also found that the visit rate of infertile couples was approximately 40%, of which approximately 20% underwent ART, which was consistent with previous literature reports2,10. Our results indicate that infertility is mainly due to female factors. But men patients are easily missed detection. Due to social beliefs and childbearing expectations from the female, in most cases only infertility evaluations are conducted on women, without evaluating male partners22.
Based on the prevalence rate, we speculated that there were 4.102–11.792 million infertile couples in China, with an annual increase of 1.189–1.867 million. This was much lower than the 50 million previously reported in some studies10,23,24, which mistakenly multiplied the infertility rate of couples at risk by the number of all couples, thus seriously overestimating the number of people experiencing infertility. People who have given birth and do not want to give birth again, even if they have lost their reproductive function, should not be counted in the infertile population. According to the research of the Center for Population and Development Studies of Renmin University of China, the lifetime infertility rate of women over the age of 40 years was 0.27–1.00%, which was close to our results24.
ART in China
After the first baby was born as a result of IVF in China in 1988, an increasing number of infertile couples has benefited from ART23. According to the information released by the National Health Commission, there are 536 ART institutions in China, of which 411 can carry out IVF and ICSI, and 78 can carry out PGD/PGS. There are more than 1 million ART cycles and more than 300,000 newborns every year8. The average LBR per transplantation in China is 40.5%, similar to that of 43% in the United States25. However, the multiple birth rate of ART in China is 25.4%, which is much higher than that of 13.1% in the United States25 and 0.65% of natural pregnancies in China26.
ART is a long and expensive process. In China, the cost of ART needs to be borne by the patients themselves. Economic research on ART has mainly been concentrated in Europe and the United States, accounting for 88% of studies27. Prior to this, there has been no multicentre survey, review or meta-analysis on the cost of ART in China. Our results showed that the cost per live birth was 67,002 yuan and that per complete cycle was 23,901 yuan. Age composition was an important factor affecting the cost. Among the people we included, 27.6% were women over the age of 35 years, which was in line with the actual proportion of 30%13,14,15, indicating that the costs were unbiased. Based on the clinical data of the reproductive medicine centre of Peking University People’s Hospital in 2008, Dr. Zheng studied the economic burden of infertility diseases in China10. He estimated that the direct medical cost per patient was 62,150 yuan, which was close to our results. Compared with the average hospitalization expenses of 30 serious diseases listed in the 2020 China Health Statistics Yearbook (published by China Union Medical College Press in 2021), only the cost of coronary artery bypass grafting for myocardial infarction (74,942 yuan) was higher than the direct medical cost of infertility. Compared to countries worldwide, China’s disease burden is high. And the probability of high-income groups receiving ART treatment is much higher than that of low-income groups28. At present, 44 countries have included all or part of the costs of ART in MI, mainly in the Americas and Western Europe. The covered costs include: drugs, ART procedures and hospital stays, complication management, and pregnancy diagnosis29. In the United States, the use rate of in IVF is 277% higher in states with complete insurance coverage than in states without coverage30.
Financial expenses and cost-effectiveness after the inclusion of ART in MI
To verify the stability of the results, we used the average cost per complete cycle and per live birth to calculate the cost of ART for all infertile couples. The results were very close. We took the average of the two as our estimate. Finally, we found that the fund would need to pay 72.313–207.878 billion yuan, and the subsequent annual payment would be 20.961–32.913 billion yuan. The LEV per complete cycle was 3.174 million yuan; the financial input‒output ratio was 13.022.
Of course, it is impossible that 100% of infertile couples will choose to undergo ART. At present, this proportion is 38%9, and it may increase with the inclusion of ART in MI. Other treatments include artificial insemination, clomiphene, surgery, and observation, which together account for 62% of all treatments9, but only 10–20% of all treatment costs10. This means that when the proportion of ART decreases by 10%, the total cost will decrease by 8–9%. At present, ART accounts for approximately 40% of infertile couples, so the actual financial burden may be less than half of our previous estimate.
If MI does not cover ART, the total population of mainland China is expected to reach 1.413 billion in 2050, which is consistent with Yi Zeng’s forecast of 1.420 billion31. With the inclusion of ART in MI, the total population would be expected to be 1.450–1.478 billion in 2050. This means that by 2050, 37–65 million people would be born due to the inclusion of ART in MI.
Feasibility of MI including ART
Whether ART needs to be incorporated into MI is controversial. In March 2021, a deputy of the NPC suggested that infertility treatment be included in MI to improve population growth. The NHSA replied that ovulation-promoting drugs such as bromocriptine, triptorelin and clomiphene have been included in MI, and supported the inclusion of ART in commercial MI. However, in fact, these drugs can only be paid by MI in some special departments, while patients undergoing ART need to pay for these drugs themselves. Moreover, at present, less than 15% of resident families in China buy commercial MI32, and the vast majority of infertile couples cannot benefit from commercial MI. With the implementation of China’s three-child policy, the support for the inclusion of ART in MI is increasing. In 2022, at least five NPC deputies proposed incorporating ART into MI. Starting from July 1, 2023, Beijing has included ART in medical insurance.
Incorporating ART into MI is very important33. First, the right to have children is considered a fundamental human right34, and the government has the responsibility and obligation to provide help for infertile couples. Second, the inclusion of ART in MI will indeed help alleviate the decline in the birth rate. Third, infertility will increase patients’ depression and anxiety35 and lead to social problems such as divorce and domestic violence36. Fourth, twins cost four times as much as singletons, while triplets cost ten times as much as singletons37, and the inclusion of ART in MI can effectively reduce the incidence of multiple births30,38.
The income of China’s MI fund exceeds the expenditure every year. In 2021, the fund income was 2, 871.03 billion yuan, the expenditure was 2, 401.11 billion yuan, and the accumulated balance was 3, 612.15 billion yuan. The cost of incorporating ART into MI accounted for only 2–6% of the current fund balance; the subsequent annual expenses accounted for only 4–7% of the annual fund balance. This was assuming that all infertile couples would undergo ART, and the actual cost was likely to be lower. At least, from the data point of view, it seemed feasible to include ART in MI, and the benefits were obvious. It should be noted that about 30% of the surplus of the MI fund is deposited into the insured’s personal account. But according to the above calculation, after deducting the surplus from personal accounts, the funds should also be sufficient. Lin Wang also believed that it is feasible to access selective reimbursement and subsidies for those in particular need 12.
How to incorporate ART into MI is also a topic worth exploring. Referring to the Affordable Care Act of the United States39, it should have three goals: provide ART healthcare for all patients, control costs of healthcare, and improve the quality of healthcare. Expand fund sources, training doctors, professional regulatory agencies, opposing waste, reasonable payment systems, reward and punishment measures are considered good experiences39. It is also important to adopt low-cost ART treatment strategies40 and implement strict admission policies12. In addition, ART coverage for MI by government can be launched in the beginning by partial reimbursement of ART treatment expenses for special groups such as patients belonging to low- or middle-income classes, and elderly patients. Finally, we can also determine the payment ratio based on the number of children; For those who have never given birth, the payment ratio is the highest, and as the number of children increases, the payment ratio gradually decreases.