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    China’s Rh-Negative Expectant Moms Still Rely on Smuggled Drugs

    Experts call for fast-tracked approval of Rho(D) immune globulin, widely used abroad.
    Aug 13, 2018#health#policy

    For pregnant women with rare Rh-negative blood living on the Chinese mainland, Rho(D) immune globulin smuggled from Hong Kong remains their only hope for keeping their unborn babies safe from a potentially fatal blood disease, China Newsweek reported Monday.

    The issue became a subject of widespread discussion in February of last year, when a couple from Guangdong province were caught carrying 54 doses of Rho(D) immune globulin at the entry-exit point from Hong Kong to Shenzhen. Yet despite being fast-tracked for approval three months later, the drug still isn’t available on the mainland market.

    There are an estimated 6.8 million people with Rh-negative blood living on the Chinese mainland. If an Rh-negative woman gets pregnant and her baby has Rh-positive blood, there is a risk she will develop antibodies that attack the baby’s red blood cells, potentially causing jaundice or even heart failure. Rho(D) immune globulin, however, stops the mother’s body from producing these antibodies.

    In December 2017, a mother in eastern Zhejiang province gave birth to a baby that was immediately diagnosed with severe hemolytic disease, its blood cells under attack from the mother’s antibodies. Though the newborn’s life was saved after four blood transfusions, the attending doctors suggested the incident could have been prevented if the mother had received Rho(D) immune globulin injections.

    “Although we’ve established a strict protocol for closely monitoring the condition of pregnant women with Rh-negative blood — and from time to time we monitor the hemolysis level of the fetus — we lack the core weapon for dealing with extreme cases,” Duan Tao, former chief physician at Shanghai First Maternity and Infant Hospital Corporation, told China Newsweek, referring to practices at his hospital.

    Injections should be administered around the 28th week of pregnancy and within 72 hours after labor. In May of last year, Rho(D) immune globulin was included in the National Health and Family Planning Commission’s list of children’s drugs that should be prioritized for research and development. But clinical trials did not start until this year, and they won’t conclude for another three to five years.

    “This is a very mature drug and should be given an ‘express pass’ for approval,” Duan said. “For various reasons, the introduction of imported anti-cancer drugs has been sped up and their prices lowered. The problem of Rho(D) immune globulin should be handled in an equally efficient manner.”

    With Chinese couples now being encouraged to have more children — and with second pregnancies being riskier for the fetus in the absence of Rho(D) immune globulin — Rh-negative women see access to such drugs as more important than ever.

    Wang Rui, a Shanghai mother with Rh-negative blood, said that compared with anti-cancer medication being overpriced, the Rho(D) immune globulin issue is more concerning to women like her because the drug is nowhere to be found in the mainland market. “It’s not the price that bothers us, but a lack of access — whether injections purchased by ‘agents’ are trustworthy, and who can help administer these injections,” she told Sixth Tone.

    These ‘agents’ are intermediaries who help women purchase Rho(D) immune globulin from Hong Kong, charging around 2,000 yuan ($291) per injection — a price that’s acceptable to most, Wang says, though she’s not confident that the drugs have been kept within the recommended temperature range of 2 to 8 degrees Celsius throughout their journey. Because local hospitals refused to administer the injections, Wang went to her hometown in eastern Jiangsu province seeking help with the first injection from a family friend who works as a nurse. The second injection, meanwhile, was administered by Wang’s own husband.

    Because Rho(D) immune globulin hasn’t received domestic approval, mainland hospitals do not stock the drug, and most won’t administer it for fear of liability should anything go wrong. Of the hospitals Sixth Tone called, only a handful of international clinics — prohibitively expensive to many Chinese couples — said they could pair patients with agents to obtain the drugs and later administer the injections on-site.

    But according to Duan, even this is pushing the limits of the law. “If hospital exams determine that it’s essential for the woman to get the drug, all the doctors can do is recommend that she obtain it on her own,” he told Sixth Tone. “It’s illegal for the hospitals to inject the drug for her, let alone stock it themselves.”

    Editor: David Paulk.

    (Header image: A nurse looks after a newborn with hemolytic disease at a hospital in Shenyang, Liaoning province, June 9, 2011. VCG)