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German Health Minister Jens Spahn has declined to comment on a call by women’s health groups for him to help ensure access to a drug used in medication-induced abortions, following a halt on parallel imports of the medicine.
Women wanting such abortions in Germany face few options after the country’s drug regulator suggested that parallel importers stop bringing in Cytotec, which has the active ingredient misoprostol. Along with being used off label to induce abortion, it’s prescribed for procedures such as miscarriages and before certain gynecological surgeries.
The importers then waived their permits for the drug, meaning that they’ll no longer bring the drug into the country.
On April 16, organizations including the German Society for Gynecology and Obstetrics, pro familia and Doctors for Choice sent their letter to Spahn, warning that the care of women in emergency situations is “at risk” because of the difficulties in accessing the drug. “It is not acceptable for Germany to make access to an essential drug significantly more difficult,” they wrote. The drug is involved in around 30,000 abortions in Germany each year, they noted.
A spokesperson for Spahn said Monday that while the ministry tries to respond to all letters, it doesn’t do so in public.
Asked about the restrictions, the country’s drug regulator said that the decision was taken following an assessment of factors such as patient safety and current case law. There has been significant media reporting on possible negative side effects of Cytotec, including death.
Another drug that also contains misoprostol — Angusta — could be used for the “induction of labor” as it comes in the “correct strength,” the regulator stated. Angusta comes in 25 microgram doses, compared with the 200 microgram dose of Cytotec.
The groups’ letter, however, notes that using Angusta would require dozens of pills to induce abortion.
The other alternative is MisoOne, which comes in 400 microgram doses and would need to be divided to achieve a 200 microgram dose for some procedures. But it can require a degree of bureaucracy that de facto leads to fewer practices offering medication-induced abortion, the letter said.
“We don’t really have a good alternative [to Cytotec],” explained Katharina Rohmert, a medical consultant at pro familia. “We want women to be able to decide on their reproduction health rights.”
This article is part of POLITICO’s premium policy service: Pro Health Care. From drug pricing, EMA, vaccines, pharma and more, our specialized journalists keep you on top of the topics driving the health care policy agenda. Email [email protected] for a complimentary trial.
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