The top drug authority is set to approve imports of a hemophilia treatment to help make up for a shortfall that has deprived some patients of the medication they need.
The recombinant-clotting factor produced by the German pharmaceutical company Bayer Healthcare will be on the market soon, according to an announcement on the State Food and Drug Administration (SFDA) website.
"This does not mean that we are easing the two-decade ban on imported blood and plasma-derived products of all kinds," SFDA spokeswoman Yan Jiangying said yesterday.
The authorities imposed the ban in 1986, in response to a case of HIV infection caused by imported factor VIII that was detected around 1983.
The German-made treatment does not fall into the categroy of products that are subject to the embargo because it is not made from human plasma, said Yin Hongzhang, a division director with the SFDA's department of drug registration.
However, the recombinant-clotting factor has the same medical effect as plasma-derived factor VIII. It is widely used to treat hemophiliacs in China.
Many clinicians believe such treatments pose little risk of transmitting an infectious disease.
Larry Zhang, regional head for Asia Pacific of Bayer Healthcare, said the treatment would be made available at a lower price in China than in other countries because of the financial difficulties that many patients here face and the lack of a comprehensive health insurance scheme.
Recombinant-clotting factor will cost no more than 5 yuan (0.65 US dollar) in China, Zhang said. The average international price is 30 yuan.
A unit of factor VIII currently costs more than 1 yuan in China. In case of a hemorrhage, 1,000 units are required to stop a potentially fatal bout of bleeding.
Chu Yuguang, a Beijing-based hemophiliac and the director of the Hemophilia Home of China, a volunteer group of more than 3,000 patients, applauded the plan to import recombinant-clotting factor, describing it as as a timely measure by the government.
"However, many patients cannot even afford locally made factor VIII, let alone the much more expensive import," Chu said.
In another development, recombinant-clotting factor donated by Bayer Healthcare, enough for roughly 650 patients, is on its way from the US to China and should arrive at six Chinese hospitals next week, Zhang said.
(China Daily September 20, 2007)