In 2016 Dutch cancer patients were treated with medicines of which the active substance came from a rejected Chinese factory, where there was a serious risk of products being contaminated, Zembla reports based on its own research.
The factory of Zhejiang Hisun Pharmaceutical was rejected by European inspection services in 2016. They found problems at the factory which could result in active substances coming into contact with substances of other medicines during the production process. In addition, some substances were found to be made in an unknown location, which meant that there were no quality guarantee.
Zhejiang Hisun Pharmaceutical provided 20 raw materials used in Dutch chemotherapy medicines. The Healthcare and Youth Inspectorate pulled 18 of these materials from the market. But according to Zembla, the other two substances were still used because no other supplier was available. The two substances involved are methotrexate and mitomycin. They’re used in treatments for bladder cancer, breast cancer and tumors in the head and neck. Mitomycin was still available on the Dutch market as late as September 2017.
The Inspectorate would not tell the television program which manufacturers put the raw materials from the rejected factory on the Dutch market. It also refused to say how many patients were treated with medicines containing these substances. According to the Inspectorate, the substances were tested safely and sufficiently by the manufacturers who used them. The Inspectorate did not test the substances itself.
Ronald Jansen, manager of pharmaceutical companies at the Inspectorate, told Zembla that the Inspectorate has to choose between two evils several times a year. “Do we want the product with a possible defect, versus do we not want the product at all”, he said.
Minister Bruno Bruins of Medical Care called the Zembla revelation worrying. “I know that more and more medicines are based on raw materials coming from China and India, and that means that you become dependent on suppliers far away”, he said to the television program.