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Since 1986 Chinese government policy has forbidden all blood and plasma-derived products from being imported into China, with the exception of human albumin. This three-decades-long ban was a response to four cases of HIV infection caused by imported factor VIII (FVIII), detected in 1983. Today China has around 25 domestic plasma fractionators supplying plasma-derived products, such as immunoglobulin and coagulation factors, to its population of 1.4 billion people.
Despite its embargo on foreign imports, China is not selfsufficient in plasma products. In China plasma collection is forbidden in the big cities and takes place only in rural areas. There is some stigma attached to donating plasma. Recently Chinese domestic fractionators launched campaigns to educate the population and explain how plasma donations can help save many people’s lives.
In China there is a huge demand for albumin with approximately 50% of that product being imported. Albumin is widely used in Chinese hospitals and is a critical component in saving lives. It is used mostly in critical care or emergency situations when people have traumatic injuries and burns. It is also used in the treatment of gastrointestinal conditions and liver disease.
Each year Octapharma supplies China with large volumes of its human albumin product albunorm®, the majority of which is produced in our Vienna production site. In 2016 we also started producing albunorm® for China in our Stockholm production facility.
The China Food and Drug Administration (CFDA) introduced a policy that every medical product requires serialisation. China is the first country to introduce the system, which aims to improve the traceability and classification of medical products. Each packaging level, from carton to pallet, is furnished with a unique serial number. Serialisation enhances patient safety and product traceability, making forgery of medicine and the illegal intermediary trade business more difficult. While China is the forerunner, more and more countries are enhancing protection against forgery. A multidisciplinary team, including experts in artwork, IT, packaging and production, collaborated to implement these track and trace systems in our Vienna and Stockholm production sites.
I hope that in future the Chinese government will lift its ban on importing plasma-derived products into China. Today Chinese patients with haemophilia experience shortages of plasma-derived coagulation products. Some patients have died as a result of not having access to treatment. The government eventually agreed to allow recombinant coagulation factor products to be imported to make up for the shortage. Octapharma is currently conducting a clinical trial in China for its human cell line recombinant FVIII Nuwiq®. There are many challenges in the Chinese market, but there is a Chinese proverb: “Where there is a will there is a way.” We will continue to work hard to advocate, educate and try to influence change in China and its approach to supplying patients with these lifesaving medicines.