From March 1, 21 drugs with rare diseases will be reduced by 3%

[China Pharmaceutical network industry trends] on February 22, four ministries and commissions including the drug regulatory bureau announced the notice on the value-added tax policy of rare disease drugs From March 1, 2019, the general VAT taxpayers who produce, sell, wholesale and retail rare disease drugs can choose to pay the value-added tax according to the simple method and the 3% collection rate For the imported drugs with rare diseases, the import value-added tax shall be reduced by 3% The initiative will further encourage the development of the pharmaceutical industry for rare diseases and reduce the burden of drug use for patients Rare diseases are also called orphan diseases WHO (WHO) defines rare diseases as diseases with 0.65-1 incidence rate The global global estimates of 300 million rare diseases are about 7000-8000 rare diseases identified But for the definition of rare diseases, the standards of different countries and regions are different With reference to the prevalence rate in European and American countries, due to the large population base in China, it is estimated that there are nearly 20 million cases of rare diseases in China, half of which are children It can be seen that rare diseases are not rare in China But the doctors who can diagnose rare diseases and the drugs which can treat rare diseases are in short supply It is understood that due to the high R & D cost of rare disease drugs and the lack of relevant laws and regulations in China, pharmaceutical companies are not willing to actively produce rare disease drugs, resulting in a small number of patients with rare diseases who are difficult to buy drugs and expensive to buy drugs At present, however, the situation is gradually improving On May 22, 2018, the national health and Health Commission, the Ministry of science and technology, the Ministry of industry and information technology, the drug administration and other five departments jointly issued the catalogue of rare diseases, involving 121 kinds of diseases, including albinism, amyotrophic lateral sclerosis, angel syndrome, Zener syndrome, autoimmune encephalitis, biotinase deficiency, cardiac ion channel disease, congenital myasthenia syndrome, Fabre disease, and Gaucher disease In addition, with the support of the national health and Health Commission, Beijing Union Medical College Hospital, China Association of hospitals, China Association for the promotion of pharmaceutical innovation and other institutions launched the China rare diseases alliance at the end of 2018, which will explore Chinese programs for patients with rare diseases It is reported that as early as 2016, Beijing Union Medical College Hospital took the lead in establishing a national rare disease registration platform with unified standards in 19 hospitals including West China Hospital At present, more than 120 rare diseases have been registered on the platform With the release of the catalogue of rare diseases, the establishment of China rare diseases alliance and the notice jointly issued by the four departments, the value-added tax policy of rare diseases drugs has been clarified, the tax rates of some APIs and imported drugs have been reduced, and it is believed that the drug burden of patients with rare diseases will continue to be reduced in the future There are also calls from patients with rare diseases for more rare disease drugs to be included in the medical insurance According to this notice, the taxpayer shall separately calculate the sales volume of drugs with rare diseases In case of no separate accounting, the simple collection policy as stipulated in this Circular shall not apply "Drugs with rare diseases" mentioned in this Circular refers to preparations and APIs of drugs with rare diseases approved and registered by the State Drug Administration The scope of drugs for rare diseases shall be adjusted dynamically, which shall be made clear by four ministries and commissions such as the drug administration according to the changes According to the list of rare disease drugs (batches), 21 rare disease drug preparations including bosentan tablets, alisentan tablets, lyoxigua tablets, maxitan tablets, iloprost solution for inhalation, and 4 APIs including bosentan, pirfenidone, penicillamine and riluzole were included.