On February 22, the Ministry of Finance, the General Administration of Customs, the State Administration of Taxation and the State Drug Administration jointly issued the "Notice on Value-Added Tax Policies for Rare Disease Drugs" (hereinafter referred to as the "Notice"), and the first batch of rare disease drugs value-added tax concessions Officially landed.

On February 11, Premier Li Keqiang of the State Council presided over an executive meeting of the State Council and decided to give preferential value-added tax to rare disease drugs. Starting from March 1, the first batch of 21 rare disease drugs and 4 APIs will be reduced by 3% with reference to anti-cancer drugs. VAT will be levied on the import link, and the domestic link can choose to levy VAT according to the simple method of 3%.

The notice pointed out that in order to encourage the development of the rare disease pharmaceutical industry and reduce the cost of drug use for patients, starting from March 1, general taxpayers of value-added tax can choose to calculate and pay value-added tax according to the 3% collection rate according to the simple method. After the above-mentioned taxpayers choose the simple method to calculate and pay VAT, they shall not be changed within 36 months. Starting from March 1, import value-added tax will be levied at a reduced rate of 3% on imported drugs for rare diseases. Taxpayers should separately account for sales of rare disease drugs.

The so-called rare disease drugs, refers to the national drug regulatory authorities approved the registration of rare disease drug preparations and raw materials. According to the notice, the first batch of rare disease drugs include bosentan tablets, amrisentan tablets, lioxigun tablets, human coagulation factor VIII, human prothrombin complex and other 21 rare disease drug preparations, as well as bosentan, pirfenidone, penicillamine, riluzole 4 rare disease drug raw materials.

The notice clearly stated that the scope of rare disease drugs will be dynamically adjusted, and the Ministry of Finance, the General Administration of Customs, the State Administration of Taxation, and the State Food and Drug Administration will make it clear in time according to changes.