The State Council clarifies further beneficial policies for the medical industry

China

In a recent executive meeting of the State Council, the Premier, Li Keqiang, confirmed the strategy of developing “Internet +” medical and healthcare services to make medical services more efficient for patients and to balance medical resources between developed and less-developed areas. In addition, the meeting also issued several beneficial policies for the pharmaceutical industry.

The key points of the beneficial policies are summarised below:

  1. Certain imported drugs will be free from tariffs from 1 May 2018, including all general drugs, anti-cancer alkaloids and any imported Chinese patent medicines. All imported anti-cancer drugs will enjoy no tariffs.
  2. Changes to decrease drug prices by using government collective procurement and cross-border e-commerce, and include imported innovative drugs in the healthcare reimbursement system. In particular, for anti-cancer drugs where there is an urgent clinical need.
  3. To make the marketing process for imported innovative drugs more efficient, such as changing the clinical trial approval regime into an implied permission regime.
  4. To strengthen Intellectual Property protection, such as, giving up to a 6 year data protection period to innovative chemical drugs (during which the authority will not approve the marketing of drugs in the same category); and giving up to a 5 year patent term extension to innovative drugs that apply for marketing in China and overseas simultaneously.
  5. To strengthen the quality control regime, such as strengthening the supervision of overseas manufacturing factories, and cracking down on the manufacturing and distribution of counterfeit drugs.

These policies follow up on the significant policy issued on 8 October 2017. In particular, the terms of data protection and patent term extensions have been clarified. This suggests that practical measures for both regimes may be issued soon.