January: Among the healthcare-related policies announced in 2012, the following 10 are considered to have impact on the Chinese healthcare industry according to 21st Century Pharmacy Online
The 12th Five-Year Plan:
The State Council officially issued the "12th, Five-Year Plan for National Drug Safety" on February 13, 2012. This plan aims to improve the quality of medicines by standardizing and better regulating the manufacturing and distribution of all medicines. It will also strictly punish those who have produced and/or sold counterfeit and other illegal medicines. Also with this plan, all pharmacies will need to have a licensed pharmacist present during business hours by 2015.
Elimination of drug markups - Pilot reform programs in public hospitals:
Separating medical care and drug sales was one of the key topics during the NPC (National People's Congress) & CPPCC (Chinese People's Political Consultative Conference) Annual Sessions in March, 2012. One of the policies announced as a part of the hospital reform program was the elimination of drug markups (up to 15%) that the hospitals could charge for their drug sales, and a pilot program which eliminated this drug markup was implemented in public hospitals in Shenzhen and Beijing.
Strict regulations on antibiotic use:
On May 8th, the Ministry of Health announced a regulation for the clinical application of antibiotics, which took effect from August 1st. The key 3 elements of this regulations are; categorization of antibiotics to "non-restricted", "restricted", and "for special use", limitations on the number of types of antibiotics a medical institution can purchase, and the implementation of a system to manage and supervise the use of antibiotics including legal responsibilities (e.g. punishments for misuse).
Further cut on drug prices:
On October 8th, the National Development and Reform Commission (NDRC) announced a new round of retail price cuts for 95 drugs and more than 200 formulations for oncology drugs, immune system drugs and blood products. The retail price reduction averaged 17%. This price cut is in line with the previous price adjustment that the NDRC made in March, mainly for digestive drugs, which also cut the prices by 17% on average.
Expansion of the National Essential Drugs List:
The previously issued China's National Essential Drug List in 2009 (a catalog of drugs that is covered by all insurance plans) included 307 drugs (205 Western drugs and 102 TCMs). The Ministry of Health announced that they plan to increase this list to around 700.
Blacklist system for unsafe drugs:
On August 15th, the State Food and Drug Administration (SFDA) released a regulation that will go into effect from October, which will blacklist manufacturers of unsafe medication. With this regulation, the information of those found responsible for seriously violating drug safety regulations and medical equipment regulations will be blacklisted and posted on government websites for public supervision. Offenders may also be faced with a 10 year suspension of their operations.
Five standards for the pharmaceutical circulation industry:
On December 1st, the Ministry of Commerce officially announced five standards for the drug distribution industry, which are; "Assessment indicators for logistic service capability of wholesale enterprises" "Service standards of retail pharmacies" "operational guidelines for pharmaceutical circulation enterprises" "qualification standards for professional managers in the industry" and "position setting standards (such as president, store managers, quality control managers etc.) for pharmaceutical circulation enterprises".
Six OTC ephedrine-containing medications switched to prescription medication:
Following the earlier policy in September that required pharmacies to check and register IDs for people purchasing ephedrine-containing OTC medications, the SFDA announced on December 6th, that they have restricted the sale of six OTC medications that contain over 30mg of ephedrine. These medications will now only be available as a prescription drug.
