On August 18, China's Ministry of Health ("MoH") released the following three major measures to establish its Essential Drug System envisaged by the China Healthcare Reform:
- National List of Essential Drugs (for Primary Healthcare Facilities) 国家基本药物目录（基层医疗卫生机构配备使用部分）("Essential Drug List")
- Provisional Regulation on Administration of National List of Essential Drugs 国家基本药物目录管理办法 ("Administration Regulation")
- Implementing Opinion on Establishment of Essential Drug System 关于建立国家基本药物制度的实施意见 ("Implementing Opinion")
The establishment of a drug supply system based on Essential Drug List is one of the major priorities in the Healthcare Reform that China launched in March, 2009. China aims to establish a more efficient system for drug manufacture, procurement, and prescription based on the Essential Drug List. Those three measures provide some much anticipated details on the essential drug system.
The Essential Drug List
Prior to August 18, China's Essential Drug List (2004) covered more than 2,000 drugs, including 773 western medicines and 1260 traditional Chinese medicines ("TCM"). The newly released 2009 Essential Drug List covers 307 items: 205 western medicines (all generic) and 102 TCM – a substantial reduction from its 2004 version. The release of this Essential Drug List has been much delayed from April, 2009 due to the difficulty in balancing the interests of drug manufacturers and distributors.
However, there is more to come. As the MoH explains, the complete Essential Drug List will compose of two parts: one for primary healthcare facilities and one for other healthcare facilities. This newly released list is only part I of the Essential Drug List, i.e. all drugs on this list are for the primary healthcare facilities. Primary healthcare facilities include all disease prevention centers which provide free wellness services such as immunizations and regular physical check-ups, and grass-root level medical facilities which include village clinics, township hospitals, and community health centers.
Part II of the Essential Drug List will cover the essential drugs that are prohibited or restricted from use in primary healthcare facilities, such as drugs that may cause severe harm if not properly used or drugs for treatment of major diseases only. Therefore, only higher level hospitals, which deal more often with major diseases, can prescribe these drugs. This part II of the Essential Drug List is expected to be released in November, 2009.
The Administration Regulation
The Essential Drug List will be updated every three (3) years. The newly released Administration Regulation provides general principles in selection of essential drugs, the procedure of such selection, and the composition of the working committee for the Essential Drug List.
The Implementing Opinion
While the Essential Drug List and the Administration Regulation provide the basis of the Essential Drug System, the Implementing Opinion sets the basic structure of the system. It provides guidance for the manufacture, distribution, prescription, and price control mechanisms of the Essential Drug System. All state-owned hospitals shall procure and sell essential drugs with zero mark-ups. The procurement of essential drugs shall be carried out through online tender / bidding process with all information published online for the sake of transparency.
The timetable of completing this essential drug system is for each province to implement this system in at least 30% of the state-owned primary healthcare facilities by December, 2009. By the end of 2011, the end of phase one of the healthcare reform, essential drug system is expected to be implemented throughout China.