The selection of essential medicines in China: progress and the way forward

Analysis The selection of essential in China: progress and the way forward Difei Wang, Xinping Zhang School of Health and Medical Management, Tongji Medical College of Huazhong University of Science and Technology, Wuhan, China. Address for Correspondence: Xinping Zhang. School of Medical and Health Management, Tongji Medical College of Huazhong University of Science and Technology, Wuhan City, Hubei Province. Peoples Republic of China. E-mail: xpzhang602@163.com Citation: Wang D, Zhang X. The selection of national essential in China: progress and the way forward. Southern Med Review (2011) 4;1:22-28 10.5655/smr.v4i1.71 Abstract Objective: The objective of this paper is to analyze the development of China s national essential list (NEML) from 1979 to 2010. These findings were then used as a basis to provide suggestions on how to improve essential selection in China. Methods: The literature search was conducted on the issues related to essential, China and national essential lists. The information on essential principles, criteria and procedures was also reviewed. Literature review and key informants interview were also conducted. Key informants were interviewed mainly on how are selected at central and provincial level and how medicine selection could be improved in China. Results: In the past, China s national essential list has not been successful in promoting access to essential. Reasons for this failure included biased selection and non evidence-based selection. Analysis of China s essential list and WHO s generic essential show that two lists varied substantially in disease coverage. The NEML failed to cover some diseases of public health significance in China such as cancers. The way are classified and defined is also different between the two lists, e.g., in the NEML are listed without defining the dose. There are differing levels in transparency, involvement, collaboration and accountability in the way the are selected. Lastly, most of the provinces selected additional to complement NEML. However, in 2009 version of Chinese essential list, some improvements have been noted. Conclusions: There has been significant improvement in China s NEML. The latest NEML made progress by setting achievable targets, adopting balanced guidelines and updating principles and criteria. However, there is still need to increase evidence-based selection, reassess which diseases are in need to be covered and define with dosage forms and doses. In selecting, efforts should be made towards higher transparency, involvement, collaboration and accountability. Provincial selection should be improved by establishing relevant measures and receiving technical support from the national government. Keywords: essential, list, selection, China Introduction Essential (EMs) are that address the priority health care needs of the population. They are selected with regards to public health relevance, evidence on efficacy and safety and comparative cost-effectiveness 1. Establishing a national essential list (NEML) is a core element to national pharmaceutical policy 2,3. As the largest developing country with the population of more than 1.34 billion and accounting for over 40% of total health expenditure, promoting essential use in China is extremely important. China s public health facilities sell for profit with a mark up of 15% 4. Over 45% of total income in public health facilities in 2009 was generated by using and selling 5. The high medicine expenditure was indeed attributable to irrational use of and prescriber s preference of high price over low price genenics 6. The use and access of could be improved by proper selection and implementation of a national essential list (NEML). In the latest health reform initiated in 2008, the government made a commitment to provide basic health care, including essential, to all by 2020 7. This paper describes and identifies the progress and challenges in the essential selection from 1979 to 2010. We compare the latest NEML to the WHO model list in terms of 22 Southern Med Review Vol 4 Issue 1 April 2011

The selection of essential in China medicine inclusion criteria and selection procedures. We use these as a basis to provide suggestions on how to improve essential selection in China. Methodology The literature review was performed on published peerreviewed papers on essential in China. The search was performed in English and Chinese. We indentify publications through PubMed for English written papers and the China National Knowledge Infrastructure (CNKI) for Chinese written papers. Our search terms includes: essential, essential drugs, medicine selection, essential list and essential drug list. One hundred and seventeen (117) English language scientific articles and 771 Chinese articles were retrieved from PubMed and CNKI respectively. We included research papers which are relevant to essential selection. Duplicated Chinese papers, research within one area and information papers were excluded. We performed Google online search for technical documents published by international organizations such as World Health Organization (WHO), World Bank, and Health Action International (HAI). Key informants were interviewed on how national and provincial essential are selected and how to improve the selection. We interviewed 17 informants in both China and at WHO. These include 4 technical officers in WHO (Essential Medicines and Policy Department in Geneva, WHO Headquarters, Essential Medicines Unit in WHO/WPRO and in WHO China country office). We also interviewed 7 government officers in China whose work was related to essential selection. Out of 7, 3 worked at Ministry of Health in Department of Essential Medicines System, while 4 were from Unit of Pharmaceutical Policy in each province. Six physicians and pharmacists were also interviewed who have participated in the selection of national essential selection. The key questions asked from them were (1) how essential at national and provincial level are selected and (2) how essential selection in China could be improved. Results The history of essential in China Following the resolution of World Health Assembly in 1978 which urged WHO member states to establish their own list of EMs, the Chinese government introduced the concept in 1979 8. An expert group to select for the National Essential Medicines List (NEML) was established by Chinese Ministry of Health (MOH) and former State Food and Drug Administration (SFDA). The first edition of NEML was produced in 1982 with 278 western 9. A committee which acted as overall managing authority for the selection of NEML was assembled in 1992. It included representative from the Ministry of Health and three other government departments. In 1996, it issued the first revised list which increased the number of in Table 1. Changes in NEML from 1982-2004 Year Modern TCMs 1982 278 0 278 1996 699 1699 2398 1998 740 1333 2073 2000 770 1249 2019 2002 759 1242 2001 2004 773 1260 2033 Total the essential medicine list to 2398. The list contained 699 modern and 1699 Traditional Chinese Medicines (TCMs). From 1998 to 2004 i, the NEML was revised every two years. During this time the NEML served as a base for the selection of social health insurance lists 9. From 2004 the NEML ceased updating until the latest NEML was released in 2009 ii. The changes of NEML from 1982 to 2004 are summarized in Table 1. A number of studies quoted that the NEML was not successful in promoting the use of EMs and the accessibility of the 10-12. The principle which stated that NEML should include 40%-50% registered was accountable for the sharp expansion of the list 13. During this period, health providers preference of non EMs and fierce competition in generics also pushed down the volume and prices of EMs 14. Manufactures and distributors were therefore reluctant to produce that were neither preferred nor profitable 15. Availability of EMs in China remained low in both public and private sector. Many essential could not been found in many health facilities or drug stores in both rural and urban areas 16-18. Data from the WHO suggest that the availability of EMs was below 20% in China which is significantly lower than neighboring countries with similar economic development level 19. Latest NEML and its selection A new general idea for essential was established in 2009. It reiterated that the national essential system, the overall supporting policy system for the promoting access to EMs, should focus on providing basic to meet people s basic need 20. Under this, the latest NEML for grass root health facilities was established in August 2009. National formulary and clinical guidelines for EMs were established and disseminated in Dec 2009 in order to guide use of EMs at grass root level 21. This edition of NEML contains 307 items, including 255 western and 102 Traditional Chinese Medicines (TCMs) as one item in NEML may include a series of or variation of one medicine. Western are listed by their generic names (or part of international non proprietary names which indicate its main active chemical ingredients) and forms. i China s National Essential Medicines List 2004, http://archives.who.int/tbs/chinesepharmaceuticalpolicy/backgroundengdefault.htm ii China s National Essential Medicines List 2009, http://www.moh.gov.cn/publicfiles/business/htmlfiles/mohywzc/s3580/200908/42506.htm 23 Southern Med Review Vol 4 Issue 1 April 2011

The selection of essential in China Table 2. Discrepancies between the WHO list and the NEML Items The WHO model list 16th edition Medicines 358 357 Western 358 255 TCMs 0 102 Complementary NEML for grass root level Complementary list Provincial selection Revising interval 2 years 3 years Classification methodology Defined forms for western Supporting documents Essential medicine list for children Anatomical Therapeutic Chemical Classification STGs, formulary for essential Clinical Pharmacology Classification National formulary and guidelines for EMs The overall managing authority called National Essential Medicines Working Group decides the new principles and criteria 22. Medicines are listed on the basis that they should be necessary for clinical use and disease prevention and should be of high efficacy, safety and assured quality. They should be convenient to use and rationally priced. The managing authority reiterates that TCMs should be considered with same importance as western. Selecting principles and criteria apply to both western and TCMs. It also states that the selection should learn from international experience 22. The Ministry of Health (MOH) is responsible for selection of EMs for the latest NEML. The MOH has formed a committee which consists of a pool of experts in the field of medicine, pharmaceutical economics, pharmacy, health insurance, health management and pricing. Experts are divided into a review group and a consult group whose members are mutually exclusive. The consult group evaluates and proposes their opinions on the before forming candidate lists. The reviewing group votes for the candidate lists and determines the draft list. The draft list receives comments from government departments before handing to managing authority for final approval 23. The WHO model list and the NEML By comparing the WHO EM list and the NEML of China, we can see some important differences. First, the quantity of included western varied substantially. As a result, the diseases covered by the two lists are different. The WHO list has 358 western which is 103 more than NEML. The WHO list covers some important diseases such as cancers that the NEML does not cover. The WHO list also covers more within some disease, e.g. there are more for diabetes in the WHO list than the NEML 24. In the WHO list, are defined using doses and dosage forms. In the NEML list are only defined using dosage forms for both No western and TCMs. This influences the EMs manufacturing, procurement and use. Second, medicine classification and the definition of varies between the two lists. The Anatomical Therapeutic Chemical Classification (ATC-C) is used in the WHO list to classify while Clinical Pharmacology Classification is used for western in the NEML. This is because the NEML may need to conform to other lists for social health insurance schemes. Third the WHO has selected a complementary list which presents EMs for priority diseases that need specialized diagnostic or monitoring facilities and may have lower cost-effectiveness in some circumstances 25. The WHO has also selected two editions of essential for children. Even though a group of national representatives in China urged the government to select essential for children 26, no official response has been found for this appeal. The NEML does not have complementary ; however, provincial selection is allowed to add to complement NEML but must include every medicine in the NEML 27. We summarize discrepancies between the two lists in Table 2. Discrepancies in selection The different selection procedures of the WHO list and the NEML could have an effect on end users. The WHO s selection criteria, used as a model for countries, emphasizes evidence of safety and efficacy, cost-effectiveness and total cost of treatment, availability and stability of and high priority of single-compound 1. The NEML, which is aimed at the needs of China, emphasizes similar criteria of WHO s selection with additional consideration given to the needed in grass root level, local availability, affordability, priority diseases 22. Although it is important that China establishes its own list, the list should be made in a way that is transparent, involves all stakeholders and accountable to the population. The WHO makes its list using a presenter from the expert committee who is appointed to summarize data on comparative efficacy, safety and cost-effectiveness. The recommendation is written by the presenter and is sent to experts inside the WHO for review and is posted on the WHO website for public comments. The expert committee reviews all the information and makes final selection recommendations 28. In China, are chosen and the candidate list is made by a group of consultants. The candidate list is sent to a review group whose members vote for in the candidate list. The draft list is built on the result of voting 29. Detailed information of selection procedures is not revealed and information on the methods of selection is not disclosed. There are also differences in the number of experts and the size of the selection committee. The expert advisory panels and committees contain 781 experts of various areas (January 2006) 30. When selecting the WHO list, 8-12 members are chosen from expert committees for the selection of EMs, who then make the selection decision for the WHO list 28. The expert pool for the NEML is substantially larger, containing over 3000 24 Southern Med Review Vol 4 Issue 1 April 2011

The selection of essential in China Table 3. Discrepancies in selection between the WHO list and the NEML. Unit for selection decision Items WHO selection NEML selection expert committee for selection WHO expert committee for EMs selection Core members in selection pool 8 to 12 Unknown expert pool 781 Over 3000 Table 4. Quantity of additional in provincial lists Provinces selected Selected Western Hubei 118 113 5 Shandong* (rural areas) 210 142 68 Shandong* (urban areas) 206 143 63 Selected TCMs Involved technical organization Cochrane, MSH, UNICEF, MSF, WCCs Unknown Anhui* (rural areas) 172 120 52 Procedures Detailed procedures for processing applications and systematic review General steps for selecting and establishing the Anhui* (urban areas) 114 77 37 Guangdong 244 120 124 Jiangsu 292 179 113 professionals from various fields related to the selection within China. The organization structures of two selections also have substantial difference. The selection of the WHO list is an open system, in which the work is performed by technical clusters inside the WHO, WHO Cooperating Centers and external organizations. The selection system also accepts suggestions from the public and stakeholders for changes to the list 31. The NEML selection is completed by experts chosen from the expert pool. Table 3 outlines discrepancies found in selection procedures, arrangements and structures between the WHO list and the NEML. Provincial selection The central government gave authority to provincial governments to select additional to complement the NEML. These complementary are from the national basic health insurance and working injury list, which is the medicine reimbursement list for social health insurance scheme. The reason the authority was given to the provinces is to address local need. Provincial governments cannot remove already in the NEML. Provincial government can add more at provincial level and publish provincial list, transfer the power of selection to municipal governments while setting upper limit or range, or the provinces may opt not to conduct provincial selection 27. Up to the end of 2010, out of 31, 22 provinces had published their own lists, and of those, 17 provinces published provincial lists with additional western and TCMs. Shandong province and Anhui province have published separate lists for urban and rural areas. In terms of numbers of selected, the provincial selection of the 17 provinces ranged between 76 and 381 with an average of 179.9. We summarize the provincial lists in Table 4. Three of the provinces have set an upper limit or range of additional at provincial level and gave the authority of selection to cities. In Guangxi, the provincial government allows municipal governments to select 30% more than the NEML. In Hunan province, the provincial government authorizes the municipal government to select 70-90 additional. Jiangxi 76 75 1 Zhejiang 150 97 53 Yunnan 96 62 34 Sichuan 143 87 56 Chongqing*** 200 N.A N.A Hebei 193 99 94 Fujian 148 99 49 Shanxi** 209 132 77 Tianjin 230 120 110 Shanghai 381 236 145 Qinghai 100 30 70** Shanxi** 191 112 79 Average 179.9 112.6 70.0 * Shandong and Anhui publish separate lists for rural and areas. We calculate them by adding them and divide them by 2 **Two independent provinces with similar pronunciation ***Of the 70 40 are ethnic Most of the cities have selected 90 additional. Henan province authorizes the municipal government to select 200 additional. Two provinces, both of which are autonomous regions, have selected a considerable number of ethnic to complement the NEML. Tibet selected 340 Tibetan while Inner Mongolia selected 122 Mongolian. Economic and technical influence on provincial selection We allocated provinces to one of three categories according to their level of Gross Domestic Product per capita. More developed provinces included more than less developed provinces. The eight provinces that do not have complementary 25 Southern Med Review Vol 4 Issue 1 April 2011

The selection of essential in China Table 5. Quantity of additional at provincial level Most developed areas Medium developed areas Least developed areas Name Name Shanghai 381 Shanxi* 191 Guangxi 93 Shandong 208* Hubei 118 Anhui 134* Guangdong 244 Hunan 90 Jiangxi 76 Jiangsu 292 Henan 200 Yunnan 96 Name Zhejiang 150 Chongqing 200 Sichuan 143 Fujian 148 Hebei 193 Qinghai 100 Tianjin 230 Shanxi* 209 Average 236.1 Average 171.6 Average 107.0 *Shandong and Anhui publish separate lists for rural and urban areas. We calculate them by adding them and then dividing them by 2 Table 6. Difference in transparency and accountability in the selection of the WHO list and NEML Items Public accessibility to information WHO selection NEML selection Information on experts in expert pool but limited Signed conflicts of interest by experts No Result of review No Proper involvement of stake holders but limited Accept public application to add or delete Standard operating procedures for decision making No but limited provincial selection fall in the medium developed area or least developed area with the exception of Beijing. This may reflect financial barriers. Table 5 illustrates economic influence on provincial selection. Due to insufficient human resources, poor and remote provinces may have difficulty in conducting the evidence based selection process. Discussion Improving selection by comparing the model list and NEML The WHO list is meant to be a model for countries to follow but must be adapted in country to fit the needs of the population 32. However, many national lists tend to include that are not in the WHO list 33. The nationally and locally selected which do not appear in WHO list should be systematically evaluated to justify their inclusion in the NEML. Special attention should be paid to those that were deleted from WHO list. Health policy makers must analyze the disease burden and medicine expenditure before deciding on for the NEML. Another important step to improve the list would be to include forms and dosage of. Defining the form(s) and dosage(s) has three obvious advantages: 1) it is helpful on comparison among candidate ; 2) it allows prescribers to prescribe accurately; and 3) it makes procurement and logistics more efficient. Because of these reasons, in most national EM lists, are defined by both form and dosage. In the WHO list, the ratio of number of dosage forms plus dose (F+D) divided by number is around 1.8. The ratio varies greatly in national lists; some countries have a higher ratio while the other has a lower ratio 34. When updating the NEML, the F+D of should be defined. When defining forms and dose for, attention should be paid to available on the market as EMs in China tend to have much different doses and forms than other countries 17-18. Increasing transparency, involvement and accountability in selection The selection in general should be transparent, involve stakeholders and should be accountable to the population. Transparency will help ensure that the selection is unbiased and that the included meet the needs of the population. The selection process has improved, but there is still a need to improve it further. The government should be more open about how the evidence-based selection is conducted. Criteria for selecting committee members, conflict of interests and standard operating procedures should also be provided to make the board more accountable. Opinion from the public, especially from patients should be asked for and considered during the drafting of the NEML list. Table 6 summarizes the difference in transparency and accountability in the selection of the WHO list and the NEML. 26 Southern Med Review Vol 4 Issue 1 April 2011

The selection of essential in China Graph 1. Correlation of GDP per capita and number of additional GDP per capita (US$) 13500 11500 9500 7500 5500 3500 1500 50 100 150 200 250 300 350 400 Additional medcines selected at provincal level Enhancing collaboration to maximize efficiency The selection of NEML should fully utilize the results of evidencebased selection completed by the WHO and its partners. Using the evidence-based selection already completed by the WHO would decrease the costs of making the NEML because it would not have to do its own evidence evaluation. Within China, a cooperative network could be assembled to fully utilize existing resources and established facilities. Instead of the national and provincial governments drawing up their lists independently, they can do so cooperatively and merge some procedures which could reduce costs of making the lists for both parties. The MOH should provide technical support to provinces, especially to undeveloped provinces which might not be able to carry out evidence-based selection. Information on selection should be shared among the NEML selection and provincial selection. China covers a vast and diverse territory. Within the country, different provinces have different disease profiles and social development levels which lead to difference in selecting provincial lists. We summarize this in Graph 1. It is also important to make sure that appropriate local are included because the provincial lists are used in health facilities. Although the provinces can make their own lists, it is important to examine why the number of on the provincial list varies. One consideration that needs to be made is that less developed provinces may have higher need for EMs. Conclusion The latest NEML for health facilities in grass root level is significantly improved over the past lists. The establishment of China s latest NEML has made great progress in setting appropriate targets, selection principles and criteria. The selection is more transparent and evidence-based than in the previous years. With the updated selection process, promoting NEML should be within national capacity and relevant to meet the basic needs of in China. To build a better selection system, it is necessary to increase transparency, participation and accountability in the selection process to ensure the selection process is unbiased. The national government should assist and cooperate with the provinces to make sure that they have the financial resources and expertise to establish a list that meets the needs of the people. Reference: 1. WHO. The Selection of Essential Drugs: Report of a WHO Expert Committee. (Tech Rep Ser WHO no 914). Geneva: World Health Organization, 2002 2. WHO. Continuity and Change: Implementing the Third WHO Medicines Strategy 2008-2013. Geneva; 2009. 3. WHO. 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