A Proposal for High Level Forum on Developing National Medicines Policy (NMP) to Secure the Essential Medicine System in China

MoH and SFDA in partnership with WHO

Background Equity in access to, and financing of, health care has been increasingly worsening over the past two decades, due largely to a rapid rise of medical care costs and declined coverage of health insurance arrangements. The poor and the vulnerable are most likely not to see any health services, when they need, simply because they cannot afford them. According to the national health account study conducted in 2005, 5.6% of GDP in 2004 was spent on health care in China, equivalent to 759 billion Chinese yuan, of which 44% (333 billion Chinese yuan) was associated with pharmaceutical costs. In China, too many pharmaceutical manufactories (over 4,500) are producing too many pharmaceutical products that are necessarily of high quality. The distribution of pharmaceuticals is not well regulated and managed by the State. Too many distributors and retail pharmacies have been operating in China and many of them are not qualified according to the national guidelines. Lack of robust regulation and transparency has been identified as one of key problems in effective distribution of pharmaceuticals in China. Furthermore, many drugs are used in a way that is far from rational. Doctors, particularly in the low level health facilities, have often over used antibiotics and steroids, because of perverse financial incentives.

The experience of many countries has shown that all these problems can best be resolved by developing and implementing effective pharmaceutical policies. WHO recommends that strengthening pharmaceutical sector and encouraging rational use of medicines/drugs be organised under the umbrella of a National Medicines Policy that can ensure that medicines with good quality, safety and efficacy are available at affordable prices to all those who need them; where and when they need them. It also can ensure that medicines are rationally used. China has not yet developed an integrated National Medicines Policy, which may have impeded China’s overall health system reform, and slow down the development of a healthy and efficient pharmaceutical industry. WHO China Office has been actively working with the State Food and Drug Administration (SFDA) and Ministry of Health (MoH) to support national drug regulatory capacity building including quality assurance and control, drug standards, combating counterfeit drugs, post-marketing surveillance and rational use of drugs. WHO also has encouraged the Government of China to develop a National Medicines Policy in the near future. Against this background, WHO and SFDA have been proposing a high level forum aimed to bring senior policy makers from several line ministries responsible for health and pharmaceutical policy in China, and international experts/consultants to discuss and analyse key problems associated with pharmaceutical production and registration, distribution and rational use of drugs, and develop policy options/recommendations for formulating appropriate pharmaceutical policies.

Aim and Objectives The high level forum on pharmaceutical policy development aims to contribute to the development of National Medicines Policy. The Forum will achieve the following specific objectives:  Identify key problems existed in pharmaceutical production and registration, distribution and rational use of drugs;  Analyse and discuss main causes of these problems;  Introduce good practices and lessons learnt from other countries with similar economic development levels;  Develop policy options and suggestions on making essential drugs more accessible and affordable

Approaches The Forum is suggested to be held on 14 June 2007 in Beijing. WHO China Office will be closely working with MoH and SFDA, as well as leading national experts on pharmaceutical policy research, to organize forum. The representative of the following government agency will be invited to attend the Forum and give presentations on different policy issues and problems.

Research office of the Chinese Communist Party Committee Research office of the State Council Development and Research Centre of the State Council National Development and Reform Committee Ministry of Health Ministry of Labour and Social Security Ministry of Science and Technology Ministry of Commerce Ministry of Civil Affairs State Food and Drug Administration State Administration of Traditional Chinese Medicines

In addition, the Forum will invite at least three international experts from selected countries (e.g. India, South Africa and Australia) to present good practice and lessons from these countries. WHO staff from HQ and the regional office will be also be invited to present the development of NMP from international perspective.

Leading university and research institutions involved in pharmaceutical policy research (e.g. Peking University Centre for Pharmaceucoeconomics Research and School of Public Health, Fudan University School of Public Health) will also be invited to make their contributions to the Forum.

进行高质量 RCT 试验，在课题审核时，严把质量关，低质量重复的实验，不 给资助。