欧盟形成医药单一市场的挑战与趋势

本文通过综述欧盟医药卫生政策,阐述了欧盟相关的平衡医疗保障政策、医药产业政策和公共卫生政策的重要性,欧盟与成员国、成员国内等因素对欧盟医药政策的影响,以及政府与医药企业之间的关系,系统分析了欧洲医药单一市场迟迟没有形成的原因。由于欧盟与成员国、政府与医药企业之间存在强大利益冲突,欧盟目前仍无法形成医药单一市场。     

欧盟国家药品价格平衡措施：药品平行进口政策及启示

近年来,我国药品价格居高不下,1998--2010年,国家发改委对药品实施了26次降价,但效果不太理想。及时了解国际药品平行进口政策,将有可能使药品平行进口成为降低药品价格的重要措施。本文首先介绍了平行进口的理论依据,然后介绍了欧盟国家药品平行进口的相关规则以及部分欧盟国家药品平行进口的实施情况,进而对药品平行进口对各利益相关方的影响进行分析,最后认为欧盟国家的药品平行进口政策有效平衡了欧盟内部药品的价格。然而,实施药品平行进口,我国还需进一步建立健全药品平行进口的法律体系、完善医疗保险制度、严格遵守药品知识产权以及完善对各利益相关方的补偿措施等。     

Improving vaccination programmes in the European Union

Aim  In this article, we describe what the role of the European Centre for Disease Control and Prevention (ECDC) is and should be in supporting national vaccination programmes and improving the exchange of data and best practice. Subjects and methods  On the basis of information provided to the ECDC by two networks (EUVAC, VENICE) as well as the World Health Organisation (WHO) data, we examine childhood vaccination programmes in the European Union (EU), components of national vaccination programmes, and decision-making processes both at regulatory (EU) and epidemiological, socio-economic (national) levels. Results  The ECDC provides added value to national vaccination policies by sharing data in the areas of epidemiology, vaccination coverage, vaccine schedules and schemes, and evaluation of national programmes. Conclusion  National sovereignty in the field of vaccination policy should prevail; however, international support is paramount if we wish to enhance performance by sharing experience.     

Price competition in the chinese pharmaceutical market

We study price competition between high-quality global products and low-quality local products in a developing country, i.e., China, Nearly all previous studies on pharmaceutical price competition focused on developed countries with bioequivalent generics. In China, local generic products are not bioequivalent and are deemed of lower quality, while global products in the same class are considered similar in quality and better substitutes. We hypothesize that local generic competition drives down local product price but not global product price. In addition, we hypothesize that therapeutic competition among similar global products lowers global product price. Our empirical results support both hypotheses. Number of local generic competitors has a significantly negative effect on local product price but no effect on global product price, while number of global therapeutic competitors has a significantly negative effect on global product price. Policy changes that encourage bioequivalent local products and accelerate global product approvals will enhance price competition in China. JEL Code I11, L11 Disclosure: This project was funded by AstraZeneca Pharmaceuticals. The views expressed in this article do not represent those of AstraZeneca Pharmaceuticals.     

EU Country Specific Recommendations for health systems in the European Semester process: Trends,discourse and predictors

In the framework of “Europe 2020”, European Union Member States are subject to a new system of economic monitoring and governance known as the European Semester. This paper seeks to analyse the way in which national health systems are being influenced by EU institutions through the European Semester. A content analysis of the Country Specific Recommendations (CSRs) for the years 2011, 2012, 2013 and 2014 was carried out. This confirmed an increasing trend for health systems to feature in CSRs which tend to be framed in the discourse on sustainability of public finances rather than that of social inclusion with a predominant focus on the policy objective of sustainability. The likelihood of obtaining a health CSRs was tested against a series of financial health system performance indicators and general government finance indicators. The odds ratio of obtaining a health CSR increased slightly with the increase in level of general Government debt, with an OR 1.02 (CI: 1.01, 1.03; p = 0.007) and decreased with an increased public health expenditure/total health expenditure ratio, with an OR 0.89 (CI: 0.84, 0.96; p = 0.001). The European Semester process is a relatively new process that is influencing health systems in the European Union. The effect of this process on health systems merits further attention. Health stakeholders should seek to engage more closely with this process which if steered appropriately could also present opportunities for health system reform.     

Health impacts of increasing alcohol prices in the European Union: A dynamic projection

Objective

Western Europe has high levels of alcohol consumption, with corresponding adverse health effects. Currently, a major revision of the EU excise tax regime is under discussion. We quantify the health impact of alcohol price increases across the EU.

Data and method

We use alcohol consumption data for 11 member states, covering 80% of the EU-27 population, and corresponding country-specific disease data (incidence, prevalence, and case-fatality rate of alcohol related diseases) taken from the 2010 published Dynamic Modelling for Health Impact Assessment (DYNAMO-HIA) database to dynamically project the changes in population health that might arise from changes in alcohol price.

Results

Increasing alcohol prices towards those of Finland (the highest in the EU) would postpone approximately 54,000 male and approximately 26,100 female deaths over 10 years. Moreover, the prevalence of a number of chronic diseases would be reduced: in men by approximately 97,800 individuals with diabetes, 65,800 with stroke and 62,200 with selected cancers, and in women by about 19,100, 23,500, and 27,100, respectively.

Conclusion

Curbing excessive drinking throughout the EU completely would lead to substantial gains in population health. Harmonisiation of prices to the Finnish level would, for selected diseases, achieve more than 40% of those gains.     

Regulatory agencies, pharmaceutical information and the Internet: a European perspective

The Internet facilitates access to health information and can therefore support the effectiveness of healthcare provision and empower patients in healthcare decisions. In the field of pharmaceutical therapy the electronic provision of information can improve compliance and strengthen the general understanding of pharmaceutical risks and benefits. Current political developments in Europe encourage a stronger role of the pharmaceutical industry in this regard. In light of potential conflicts inherent to the private provision of information and given their public health mandate, regulatory bodies in the pharmaceutical sector may represent an important alternative source of information. The explorative analysis in this paper reviews the websites of European pharmaceutical regulatory agencies regarding the usability and provision of information from a Layman's perspective. It is found that while the majority of agencies do provide product-related information, the usability of websites from the lay perspective is subject to variation. The reluctant position of agencies can be attributed to sectoral path dependencies, the regulatory approach and a lack of regulatory resources.     

Health professional mobility in the European Union: Exploring the equity and efficiency of free movement

The WHO Global Code of Practice on the International Recruitment of Health Personnel is a landmark in the health workforce migration debate. Yet its principles apply only partly within the European Union (EU) where freedom of movement prevails. The purpose of this article is to explore whether free mobility of health professionals contributes to “equitably strengthen health systems” in the EU. The article proposes an analytical tool (matrix), which looks at the effects of health professional mobility in terms of efficiency and equity implications at three levels: for the EU, for destination countries and for source countries. The findings show that destinations as well as sources experience positive and negative effects, and that the effects of mobility are complex because they change, overlap and are hard to pin down. The analysis suggests that there is a risk that free health workforce mobility disproportionally benefits wealthier Member States at the expense of less advantaged EU Member States, and that mobility may feed disparities as flows redistribute resources from poorer to wealthier EU countries. The article argues that the principles put forward by the WHO Code appear to be as relevant within the EU as they are globally.     

Prevalence of physical activity in the European Union

Summary Objectives:This article is the second in a series of four that present data about physical activity in the 15 member states of the European Union collected by the Eurobarometer 58.2. The focus of this article is on days of vigorous and moderate physical activity, days of walking, and metabolic equivalence estimates (METs) for total physical activity from 15 member states of the European Union using the International Physical Activity Questionnaire (IPAQ).Methods:Data were collected in 2002 as part of the Eurobarometer by face-to-face interviews. A total of 16230 respondents age 15 years and older were interviewed. Sample sizes ranged about 1000 respondents in most nations. Physical activity was assessed with the last 7-days short version of the IPAQ.Results:: Median METs estimates in hours per week were the highest in the Netherlands (39.43 MET-hours/week), Germany (34.65 MET-hours/week in the eastern part, 33.90 MET-hours/week in the western part), and Luxembourg (31.55 MET-hours/week). The lowest METs estimates were reported in Northern Ireland (11.55 MET-hours/week), Sweden (18.65 MET-hours/week) and France (19.55 MET-hours/week).Conclusions:A comparison of the results with existing data on physical activity prevalence in the member states indicate some inconsistencies between studies which may be related to measurement problems, as well as to conceptual differences in the assessment of physical activity.     

Inequalities in the prevalence of smoking in the European Union: comparing education and income

BACKGROUND: The aim of the study was to determine whether education or income was more strongly related to smoking in the European Union at large, and within the individual countries of the EU, at the end of the 1990s. METHODS: We related smoking prevalence to education and income level by analyzing cross-sectional data on a total of 48,694 men and 52,618 women aged 16 and over from 11 countries of the European Union in 1998. RESULTS: Both education and income were related to smoking within the European Union at large. After adjustment of the other socioeconomic indicator, education remained related to smoking in the EU at large, but income only remained so among men. Educational inequalities were larger than income-related inequalities among younger and middle-aged men and women. Educational inequalities were larger than income-related inequalities among men in all individual countries, and among women in Northern Europe. For women from Southern European countries, the magnitude of education- and income-related inequalities was similar. CONCLUSIONS: Education is a strong predictor of smoking in Europe. Interventions should aim to prevent addiction to smoking among the lower educated, by price policies, school-based programs, and smoking cessation support for young adults.     

Perceptions of environmental opportunities for physical activity in the European Union

Summary Objectives:This article is the last in a series of four that present data about physical activity in 15 members states of the European Union collected by the Eurobarometer 58.2. The focus of this article is on the perception of environmental opportunities for physical activity across the European Union. Methods:Data were collected in 2002 as part of the Eurobarometer by face-to-face interviews. A total of 16230 respondents age 15 years and older were interviewed. Sample sizes ranged about 1000 respondents in most nations. Physical activity was assessed with the last 7-days short version of the International Physical Activity Questionnaire (IPAQ). Results:Results indicate relationships between the perceptions of environmental opportunities; gross household income and physical activity level (in MET-hours/per week) of respondents. Respondents who reported lower income and less physical activity had also more negative perceptions of environmental opportunities. Across nations, respondents in Denmark, the Netherlands, Luxembourg, and Western Germany had the highest satisfaction with environmental opportunities for physical activity. In some nations, positive correlations between the perception of environmental opportunities and physical activity levels could be observed. Conclusions:Results show variations in the perception of environmental opportunities across the EU. Overall, the majority of respondents rated their environmental opportunities for physical activity favourable.     

Modelling future mortality reduction through smoking cessation in the European Union

BACKGROUND: To assess public health relevance of targets on tobacco smoking, information is needed on the decline in future mortality following smoking cessation. WHO's Health for All (HFA) and other targets on tobacco smoking in the European Union (EU) were therefore simulated. METHODS: A computer simulation model, Markov multi-state type, was developed using published age- and sex-specific information on population sizes, smoking prevalences, total and cause-specific mortality rates and corresponding relative risks for ex- and current smokers. The probabilities to start and quit smoking (transition rates) were estimated. Targets on smoking cessation included WHO's HFA target (country-specific smoking prevalence is reduced to 20% by 2015), and a theoretical maximum target (all smokers quit instantly). Simulation of these targets was based on changes in transition rates for smoking behaviour. For each target, the cumulated number of all-cause and cause-specific deaths between 1994 and 2015 was estimated for each EU member state. Then, the absolute and relative reduction in the number of deaths compared to a reference scenario, in which transition rates for smoking behaviour remained constant, were estimated for the EU as a whole. RESULTS: WHO's HFA target was expected to give a total mortality reduction by 2015 of 2.5% (around 1.1 million deaths) among men and 0.8% (almost 350,000 deaths) among women in the EU. Overall, the expected mortality declines in the HFA target were about 40-50% (men) and 30% (women) of the expected declines in the maximum target. The largest impact of the HFA target would be reached for lung cancer mortality. CONCLUSIONS: These results emphasize the need for policymakers in each EU member state to put strong effort into encouraging smokers to quit smoking.     

Occupational health in the European Union

Despite extensive legislation in the European Union, employees remain exposed to occupational risks and there is still a significant burden of work-related ill-health. The trend for more people to work in service industries rather than manufacturing has resulted in a change in the nature of risk and pattern of occupational illness. Worker access to occupational health services ranges from 15 to 96% and depends on the country in which employees live and the type of operation in which they work. The increasing number of small enterprises provides a particular challenge when trying to provide occupational health support to the European Union's 158.4 million workers. European law alone is not sufficient to improve the health of those at work and further action is needed at state, employer and professional level. New initiatives seek to improve the health of the Union's workforce, including a drive for better compliance with new law by every member state. Governments are working with key stakeholders through partnering strategies to develop innovative approaches for better access to quality occupational health services. Furthermore, targets for reduction in occupational ill-health have been identified. Where country laws do not mandate the provision of occupational health services, employers need to see the benefit of providing occupational health support. Finally, the medical profession is making procedures for self-regulation more rigorous and professional bodies are actively engaged in issuing professional standards and guidelines. Ultimately, the individual practitioner is responsible for ensuring that he or she develops and maintains the necessary knowledge and skills to provide competent services.     

浅谈欧盟医疗器械监管模式

主要介绍了近年我国医疗器械监管工作的重点及欧盟发展相对成熟的医疗器械监管模式。