Pharmaceutical Policy and the Lay Public<Superscript>*</Superscript>

Almost every national and supranational health policy document accords high importance to the need to listen to and ‘empower’ patients. The relationship between pharmaceutical policy and the lay public is not direct but mediated by several actors, including health care workers, patient organisations, industry and, most recently, the media. Although the overall aim of health and pharmaceutical policy is to address the needs of all citizens, there are only a few, well organised groups who are actually consulted and involved in the policymaking process, often with the support of the industry. The reasons for this lack of citizen involvement in health and pharmaceutical policymaking are many, for example: there is no consensus about what public involvement means; there is a predominance of special interest groups with narrow, specific agendas; not all decision makers welcome lay participation; patients and professionals have different rationalities with regard to their views on medicine. Because the lay public and medicine users are not one entity, one of the many challenges facing policy makers today is to identify, incorporate and prioritise the many diverse needs. The authors recommend research which includes studies that look at: lay attitudes towards pharmaceutical policy; lay experiences of drug therapy and how it affects their daily lives; the problem of identifying lay representatives; the relationship between industry and the consumers; the effect of the media on medicine users and on pharmaceutical policy itself. The authors acknowledge that although lay involvement in policy is still in its infancy, some patient organisations have been successful and there are developments towards increased lay involvement in pharmaceutical policymaking.     

Studying and evaluating pharmaceutical policy—becoming a part of the policy and consultative process

In this last article in the series the authors focus on the issue of researching and evaluating pharmaceutical policy. The past five articles made an argument for why pharmaceutical policy is important and why it is different from health policy. The evidence base needed for pharmaceutical policymaking is also somewhat specialized in relation to health policy. Taking these differences into consideration the authors provide their definition of pharmaceutical policy. The knowledge base for good pharmaceutical policymaking needs to be broad and include approaches and methodologies ranging from the highly quantitative and experimental to the purely qualitative. Other policy questions such as those concerned with rational use of medicines and economics illustrate that pharmaceutical policy needs more varied approaches than randomized clinical trials alone can provide. The importance of gaining a thorough overview and understanding of the available design and methodological options for policy analysis is emphasized. Research into pharmaceutical policy has many commonalities with evaluation and policy analysis. Some of the main pitfalls that policymakers, researchers and analysts can fall into when formulating and evaluating pharmaceutical policy are discussed and include: using too narrow evaluation questions; choosing inappropriate methods/designs; and the problem of bias and self-censorship. The␣authors conclude this series by advocating a strong focus on research and an international evaluation culture around pharmaceutical policy. They emphasize the importance of pharmaceutical specialists’ (i.e., pharmacists’) involvement in pharmaceutical policy analysis and the policy consultative process.     

Cost-Containment as Part of Pharmaceutical Policy

In this article the authors provide insight into the basis for price setting of medicines, the increasing pharmaceutical budgets in the past decades, and the measures governments and insures have taken to curb rising pharmaceutical costs. Four reasons are out lined for the fact that medicines are by some considered expensivey: 1) there are fundamental differences between medicines and other consumer products; 2) medicines are technology requiring an inordinate amount of research and development; 3) medicines are developed, manufactured, and distributed according to strict regulatory requirements; 4) medicines are most often selected by a physician for a specific patient and reimbursed in whole or in party by a third-party insurer or the state. Pharmaceuticals mean share of GDP has been 1.2% in OECD countries in recent decades. Pharmaceuticals accounted for 15.4% of total health expenditure, with public spending about half of this amount. Since 1970, the average share of GDP for pharmaceuticals in most countries has increased 1.5% more per year than GDP growth. Four types of strategies to curb rising Pharmaceuticals costs are described and a taxonomy of strategies provided These are:1)price and profit controls; 2) reimbursement system charges; 3) other fiscal measures; 4) quality measures. Pharmaceuticals policy has suffered from the pervasive misunderstanding that drugs are like any other commodity; resulting in policy makers viewing pharmaceuticals expenditures without thinking about drugs in their proper content of health care. The authors conclude by advocating a balanced approach to policymaking in a environment of rising pharmaceuticals costs. * This article is the third in a series of articles on this topic that will appear in Pharmacy World & Science during 2005. An erratum to this article can be found at .     

A role for two-stage pharmacoeconomic appraisal? Is there a role for interim approval of a drug for reimbursement based on modelling studies with subsequent full approval using phase III data?

Healthcare decision makers and pharmaceutical companies are increasingly using techniques of economic evaluation, particularly modelling, to assist them in their decisions about drug purchasing and drug development. The use of models in other types of policy decisions is also well established. One option, to shorten the time to a purchasing decision, would be for an interim decision for approval for reimbursement to be based on an economic model. Such a system would mainly benefit the drug development process and thus the pharmaceutical industry; however the approach could also lead to poor decision making, unethical marketing and withdrawal of drugs from the consumer. In this article, we consider the option of a two-stage economic appraisal process from the point of view of the seller, the purchaser and the patient and public. Although a two-stage process may offer some advantages in terms of early return on investment and access, there are significant disadvantages in terms of certainty about effects and public policy and expenditure. Until there are better methods of predicting the effectiveness of a new product, it is unlikely that interim decisions can be seen as a reasonable health policy alternative, although it seems likely that industry may continue to lobby for such an approach.     

Primary care purchasing. Are integrated primary care provider/purchasers the way forward?

Integrated primary care provider/purchaser organisations are currently being developed in the UK and other countries. In common with many other European countries and New Zealand, there has been a swing away from market-orientated models of healthcare organisation towards models which blend centralised planning and quasi market approaches. Primary care groups in the UK and independent practice organisations in New Zealand provide new opportunities to combine micromanagement techniques in the delivery of patient care and approaches to improving population health. These new organisations are building on the experience of health maintenance organisations (HMOs) in the US and physician-led purchasing in the UK and other countries. However, there are distinct differences between countries due to differences in health and social care systems and the degree of emphasis on primary physician involvement. Moreover, the continuing emphasis on a physician-led medical model may be at odds with developing a public health approach which emphasises participative and collaboration with local populations and other primary care providers--an area where physicians have little experience.     

影响药物政策制定的因素分析

目的:探讨药物政策制定过程中的各种影响因素。方法:采用系统的思维对可能影响药物政策制定的各种因素进行举例分析。结果与结论:列举了影响药物政策制定的8种因素,分别是政治经济环境、法律环境、社会舆论、突发事件、国际经验、历史经验、领导意志和利益群体等,在政策制定过程中要充分重视这些影响因素。     

Pharmaceutical Policy and the Pharmacy Profession*

In this article, the authors look at the relationship between pharmaceutical policy and the pharmacy profession with focus on pharmacy practice and pharmacists in the health care sector. Pharmaceutical policy encompasses three major policy inputs: public health policy, health care policy and industrial policy. In order to analyse and understand pharmaceutical policy, it is important to know how policymakers view pharmacy and pharmacists. The authors look at the issues that arise when policy regulates pharmacy as a business, and what this means for the profession. The perspective of pharmacy as a health care profession, as well as what it means when we view pharmaceutical policy in the context of the health sector labour market, is discussed. The authors also discuss how factors external to the profession are affecting its purpose and realm of practice, including the current trend in managerialism, and how the division of labour with other health professionals such as physicians and pharmacy assistants is affecting the pharmacy profession’s position in the labour market. Next the authors look at ways in which the pharmacy profession has affected policy. Pharmacists have been instrumental in developing new and expanding roles for the profession, sometimes inspired by external events, but often as a result of their own prerogative. The pharmacy profession is encouraged to take a leading role in forming and contributing to policy, in this way making visible its contribution to society in general and public health in particular. If not, the profession will forever be reacting to policy and will remain at the mercy of policymakers and other strong actors in society. This article is the fifth in a series of articles on this topic that will appear in Pharmacy World & Science during 2005.     

我国制药机械行业的现状与发展趋势

目的对我国制药机械行业的发展现状、存在的问题及发展机遇与趋势进行综述,为制药机械行业的发展提供参考。方法查阅国内外近几年的文献,进行归纳总结。结果与结论我国制药机械行业的发展虽然存在一定问题,但随着制药行业的快速发展和新版GMP的实施,将给制药设备行业带来前所未有的发展机遇,只要能正确认识和应对存在的问题,我国制药机械行业将会有广阔的发展空间。     

俄罗斯医药产业基本情况介绍

目的：介绍俄罗斯医药产业现状。方法：以俄罗斯的医疗,医药．医药行业市场和政府政策为切入点。结果：俄罗斯医疗配置完整．国产医药行业发展滞后。结论：俄罗斯医药市场处在重要的调整和发展时期。     

Illuminating the invisible voices in mental health policymaking

In public mental health policymaking, the inclusion of numerous stakeholders across lay and professional communities is expected. How the voices of these stakeholders meld to create a single unifying accounting of their actions and recommendations for policy is often unexpected. Unexpected in that, while all voices are important and participation often mandated, what is incorporated into the formal accounting of the policymaking process often does not reflect the elements of services that work most successfully for persons with mental illnesses and their family members. In this paper, I show how existing agendae of members of public policy task forces recontextualize the stories of persons with mental illnesses and their family members to reify societal expectations of these stories. I offer suggestions on how these stories should be incorporated into task force reports to further the development of appropriate policy and services that meet the needs and expectations of persons with mental illnesses and their family members.     

The changing environment for US pharmaceuticals

Health reform is currently the predominant health policy issue in the US. It carries profound implications for the pharmaceutical field, including the possibility of price controls that could stifle pharmaceutical research. While policy makers are contemplating alternative approaches to reform, the marketplace for pharmaceuticals has changed dramatically. For example, price increases have lessened, price discounting has increased, and new drugs are typically launched at prices lower than those of the leading product in the therapeutic class. These changes are driven in part by the growth of managed care. Further evidence of change in the industry is the number of job reductions announced and the decline in market valuation of pharmaceutical companies. Policy makers need to take the changed marketplace into consideration as they proceed with health reform, to avoid layering additional policy impediments on top of an increasingly harsh and unforgiving market. Such an approach could seriously compromise incentives for pharmaceutical research.     

我国医药产业集聚的现状及特点分析

目的:为明确我国医药产业今后发展的产业政策定位提供参考。方法:基于对医药产业集聚的必要性和对"火炬计划"中的国家级高新技术开发区和特色产业基地现状的了解,分析我国医药产业集聚的特点,进而探索优化我国医药产业集聚的策略。结果与结论:我国医药产业集聚中存在一些不利于长远发展的因素,如集聚领域方面多集中在生物制药领域,集聚特色需进一步开发;集聚进程方面多处于构建成长阶段,集聚优势未凸显;集聚的区位因子方面多由政府政策引导规划,市场属性需进一步强化。需要从集聚前的区位选择机制、集聚中产业领域选择以及集聚后区域产业升级3个阶段进行针对性策略调整。     

Harm reduction by a “user-run” organization: A case study of the Vancouver Area Network of Drug Users (VANDU)

The Downtown Eastside of Vancouver has experienced ongoing epidemics of HIV infection and illicit drug overdoses since the mid 1990s. In 1997, in response to the emerging health crisis among injection drug users (IDU) and government inaction, individuals gathered in Vancouver to form a drug user-run organization. This group eventually became known as the Vancouver Area Network of Drug Users (VANDU). Because of the growing interest in drug user organizations, this case study was conducted to document the genesis, structure, and activities of VANDU. In accordance with VANDU's philosophy of “user involvement and empowerment,” we employed a community-based case study methodology to achieve these aims. The findings demonstrate that through years of activism, advocacy, and public education, VANDU has repeatedly voiced the concerns of drugs users in public and political arenas. VANDU has also performed a critical public health function by providing care and support programmes that are responsive to immediate needs of their peers. This study indicates that greater efforts should be made to promote the formation of drug user organizations, and that health authorities and policy makers should explore novel methods for incorporating the activities of drug user organizations within existing public health, education, and policy making frameworks.     

加入世界贸易组织对我国制药行业影响的再评价

目的:重新认识加入世界贸易组织(WTO)对我国制药行业的影响。方法:对加入WTO前相关学者的观点进行回顾,并分析加入WTO后我国制药行业的实际发展情况,进而对加入WTO的影响进行再评价。结果与结论:加入WTO促进了我国药品的大量出口,知识产权协议对我国制药行业造成了较大的影响,这与之前的判断基本相符;同时,药品进口稳步增长,加入WTO并没有对制药行业形成巨大冲击,中药出口依然困难重重,这与部分学者的观点是相左的。     

Methamphetamine-associated psychosis: a new health challenge in Iran

The rapidly growing popularity of methamphetamine use in Iran has posed a new health challenge to the Iranian health sector. Methamphetamine-associated psychosis (MAP) has been frequently reported in Iran in recent years. Although methamphetamine use and MAP are considerable health problems in Iran but there is still a need to conduct epidemiological studies on the prevalence of MAP and its health-related problems. The present paper emphasizes that health policy makers should consider the immediate needs of drug users, their families and the community to be informed about the detrimental health effects associated with MAP. Although MAP could be managed by prescribing benzodiazepines and psychiatric medications but the most effective regime for stabilizing patients with MAP still needs to be studied in Iran. Constant collaborations among psychiatric services and outpatient psychotherapeutic services should be established to successfully manage MAP in Iran. Iranian clinicians especially emergency medicine specialists should be informed about the differences between the two forms of transient and recurrent MAP in order to implement appropriate pharmacological therapies to manage MAP. It is hoped that special training courses are designed and implemented by health policy makers to inform clinicians, health providers and especially emergency medicine specialists to effectively deal with MAP.     

Commentary: Where and how could biomarkers be used in 2016

Since the beginning of the human genome project there has been considerable speculation about how this resource and the knowledge creation it enabled would change therapeutic discovery, development, and delivery. As the project neared completion, considerable claims and predictions were made about the changes that soon would be forthcoming. Many of these early predictions failed to materialize, however, leading to further speculation about the reasons, including the role of the pharmaceutical industry in realizing the promise of "genomic medicine." During this same period, considerable strides were made in other areas of molecular biology and medicine, and in response scientific thinking naturally evolved. Researchers and regulators moved from a genotype-centric view to a view that all biomarkers are potential tools to improve drug development and therapeutic decision making. Molecular biology is now seen as encouraging more "personalized medicine"-the closer alignment of biological information (derived from molecular diagnostics) and therapy selection. Meanwhile, there are growing concerns that increasing expenditures in pharmaceutical research and development are not sustainable and not reaping sufficient gains for shareholders or society at large. Thus, there is new speculation about how biomarkers, personalized medicine, and the industry will interact and create value for patients. This overview seeks to explore the issues driving pharmaceutical productivity and the likely contribution of biomarkers in the future.