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欧洲的阳光政策与阴暗面:九个欧洲国家向卫生专业人员披露制药业付款情况。

Sunshine Policies and Murky Shadows in Europe: Disclosure of Pharmaceutical Industry Payments to Health Professionals in Nine European Countries.

机构信息

Charles Perkins Centre and Faculty of Pharmacy, The University of Sydney, Camperdown, NSW, Australia.

Health Action International, Amsterdam, The Netherlands.

出版信息

Int J Health Policy Manag. 2018 Jun 1;7(6):504-509. doi: 10.15171/ijhpm.2018.20.

DOI:10.15171/ijhpm.2018.20
PMID:29935127
原文链接:https://pmc.ncbi.nlm.nih.gov/articles/PMC6015505/
Abstract

Relationships between health professionals and pharmaceutical manufacturers can unduly influence clinical practice. These relationships are the focus of global transparency efforts, including in Europe. We conducted a descriptive content analysis of the transparency provisions implemented by February 2017 in nine European Union (EU) countries concerning payments to health professionals, with duplicate independent coding of all data. Using an author-generated, semi-structured questionnaire, we collected information from each disclosure policy/code on: target industries, categories of healthcare professionals covered, scope of payments included, location and searchability of the disclosed data. Our analysis shows that although important improvements have been put in place in the past few years, significant gaps remain in disclosure requirements and their implementation. The situation differs substantially from country to country and the most striking differences are between governmental and self-regulatory approaches, especially with regard to the comprehensiveness of the disclosed data. In many cases, individuals can still opt out and reporting is incomplete, with common influential gifts such as food and drink excluded. Finally, in several countries data are only available as separate PDFs from companies, thus making the payment reports difficult to access and analyse. In order to overcome these gaps, minimum standards for disclosures should be implemented across Europe. All payments to healthcare professionals and organizations should be included, all health-related industries should be required to submit reports, and usability of disclosed data should be guaranteed.

摘要

卫生保健专业人员与制药厂商之间的关系可能会不当地影响临床实践。这些关系是全球透明度努力的重点,包括在欧洲。我们对截至 2017 年 2 月在九个欧盟国家实施的关于向卫生保健专业人员支付款项的透明度规定进行了描述性内容分析,所有数据均进行了独立的重复编码。我们使用作者生成的半结构化问卷,从每个披露政策/法规中收集了有关以下方面的信息:目标行业、涵盖的医疗保健专业人员类别、所包括的支付范围、披露数据的位置和可搜索性。我们的分析表明,尽管在过去几年中已经采取了重要的改进措施,但在披露要求及其实施方面仍存在重大差距。情况因国家而异,最大的差异存在于政府和自我监管方法之间,尤其是在披露数据的全面性方面。在许多情况下,个人仍然可以选择退出,报告也不完整,常见的有影响力的礼物(如食品和饮料)被排除在外。最后,在几个国家,数据仅作为公司的单独 PDF 提供,因此使支付报告难以访问和分析。为了克服这些差距,欧洲应实施披露的最低标准。应包括向卫生保健专业人员和组织支付的所有款项,应要求所有与卫生相关的行业提交报告,并应保证披露数据的可用性。

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本文引用的文献

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Association between physicians' interaction with pharmaceutical companies and their clinical practices: A systematic review and meta-analysis.医生与制药公司的互动与其临床实践之间的关联:一项系统评价与荟萃分析。
PLoS One. 2017 Apr 13;12(4):e0175493. doi: 10.1371/journal.pone.0175493. eCollection 2017.
2
Transparency is good, independence from pharmaceutical industry is better!透明是好事,独立于制药行业则更好!
Aust Prescr. 2016 Aug;39(4):112-113. doi: 10.18773/austprescr.2016.051. Epub 2016 Aug 1.
3
Disclosure UK website gives "illusion of transparency," says Goldacre.戈德acre称,英国的信息披露网站营造出了“透明的假象”。
BMJ. 2016 Jul 6;354:i3760. doi: 10.1136/bmj.i3760.
4
Pharmaceutical Industry-Sponsored Meals and Physician Prescribing Patterns for Medicare Beneficiaries.制药业赞助的餐饮与医疗保险受益人的医师处方模式
JAMA Intern Med. 2016 Aug 1;176(8):1114-1122. doi: 10.1001/jamainternmed.2016.2765.
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Physician Payments from Industry Are Associated with Greater Medicare Part D Prescribing Costs.医生从医药企业获得的报酬与更高的医疗保险D部分处方成本相关。
PLoS One. 2016 May 16;11(5):e0155474. doi: 10.1371/journal.pone.0155474. eCollection 2016.
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JAMA Intern Med. 2016 Jun 1;176(6):763-8. doi: 10.1001/jamainternmed.2016.1709.
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Key opinion leaders and the corruption of medical knowledge: what the Sunshine Act will and won't cast light on.关键意见领袖与医学知识的腐败:阳光法案将照亮与不会照亮的领域。
J Law Med Ethics. 2013 Fall;41(3):635-43. doi: 10.1111/jlme.12073.
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Information from pharmaceutical companies and the quality, quantity, and cost of physicians' prescribing: a systematic review.来自制药公司的信息以及医生处方的质量、数量和成本:系统评价。
PLoS Med. 2010 Oct 19;7(10):e1000352. doi: 10.1371/journal.pmed.1000352.