Download or read book Transparency Power and Influence in the Pharmaceutical Industry written by Katherine Fierlbeck and published by University of Toronto Press. This book was released on 2021 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry to account through greater transparency.
Download or read book Transparency Power and Influence in the Pharmaceutical Industry written by Katherine Fierlbeck and published by University of Toronto Press. This book was released on 2021-06-29 with total page 303 pages. Available in PDF, EPUB and Kindle. Book excerpt: There is plenty of controversy surrounding pharmaceuticals, but it cannot be denied that the pharmaceutical industry is both socially beneficial and profitable. Regulators are expected to ensure that the economic success of the industry does not come at the expense of public safety, yet they have also assumed a cooperative role by providing advice on regulation and by targeting unmet medical needs. Concerns over regulatory standards, conflicts of interest, and the manipulation of information on drug safety and effectiveness have led to public mistrust and a greater need for transparency between the pharmaceutical industry and government regulators. Transparency, Power, and Influence in the Pharmaceutical Industry evaluates the progress made in holding the pharmaceutical industry responsible for creating transparency in the industry, from development to market. The contributors to this volume examine the various mechanisms introduced to make the regulatory process more informative and situate these efforts within the larger project of enhancing the safety of drugs, vaccines, and other products.
Download or read book Transparency in Drug Regulation written by Joel Lexchin and published by Canadian Centre Policy Alternatives. This book was released on 2004 with total page 32 pages. Available in PDF, EPUB and Kindle. Book excerpt: One way this relationship is manifested is the But the state does not possess the wherewithal to agreement between the industry and the TPD that undertake the elaborate clinical and pre-clinical all of the information that companies submit as trials required to meet the objective of providing part of the regulatory approval process is deemed safe and effective medications. [...] Accordingly, in November 1996 I made a "loaned" to the government for purposes of review request through the Access to Information Act for but the companies do so with the expectation that "all studies that the Health Protection Branch has the review will produce material gains through that deal with the question of the efficacy of: marketing of their products. [...] Personal data or usefulness of the data submitted; the scientific that enters the files of regulatory agencies like the atmosphere in the agency may be stifled and the TPD can include the identity of individual patients professional growth of its staff severely inhibited. [...] This part of the Out of the three proposals that have been put protocol was not followed and the authors made forward, the use of SBDs is the most advanced conclusions about subgroups despite the lack of and therefore merits a detailed analysis. [...] Canadian Centre for Policy Alternatives VII: Is the Summary Basis of Decision Adequate IN EACH OF THE FOUR EXAMPLES the Once a drug has been approved in the United problems would not have been discovered using States the FDA posts on its web site a detailed sum- Health Canada's SBDs due to the lack of detailed mary of the information that the company has sub- information of various types in these.
Download or read book Transparency in the Pharmaceutical Industry written by Martijn Broekhof and published by . This book was released on 2002 with total page 68 pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector written by Who Regional Office for the Eastern Medi and published by World Health Organization. This book was released on 2009 with total page 71 pages. Available in PDF, EPUB and Kindle. Book excerpt: This report presents the findings of the first phase of the national Good Governance for Medicines programme in Jordan. In recent years, countries of the WHO Eastern Mediterranean Region have made significant achievements in the provision of health services. In the pharmaceutical field, countries have been striving to improve the structures and regulations pertaining to medicines and have progressed in many ways. However, there are still important challenges. The goal of the WHO Good Governance for Medicines programme is to improve the situation of medicines regulation and supply. National transparency assessment is the beginning of a process aimed at bringing about desirable and sustainable changes in the governance of the pharmaceutical sector.
Download or read book Transparency in the Pharmaceutical Industry A Cost Accounting Approach to the Prices of Drugs Martijn Broekhof written by Martijn Broekhof and published by . This book was released on 2002 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt:
Download or read book Making Medicines Affordable written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2018-03-01 with total page 235 pages. Available in PDF, EPUB and Kindle. Book excerpt: Thanks to remarkable advances in modern health care attributable to science, engineering, and medicine, it is now possible to cure or manage illnesses that were long deemed untreatable. At the same time, however, the United States is facing the vexing challenge of a seemingly uncontrolled rise in the cost of health care. Total medical expenditures are rapidly approaching 20 percent of the gross domestic product and are crowding out other priorities of national importance. The use of increasingly expensive prescription drugs is a significant part of this problem, making the cost of biopharmaceuticals a serious national concern with broad political implications. Especially with the highly visible and very large price increases for prescription drugs that have occurred in recent years, finding a way to make prescription medicinesâ€"and health care at largeâ€"more affordable for everyone has become a socioeconomic imperative. Affordability is a complex function of factors, including not just the prices of the drugs themselves, but also the details of an individual's insurance coverage and the number of medical conditions that an individual or family confronts. Therefore, any solution to the affordability issue will require considering all of these factors together. The current high and increasing costs of prescription drugsâ€"coupled with the broader trends in overall health care costsâ€"is unsustainable to society as a whole. Making Medicines Affordable examines patient access to affordable and effective therapies, with emphasis on drug pricing, inflation in the cost of drugs, and insurance design. This report explores structural and policy factors influencing drug pricing, drug access programs, the emerging role of comparative effectiveness assessments in payment policies, changing finances of medical practice with regard to drug costs and reimbursement, and measures to prevent drug shortages and foster continued innovation in drug development. It makes recommendations for policy actions that could address drug price trends, improve patient access to affordable and effective treatments, and encourage innovations that address significant needs in health care.
Download or read book Measuring Transparency to Improve Good Governance in the Public Pharmaceutical Sector written by Who Regional Office for the Eastern Medi and published by . This book was released on 2009-05-01 with total page 48 pages. Available in PDF, EPUB and Kindle. Book excerpt: In recent years, countries of the WHO Eastern Mediterranean Region have made significant achievements in the provision of health services. In the pharmaceutical field, countries have been striving to improve the structures and regulations pertaining to medicines and have progressed in many ways. However, there are still important challenges. The goal of the WHO Good Governance for Medicines program is to improve the situation of medicine regulation and supply. National transparency assessment is the beginning of a process aimed at bringing about desirable and sustainable changes in the governance of the pharmaceutical sector. These reports present the findings of the first phase of the national Good Governance for Medicines program in Jordan, Lebanon, Morocco, Pakistan and Syrian Arab Republic.
Download or read book What are the Implications of Policies Increasing Transparency of Prices Paid for Pharmaceuticals written by Erin Webb and published by . This book was released on 2022 with total page 0 pages. Available in PDF, EPUB and Kindle. Book excerpt: 1. Public payers and pharmaceutical manufacturers have a shared interest in enabling timely access to necessary and innovative medicines. At the same time, there is a tension between the interests of purchasers (to contain costs) and of manufacturers (to provide return on investment and maximize profits).2. The most common pricing mechanisms in Europe - such as external reference pricing (ERP) and managed entry agreements (MEAs) - tend to create incentives for pharmaceutical companies to give confidential discounts on the official list prices. This obscures the actual prices paid for medicines.3. Net price transparency (NPT) for pharmaceuticals - the public disclosure of prices paid to manufacturers - is seen by many as key to overcoming the opacity of pharmaceutical systems and to addressing the imbalance between countries with different levels of negotiating power (as larger or smaller purchasers, or richer or poorer countries). It is also regarded as a means of ensuring that public payers purchasing pharmaceuticals for their populations can be held accountable.4. However, policy action on NPT is not straightforward:1.1. Empirical evidence on the effect of NPT is extremely limited. Economic simulations do not provide a clear answer and evidence from natural experiments only comes from very specific settings, not least because NPT policies have never been fully implemented.1.2. Some policy-makers are concerned that moves towards increased price transparency would have a negative impact on accessibility, because pharmaceutical companies may then withdraw from markets or set prices at unaffordable levels, in particular in cases of less attractive (e.g. smaller) markets.1.3. Payers in different health systems may consider measures to increase price transparency for pharmaceuticals as more or less necessary to increase affordable access to medicines.5. Any movement towards NPT requires a re-examination of the established trade-offs in pharmaceutical policy in Europe and worldwide. It is important to consider:1.1. the differing needs and negotiating capacities across countries1.2. the complexities of the interactions between stakeholders1.3. the particularities of specific market segments1.4. the way the process of implementation may shape the policy's impact1.5. the consequences for different countries and the 'knock on' implications of these effects for availability and affordability in other (national) health systems1.6. the likely implications for innovation.6. Increasing transparency in the pharmaceutical system will require greater European and international collaboration - strengthening and going beyond existing initiatives. It also demands a clear focus on maintaining access, innovation and sustainability. Recent experience with joint purchasing, such as in the case of the COVID-19 vaccines, may bolster similar initiatives in future.
Download or read book Access to Medicines as a Human Right written by Lisa Forman and published by University of Toronto Press. This book was released on 2012-08-27 with total page 225 pages. Available in PDF, EPUB and Kindle. Book excerpt: According to the World Health Organization, one-third of the global population lacks access to essential medicines. Should pharmaceutical companies be ethically or legally responsible for providing affordable medicines for these people, even though they live outside of profitable markets? Can the private sector be held accountable for protecting human beings' right to health? This thought-provoking interdisciplinary collection grapples with corporate responsibility for the provision of medicines in low- and middle-income countries. The book begins with an examination of human rights, norms, and ethics in relation to the private sector, moving to consider the tensions between pharmaceutical companies' social and business duties. Broad examinations of global conditions are complemented by case studies illustrating different approaches for addressing corporate conduct. Access to Medicines as a Human Right identifies innovative solutions applicable in both global and domestic forums, making it a valuable resource for the vast field of scholars, legal practitioners, and policymakers who must confront this challenging issue.
Download or read book Consumer Pharmaceutical Industry Relationships Building Trust and Transparency written by Lisa Parker and published by . This book was released on 2020-07-28 with total page pages. Available in PDF, EPUB and Kindle. Book excerpt: An outcome of the workshop held on 11 March 2020, Charles Perkins Centre at the University of Sydney, convened by the Charles Perkins Centre, Health Consumers NSW, Consumers Health Forum of Australia, funded by the Charles Perkins Centre
Download or read book Crossing the Global Quality Chasm written by National Academies of Sciences, Engineering, and Medicine and published by National Academies Press. This book was released on 2019-01-27 with total page 399 pages. Available in PDF, EPUB and Kindle. Book excerpt: In 2015, building on the advances of the Millennium Development Goals, the United Nations adopted Sustainable Development Goals that include an explicit commitment to achieve universal health coverage by 2030. However, enormous gaps remain between what is achievable in human health and where global health stands today, and progress has been both incomplete and unevenly distributed. In order to meet this goal, a deliberate and comprehensive effort is needed to improve the quality of health care services globally. Crossing the Global Quality Chasm: Improving Health Care Worldwide focuses on one particular shortfall in health care affecting global populations: defects in the quality of care. This study reviews the available evidence on the quality of care worldwide and makes recommendations to improve health care quality globally while expanding access to preventive and therapeutic services, with a focus in low-resource areas. Crossing the Global Quality Chasm emphasizes the organization and delivery of safe and effective care at the patient/provider interface. This study explores issues of access to services and commodities, effectiveness, safety, efficiency, and equity. Focusing on front line service delivery that can directly impact health outcomes for individuals and populations, this book will be an essential guide for key stakeholders, governments, donors, health systems, and others involved in health care.
Download or read book Conflict of Interest in Medical Research Education and Practice written by Institute of Medicine and published by National Academies Press. This book was released on 2009-09-16 with total page 436 pages. Available in PDF, EPUB and Kindle. Book excerpt: Collaborations of physicians and researchers with industry can provide valuable benefits to society, particularly in the translation of basic scientific discoveries to new therapies and products. Recent reports and news stories have, however, documented disturbing examples of relationships and practices that put at risk the integrity of medical research, the objectivity of professional education, the quality of patient care, the soundness of clinical practice guidelines, and the public's trust in medicine. Conflict of Interest in Medical Research, Education, and Practice provides a comprehensive look at conflict of interest in medicine. It offers principles to inform the design of policies to identify, limit, and manage conflicts of interest without damaging constructive collaboration with industry. It calls for both short-term actions and long-term commitments by institutions and individuals, including leaders of academic medical centers, professional societies, patient advocacy groups, government agencies, and drug, device, and pharmaceutical companies. Failure of the medical community to take convincing action on conflicts of interest invites additional legislative or regulatory measures that may be overly broad or unduly burdensome. Conflict of Interest in Medical Research, Education, and Practice makes several recommendations for strengthening conflict of interest policies and curbing relationships that create risks with little benefit. The book will serve as an invaluable resource for individuals and organizations committed to high ethical standards in all realms of medicine.
Download or read book The Influence of the Pharmaceutical Industry written by Great Britain: Parliament: House of Commons: Health Committee and published by The Stationery Office. This book was released on 2005-04-26 with total page 556 pages. Available in PDF, EPUB and Kindle. Book excerpt: Incorporating HC 1030-i to iii.
Download or read book Global Pharmaceuticals written by Adriana Petryna and published by Duke University Press. This book was released on 2006-03-15 with total page 314 pages. Available in PDF, EPUB and Kindle. Book excerpt: DIVAnthropological study of the globalization of pharmaceuticals and its effects on local cultures, health, and economics./div
Download or read book Bad Pharma written by Ben Goldacre and published by Macmillan. This book was released on 2014-04 with total page 479 pages. Available in PDF, EPUB and Kindle. Book excerpt: Originally published in 2012, revised edition published in 2013, by Fourth Estate, Great Britain; Published in the United States in 2012, revised edition also, by Faber and Faber, Inc.
Download or read book Sharing Clinical Trial Data written by Institute of Medicine and published by National Academies Press. This book was released on 2015-04-20 with total page 236 pages. Available in PDF, EPUB and Kindle. Book excerpt: Data sharing can accelerate new discoveries by avoiding duplicative trials, stimulating new ideas for research, and enabling the maximal scientific knowledge and benefits to be gained from the efforts of clinical trial participants and investigators. At the same time, sharing clinical trial data presents risks, burdens, and challenges. These include the need to protect the privacy and honor the consent of clinical trial participants; safeguard the legitimate economic interests of sponsors; and guard against invalid secondary analyses, which could undermine trust in clinical trials or otherwise harm public health. Sharing Clinical Trial Data presents activities and strategies for the responsible sharing of clinical trial data. With the goal of increasing scientific knowledge to lead to better therapies for patients, this book identifies guiding principles and makes recommendations to maximize the benefits and minimize risks. This report offers guidance on the types of clinical trial data available at different points in the process, the points in the process at which each type of data should be shared, methods for sharing data, what groups should have access to data, and future knowledge and infrastructure needs. Responsible sharing of clinical trial data will allow other investigators to replicate published findings and carry out additional analyses, strengthen the evidence base for regulatory and clinical decisions, and increase the scientific knowledge gained from investments by the funders of clinical trials. The recommendations of Sharing Clinical Trial Data will be useful both now and well into the future as improved sharing of data leads to a stronger evidence base for treatment. This book will be of interest to stakeholders across the spectrum of research-from funders, to researchers, to journals, to physicians, and ultimately, to patients.
