Joel Lexchin
Dados Biográficos
| ID | 349634 |
|---|---|
| NOME | Joel Lexchin |
| PRENOMES | Joel |
| SOBRENOME | Lexchin |
| ASSINATURA | LEXCHIN J |
| AFILIAÇÕES | University of Toronto |
| ORCID | 0000-0001-5120-8029 |
| VERIFICADO | Sim |
| TOTAL DE OBRAS | 29 |
| TOTAL DE CITAÇÕES | 30 |
| TOTAL COMO AUTOR | 29 |
| TOTAL COMO EDITOR | 0 |
| PRIMEIRO ANO DE PUBLICAÇÃO | 1980 |
| ANO MAIS RECENTE DE PUBLICAÇÃO | 2026 |
| ÍNDICE H | 3 |
Addressing the challenge of post-approval regulation of pharmaceuticals
Are gaps in the time of submissions and approvals of new drugs between Health Canada and the Food and Drug Administration related to therapeutic value? A cross-sectional study
Time to completion of conditions required by Health Canada after approving new drugs
BACKGROUND: To ensure that promising drugs for serious illnesses reach Canadians in a timely manner, Health Canada can approve them conditionally provided companies commit to conducting confirmatory studies to verify the benefits. OBJECTIVE: To determine how long it takes until the conditions are fulfilled and if certain factors affect that length of time. METHODS: A list of conditional approvals for new drugs and new indications for existing dru…
Protecting Access to Medicines After Cambodia Graduates From Least Developed Country Status
Cambodia is a least developed country (LDC); however, it may graduate from the LDC status by 2029 Membership in the World Trade Organisation, will require Cambodia to provide patent protection for medicines that meet standard criteria. This qualitative policy analysis examines Cambodia's readiness for LDC graduation in terms of protecting access to medicines and explores how it can prepare to mitigate the impact of graduation on access to medicin…
The potential impact of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership on Thailand’s hepatitis C treatment program
BACKGROUND: Thailand has expressed interest in joining the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a twelve-country plurilateral trade agreement whose original incarnation included the United States of America (USA). When the USA withdrew from this agreement, key intellectual property clauses relevant to pharmaceuticals were suspended. These could be reinstated should the CPTPP Parties decide to do so. METHO…
Improving access to medicines and beyond
Since 2019, the Chinese central government has taken significant steps to centralize national purchasing power and has implemented a pooled procurement system. In this paper, we provide an in-depth analysis of China's National Volume-Based Procurement (NVBP) policy, which represents a unique approach to pooled procurement within the pharmaceutical sector. The primary objectives of the NVBP are to reduce drug prices, enhance access to affordable m…
Therapeutic value of new medicines not submitted to Health Canada 2014-2021
Medicine donations
Reforms to the patented medicine prices review board and the introduction of new drugs in Canada
"Pharmaceuticals as a market for "lemons
Variation in the prescription drugs covered by health systems across high-income countries
BACKGROUND: Because not all medicines are equally safe, effective, and affordable, health systems often use formularies to define explicitly which medicines will be included and excluded from coverage. OBJECTIVE: We sought to synthesize methods and findings from published studies of formulary variation across health systems in high-income countries. METHODS: We conducted a systematic review of peer-reviewed research papers published from 2000 to …
Analyzing the impact of trade and investment agreements on pharmaceutical policy
BACKGROUND: Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which …
Transnational pharmacogovernance
BACKGROUND: As a transnational policy network, the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aligns international regulatory standards to address the pressures of globalization on the pharmaceutical industry and increase access to new medicines. Founding ICH members include regulators and pharmaceutical industry trade associations in the European Union, the United Sta…
The Pharmaceutical Industry in Contemporary Capitalism
The pharmaceutical industry has been enormously profitable for many decades. The myth is that these windfalls are warranted by the therapeutic advances made by pharmaceutical companies—but the reality is far different.Click here to purchase a PDF version of this article at the Monthly Review website
The Trans Pacific Partnership Agreement, intellectual property and medicines
The final text of the Trans Pacific Partnership Agreement (TPP), agreed between the 12 negotiating countries in 2016, included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines. It drew wide criticism for including such provisions in an agreement that involved developing countries (Vietnam, Peru, Malaysia, Mexico, Chile and Brunei Darussalam) because of the effect on delayi…
Ceta and pharmaceuticals
On a per capita basis, Canadian drug costs are already the second highest in the world after the United States and are among the fastest rising in the Organization for Economic Co-Operation and Development. The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada will further exacerbate the rise in costs by: Committing Canada to creating a new system of patent term restoration thereby delaying entry of gene…
Canada and access to medicines in developing countries
Canadian reports have recommended that health as a human right must be Canada's overarching global commitment and that the primacy of human rights should be prioritized over other elements of international law including international trade and investment law as it applies to access to pharmaceuticals. This paper uses a series of case reports to examine Canada's commitment to this goal. Specifically it examines cases where improved access has been…
Models for financing the regulation of pharmaceutical promotion
Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models consi…
One step forward, one step sideways? Expanding research capacity for neglected diseases
BACKGROUND: There is general agreement, including from the pharmaceutical industry, that current market based methods of generating research into the development of pharmaceutical products that are relevant for developing countries do not work. This conclusion is relevant not just for the most neglected diseases such as leishmaniasis but even for global diseases such as cancer and cardiovascular disease. DISCUSSION: Stimulating research will mean…
Prohibiting or ‘managing’ conflict of interest? A review of policies and procedures in three European drug regulation agencies
Pharmaceutical innovation
Réglementation pharmaceutique au Canada et prescription inadéquate de médicaments
Le processus d'approbation des médicaments joue un rôle déterminant dans la façon dont les médicaments sont prescrits au Canada. Cet article examine la nature de la réglementation du processus d'approbation, les décisions qui en découlent, la manière dont ces dernières s'expriment dans la publicité pharmaceutique, et l'impact ultime de ces facteurs sur la prescription des psychotropes en général, et plus particulièrement, des benzodiazépines. Un …
Qualitative research and the politics of knowledge in an age of evidence
Regulating Drugs for Effectiveness and Safety
Zito, Julie M. PhD*; Socolar, Sidney J. PhD†; Eilers, Robert MD‡; Crystal, Stephen PhD§; Lexchin, Joel MD¶ Author Information
Pharmaceutical industry sponsorship and research outcome and quality
Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Methods Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and i…
Qualitative research and the politics of knowledge in an age of evidence
Drug makers and drug regulators
Everyday experiences of implicit rationing
Managed Care in the U.S. is one of the more controversial strategies to implicitly ration health care. It has also been creeping into Canada where care is similarly being managed albeit in a different socio-political environment. Based on nine group interviews with 35 RNs in California and 10 group interviews with 39 RNs in British Columbia, we find that the price to be paid for the promise of cheaper, more efficient health care through manageria…
"Pharmaceuticals as a market for "lemons
The Trans Pacific Partnership Agreement, intellectual property and medicines
The final text of the Trans Pacific Partnership Agreement (TPP), agreed between the 12 negotiating countries in 2016, included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines. It drew wide criticism for including such provisions in an agreement that involved developing countries (Vietnam, Peru, Malaysia, Mexico, Chile and Brunei Darussalam) because of the effect on delayi…
The Miracle of the Empty Beds
The Pharmaceutical Industry in Contemporary Capitalism
The pharmaceutical industry has been enormously profitable for many decades. The myth is that these windfalls are warranted by the therapeutic advances made by pharmaceutical companies—but the reality is far different.Click here to purchase a PDF version of this article at the Monthly Review website
The Miracle of the Empty Beds
Drug makers and drug regulators
Everyday experiences of implicit rationing
Managed Care in the U.S. is one of the more controversial strategies to implicitly ration health care. It has also been creeping into Canada where care is similarly being managed albeit in a different socio-political environment. Based on nine group interviews with 35 RNs in California and 10 group interviews with 39 RNs in British Columbia, we find that the price to be paid for the promise of cheaper, more efficient health care through manageria…
Pharmaceutical industry sponsorship and research outcome and quality
Objective To investigate whether funding of drug studies by the pharmaceutical industry is associated with outcomes that are favourable to the funder and whether the methods of trials funded by pharmaceutical companies differ from the methods in trials with other sources of support. Methods Medline (January 1966 to December 2002) and Embase (January 1980 to December 2002) searches were supplemented with material identified in the references and i…
Safeguarding the Quality of Clinical Research
A Canadian physician reports there is systematic bias to the outcome of published research funded by the pharmaceutical industry and believes more steps need to be taken to improve the integrity of clinical research reports in the United States and Canada. Virtual Mentor is a monthly bioethics journal published by the American Medical Association
Regulating Drugs for Effectiveness and Safety
Zito, Julie M. PhD*; Socolar, Sidney J. PhD†; Eilers, Robert MD‡; Crystal, Stephen PhD§; Lexchin, Joel MD¶ Author Information
Réglementation pharmaceutique au Canada et prescription inadéquate de médicaments
Le processus d'approbation des médicaments joue un rôle déterminant dans la façon dont les médicaments sont prescrits au Canada. Cet article examine la nature de la réglementation du processus d'approbation, les décisions qui en découlent, la manière dont ces dernières s'expriment dans la publicité pharmaceutique, et l'impact ultime de ces facteurs sur la prescription des psychotropes en général, et plus particulièrement, des benzodiazépines. Un …
Qualitative research and the politics of knowledge in an age of evidence
One step forward, one step sideways? Expanding research capacity for neglected diseases
BACKGROUND: There is general agreement, including from the pharmaceutical industry, that current market based methods of generating research into the development of pharmaceutical products that are relevant for developing countries do not work. This conclusion is relevant not just for the most neglected diseases such as leishmaniasis but even for global diseases such as cancer and cardiovascular disease. DISCUSSION: Stimulating research will mean…
Prohibiting or ‘managing’ conflict of interest? A review of policies and procedures in three European drug regulation agencies
Pharmaceutical innovation
Models for financing the regulation of pharmaceutical promotion
Pharmaceutical companies spend huge sums promoting their products whereas regulation of promotional activities is typically underfinanced. Any option for financing the monitoring and regulation of promotion should adhere to three basic principles: stability, predictability and lack of (perverse) ties between the level of financing and performance. This paper explores the strengths and weaknesses of six different models. All these six models consi…
Canada and access to medicines in developing countries
Canadian reports have recommended that health as a human right must be Canada's overarching global commitment and that the primacy of human rights should be prioritized over other elements of international law including international trade and investment law as it applies to access to pharmaceuticals. This paper uses a series of case reports to examine Canada's commitment to this goal. Specifically it examines cases where improved access has been…
Ceta and pharmaceuticals
On a per capita basis, Canadian drug costs are already the second highest in the world after the United States and are among the fastest rising in the Organization for Economic Co-Operation and Development. The Comprehensive Economic and Trade Agreement (CETA) between the European Union (EU) and Canada will further exacerbate the rise in costs by: Committing Canada to creating a new system of patent term restoration thereby delaying entry of gene…
The Trans Pacific Partnership Agreement, intellectual property and medicines
The final text of the Trans Pacific Partnership Agreement (TPP), agreed between the 12 negotiating countries in 2016, included a suite of intellectual property provisions intended to expand and extend pharmaceutical company exclusivities on medicines. It drew wide criticism for including such provisions in an agreement that involved developing countries (Vietnam, Peru, Malaysia, Mexico, Chile and Brunei Darussalam) because of the effect on delayi…
Transnational pharmacogovernance
BACKGROUND: As a transnational policy network, the International Council for Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) aligns international regulatory standards to address the pressures of globalization on the pharmaceutical industry and increase access to new medicines. Founding ICH members include regulators and pharmaceutical industry trade associations in the European Union, the United Sta…
The Pharmaceutical Industry in Contemporary Capitalism
The pharmaceutical industry has been enormously profitable for many decades. The myth is that these windfalls are warranted by the therapeutic advances made by pharmaceutical companies—but the reality is far different.Click here to purchase a PDF version of this article at the Monthly Review website
Analyzing the impact of trade and investment agreements on pharmaceutical policy
BACKGROUND: Trade and investment agreements negotiated after the World Trade Organization's Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) have included increasingly elevated protection of intellectual property rights along with an expanding array of rules impacting many aspects of pharmaceutical policy. Despite the large body of literature on intellectual property and access to affordable medicines, the ways in which …
Variation in the prescription drugs covered by health systems across high-income countries
BACKGROUND: Because not all medicines are equally safe, effective, and affordable, health systems often use formularies to define explicitly which medicines will be included and excluded from coverage. OBJECTIVE: We sought to synthesize methods and findings from published studies of formulary variation across health systems in high-income countries. METHODS: We conducted a systematic review of peer-reviewed research papers published from 2000 to …
"Pharmaceuticals as a market for "lemons
Reforms to the patented medicine prices review board and the introduction of new drugs in Canada
Improving access to medicines and beyond
Since 2019, the Chinese central government has taken significant steps to centralize national purchasing power and has implemented a pooled procurement system. In this paper, we provide an in-depth analysis of China's National Volume-Based Procurement (NVBP) policy, which represents a unique approach to pooled procurement within the pharmaceutical sector. The primary objectives of the NVBP are to reduce drug prices, enhance access to affordable m…
Therapeutic value of new medicines not submitted to Health Canada 2014-2021
Medicine donations
The potential impact of the Comprehensive and Progressive Agreement for Trans-Pacific Partnership on Thailand’s hepatitis C treatment program
BACKGROUND: Thailand has expressed interest in joining the Comprehensive and Progressive Agreement for Trans-Pacific Partnership (CPTPP), a twelve-country plurilateral trade agreement whose original incarnation included the United States of America (USA). When the USA withdrew from this agreement, key intellectual property clauses relevant to pharmaceuticals were suspended. These could be reinstated should the CPTPP Parties decide to do so. METHO…
Pharmaceutical Economics and Policy (19 obras) · Medicine (18 obras) · Business (17 obras) · Political science (17 obras) · Health Systems, Economic Evaluations, Quality of Life (13 obras) · Economics (11 obras) · Law (11 obras) · Economic growth (9 obras) · Pharmaceutical industry and healthcare (8 obras) · International trade (7 obras)