Explore the vast range of titles available.

\"The widespread condemnation of drastic price increases on life-saving drugs highlights our growing dependency on and vulnerability to international pharmaceutical conglomerates. However, aren't the interests of the public supposed to supersede the pursuit of private profit? In his new work, Private Profits versus Public Policy, Joel Lexchin addresses this question as he examines how public policy with respect to the pharmaceutical industry has evolved in Canada over the past half century. Although the Canadian government is supposed to regulate the industry to serve the needs of public health, waves of deregulatory reforms and intellectual property rights legislation have shifted the balance of power in favour of these companies' quest for profit. Joel Lexchin offers a series of recommendations to tip the scale back in the public's favour. This enlightening work is the first book that deals exclusively with the pharmaceutical industry in Canada in over thirty years.\"-- Provided by publisher.

The independent French drug bulletin Prescrire International rates the therapeutic innovation of new drug-indications approved for marketing in France using an ordinal scale with the lowest rating being \"not acceptable\". This study investigates whether these drugs were approved by Health Canada. A list of \"not acceptable\" drug-indications was generated by handsearching all issues of Prescrire International between January 2013 and December 2022. The generic names, indications and reasons why Prescrire labeled them not acceptable were recorded. The approval date was determined by consulting the website of the European Medicines Agency (EMA). The status of these drug-indications in Canada was determined by searching multiple Health Canada websites. Therapeutic Evaluations for new drug-indications done by the Patented Medicine Prices Review Board (PMPRB) were recorded. Prescrire rated 57 new drug-indications and 42 new indications for existing drugs as not acceptable. Seventy of these drug-indications were available in Canada- 42 new drug-indications and 28 new indications for existing drugs. Twenty (90.9%) of the 22 new drugs evaluated by the PMPRB were rated as slight/no therapeutic improvement and 2 as moderate therapeutic improvement. The median difference, in days, between approval times by the EMA/ANSM and Health Canada was 129 (interquartile range -102, 341) in favour of the former. The majority of the not acceptable drug-indications were approved by Health Canada. The difference between when Prescrire and Health Canada examined the evidence for these drug-indications is unlikely to explain the difference in their evaluations. A change in regulatory standards at Health Canada may be one factor behind the presence of these drugs. To what degree those drugs led to more harms than benefits for patients who are taking them needs to be urgently investigated. Finally, the reasoning behind Health Canada's approval of these drugs should be interrogated.

Health Canada posts the outcomes of all New Drug Submissions. In some cases, companies have withdrawn submissions or submissions have been rejected by Health Canada for new active substances (NAS). This study explores the reasons for those decisions and compares them with decisions made by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA). This is a cross-sectional analysis. Submissions for NAS between December 2015 and December 2022 were identified along with the original indications for the NAS, the information that Health Canada had available and the reasons for its decisions. Similar information was sourced from the FDA and the EMA. Their decisions were compared to those made by Health Canada. The time between decisions by Health Canada, the FDA and the EMA were calculated in months. Health Canada considered 272 NAS and approved 257. Sponsors withdrew 14 submissions for 13 NAS and Health Canada rejected submissions for 2 NAS. The FDA approved 7 of these NAS and the EMA approved 6, rejected 2 and submissions were withdrawn by 2 companies. Health Canada and the FDA considered similar information in 4 of 7 cases. Indications were the same except in one case. The FDA made decisions a mean of 15.5 months (interquartile range 11.4, 68.2) before companies withdrew their submissions from Health Canada. There were 5 cases where Health Canada and the EMA considered the same information and in 2 of those the outcome was different. Health Canada and EMA decisions were generally made within 1-2 months of each other. Indications were the same in all cases. Differences in decision making by regulators are due to more than the data which with they are presented, the timing of the presentations and the indications for the drugs. Regulatory culture may have influenced decision making.

Health Canada conditionally approves new drugs using its Notice of Compliance with conditions (NOC/c) policy. Under this policy Qualifying Notices (QNs) list confirmatory studies that need to be conducted to confirm the drug's efficacy. This study examines the depth of information about methodology and patient demographics in the confirmatory studies. It also compares the outcomes (surrogate or clinical) used to approve the drugs with the outcomes proposed in the confirmatory studies. A list of drugs approved under the NOC/c policy and their QNs were sourced from two previous publications as well as Health Canada's NOC/c website. Patient demographics and study methodology in the confirmatory studies listed in the QNs was recorded and counted. The primary outcome used to approve new drugs was recorded from Health Canada's Summary Basis of Decision website and compared to the type of outcome for studies mentioned in the QNs. Seventy-eight drugs were approved using a NOC/c from the time the first drug was approved under the program in July 1998 until May 18, 2022. QNs were missing or all information was redacted for 3 drugs, the remaining 75 QNs listed 154 studies (median of 2 studies per QN, interquartile range 1,3). The outcome, randomization and blinding could not be determined for any study in 43 (57.3%), 36 (48.0%) and 42 (56.0%) QNs, respectively. No study gave the distribution of men and women and the number of patients was given in 23 (14.9%) studies. The expected time of completion of the studies was available for 36 (23.4%) out of 154 and information to identify studies was present for 77 (50.0%), absent for 23 (14.9%) and unclear for 26 (16.9%). Surrogate outcomes were used to approve 54 (84.4%) of 64 drugs. Eight (14.8%) confirmatory studies for these 54 drugs used clinical outcomes, 15 (27.8%) used surrogate outcomes and outcomes were unknown for 31 (57.4%). Specifically for oncology drugs, 44 were approved with surrogate outcomes and one with a clinical outcome. Eight (18.2%) of the 44 oncology drugs approved with surrogate outcomes had confirmatory studies that used clinical outcomes, 14 (31.8%) used surrogate outcomes and the outcome could not be determined for 22 (50.0%). The sole oncology drug approved with a clinical outcome had a confirmatory study with a surrogate outcome. QNs contain little information about the methodology or patient demographics of confirmatory studies. Confirmatory studies with surrogate outcomes were used almost one-third of the time to validate efficacy in drugs initially approved using surrogate outcomes. Health Canada needs to develop a template about what information regarding confirmatory studies should be contained in a QN and rethink its use of confirmatory studies using surrogate outcomes. All the data were gathered by a single individual possibly introducing unintended biases.

Patient groups represent the interest of their members when it comes to drug funding. Many patient groups receive grants from pharmaceutical companies that make products being considered for funding. This research examines whether there is an association between the positions that Canadian groups take about the products and conflicts of interest with the companies. The Common Drug Review (CDR) and panCanadian Oncology Drug Review (pCODR) make recommendations to Canadian provincial and federal drug plans about funding particular drug-indications. Both utilize input from patient groups in making their recommendations. Patient group submissions are available from both organizations and these submissions contain statements about conflicts of interest. Views of the patient groups, with and without a conflict with the company making the drug under consideration and without any conflicts at all, were assessed and then compared with the recommendations from CDR and pCODR. There was a total of 222 reports for drug-indications. There were 372 submissions from 93 different patient groups. Groups declared a total of 1896 conflicts with drug companies in 324 (87.1%) individual submissions. There were 268 submissions where groups declared a conflict with the company making the product or said they had no conflict. Irrespective of whether there was a conflict, the views of patient groups about the drug-indications under consideration were the same. There was no statistically significant difference between views of patient groups and the recommendations from CDR and/or pCODR. The large majority of patient groups making submissions about funding of particular drug-indications had conflicts with the companies making the products and their views about the products were almost always positive. This association between funding and views needs to be further investigated to determine if a true cause and effect exists.

Objectives This study looks at the number of cancellations by companies and refusals by Health Canada of new drug applications from 1 June 2019 to 1 July 2025 and the amount of information given for the decisions taken. Design Cross-sectional. Setting Canada. Participants New drug applications. Main outcome measures Number of applications cancelled or refused and reasons for decisions. Results There were 270 regulatory decisions of which 33 (12.2%) were either cancelled by the company (30) or refused by Health Canada (3). In 10 of the 30 cases where the submission was cancelled, there was no information about the reason for the company's decision. In the remaining 20 cases, the website just said that a decision had been made by the company. Two of the three refusals by Health Canada were because of concerns about safety and efficacy and quality-related issues. The third refusal was due to deficiencies and/or significant omissions in the clinical and non-clinical information. In the 30 submissions cancelled by the company, there was no information about what Health Canada thought in 6 cases. In 16 cases, Health Canada had not completed its evaluation, and in the remaining 8, the evaluation was completed. Conclusion Over 12% of new drug submissions to Health Canada are either cancelled or refused. Health Canada does not always fully communicate the information that it has regarding the reasons for these decisions and needs to be much more transparent about its decision-making.

This study examined multiple aspects about the approval of new drugs: the characteristics of the drugs, the quality and quantity of information that Health Canada discloses about the demographics of patients enrolled in clinical trials, the characteristics of the trial, and the type of review that it uses. It examines whether there have been changes in these measures between 1 September 2012 and 31 March 2022. A list of all new drugs approved, type of review used, and drug characteristics was generated from Health Canada annual reports. Therapeutic categories were identified from the World Health Organization Collaborating Center for Drugs Statistics Methodology. The Summary Basis of Decision documents of Health Canada were used to identify patient demographics in clinical trials and clinical trial characteristics. Health Canada approved 326 new drugs for 407 indications. The percent of orphan drugs approved increased from 35.6 to 51.3%. The number of indications per drug decreased (  = 0.0817) as did the number of pivotal trials per drug (  = 0.0091). The percent of Phase 3 trials dropped from 76.3% in 2012-2015 to 64.8% in 2019-2022 (  = 0.005). There was also a statistically significant decrease in the percent of trials that were randomized, controlled, and blinded. The clinical trial characteristics of orphan drugs and the type of review used were both significantly different compared with non-orphan drugs. The percent of trials which had information about the number of patients enrolled, the percent of trials that provided the age of the patients, and the sex breakdown all significantly increased. The results show that there has been a change in regulatory standards that may be due to them becoming less rigorous, because of an adaptation to the number of orphan drugs being submitted or a combination of both reasons. At the same time, there has been some improvement in the transparency of data. Health Canada has recently embarked on a series of reforms in drug regulation and clinical trial management. These changes need to be closely evaluated to be sure that they enhance the efficacy and safety of new drugs.

The number of drugs for orphan indications has been increasing significantly in Canada and the federal government recently announced an investment of $1.5 billion dollars over 3 years primarily directed at helping to fund the cost of these drugs. There are claims and counterclaims about what percent of Food and Drug Administration (FDA) orphan drugs are available in Canada and how delayed these drugs are in being approved by Health Canada. This study uses FDA and Health Canada databases and data from three health technology assessment agencies and one drug bulletin to provide objective data about the percent of FDA approved drugs that were also approved by Health Canada, any delays in Canadian approval and the additional therapeutic value of new orphan drugs. Decisions about what drugs should be publicly covered and how long it took to make those decisions were not investigated. From 1999 to 2022, the FDA approved 326 new drugs for an orphan indication and Health Canada approved 231 (70.9%) for the same indication. The median time between FDA and Health Canada approval was 346 days (interquartile range [IQR] 181, 785). The percent rated as major improvements declined from 50% of the total in 2004-2008 to 13.6% in 2019-2022. These findings need to be taken into account as Canada develops an orphan drug policy and decides on criteria for funding this group of drugs. Specifically, when high quality evidence about the additional therapeutic value of orphan drugs is not available at the time of approval, risk sharing funding agreements with manufacturers should be put in place. Manufacturers should understand that if the results of post-market trials do not provide convincing evidence of value, funding will be withdrawn. Finally, the quality of any research plan should be used to prioritize candidates for federal funding.

The pharmaceutical industry has a long history of prioritizing the research and sale of medicines that will yield the largest amount of revenue and placing the health of people second. This gap is especially prevalent in countries of the Global South. This article first explores the dichotomy in research between the Global North and the Global South and then looks at examples of how access to key medicines used in diseases such as HIV, oncology and hepatitis C is limited in the latter group of countries. The role of pharmaceutical companies during the COVID-19 pandemic prompted negotiations for a pandemic accord that would ensure more equity in both research and access when the next pandemic comes. However, efforts by a combination of the pharmaceutical industry and some high-income countries (HICs) are creating serious obstacles to achieving the goal of an accord that would place health over profits.

ObjectivesThis study examines the length of time between when a patent application is filed in Canada for a new drug and when it is available for patients (time to market) and various components of that time. It also looks at whether various factors explain the time between patent application to New Drug Submission (NDS) and compares Canadian and American times. Drugs approved between 1 January 2014 and 31 December 2018 are examined.DesignDescriptive study.Data sourcesWebsites from Health Canada, Food and Drug Administration, Merck Index, United States Patent and Trademark Office, WHO and previously published articles.InterventionsNone.Primary and secondary outcomesThe primary outcomes are time to market, time from patent application to NDS (pre-NDS time), review time, time from approval to availability (postapproval time) and factors that may influence the pre-NDS time. The secondary outcome is a comparison of Canadian and American review times and times between patent application and approval.ResultsThere were 113 drugs available for analysis. The median time to market was 11.80 years (IQR 9.40–14.05). The component median times were pre-NDS 10 years (IQR 8.05–12.80), review time 0.96 years (IQR 0.75–1.15) and postapproval time 0.15 years (IQR 0.08–0.28). Less than 8% of the pre-NDS time was explained by the factors that were analysed in a multiple linear regression equation. There was no statistically significant difference between Canadian and American pre-NDS times.ConclusionOnce a drug reaches the market, companies have a median of 8.2 years before the patent expires and generics can reach the market. Most of the time between the filing of a patent application and when a drug is marketed is determined by decisions that are largely under the control of the company.