“This report finds, in part, that an innovation framework in which drug R&D is supported by private patents, without government price intervention, provides the best possible environment for patients to access new treatments. I am revealing to.”
Today, the Global Innovation Policy Center (GIPC) of the U.S. Chamber of Commerce announced Patient access report In many cases, drug pricing controls enacted in the guise of ensuring broad access to low-cost medicines actually reduce access to innovative medicines that are more widely available on the free market. I am profiling the method of The GIPC report comes at a time when the Biden administration took recent action on drug pricing provisions included in the Control Inflation Act passed last August. This could adversely affect patient access in the United States.
Government pursues drug price controls despite surprising industry response to COVID-19
This report provides an update to GIPC’s first Patient Access Report published in 2019. In particular, it focuses on pharmaceutical pricing and access regulation benchmarks, which comprise about a quarter of the first survey in 2019. According to the GIPC, these indicators “are intended to measure the extent to which national biopharmaceutical regulations, including pricing and reimbursement (P&R) policies, restrict access to domestic markets and give priority to local producers.” I am dedicated.”
The cost of new drug development remains high, and only about 1 in 10,000 of the compounds studied become marketable drugs. However, as noted at the beginning of the GIPC report, existing pharmaceutical R&D systems have responded to the COVID-19 pandemic with alarming speed. “These technologies and products are the result of an existing ecosystem of innovations centered around intellectual property rights, offering innovators the opportunity to earn a return on investment and establish avenues for knowledge-related commerce. ,” the report said. Although this report focuses primarily on the impact of drug pricing controls implemented by national governments, it is important to note that the innovation framework, where private patents support drug R&D without government price It has also been shown to provide the best possible environment for accessing therapeutics. .
The latest drug pricing and access control scores for nine high-income Organization for Economic Co-operation and Development (OECD) countries show that the United States significantly outperforms other surveyed OECD countries in terms of patient access to innovative medicines. It shows that you are leading. medicines that save lives. A GIPC report finds that the lack of drug pricing controls in the United States, prior to the passage of the Inflation Reduction Act, underpinned widespread access to treatment. One of the key findings of the report is that drug pricing controls have led to lower overall biopharmaceutical launches, biologics launches, and oncology product launches in countries implementing such controls. will decrease. Additionally, drug regulations that delay government reimbursement tend to lengthen the time it takes for patients to access new treatments, even if they are marketed domestically. Often the delay he may last for a year or more.
Fewer biologics and oncology products launched in countries with strict price controls
Comparing recent drug price benchmarks with the GIPC 2019 score, seven of the nine OECD countries that make up the study show that patient access conditions have remained the same or worsened. understand. Both France and Italy improved their scores, but their scores for pricing and access controls, based on the GIPC indicator, increased by only one point in both countries to 63.94% and 57.69% respectively. Significant drops in scores were seen in Japan, where a new health technology rating system was introduced as part of the national P&R process, and Canada, where regulators introduced new cost-saving reforms to the Patent Pricing Board’s assessment methodology. rice field.
Economic globalization and regulatory harmonization have improved global access to the pharmaceutical supply chain, but data collected by the GIPC from the consultancy IQVIA show that strict drug pricing controls have prevented these controls from being enforced. fewer medicines are being introduced into countries where This conclusion was underscored by the low proportion of new drugs launched in South Korea and Australia, his two high-income OECD countries that have introduced very strict drug pricing regulations. Between 2000 and 2019, only 56% of new actives were launched in South Korea, while only 47% of new actives were launched in Australia during this period.
Similar results were seen when looking at the impact of price controls on the number of new bioactive agents and new oncoactive agents launched in these two countries between 2000 and 2019. , especially in Australia, where the share of new biologics (38%) and new oncology products (41%) is low. By contrast, in the United States, which had not introduced major drug price controls until the Inflation Reduction Act was passed, about 90% of new product launches were made across his three categories tracked in the GIPC report. .
Biden administration actions will be reflected in late 2023 update of GIPC report
Significant delays between product launches and product inclusion in government reimbursement programs are another result of stringent P&R regimes that create patient access issues. Such delays ranged from 133 days in Germany to about 500 days, or almost 1.5 years, in France and Spain. The GIPC report, citing further data from Innovative Medicines Canada, showed that the average time from market approval to reimbursement for new drugs in Canada rose by 632 days, or nearly 1.75 years. increase.
The GIPC report finds that while the United States has been a leader among high-income OECD countries in terms of patient access to innovative medicines, the It concludes that management will adversely affect patient access in this country. To assess the impact of these pricing controls on American patients, GIPC plans to publish another update to its Patient Access Report drug pricing standards by the end of 2023.
In a press release issued with the report, Tom Quaadman, executive vice president of the U.S. Chamber of Commerce, said: Leadership is at stake. Sadly, policies like the Inflation Reduction Act (IRA) pricing mechanism could lead to a decline in breakthrough treatments and the distribution of life-saving drugs to American patients. “
The steps taken by the Biden administration to implement these new drug price controls this spring can well support the GIPC’s claim that tight price controls hinder patient access to treatment. In May, the U.S. Department of Health and Human Services (HHS) announced an important date for implementing a new Medicare bargaining program. This will allow HHS Secretary Xavier Becerra to directly negotiate prices for certain expensive drugs in the Medicare program with pharmaceutical companies. Then, in mid-March, HHS and the Centers for Medicare & Medicaid Services announced that a new inflation rebate program will make additional savings available to Medicare Part B beneficiaries on a set of 27 drugs approved for use in the program. announced that it will be
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