The Pharmaceutical Research and Manufacturers of America (PhRMA) recently published a new report that analyzes the share of new medicines available in more than 70 countries and how long patients typically wait to receive them. The Global Access to New Medicines Report includes comparisons across countries in the G20, Organization for Economic Cooperation and Development (OECD) and several other geographic regions.
In the report, PhRMA defined a new medicine as “all new active substances approved by the United States Food and Drug Administration, European Medicines Agency and/or Japan Pharmaceuticals and Medical Devices Agency and first launched in any country between January 1, 2012, and December 31, 2021.” Additionally, a record number of new medicines launched in 2021, with 67 new medicines launched that year.
The report found that while a record number of new prescriptions are launched on a global scale, patients can only access a small percentage. For example, patients in OECD countries can access only 29% of new medicines through a government health plan, compared to the 85% of patients who can access them in the United States. Additionally, the report notes that patients in OECD countries wait an average of 41 months longer than patients in the United States for their government health plan to cover new medicines.
PhRMA found that the delay in patient access across OECD countries happens after a new medicine has been deemed safe and effective by the local regulatory authorities and oftentimes after the product has been shipped by the manufacturer. They provide the example of in Canada, 45% of new medicines were approved and launched by manufacturers 17 months after the global first launch, but many patients waited almost three years for those medicines to be covered by their local government plan.
Additionally, looking at access to new medicines in G20 countries, the availability of new medicines varied significantly across the countries, with 85% of patients in the United States having access compared to 61% in Germany, 59% in the United Kingdom and only 9% in Indonesia. The G20 average was 36%. On average, G20 countries have 16% of new medicines available within one year of the global first launch. Again, the United States leads the pack at 78%, followed again by Germany and the United Kingdom (44% and 38% respectively).
Turning to countries in the Americas, on average, 26% of new medicines are available. The United States again leads the pack with 85%, followed by Canada at 45% and Brazil at 37%. When it comes to new medicines available within one year of global first launch, the United States is in the lead with 78%, followed by Canada at 21% and Mexico with 7%. The regional average is 10%.
In the Asia-Pacific markets, on average 20% of new medicines are available, with Japan in the lead at 51% followed by Taiwan and Australia, 38% and 34%, respectively. On average, Asia-Pacific markets have 5% of new medicines available within one year of first global launch.
PhRMA noted that the report “shines a light on the impact of policies that let governments act as gatekeepers between patients and new treatments.” PhRMA referred to the United States as the “world’s engine of biopharmaceutical innovation,” noting that it had the most global first launches, the highest share of new medicines available, and the fastest access rates for patients. However, PhRMA is concerned about provisions in the Inflation Reduction Act that may threaten to reduce the number of new medicines developed, particularly provisions that impose government price setting.
PhRMA concluded that strong intellectual property rights and enforcement, science-based and globally-harmonized regulatory review, transparent pricing and reimbursement policies that value innovation, as well as open and nondiscriminatory trade can help ensure timely patient access to new medicines.