A study conducted by Yale shows that new drugs and vaccines approved for use in the United States are often unavailable in countries where their clinical trials were conducted, suggesting the benefits of drug discovery among the Population groups participating in tests are not fairly distributed.
The study, published May 5 in JAMA network openincludes 34 novel drugs sponsored by major pharmaceutical companies and approved by the U.S. Food and Drug Administration (FDA) between 2012 and 2014. The approvals were based on a total of 898 studies in the US and 70 other countries worldwide.
When analyzing the 563 studies for which location data were available, the researchers found that five years after approval in the United States, only 15% of drugs (five out of 34) were approved in each country where studies were conducted. Of the 70 countries that contributed research participants, 7% (five countries) gained market access to the drugs they tested within one year of FDA approval and 31% (22 countries) within five years. Approvals were faster in high-income countries like Germany and Canada, while access was lowest in Africa, where none of the drugs were available anywhere, except in South Africa, which only had access to 24% of drugs after five years.
“We have discovered significant gaps in access to new medicines that raise concerns about the equitable distribution of research benefits,” said Jennifer Miller, assistant professor at Yale School of Medicine, founder of Bioethics International – a nonprofit advocate for patient-centered medical innovation – and the lead author of the study. “Ensuring market access to medicines for the countries involved in their development can help realize a fundamental principle of research ethics: the benefits and burdens of research should be fairly shared among those affected.”
Most of the clinical research for drugs and vaccines for which FDA approval is pending is conducted outside of the United States and increasingly in lower-income countries. While FDA approval is required for drugs to be available in the United States, it does not guarantee market access in other countries. Research sponsors such as pharmaceutical companies must submit marketing authorization applications to make the drugs and vaccines available in countries where studies have been conducted. While access to marketing does not guarantee that a patient can afford a drug or vaccine, or that there is an adequate supply of a pharmaceutical product, it is an important requirement for access to new drugs, the researchers explained.
“We found that the FDA-cleared typical drug has been tested in 25 different countries,” said Dr. Cary Gross, professor of medicine at the Yale School of Medicine and co-author of the paper. “If the citizens of these countries never get access to the new drug, one must ask why they are even participating in the research. Just to see if it’s safe in the US and other rich countries? “
“Drug discovery across international borders gives US patients access to new drugs and vaccines and could theoretically maximize benefits for all: The US contributes capital that other countries lack, while these countries provide volunteers and labor to help them graduate clinical trials are needed quickly, ”said Peter Bach, director of the Center for Health and Policy Outcomes at Memorial Sloan Kettering Cancer Center and co-author of the study. “For these partnerships to be truly fair, host countries must benefit from the research by giving them quick access to the new drugs once they have been approved by the FDA.”
To make the process fairer, the researchers suggest that host country governments require, as a condition of conducting clinical trials, that pharmaceutical companies commit to filing an application for marketing authorization within a set period of time after FDA approval. They encourage companies to think about guidelines not to test drugs in countries where they do not want to sell the product being tested. The researchers also call for transparent tracking, review and reporting of product registrations in countries where studies are being conducted to expand access to new drugs and vaccines around the world.
Edited by Gary Cramer