In the wake of a global pandemic, the world is looking ahead towards new measures in providing medicine to the masses. Distribution plays an important role as much as the procurement of these said medicines. A recent study has shown that the distribution of medicines derived from global drug research has been favoring wealthy countries compared to the rest of the world.
U.S. pharmaceutical drug and vaccine trials are often conducted internationally. However, a new study has recently revealed that there are substantial gaps between where these U.S.-approved products are tested and where they become available to patients.
After undergoing clinical trials abroad, new medicines and vaccines approved for use in the United States are often unavailable in the countries where the clinical trials were hosted. This gap has been seen as a massive flaw in the system, as distribution should be just as important as the trial phase of a certain medicine.
A recent study led by Yale University and published on Wednesday in the Journal of the American Medical Association found that there are some drug research methods in the United States that are misaligned with a “bedrock” principle of research ethics: that the benefits and burdens of research should be shared equitably by the people affected by it.
In the study, five years after the drugs had been approved in the United States., only 15% were approved in all the countries where clinical trials had been hosted. Researchers surveyed 34 U.S. pharmaceutical company-sponsored drugs approved by the United States Food and Drug Administration in 2012 and 2014. Almost 900 trials were performed in 70 countries in medical areas concerning infectious diseases, neurology, and many more. Of the 70 countries that were tested, 7% received market access to the drugs tested within their borders within one year of FDA approval, while 31% gained access within five years.
A much more damning statistic proved that among all the countries that participated in the drug and vaccine trials, high-income countries such as Canada and European nations gained approval faster and at higher rates, while lower-income countries took longer to gain access if they did so at all. Countries that were considered as part of the low-income brackets like Kenya and South Africa had the lowest access of any region, followed by nations in the Middle East.
International research participation allows U.S. patients to benefit from new medications, according to the report, but “not often mentioned is that clinical research supporting U.S. medicine and vaccine approvals has been globalized and is largely conducted in other countries, increasingly lower-income countries.
The report states that these clinical trials that are being conducted yield a positive benefit to both the U.S. and other international countries involved. The report, however, states that for the prior statement to be true, the other countries would also need to have access to the investigational products ultimately approved for marketing.
The findings come as low- and middle-income countries are pushing wealthy countries to temporarily suspend patent protections for COVID-19 vaccines, making them more easily accessible internationally. In the U.S., the Biden administration on Wednesday announced its public support for the waiver idea, along with French President Emmanuel Macron, while other world leaders praised the move.