Pharmacy Daily | Distributive justice failing

A NEW study has found that medicines tested internationally for approval by the US Food and Drug Administration (FDA) are not available in many of the countries where the testing was conducted, raising ethical concerns about exploitation and who benefits from drug testing.

The team from Yale School of Medicine analysed 172 FDA-approved medicines tested between 2015 and 2018 in nearly 90 countries.

They found that five years after testing, only 24% of the medicines had received market authorisation, or approval for distribution and patient access in the countries where the clinical trials took place.

High-income countries had greater physical access to the medicines than upper-middle- and lower-middle-income countries.

"This gap raises concerns," said study lead Dr Jennifer Miller.

"According to ethical guidance, if you enrol a population in clinical research, they must stand to benefit from it."

This principle, known as distributive justice, is reflected in major internationally recognised ethical frameworks for medical testing on humans.

But according to Dr Miller, these guidelines are vague.

"There's enough ambiguity that, if someone wanted to get around it, they could," she said.

Study co-author Professor Cary Gross explained that people enrol in clinical trials for many reasons, including the opportunity to "contribute to scientific progress".

"But there is also a frequently-unstated part of this 'bargain': that if the new treatment works, then presumably people in your community - or country - will be able to access it," he said.

The study's findings confirm that many countries still host trials without ever gaining timely access to the medicines they help test.

The team identified countries that were able to secure access to the medicines they helped test, including Ethiopia and Uganda, and they are engaging with health ministers and clinical trial leaders from those countries to share lessons with peer nations.

Dr Miller said that addressing the "test it (but) don't sell it" issue will require collective effort involving pharma companies, the media, NGOs and patient groups.

Read the study HERE. KB