Drug Registration: A Necessary but Not Sufficient Condition for Good Quality Drugs
A Preliminary Analysis of Twelve Countries

There is a tacit assumption amongst healthcare workers that all drugs of the same therapeutic type, whether innovator brands, generic brands, or a variety of copies of the product, are interchangeable. While there may be concern that some countries' products are more likely to be counterfeited, if one assumes the product is genuine, then the assumption holds that the product will work.

But anecdotal reports suggest that, even when counterfeits and otherwise obviously degraded or grossly substandard products are identified and removed from any sample set, quality problems remain for some products. Given that western countries source so many drug ingredients from abroad, for instance, up to 80% of the active ingredients in U.S. drugs are now made overseas, news reports of nefarious activity have made westerners wary of drugs produced in emerging economies. A recent Pew Trusts poll indicated that 54% and 70% of Americans distrusted drugs sourced respectively in India and China. But it is not acceptable in international trade law to boycott products based on suspicion alone, nor is it prudent since many drugs made in emerging economies are demonstrably fine and are certainly cheaper than innovator brands.

This working paper is the first part of a project looking at various characteristics, including product variability, of essential drugs in developing and mid-income countries. The publication that will follow this paper will assess actual drug variability; this working paper addresses what is probably a significant driver of drug quality--the legislative environment, and in particular, the registration process in which medicines are made and, more critically, sold. . . .

Read this full paper as an Adobe Acrobat PDF.

Roger Bate is the Legatum Fellow in Global Prosperity at AEI. Emily Putze is a research assistant at AEI. Alexandra McPherson is at the Boston University School of Public Health. Sarah Naoshy is at the Boston University School of Public Health. Lorraine Mooney is a researcher, editor, economist and medical demographer at Africa Fighting Malaria.

Also Visit
AEIdeas Blog The American Magazine
About the Author

 

Roger
Bate

What's new on AEI

Making Ryan's tax plan smarter
image The teacher evaluation confronts the future
image How to reform the US immigration system
image Inversion hysteria
AEI on Facebook
Events Calendar
  • 01
    MON
  • 02
    TUE
  • 03
    WED
  • 04
    THU
  • 05
    FRI
Wednesday, September 03, 2014 | 9:00 a.m. – 10:30 a.m.
From anarchy to Augustus: Lessons on dealing with disorder, from Rome’s first emperor

We invite you to join us for two panel discussions on how Augustus created order from chaos 2,000 years ago, and what makes for durable domestic and international political systems in the 21st century.

Wednesday, September 03, 2014 | 12:00 p.m. – 1:30 p.m.
Multiple choice: Expanding opportunity through innovation in K–12 education

Please join us for a book launch event and panel discussion about how a marketplace of education options can help today's students succeed in tomorrow's economy. Attendees will receive a complimentary copy of the featured book.

Thursday, September 04, 2014 | 12:00 p.m. – 1:30 p.m.
How conservatives can save the safety net

Please join us for a luncheon event in which our panel will discuss what conservatives can learn from how liberals talk and think about the safety net and where free-market economics, federalism, and social responsibility intersect to lift people out of poverty.

No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled this day.
No events scheduled today.
No events scheduled this day.