Drug Quality and the Heart of Darkness

Can there be a floor and a ceiling for global drug safety and quality? Even as we move toward differential pricing, should we allow some countries to have lower standards than others “based on local situations?”

In his 1946 “Sinews of Peace” speech Winston Churchill famously remarked, “From Stettin in the Baltic to Trieste in the Adriatic, an iron curtain has descended across the Continent.”

Has an iron curtain today descended on drug safety and quality on many other continents?

Word has it a new WHO study reports that only 20% of member nations have drug regulatory capacity to properly ensure the safety of their national drug supplies. Yikes.

To paraphrase the British Bulldog, the safety of the world’s drug supply, ladies and gentlemen, requires a new unity from which no nation should be permanently outcast.

It’s time to actively and aggressively pursue FDA Commissioner Peggy Hamburg’s call for a regulatory Marshall Plan to help build, nation-by-nation, global systems for both quality and safety.

Unarguably, two of the most important health advances of the past 200 years are public sanitation and a clean water supply. Those achievements helped to control as many public health scourges as medical interventions helped eradicate. A rising tide floats all boats.

Working together to raise the regulatory performance of all nations will help all nations (even the 20% deemed “capable” by the WHO) to create sound foundations to address a multitude of quality and safety dilemmas such the manufacturing of biosimilars, the control of API and excipient quality, pharmacovigilance and, yes, even counterfeiting.

When Paul Orhii, Director-General of Nigeria’s National Agency for Food and Drug Administration and Control, complained to the Chinese government that China was the origin of many of the counterfeit medicines in Nigeria, he was bluntly told Beijing was not responsible for the quality of medicines in Nigeria

When it comes to the safety of pharmaceuticals and medical devices, can one man’s ceiling be another man’s floor?

And how does this fit into the debate over trade policy versus trade practice? Should medical products that are determined not to meet any given national standard be allowed to be exported to other countries? Should there be a “good enough for me, good enough for thee” standard for international trade in pharmaceuticals and medical devices?

According to Poor Quality Drugs and Global Trade: A Pilot Study (a new paper from the National Bureau of Economic Research), Indian pharmaceutical companies are selling lower quality drugs at higher prices in Africa while at home on the Subcontinent, they’re selling the same drugs, manufactured to a higher quality standard at lower prices.

According to the paper’s abstract:

Experts claim that some Indian drug manufacturers cut corners and make substandard drugs for markets with non-existent, under-developed or emerging regulatory oversight, notably Africa. This paper assesses the quality of 1470 antibiotic and tuberculosis drug samples that claim to be made in India and were sold in Africa, India, and five mid-income non-African countries. We find that 10.9% of those products fail a basic assessment of active pharmaceutical ingredients (API), and the majority of the failures are substandard (7%) as they contain some correct API but the amount of API is under-dosed. The distribution of these substandard products is not random: they are more likely to be found as unregistered products in Africa than in India or non-African countries. Since this finding is robust for manufacturer-drug fixed effects, one likely explanation is that Indian pharmaceutical firms and/or their export intermediaries do indeed differentiate drug quality according to the destination of consumption.

That’s the unfortunate distinction between trade policy and trade practice. Is this an issue for TRIPS? Should TRIPS Article 61 be amended to include punishments and penalties for those who export medicines and medical devices that do not meet a certain global standard?

While domestic standards are undeniably an issue of domestic sovereignty, shouldn’t there be transparency as to how any given nation defines safety and quality? “Market authorization” means one thing in the context of the MHRA, the FDA, the EMA, and Health Canada (to choose only a few “gold standard” examples), but how are we to judge the regulatory competencies of other national systems? Is that the responsibility of the WHO via a better-developed (and far more transparent) pre-qualification scheme? Or regional arbiters? Should there be “reference regulatory systems” as there are reference nations for pricing decisions? Should there be regulatory reciprocity?

All the more reason for “gold standard” nations to undertake a regulatory Marshall Plan to help build global systems for drug quality and safety.

The harmonization of global trade policy and practice is essential to the sinews of international medicines quality and safety.