In recent statements ANVISA, the Brazilian equivalent of the FDA, has put forward the proposition that (relative to raising the level of international drug quality and safety) there isn’t a way forward but rather “ways to move forward based on local situations.
While the solution must fit the problem, this poses an interesting question – 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?”
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?
For example, should Beijing allow substandard API -- illegal for use in the Middle Kingdom -- to be exported to, say, Nigeria?
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.
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 (such as PAHO)? 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.