As I was browsing the web I came across this Forbes healthcare blog article, entitled “Could China Steal America’s Biotech Crown?” and written by Matthew Herper.

The article itself is a good read, and it touches on not just U.S.-China competition, but also on globalization, a subject near and dear to my heart. Though I’ve been doing a lot of thinking about the globalization of intellectual property law, especially patent law, and China’s up and coming heavyweight influence in international IP regimes, I have to admit I really hadn’t thought about their potential to influence pharma and medical device regulatory standards. I’ve definitely thought about Chinese pharma regulations in the context of stem cell regulation and how China’s own differ from the rest of the world, but for some reason I never connected that with the Chinese system’s potential for legal export.

The blog post references a few soundbites and musings from the CEO of a pharmaceutical service company, Quintiles Transnational (website|wiki), which does a lot of research outsourcing work and is super hot on China. He gives the standard soundbites–how China’s getting more important, why regulation will hurt American industry–but then he gives the bottom line:

This could put Asian regulators in a position to start defining standards for the world, just as the FDA once did. And it could result in the drug industry taking an Asia-centric bent, Gillings says.

This is definitely something I’ll be researching a little bit more. What I wonder is how inching down from current regulatory standards will be received by voters. Granted, it’s nowhere near, say, trying to strip people of entitlements like Social Security or Medicare, but I think it’s also slightly more of a touchy subject than other types of market-friendly relaxations. The public tends to get slightly more emotional about being peddled bad medication with disastrous side effects. Think Vioxx and the related media attention and litigation. But let’s be honest, the real issue isn’t about voters at all, it’s about how quickly corporate-backed politicians and media would steamroll any public outcry interested parties try to throw up.

There was also a worth-reading comment on the post, made by a Duke University Research Analyst, Patrick Herron. Aside from mentioning that the U.S. and China have had much success because of “bi-national research collaborations and investments, he also lists a number of “critical short-comings”:

Their pharma growth seems dependent upon a massive and opaque real estate bubble; China is short on big success stories and blockbuster drugs; China seems in comparison to other countries intolerant of innovation risk and failure even if their innovation policy anticipates it structurally; and China’s own SFDA depends upon US FDA approvals.

A first consideration is whether China will do a regulatory about face once they end up with “big success stories and blockbuster drugs.”  Sure, they have a nice domestic market whose sick people are getting richer by the day, but China’s probably intent on looking far beyond its own borders. They might play loose and fast while they play catch up, but they can’t avoid countervailing pressures that will follow economic development, such as a populace that starts to care more about health security once their economic security is taken care of. And unless all the big pharma customers decide to lower their own regulatory standards, I’m not sure how this is going lax rules in China are going to propagate through the work. Provided that the purchasing power is there, the territory that sets the bar higher wields mighty influence (e.g. California and environmental regulations).

Finally, Mr. Herron’s very last statement got me wondering about what sorts of inter-agency work is going on, and what those requirements are. This is another feature of globalization, naturally, cross-talk between niche administrative creating international standards among themselves. I’ll write about more about SFDA and USFDA links in the next post.

Tags: Chinese pharma regulation, Forbes, Quintiles, research outsourcing, SFDA, USFDA