The big news in Moscow this morning is that Russian President Dmitry Medvedev hosted the band Deep Purple (according to the official Kremlin report), “at his luxurious residence near Moscow.”
Soldier of Fortune indeed. Rock on Dmitry!
Perhaps the reason the Kremlin chose to comment on President Medvedev getting in touch with his internal groupie was to send the message that Russia (from the top down) is more Western than we in the West give it credit for. The news item on Deep Purple, after all, wasn’t in the mainstream Russian press but rather in the English language Moscow Times.
Fascination with rock stars notwithstanding, Russia is not the West. But neither is it dancing bears and balalaikas. It’s Russia. And in 2011 that’s a complicated proposition -- even more so when it comes to healthcare issues.
One of the major problems is that its regulatory framework is still quite nascent. With senior government officials entering and departing public service at an alarming pace (and rarely of their own volition), there is a lack of continuity and predictability that makes working with the FDA look like predicting the tides.
Case in point is the Russian government’s recent decision to demand that, prior to licensing any new medicine, the sponsor company must conduct clinical trials in the Rodina. Nobody’s clear whether that means Phase III trials (which is probably the case), but the practical reality is that this edict prevents over 400 new medicines (both NMEs and dosage forms) from being introduced onto the market.
Is the government concerned about safety? If so, what new safety information will additional clinical trials provide? How large must these Russia-only trials be? The government edict is unclear and nobody inside the Kremlin is willing to clarify. My sources tell me that multinational pharma wants to talk and wants to do the right thing – if they could only find someone to talk to and negotiate with. Can this new regulation be prospective – allowing the pending drugs (that are all currently on the market in both the US and the EU) be given the green light and then have all future drugs incorporate domestic trials? Seems fair and logical – but there’s no one to sit in the chair opposite industry to discuss it. Can a panel of Russian experts be asked to review the clinical trial results of these 400 pending products and offer their expert opinion as to their design and findings? That would be a good conversation – except that there’s no one to have the conversation with.
Everybody's shuffling on keeping a place in the line
Don't you think we're gonna make it
We've got a place in line
We're gonna make it some time
Somehow
From the Deep Purple song, Place in Line.
It’s also important to understand wither this new proto-regulation came from – it came directly from Vladimir Putin. Nobody knows if the Russian Prime Minister is a Deep Purple aficionado, but no one has ever accused him of being a creature of the West. His preferred methods and recent public remarks certainly do not reflect such attitudes. At the one meeting where representatives of the international pharmaceutical industry were able to discuss the clinical trial issue, the senior government official present said that industry “had made some good points.”
And the next day he was fired. So much for constructive dialogue.
As Joseph Stalin commented after a particularly brutal purge, “Life is more joyous, comrades.” Translation – you could be next, so watch your step.
At dinner with a senior member of the Russian healthcare firmament, I was told that the most significant advance Russia has made in adopting a more science-based regulatory standard was that there are now “reasonable bureaucrats.” When I asked what that meant he responded, “It means people who have been in their jobs for more than five years.” Something to think about for FDA watchers who complain that too many people at the agency have been in their jobs for too long. Be careful what you wish for.
One of the things the Russian government is wishing for is a more developed and robust domestic pharmaceutical industry. To this end they developed a plan called “Pharma 2020” – except that it was developed without any real input from industry. In other words, with (to be polite) limited expertise in this area, the government put a plan in place that prioritizes domestic pharmaceutical manufacturing over research and development. Central planning of this sort proved less than successful when it came to tractors, it will be a disaster when it comes to sowing successful seeds for it’s own domestic “Ð±Ð¾Ð»ÑŒÑˆÐ°Ñ Ñ„Ð°Ñ€Ð¼Ð°Ñ†ÐµÐ²Ñ‚Ð¸Ñ‡ÐµÑÐºÐ°Ñ Ð¿Ñ€Ð¾Ð´ÑƒÐºÑ†Ð¸Ñ” (Big Pharma). The future for Russia is too important for it’s biotech future to be a gulag archipelago.
Industry was ignored – but why did they wait to be asked? Why didn’t all of the smart and savvy representatives of multinational Big Pharma sit down and design a model program and then share it with the government? This time, alas, the problem cannot be blamed on the Kremlin’s lack of access. Rather the problem is that there is no real industry body akin to PhRMA in Russia. Best estimates are that, for all non-sales activities inside Russia, all the mutinational pharmaceutical companies spend under three million dollars combined.
For a nation with the potential of Russia and considering how much verbiage is regularly directed at the importance of this market, this is not a serious number. When it comes to Russia, industry efforts have not been nearly, um, Gudunov.
Stepping outside of Russia, the story, relative to international pharmaceutical industry engagement is just as bad if not worse. In Egypt, for example, last year non-sales spending was about $40,000 for the industry. Yes, combined.
Clearly there needs to be much better focus on organic chemistry.
In Russia and elsewhere, if industry wants to reinvent the process, they must actively and aggressively become a more important part of the process. Current lack of funding for such efforts does not match up with the rhetoric of true globalization.
Feel it coming
It's knocking at the door
You know it's no good running
It's not against the law
The point of no return
And now you know the score
And now you're learning
What's knockin' at your back door
From the Deep Purple song, Knocking on Your Back Door.
Please pass the kvass.
