What needs to happen in the US to sustain the innovation initiative of biopharmaceuticals?
Robert: Well, biopharmaceuticals is a complex issue and a lot of people try to make it a very simple one by saying to do regulatory reform through the FDA or provide additional NIH funding to do research. Biopharmaceutical innovation policies are very complex and inter-dependent onto one another. There is no one magic bullet.
So, there are three distinct environments that need to be addressed to really sustain the biopharmaceutical innovation marketplace in the US and that is the investment environment, which is basically appropriate and electoral property protection. For example, tax policy, ability to price medicines according to the marketplace.
There is the regulatory environment, which is the second environment, which requires that we do a better job of streamlining not only the FDA, but other regulatory bodies like the Centers for Disease Control. And then, more importantly, within the regulatory policy framework is how to better do clinical trials and clinical trial recruitment. That needs to be addressed.
Finally, it is the access, which in my opinion is the one that is short shifted a lot of times because unless you address the access environment for biopharmaceutical, no matter if you are investing a lot of money in it or you have a very deregulatory process to get the product out, if the patients are unable to access those medicines because they are too high cost regarding out-of-pocket costs or there is no meaningful way to get access to it because there is no way to communicate that information to the providers, innovation will suffer and patients will suffer long term with that.
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