Doctors in the U.S. have the ability to use regenerative medicine procedures like stem cell and PRP therapies as long as those therapies fall within the scope of current FDA regulations. They don’t need any further approval. The same is not true in Europe. The systemic differences between our system and theirs has led one prominent professor to state that regenerative medicine in Europe needs a paradigm shift. He makes a good point.
Prof. Ton Rabelink of the Netherland’s Leiden University limits his paradigm shift comments to the European Union, but the points he makes are just as valid in other parts of the world. They are certainly valid here. Regenerative medicine is moving along at a fairly fast clip, yet regulatory agencies are not keeping up. That’s not good for either the industry or patients in need of help.
The European System Is Slow
Prof. Rabelink explains that the current European system is governed by a regulatory agency known as the European Medicines Agency (EMA). In order for new medical procedures to make it to market, they must go through a complicated approval process that isn’t always straightforward. In many ways, EMA is a lot like our own FDA.
The problem for regenerative medicine in Europe is that EMA approval takes too long. The current system is not flexible or responsible enough to keep up with the pace of technology. As such, new procedures that are already getting a serious look in the United States and Japan are not even on the radar in Europe.
Rabelink says the solution is to streamline the process so as to get promising therapies to market more quickly. In order to do that, he says a paradigm shift is required. That shift is one that entails looking at research in a different light. Rather than requiring absolute proof that something works, regulators should be considering the relationship between potential and harm.
In other words, as long as a given procedure is proved to be largely harmless, it should be fast-tracked to approval if evidence suggests positive potential. Interestingly enough, such a system now exists here in the United States thanks to the 21st Century Cures Act.
What the Act Does
The 21st Century Cures Act was signed into law in late 2016. The legislation was intended to encourage new product development and innovation in the medical field. It specifically created two new programs, one of them focused on creating an expedited means for approval of regenerative medicine therapies, explains Utah-based Apex Biologix.
What the act essentially did was create a fast-track process to get innovative therapies to market more quickly. The system is based on the very same principle professor Rabelink talks about: comparing relative safety to potential efficacy in order to determine whether a product or procedure should be allowed to go to market.
We are already in the midst of the paradigm shift Prof. Rabelink wants to see in Europe. That’s why he is concerned that Europe will continue falling behind until the EMA institutes the systemic changes necessary to spur regenerative medicine innovation in Europe.
Letting Patients Contribute to Studies
When you boil down Rabelink’s arguments to their simplest form, what you have is a case for allowing patients to contribute to studies by giving them free access to treatments that, while experimental in nature, do no harm. It is a sensible way to do things in a day and age in which regenerative medicine technology shows a tremendous amount of promise. It’s a good thing that the paradigm shift is already underway here.