Is it time to change the regulations?

Now, this could be a controversial topic…?

I recently presented at a conference on increasing efficiency in the clinical supply chain. My presentation was partly focused on what exists already – and partly on what the future could bring – that could lead to a more flexible supply chain that would automatically react to actual events and data (e.g. actual recruitment at site or overall stock constraints). I suggested that, in the future, an automated engine could analyse the data and make decisions about IMP shipments by itself, including site-to-site shipments to reduce overall medication waste at sites.

What had I just said?! More site-to-site shipments???

The reaction in the crowd was immediate: you can’t do that, because of the regulations. This comment came from very experienced clinical supply professionals. They were right, obviously. Site-to-site transfers should be used as an exceptional resort.

I knew that this suggestion would be controversial, although I wasn’t expecting such a strong push back. Especially from the same people who, two days earlier in the same conference, said that they wanted to innovate and that they hated it when people said, “We shouldn’t change, we’ve always done it this way.” For me, this was a perfect example of regulations potentially stopping us from innovating. Had I known the regulations better, I might not even had included that suggestion in my presentation… which is the opposite of creativity. We all know that without creativity, there is no innovation.

Don’t get me wrong, I fully support having regulations in the clinical trials industry. However, I believe the past two years have taught us that flexibility and adaptability in our regulations can accelerate innovation. We, as an industry, have done thousands of site-to-patient and depot-to-patient shipments during the pandemic. The regulations in Europe were relaxed to allow it. I wonder why we would allow such shipments, but not allow site-to-site shipments?

To answer the question “Is it time to change the regulations?” I believe the answer is “Yes!” ?Now is the perfect time to review what we thought was true three years ago, apply the many learnings from the past two years, and adapt our regulations to this new world we live in. But, how do we begin?

I for one will review the rules on site-to-site shipment, and I will think creatively about how they could be adapted in the future, so we may reduce drug wastage at site level, leading to reducing the quantity of unused investigational products we burn every year. I do this to embody one of my favorite quotes from the great artist Pablo Picasso: “Learn the rules like a pro,?so you can break them like an artist.” I aim to do just that…

What do you think? Are there any regulations that you would like to change post-pandemic? What steps can / should we take to get there?