Understanding and challenging the system

Over the past few weeks, while we have been reviewing pesticide risk assessment, we have not covered 2 important issues. These are data access and challenging regulatory decisions. These are the final bits of data that I have to present: after this article will come a summary to wrap it all up. It's been quite a journey.

On the issue of data access, my personal experience is that you cannot rely on all countries working the same way. So you can use a study in support of a registration ... here ... but when you try and use the same study ... there ... it is not accepted, because you don't have access. If I find it hard, maybe other consultants do too. So I asked them.

Since you started in consultancy, do you find it easier or harder to understand your access to data?

I gave people a sliding scale for their response so I could pick up ambivalence as well as strongly held opinions. Practically the whole scale was used, so some people find it much easier and others find it much harder. Let's take a look at the spread.

 

Great news! Even though the spread of opinions is wide, the largest chunk of consultants think that it is easier to understand data access. This comment is pretty representative of the kind of comments that I received.

"The availability of lists of studies has improved. The rules for data protection have been clarified (e.g. situation for confirmatory data)."

Now turning to the issue of challenging regulatory decisions, again I find this a difficult. I may hold an opinion and articulate this opinion for the regulator. The regulator may simply disagree with me. Naturally, I want a chance to challenge the regulator, to try and demonstrate the scientific logic of my standpoint. How easy do consultants find this to do? Again I asked this question on a sliding scale and I phrased it like this:

Since you started in consultancy, do you find it easier or harder to challenge a regulatory decision?

Once again, the whole scale was used, but there was a definite trend. Take a look:

 

So, for whom is this great news? I would say it is great for the regulators... but not for us consultants. If a decision is taken that is not in line with our view, it has got harder to get our voice heard. From the comments, it seems that this issue is linked to the increased reliance on guidance documents (that we discussed in the previous post).

"The system is more rigid. Risk assessments are more difficult to pass."

"Publication of EFSA information is much improved, but challenging decisions is difficult - particularly with EFSA."

In summary, it has become easier to understand data access and I applaud the considerable efforts that have been made in improving this. However, it has become harder to challenge a decision. I worry that science will be hindered if we cannot make these challenges. I take the view that scientific risk assessment is the right way forward. Furthermore, the best way to make progress is the constant exchange and updating of ideas. I urge all sides to keep up the conversation and be open to new ideas.

Consultants are here to ease the way for both industry and regulators so everyone can have confidence that the right decisions are being made. At least, that's what I think. What about you?

Best Wishes,

James