I’m sometimes asked what you need to succeed in substance defence.
After many years representing all sides of the table, I’ve honed it down to this short list:
- Trust
- Relationships
- Science – Studies – Relevant Expertise
- Objective Evidence
- A Guide
- Luck
- Timing
- Political Support
- Legal Case
The list is in order of importance.
Trust
If governments, officials, and regulators don’t trust you, it will be tough for you. If you stonewall them with denial of evidence, from passive-aggressive to old-fashioned aggressive, trust in you and your case will deplete quickly.
In substance work, providing the data and studies the regulator requests is a good start, and if they ask for more studies, so much the better.
If you don’t provide the data on time or at all, it can seem like an admission of guilt. I know too many who started off as combative and felt the wrath of the regulator. Once they started the studies they asked for, they found that the regulator was their ally.
Relationships
Closely linked to trust, it helps to be known and respected by officials and regulators.
I know some who are known and not respected by officials and regulators, but you don’t want to be in that place. If you have colleagues in that camp, could you keep them at home when you meet the officials?
Over the views, I have witnessed a few people who officials trust implicitly. This small band of people are worth their weight in gold.
Science
You’ll need science and evidence to support your case. The more recent the better. A study from 1912 seems to carry less weight today.
Ideally, your research is not being undertaken by Dr. Erhardt Von Grupten Mundt (from Thank You for Smoking).
Your research needs to be seen as credible. There are some interesting European Court judgements on this issue.
Objective Evidence
You may want to make a lot of claims about the impact of various measures. The challenge is that as a general rule, most people won’t believe you at face value. Just because you say it is so and believe it to be so, does not make it so.
I’ve found only one around that. It involves bringing independent, top-rate, objective studies to the table. You are likely going to have to pay someone very good to do those studies for you. And, anyone very good is going to give their objective opinion, and if it does not back your viewpoint, you are going to be left in a tough spot.
As a rule of thumb, I’d always recommend publishing the raw data that is used being used. It speaks to credibility. This need increases in light of the growing debate on academic and scientific fraud.
A Guide
If you have not walked through the regulatory fires before and survived, I’d recommend you use a guide. They’ll help you bring the right evidence, to the right people, at the right time, in the right way. They’ll help you not to conflate hazard identification with risk assessment, risk management, and some other important steps.
You should check with the potential guide their track record of getting their client through the regulatory fires, relatively unharmed.
I would choose my guide like I want my oncologist – a track record of success, even in the most challenging circumstances. I have a list of less than 10 people I’d recommend, and most are not available to hire. There are a lot of faith healers in the marketplace.
Luck
After 27 years, never discount luck to help. Sometimes you have it, and sometimes you don’t. It is an important element.
One thing seems to improve the chances of good luck coming your way: good preparation. The more prepared you are with science, studies, and existing relationships, the greater your luck is.
Timing
Good scientific studies, shadow risk assessments, and credible shadow impact assessments take time to produce. It is worthless if you present your evidence too late in the day.
I learned from one of the most effective experts in this field that the best defence is to run a near-constant stream of world-class scientific studies to address each and every endpoint. When regulatory, scientific, or political concerns come up, you have the evidence to support your case.
If you opt not to turn up at the right time or at all, please don’t be surprised if things don’t go your way.
Political Support
Substance work is surprisingly apolitical.
There are few cases when political pulses moved on a substance. 99.9% go through with no political interest.
The reason is simple. Officials and politicians are reluctant to put their careers on the line with anything linked to the word ‘cancer’.
Legal Case
All regulatory decisions go through a regulatory procedure. It is not just a scientific case but a piece of law-making.
That means any measure’s adoption must follow the right procedure and some core guidelines of good lawmaking.
There is always a case to look to Court if the decision does not go your way. Just ask your lawyer for the realistic chances of success and how the last 20 or so cases on the issue have gone.
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The same list is, more or less, applicable for all regulatory advocacy.