A checklist for regulatory submissions

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From time to time, you will help clients make regulatory submissions.

  1.  Basic Rules for all Submissions

Golden Rules

  1. When preparing regulatory submissions, you should follow this golden rule: A regulatory submission should make it easy for the person considering the application.
  2. Your submission should be self-standing. Your document should convey all that needs to be said to advance your case. It should be persuasive enough that:
    1. Any official who reads your submission understands it clearly after one reading, even at 7 pm on a Friday evening, and
    2. They walk away agreeing with your recommendations.

3. For technical regulatory submissions, you should work with an established technical expert to prepare the submission. A lobbyist is not best placed to prepare the technical input for a chemical submission.  I prefer to work with technical experts whom the Commission/Member States often use. They tend to be trusted.

There is little to no point working with experts (or lobbyists) who are not trusted by the officials making the decision.  They may tell you what you want to hear, but if their signature means your submission is ignored, those sweet words in your ears will be no comfort.

Rules of Thumb

In many ways, the American legal system’s advice on pleadings, Rule 8, is a good rule of thumb to follow. It came up in recent litigation (see judgment).

To paraphrase the judgement, your submission is a “mechanism to fairly, precisely, directly, soberly, and economically inform the authorities — in a professionally constrained manner consistent with the dignity of the process”.

This includes:

  1. Use short and plain terms.
  2. Be specific, concise and direct.
  3. Address the issue at hand.
  4. Not too long – 40 pages is a good rule of thumb.
  5. Get to the point – don’t add your main claim/ask on page 81 of an 85-page document.
  6. Avoid unwarranted or irrelevant allegations.
  7. Avoid repetitive or superfluous points.
  8. Avoid abundant, florid, and enervating detail.
  9. Not use as a forum for vituperation and invective — not a protected platform to rage against an adversary.
  10. Don’t use it as a megaphone for public relations or a podium for a passionate oration at a political rally or the functional equivalent of the Hyde Park Speakers’ Corner.

I would supplement this judicial wisdom with equally obvious points that every lobbyist should know (or is presumed to know):

11. Your submissions should not be duplicitous and should not use partial or selective reference to data and evidence.

12. You can add information and supporting data that you provide in an Annexe or a link.

13. Avoid spurious claims and anything that hints of dishonesty. If you are perceived as doing this, you’ll be ignored by most well-meaning officials and politicians. Your lobbying efforts will be DOA.

14. Some of the data you use to support your position may be confidential. You can redact/black out that from the public version of the submission. If you opt not to provide the source of the data and access to the data to the officials reviewing your submission, it will be treated as less robust.

15. It should go without saying, but a regulatory submission should be honest and contain all relevant information that you have to hand. This includes both the favourable and unfavourable information available to you  at the time of submission.

 

This short checklist will, if applied, improve the chances of your submissions being co-opted by busy officials.