Regulatory Strategy and Tactics

There are two words which often sit together when organisations discuss brand plans and company objectives for these, “Strategy and Tactics”. Have you however paused to consider them in full and to understand how they can guide you and what those differences are?

If we define strategy in a regulatory setting, we can most probably put it down to being a plan of action to achieve a long term or overall aim/goal.

Let’s for a moment however think of it in a military setting – the art of planning and directing overall operations and movements in a critical situation, such as a war or battle. By adopting this analogy you get an opportunity to view history and actions which have arisen.

The “Charge of the Light Brigade” was a charge of British cavalry against Russian forces during the Battle of Balaclava on 25th October 1854 in the Crimean War. The overall commander of the British forces intended to send the Light Brigade to pursue a retreating Russian artillery battery, which was a task well-suited to light cavalry. Due to miscommunication in the chain of command, the Light Brigade was instead sent on a frontal assault against a different artillery battery; one well-prepared with excellent fields of defensive fire. Although the Light Brigade reached the battery under massive amounts of direct fire from the gunners, the badly depleted brigade was forced to retreat immediately.

The assault ended with very high British casualties and no decisive gains.

In this example we see both strategy and tactics in play, but we also see the failings which lead to a failure of the action and the task. The cavalry reached their objective, but miscommunication, poor tactics and strategy gave no benefit only losses.

What does this show us? For a company to succeed, maintain and to importantly grow their brands, a clear regulatory pathway aligned to the business plan is key. This strategy is a vital component in the company growth and should have an equal value and importance to the brands they sell to ensure their protection.

So where does this strategy start? Drill down to what is important and what is valuable and start with two questions:

What is my product?

Where/what are the opportunities?

Sounds simple but….! What legislation is in place to control and monitor? (Medicines legislation, Medical Devices legislation, Food law, Product Safety Directives, Biocidal Products/REACH Directives)

If it claims to treat, cure, prevent or alleviates it’s likely to be a medicine or a device but we have seen a growth of “borderline” products, especially within skincare, which push these boundaries.

Your regulatory strategy should be a three-dimensional tool.

Level One: Commercial – What is the claim you want to make, advertising and market access?

Level Two: Geographical – Which countries is this applicable to?

Level Three: Steps – What are the pure regulatory steps to achieve this? Legal status, existing products to abridge to, political perspective, dossier, regulatory submission route, active component level/device/ food/ biocide – links to the claim

We started this piece with mention of two words – Strategy and tactics. The final part of the jigsaw – tactics – the way you implement it!

Here at JensonR+ we can help guide and support you in the both the regulatory strategy and give you the tactics of how to succeed in those plans.

How does your company fair against the following and does it sound like your strategy and tactics?

If you know the enemy and know yourself, you need not fear the result of a hundred battles. If you know yourself but not the enemy, for every victory gained you will also suffer a defeat. 

If you know neither the enemy nor yourself, you will succumb in every battle.” 

Sun Tzu, The art of War

James Hall