Thank you for Subscribing to Life Science Review Weekly Brief
If you started your career more than 15 years ago, you may remember that most food and feed companies didn’t even have a Regulatory function. Well, now not only most of those companies have created a dedicated department, butwe are invited to provide input to defining the companystrategyand to deciding on whether or not to invest or acquire a new business – Why this transformation?
In the wake of a series of human food and animal feed crises combined with an increasing concern about the risk of consumers being misled, a number of countries decided to initiate substantial reforms of their food law in the early 2000s. Those set of international, regional and national regulations form a complex system of rules covering the entire food chain, from animal feed and health, through plant protection and food production, to processing, storage, transport, import and export and retail sales.
As outcome-based regulations have been considered appropriate for low to medium risk activities and not high-risk activities such as feeding people and animals, those reforms generally privileged prescriptive regulations which state or describe what must be done and also how work is to be carried out. An increasing number of products entering the food chain have also become subject topre-market approvals based on the assessment of extensive datasets on the identity, safety and efficacy of the product.
In practice, this means that companies operating in the food and feed sector have had to adapt to that fact that conditions for market access of their products have become more demanding and more challenging to implement in their innovation process and supply chain.
Where to play and how to win
The performance of a Regulatory teamnotonly directly impacts the speed and cost to market of innovations, but also helps mitigatethe risk of market access discontinuity in a context of constant evolution of regulations and standards.
Regulatory is now involved when a company defines it strategy, i.e., when it makes explicit choices on which things to prioritize and then builds a business around those choices.
Where to play represents the set of choices that narrow the competitive field. The questions to be asked focus on where the company will compete— in which markets, with which customers and consumers, through which channels and in which product categories. It could also lead to the decision to acquire or merge with another existing business. The role of Regulatory is to provide insight on the expected time and budget needed to access the selected markets of interest, to estimate the likelihood of success, and also to ensure that coming changes to regulations and standards will not jeopardize access to the market.
“Regulatory is now involved when a company defines it strategy, i.e., when it makes explicit choices on which things to prioritize and then builds a business around those choices.”
How to win defines the choices for winning in that field. It is the recipe for success in the chosen segments, categories, channels, geographies, and so on. It is of utmost importance to anticipate the capabilities, capacity and footprint needed for Regulatory to open the markets within the time and budget forecast in the Strategy.The ability to attractthe best regulatory experts and transforming them into an expert team, combining high level of task-related expertise and the mastering of team processes, will eat your market access strategy for breakfast.
About Chr. Hansen
Perhaps you have never heard of Chr. Hansen, but chances are you had a bite of us this morning! Founded in 1874, our natural ingredients – good bacteria, probiotics or enzymes – are in every other cheese and yogurt in the world, and we touch the lives of more than one billion people every day. We are present in over 30 countries with 3,700 employees and rank as one of the world’s most sustainable companies.