In the second part of this special series on global outsourcing trends NutraIngredients explores how the European Union nutrition and health claims regulation (NHCR) is impacting activity in the contract research organisation (CRO) sector.
The controversial legislation is changing the relationship between nutrition science and food and food supplements marketing due to the fact so much nutrition science that previously informed health food messaging is being ruled inadmissible by the EU’s head science agency.
The European Food Safety Authority (EFSA) rulings have disturbed the food industry’s marketing strategies, and they are also affecting the way nutrition science is being commissioned and conducted across the EU bloc’s industry, academic and government labs. CRO activity has also been greatly affected.
With less ambiguity in other regions like North America; and increasing cost-driven competition from places like India, the European nutrition CRO landscape is being altered.
One side effect of the NHCR rulings that have come in since August, 2008, is a migration into the nutra space by formerly pharma-focused CROs. In theory this may seem a good fit since these CROs are familiar with the medicinal, clinical trial design protocols EFSA has been favouring, but the results have been mixed according to Cédric Bourges, PhD, the founder and managing director of French claims consultancy and trial designer, Nutraveris.
“The pharma CROs have sensed an opportunity and moved in with medical protocols,” he said. “They are trying to change and think nutra but the problem is they are often far off the mark and haven’t understood the complexities of the NHCR and EFSA’s opinions and recommendations. So while there is undoubtedly a lot of good work going on, there are a lot of promises being made about how trials will meet EFSA’s expectations that are going to be difficult to keep.”
With such trials often costing 100s of 1000s of euros, Bourges said his firm often advises smaller, budget-conscious companies to consider academic labs, where control and delivery schedules may be less controlled, but costs can be significantly reduced.
That said, like NutraVeris (which designs but does not conduct trials), others in the nutra space have recorded a NHCR-fed pick-up in business.
Mary Gilsenen, PhD, from UK-based Leatherheard Food Research, said CRO activity was buoyant, a result she said was in part due to the extreme scrutiny her group gave to all health claims developments coming from EFSA’s Parma, Italy headquarters, and their interpretation by the European Commission in Brussels.
“We don’t make any false promises with potential clients as we know the requirements are stringent,” she said. “But with each EFSA opinion the situation becomes a little clearer about the kind of science required to get claims substantiated.”
This idea of a learning process that the whole sector is engaging in has been reiterated many times, none the least by EFSA’s health claims panel chief, Professor Albert Flynn. While sections of industry have complained about having their millions of research euros used to help EFSA and Brussels ‘learn’ the best way to consider nutrition science and regulate it, the learning process is a theme that has resonated beyond Europe.
Pieces in the puzzle
In California, Jay Udani, MD, the chief executive officer of Medicus Research, and assistant clinical professor at the UCLA School of Medicine, highlighted the far-flung impact of the regulation.
“We have several clients, both in the EU and from the rest of the world, who are still designing and running studies with the expectation of submitting them to EFSA,” he said.
“Based on continuous reading of all rulings, both positive and negative, we work with these companies to design studies which meet these criteria. Given the long lag-time between the initiation of the study and publication of the study, these companies know that they need to be continually investing in clinical trials to ensure that they have new data to submit as soon as possible.”
“While I don't believe that the new requirements will be relaxed, I believe that each new ruling provides a piece of the puzzle that helps us put together the best study design to meet these requirements.”
But while players were trying to comprehend the puzzle, research was being held back, Udani observed, as understandings developed about appropriate trial populations, controls, power, statistical significance, biomarkers, mechanisms of action and more.
“Certainly a company that has spent good money on clinical trials only to have their application rejected will be hesitant to proceed with another study until they are certain that the study will support their application,” he said while noting many rejections were justified, given the poor quality trials that formed the basis of many submissions.
Give it time
Joerg Gruenwald, PhD, the president of German consultancy and CRO, Analyze + Realize, said the puzzle was becoming clearer, even in areas like probiotics and antioxidants, where EFSA so far has rejected submissions with near unanimity.
“Some good ideas have come from the opinions and EFSA meetings in gastrointestinal health, in immunity, in cardiovascular health. Other areas like joint health are less clear,” he said. “In the next 1-2 years the situation will become a lot clearer. Probiotics will get their claims when they go for innovative claims and not the general list.”
He emphasised how important it was for CROs and other parties to develop working relationships with EFSA’s health claims staff to gain greater feedback on trial design.
To read part 1 of this series about contract manufacturing challenges click here.