EU Health Claims Legislation is Stifling Innovation – Stakeholders
Responding to a presentation by the renowned Max Planck Institute on the stifling of innovation, patient representatives, food industries, politicians and regulatory experts agreed that a "period of reflection" – a time-out – of the current implementation of the legislation is urgently needed.
03/06/09 Prior to the planned European Food Safety Authority (EFSA) meeting with applicants on the 15th of June 2009, stakeholders from various different societal angles convened in Brussels and agreed that the innovation element of (EC) Regulation 1924/2006 on nutrition and health claims does not function.
Responding to a presentation by the renowned Max Planck Institute on the stifling of innovation, patient representatives, food industries, politicians and regulatory experts agreed that a "period of reflection" – a time-out – of the current implementation of the legislation is urgently needed.
Furthermore, the stakeholders present called for an urgent economic and regulatory impact assessment to be undertaken as well as the introduction of a Gold, Silver and Bronze grading for the supporting science. It should be avoided that in July 2009 promising products are forced from the market whilst less effective products stay in, pending their EFSA evaluation at a later date.
The Brussels event, chaired by Members of European Parliament Jules Maaten and Karin Riis-Jorgensen, focused on a presentation by Dr. Ivan Baines of the German Max Planck Institute, who demonstrated that there is a considerable risk of further technology and R&D investment outflow from Europe comparable to recent negative trends of the pharmaceutical sector. According to Dr. Baines, "the regulation in its current form is acting as a deterrent of food R&D in Europe. This may pre-empt the development of important nutraceuticals as well as closing the door on European competitiveness in nutrition, wellness and health".
In opening the event, Danish MEP Karin Riis-Jorgensen noted the importance of a correct regulatory balance stating "we need smart and effective regulation with correct implementation". Adding that as consumers "we need choices that may prevent health conditions and that also contribute to health and wellbeing".
Commenting on Dr. Baines' presentation, representatives from Danisco and Sudzucker voiced concerns that the current implementation is unclear and unpredictable. Also, the staggering of the publication of EFSA health claim opinions would lead to an unfair level-playing field. Nigel Baldwin, regulatory consultant at CANTOX, confirmed that these are industry-wide concerns which are particularly true for Small and Medium-sized Enterprises (SMEs).
Another concern with the implementation of the health claims legislation is the lack of a proper and complete economic and regulatory impact assessment – according to the Max Planck Institute the data is not available to make effective policy. According to the European Patent Office, there is a clear link between patent applications and innovation and investment. However, it is not only the number of patent applications that should be considered when assessing the impact on innovation but also the origin of the patent application.
Ysbrand Poortman, Vice President of the World Alliance of Organisations for the Prevention and Treatment of Genetic Conditions, stressed that nutrition plays a key role in the prevention of disease and that the door should not be closed for the development of food ingredients that provide consumers and patients with healthier choices. To this end, the implementation of the Regulation should not solely be limited to the 'Gold' standard but should also encourage 'Silver' and 'Bronze' to develop their healthy ingredients – leading to a 'race to the top' among food companies and a renewed incentive to innovate.
In concluding the event, Dutch MEP Jules Maaten stated that “the lack of an impact assessment for this piece of legislation - particularly with regard to R&D, technology and innovation -, the confirmation of the European Commission that the January 2010 deadline will not be met, and the postponement of the nutrient profiling and food labelling debates raise the need for a time-out to reflect on the implementation of the health claims legislation.” As an immediate step he noted that there should be “no staggering of the publication of the EFSA health claim opinions as these would lead to a market distortion and are not in the interest of society or industry.”
