EHPM says dossier fees would cramp innovation
process dossiers submitted under EU food laws, as it could hamper
innovation by already cash-strapped SMEs.
The idea has been flagged as a potential way to overcome a budget shortfall, as EFSA's coffers are not sufficiently replete to cope with the dossier-review work with which it is charged under new legislation, such as the 2002 supplements directive and the new health and nutrition claims regulation. Last November the European Commission published a consultation paper on whether companies should pay fees to EFSA. In its response, submitted prior to the February 15 deadline, the European Federation of Associations of Health Product Manufacturers (EHPM) said that the fee scheme would have serious negative implications on innovation in nutrition and health. "Around 85 per cent of the European food supplements industry is made up of SMEs [small and medium enterprises] and the industry relies on innovation to reflect emerging science in the areas of nutrition, dietitics and health," said EHPM chairman Peter van Doorn. He called the fees an "added financial burden to the already challenging cost of compliance some SMEs face with the various legislative changes and the newly adopted regulations for food supplements". The umbrella association, which represents some 2000 health product manufacturers in Europe, maintains that the lack of funding should be addressed by a budget increase, rather than an indiscriminate fee to be borne by industry. According to EHPM, the Commission's rationale for the fee scheme is that it would entail a financial risk that would discourage companies from submitting frivolous claims. However the association argues that companies already make a financial risk when they prepare a dossier for submission, since it often requires them to pay for external expertise. Frivolous applications might be avoided by good guidance on the kind of information to submit and how to present it. EHPM said that it may be appropriate for some companies to pay fees if they stand to gain a monopolistic advantage, but it says that as many applicants are innovative SMEs, even in this case fees should be low. Last week Consumers for Health Choice also made public its opinion on the paper, which included consideration of the costs that would have to be borne by SMEs. It called the consultation "fundamentally flawed" on the grounds that it concentrated on the benefits of a charging system. The next step is for the Commission to discuss the matter and the feedback it has received with EMFA and member states.
