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The BPCC’s Healthcare Policy Group met on 21st April at the Chamber’s offices to discuss the Polish dietary supplements market. Agnieszka Deeg, partner and head of the CEE Lifesciences Sector Group at CMS Poland who runs the Healthcare Group had a presentation on legal framework for development of the sector.
Representatives of companies and the Chief Sanitary Inspectorate (GIS) discussed the most significant legal challenges facing manufacturers and distributors of dietary supplements in Poland.
The discussion concerned new regulations governing notification of dietary supplements and the conduct of explanatory proceedings by GIS. The amended Act on Food and Nutrition Safety does not set any time limits for GIS to institute explanatory proceedings concerning dietary supplements coming onto the market. Neither is there any obligation on the part of GIS to confirm that it has accepted a notification. As a result, explanatory proceedings are often instituted ten or more months after the notification date. This undermines the confidence of manufacturers and distributors, making it impossible for them to properly plan the production, sales and marketing of supplements.
It was also pointed out that the new regulations do not precisely define the circumstances under which GIS needs to apply for an opinion from the Office for Medicinal Products, Medical Devices and Biocides Registration (Urząd Rejestracji Produktów Leczniczych, Wyrobów Medycznych i Produktów Biobójczych). As a result, GIS often automatically requests companies to present such an opinion without stating the grounds for its decision.
Under the new regime, the opinion of the OMPR is binding on GIS in the course of explanatory proceedings, and a manufacturer or distributor is unable to appeal against it. As a result, the only way for companies to challenge a decision of the OMPR is to appeal against a decision of GIS in the administrative court.
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Participants also discussed material regulatory changes concerning nutritional and health claims relating to dietary supplements. In Poland, Regulation 1924/2006 is directly applicable to any nutritional and health claims presented in materials relating to dietary supplements, including advertisements, promotional or educational campaigns. Participants said that the sanitary inspection authorities interpret the concept of health claims in very broad terms, classifying as such any content, even content that only very vaguely implies a link between a dietary supplement and healing or health. Once a list of permitted health claims is published by the European Commission, which is planned to take place in the middle of this year, no claims that are not included on that list will be permitted. If a company still wishes to use such a health claim, it will have to request that the claim in question be included on that list.
The special guests of the meeting were also Grzegorz Masiejczyk, executive director of the Polish Council for Supplements and Nutritional Foods and Kinga Wójcicka, foreign affairs communication supervisor of the same organisation.
The dietary supplements market is rapidly growing – in 2009 more than 2,800 supplements were notified to GIS.
Concluding the meeting Agnieszka Deeg stressed the importance of clear legal procedures and the need to “civilise the law”. “More transparency would significantly reduce economic risk for companies,” agreed Joanna Wojasiewicz, OTC brand manager from Sandoz. “It is important that the government’s work on setting out criteria and the direction it will take, should be known to public,” said Jacek Wędrowski, partner at Bird&Bird.
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