The pharmaceuticals directive (amending Directive 2001/83/EC), which reached a second reading by the European Parliament on 17 December last year, failed to include a number of amendments supported by industry assocations that would have reduced the potential of medicines legislation to govern supplements.
The pharmaceuticals directive contains a definition of a medicinal product (as a substance that 'modifies physiological functions') that has caused much concern for the food supplement and other industries. Its scope is so wide-ranging that it could also cover the actions of products such as supplements and cosmetics.
While natural health trade assocations last year announced a victory following the first reading of the directive - they had succeeded in expanding the definition to better distinguish medicines from food supplements - such amendments were not included in the second reading.
Furthermore, the pharmaceuticals directive will also prevail over any other legislation in cases where a product comes under its ambit.
"As all food supplements would satisfy the definition of 'medicinal product' in the pharmaceuticals directive, there would always be a 'doubt' as to which regime should apply and the proposed article (2,2) of the pharmaceuticals directive would always resolve that doubt in favour of the pharmaceuticals directive," states a legal opinion commissioned by the campaign group Alliance for Natural Health (ANH).
The group has also learned that a clause known as Recital 7 included in the new directive, which states that medicines legislation should not apply to products that are 'clearly' foods, supplements, cosmetics or medical devices, may not be binding,
"This is a real problem. With an amending directive, the recitals fall away when merged with the original directive," Rob Verkerk, director of ANH, told NutraIngredients.com.
"It does not only concern borderline products. The pharmaceuticals directive actually has total supremacy under the new laws and could be disastrous for the leading edge of the supplement industry."
The group presented its legal opinion to the European Commission shortly before the Parliament reading and with support from MEP Avril Doyle has secured negotiations in the next month to discuss inserting the wording previously agreed with the Parliament's environment committee back into the text.
Moving to change a directive in such a way after its second reading has little precedence but ANH believes the Commission 'will need to come up with an explanation for this contradiction'.
If they do not succeed, a product which is clearly a food supplement could in future be seriously threatened by classification as a medicine.