The European Parliament this week rejected a Commission proposal to extend pharmaceutical powers to cover food supplements. The proposal was part of a series of amendments to the 1965 medicines directive, put forward in a bid to offer more incentives for innovative research and development to the European pharmaceutical industry, lagging behind its international competitors.
Voting on Wednesday, the Parliament however rejected the Commission's proposal that any product falling under the definition of a medicine should be treated as a medicine, regardless of whether it also fell under the scope of other EU food or supplement legislation.
The vote was the first of two readings of the European Parliament under the co-decision procedure. The proposals now need to be endorsed by the EU's Council of Ministers before the European Parliament may complete its second reading.
In a statement, the Commission said it welcomed the vote but that it hoped that agreement on a series of important issues could be reached in the future. "The Commission's wide-ranging proposals to review the EU pharmaceutical legislation aim to strike a balance between a high level of health protection for European citizens and the need to boost the competitiveness and innovative capability of the European pharmaceutical industry. These proposals will also facilitate the free movement of medicines and pave the way for EU enlargement."
The Parliament's rejection of the Commission's plans follows a hard-fought campaign by the European Health Product Manufacturers Association (EHPM) and its members, who joined forces with the European Responsible Nutrition Alliance (ERNA) and the European food industry federation (CIAA).
The campaign is part of long struggle to provide a clear legal status for food supplements under food law. The recent EU food supplement Directive (Directive 2002/46/EC passed on 10 June 2002) appeared to have provided dietary supplements with a 'safe haven' but the Commission's medicinal proposal presented a considerable threat to the industry.
Given that the current definition of a medicine includes substances that 'modify physiological functions', food supplements, foods and cosmetics could all fall under this definition and therefore be controlled by pharmaceutical authorities under the new rules.
"This would give the national medicine agencies unprecedented powers to decide on whether supplements could be sold or not and would negate the benefits of the recent supplement Directive," argued Anthony Bush, EHPM chairman. "It could lead to the sort of destructive, arbitrary decisions at a national level that necessitated the supplement Directive in the first place."
The EHPM said that the current definition of a medicine, first drafted in 1965 long before the recent interest in food supplements, has been a further successful target of the campaign. When originally drafted, the definition of a medicine was extremely broad to include emerging medicines such as the contraceptive pill, and embrace, not only the cure, prevention and treatment of disease, but also those products "modifying physiological functions". This all-inclusive definition has shaped regulators' thinking over the subsequent decades and has left the food supplement with little room for manoeuvre.
"The definition of a medicine is a critical issue that has been a thorn in the side of the food industry for over 30 years," said Bush.
A qualifying amendment proposed by EHPM, ERNA and CIAA sets out the difference between the physiological functions of foods and those of medicines. With the adoption of the amendment "modifying physiological function by exerting a pharmacological action", the European Parliament has forced the Commission and Member States to thoroughly rethink the definition of medicines.
"The food-medicine borderline issue is a notoriously tricky one," commented ERNA chairman Luc Claessens. "But yesterday's result is an important first step to redressing the balance for our industry."