Pharma legislation nears final hurdle
tomorrow on the review of the EU medicinal product directive, set
to define the boundary between dietary supplements and
pharmaceuticals. Europe's pharmaceutical industry body is urging
MEPs to vote for amendments that encourage medical research for
healthcare in Europe.
"The long-awaited reform of EU pharmaceutical legislation is an opportunity to strengthen the regulatory framework for medicines in an enlarged Europe - It is also an opportunity to encourage pharmaceutical research, which is vital to find innovative treatments and cures for the benefit of patients," said Brian Ager director general of the European Federation of Pharmaceutical Industries and Associations (EFPIA).
"Overall, the Council Common Position strikes a reasonable balance on many of the important issues. We now call on MEPs to focus only on a few remaining issues in order to set in place a modern, stable and robust pharmaceutical regulatory framework that is needed by all 450 million citizens of the enlarged Europe."
Currently undergoing its second reading by the Parliament, the legislation could also have a considerable impact on the future of the supplement industry.
The European Health Product Manufacturers' Association (EHPM) has campaigned to clarify the definition of a medicine, as one which 'modifies a physiological function by exerting a pharmacological action', to protect supplements from being regulated under the new laws.
Pedro Vicente Azua, regulatory affairs director of the EHPM, noted however that the Commission could further modify this definition to add 'immunological and metabolic functions', encompassing an extremely wide range of products.
Also causing concern for the industry is a Commission proposal in article 2.2 of the directive to provide for 'cases of doubt'. Under such circumstances, the pharmaceutical directive will apply, 'even where the product also falls within the scope of other Community legislation.'
This provision could give pharmaceucial authorities the power to question food supplements, even those complying with the new EU food supplement directive.
"We are hoping that courts would be obliged to take into account jurisprudence and that existing practice would prevent the use of medicines legislation in such cases," said Vicente Azua.
The final vote on the amendments to Directive 2001/83/EC relating to medicinal products for human use takes place in the European Parliament in December.
