This fulfillment does not constitute such a complex burden as to undermine the prescriptive freedom
Friday, October 24, 2014 – Doctor33
The state regulations governing the prescription of medicines are not significantly affected by regional resolutions which, while trying to encourage the use of less expensive medicines, also because they do not have patent protection, through specific objectives set to the general managers of the Local Health Authorities, leave unchanged the possibility of the prescribing doctor to resort to medicines other than those included in the therapeutic handbooks of the areas defined on the basis of regional indications. The Council of State held that even if the resolution requires the doctor to prepare a justification for the choice made, this fulfillment does not constitute such a complex burden as to undermine the prescriptive freedom and is in any case reasonable, taking into account that the collection of such justifications can constitute a valid documentary basis for the region to be taken into account for the adoption of future measures. [Adv. Ennio Grassini – www.dirittosanitario.net]
Marketing authorization application for a generic drug: the owner of the reference drug can object
The notion of "reference medicinal product" referred to in the Community code relating to medicinal products for human use includes a medicinal product whose Marketing Authorization (MA) was issued using a "well-established medicinal product" as a reference medicinal product. The marketing authorization holder used as a reference medicinal product in an application for marketing authorization for a generic medicinal product from another manufacturer has the right to challenge the authorization of this generic medicinal product.
In Latvia, in 2008, the pharmaceutical company Olainfarm was awarded theMarketing Authorization (MA), in accordance withart. 10 bis of directive 200183, of a medicinal product based on active substances of medical use which has been well established for at least ten years in the European Union.
In 2011, the competent national authorities – the Ministry of Health and the National Medicines Agency – granted the company Grindeks a marketing authorization of one generic drug who had used this first medicinal product (for which Olainfarm is the holder of a marketing authorization) as a reference medicinal product.
Olainfarm requested the annulment of the latter marketing authorization but its complaint was rejected on the ground that the marketing authorization holder of a reference medicinal product does not hold a subjective right enabling him to challenge the marketing authorization granted for a generic medicinal product for that medicinal product.
The question came before the Latvian Supreme Court which deemed it appropriate to ask the Court of Justice, essentially, whether a "well-established medicinal product" can be used as a reference medicinal product, or rather, more specifically, whether the notion of "reference medicinal product" within the meaning of theart. 10, paragraph 2, letter a), of directive 2001/83 must be interpreted as meaning that it includes a medicinal product whose marketing authorization was granted on the basis of Article 10a of the same directive.
Furthermore, asked the referring court, does the manufacturer of this reference medicine, within the context of EU law, have the right to challenge the decision of the national authorities to register the generic?
The EU Court answered affirmatively to both questions, specifying that the right of appeal against the decision of the competent authority granting marketing authorization is recognized to the extent that it is a matter of obtaining the judicial protection of a prerogative that the same art. 10 already recognizes.
