Portugal: The New National Formulary Of Medicinal Products
Following the creation of the National Pharmacy and Therapeutics Committee, in February 2013 by the Portuguese Health Ministry, with one of its goals being the elaboration of a National Formulary of Medicinal Products ("FNM"), the Government published in the Official Gazette, the Order 7841-B/2013 of June 17 of the Health Ministry, the principles that must be complied with on the elaboration of the FNM. The FNM is a dynamic document containing a list of all the medicinal products that shall be used by the hospitals and establishments of the National Health Service ("NHS") for the treatment of all types of diseases.
This new law that approved the principles and rules for the elaboration of the FNM, establishes that the use of the FNM is mandatory, being immediately established as a general rule that medicinal products that are not in the FNM or in one of its addenda cannot be acquired by the establishments and services of the NHS. In this regard, it should be pointed out the rule that, in the context of public procurement (or other procurement procedures), the purchase of medicinal products by the NHS establishments may only be allowed provided that the proposal to initiate the procedure includes an information from the Pharmacy and Therapeutics Committee of the Hospital or Regional Health Authority, at stake, where it states that the medicinal product to be acquired is included in the FNM, or in one of its addenda.
However, the possibility for the services and facilities of the NHS to purchase medicinal products that are not yet available in FNM, or in any of its addendas, is also foreseen in the new law. For that, the medicinal products to be purchased must be approved by the respective establishments, and the proposal to initiate the procedure shall include information from the National Hospital Pharmacy and Therapeutics, or from the Regional Health Authority concerned, which states that the medicinal product is included in the addendum approved by the service purchaser and that the product is intended for a condition not yet the subject of a monograph or therapeutic protocol in FNM.
We also note that non-compliance with these rules is severely punished. Indeed, administrators or directors of NHS hospitals and Regional Health Authorities authorizing the purchase of medicinal products in violation of the provisions of the new legislation may be civilly, criminally and financially responsible.
Finally, we point out that, until now, the National Pharmacy and Therapeutics Committee approved the therapeutic protocols for HIV and for multiple sclerosis.
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