Restitution Of The Amounts Pursuant To The Procedure Dirimborsabilita ' Conditioning For Medicinal Products Included In 2013 And 2014 Years Aifa, Monitoring Registridi. (Resolution No. 296/2015).

Original Language Title: Restituzione delle somme in applicazione delle procedure dirimborsabilita' condizionata per i medicinali inseriti nei registridi monitoraggio AIFA, anni 2013 e 2014. (Determina n. 296/2015).

Read the untranslated law here: http://www.gazzettaufficiale.it/atto/serie_generale/caricaArticoloDefault/originario?atto.dataPubblicazioneGazzetta=2015-03-24&atto.codiceRedazionale=15A02228&elenco30giorni=false&atto.tipoProvvedimento=DECRETO

The DIRECTOR-GENERAL having regard to articles 8 and 9 of legislative decree July 30, 1999, # 300 and subsequent amendments and additions ("reform of the Government, in accordance with art. 11 March 15, 1997, law No. 59); Visto l'art. September 30, 2003, 48 of Decree-Law n. 269, converted, with amendments, into law no 326 November 24, 2003 and subsequent amendments and additions, containing "urgent provisions to promote the development and correction of the trend of public finances and, in particular, paragraph 1 and subparagraph 5, letters f) and f-bis), of that Decree; Having regard to the Ministerial Decree September 20, 2004, n. 245 entitled "regulation laying down rules on the organisation and the functioning of the Italian Medicines Agency pursuant to art. 48, paragraph 13 of the Decree-Law September 30, 2003, n. 269, converted, with amendments, into law no 326 November 24, 2003», as amended by the Decree of the Ministry of health March 29, 2012, # 53 ("changing the rules and functioning of the Agenzia italiana del farmaco (AIFA), in art. 17, paragraph 10, of Decree-Law No 98 July 6, 2011, converted, with amendments, into law July 15, 2011, n. 111 '), published in the official journal of May 8, 2012, # 106; Having regard to the Decree of the Minister of health of November 8, 2011, recorded by the Central Office of the budget to the register «simple» Visas, sheet # 1282, dated November 14, 2011, with which he was appointed Director General of the Italian Medicines Agency. Luca Pani, as from November 16, 2011; Having regard to resolution No. 41 of November 6, 2014 by which the AIFA'S Board of Directors adopted a new regulation for the organisation, administration and the organisation of the Italian medicines agency staff; Having regard to regulation for the organisation, administration and the organisation of the Italian medicines agency staff, whose publication on the institutional site of the AIFA was given notice in the official journal-General series-# 22 of January 28, 2015; Given the determination HR/DC/FM # 130/May 28, 2012 DG establishing the management unit registers for monitoring drug protocols-data management experts AIFA; Visto l'art. 48, paragraph 33, of Decree-Law No September 30, 2003, # 269, converted, with amendments, into law no 326 November 24, 2003 and subsequent amendments and additions, which stipulates that, as from 1 January 2004 all the prices of medicines reimbursed by the national health service (NHS) are determined through bargaining between AIFA and producers, according to the modalities and the criteria set out in resolution CIPE 1 February 2001 , n. 3 (' identification of the criteria for drug price bargaining "); Visto l'art. 15, paragraph 6, letter c) of Decree-Law No 95 July 6, 2012, converted, with amendments, into law No 135 August 7, 2012 and subsequent amendments and additions, which provides that the hospital pharmaceutical expenditure is calculated net of repayments from pharmaceutical companies, including in the form of extra-discounts, to the regions and autonomous provinces of Trento and Bolzano in application of new listings ' conditioning procedures (payment by results, risk sharing and cost sharing), signed in the trading price of the medicinal product in accordance with art. 48, paragraph 33, of Decree Law September 30, 2003, n. 269, converted, with amendments, into law no 326 November 24, 2003 and subsequent amendments and additions; Considered the memorandum of understanding, which provides the May 29, 2014-AIFA Farmindustria forms of cooperation between the parties in order to contribute to the efficient management of the registers of monitored drugs; Considered the guideline AIFA for managing refunds conditioned through logs to prepared for the years 2012 and 2013 AIFA platform on April 15, 2014, as well as the program for enabling conditional reimbursement procedures for the years 2012-2013, both released on the institutional Portal AIFA, register section drugs monitored; View AIFA determination October 30, 2014, n. 1239, published in the official journal-General series-October 31, 2014, # 254 bearing "the Shelf is breaking the roof of 3.5% of hospital pharmaceutical expenditure 2013, pursuant to Decree-Law No 95 July 6, 2012, converted, by law No 135/2012 and subsequent modifications and integrations»; Considered that the amounts mentioned in art. 15, paragraph 6 (c), of Decree-Law No 95, the aforementioned July 6, 2012, contribute to the determination of hospital pharmaceutical expenditure and possible breakage of the roof of the 3.5% nationally; See the press release of December 30, 2014, under which AIFA announced to the users of the extension to March 31, 2015 monitoring logs for data entry describing how paper and/or awarded retrospectively, as shared in December 16, 2014 meeting with representatives of the regions and the autonomous provinces of Farmindustria; Seen the need to deploy in a span large telematic interface activation within the new platform AIFA monitoring logs; Does the opportunity to ensure a prompt return of pharmaceutical companies to the regions and the autonomous provinces of Trento and Bolzano sums for new listings ' conditioning procedures already concluded; Visto l'art. 25, paragraph 3 of law August 7, 1990, n. 241 («new rules on administrative procedure and the right of access to administrative documents ") and subsequent amendments; Visto l'art. 17, paragraph 2, of the implementing regulation 2 and 4 August 7, 1990 law articles AIFA, n. 241 and subsequent modifications and integrations for accessing documents and digitisation; Deemed necessary, therefore, to provide for the regulation of methods of payments arising from reimbursement conditioned by the presence of pharmaceutical companies in respect of public health facilities with which they relate;
Determines:

Art. 1 1. This provision lays down the rules ' on the part of pharmaceutical companies of sums relating to the application of procedures for new listings ' conditioning (payment-by-results, cost-sharing, risk-sharing, success fee, etc.) to health services of the national health service. 2. It regulates the recasting of these amounts, subject to subsequent adjustment, following the completion of the access opening of related telematic interface within the new platform AIFA monitoring logs.