Life Sciences – Pharmaceutical law
Life Sciences – and in particular pharmaceutical law – are the main area of expertise and operation of the Firm, which provides legal advice and assistance to a significant part of the major Italian and international companies operating in the sector.
For many years the Firm’s professionals have been permanently involved in the most difficult and important disputes for the pharmaceutical industry, and they now boast competence and qualified experience in litigation before the Regional Administrative Courts, the Council of State, the ordinary jurisdiction of any degree, the Constitutional Court and the European Court of Justice against:
• the resolutions regarding the settlement obligations against the companies for the exceeding of the annual expenditure ceilings set for territorial and hospital pharmaceutical care (the so-called pharmaceutical payback);
• the resolutions adopted by AIFA and the Regions with regard to the therapeutic equivalence between medicinal products based on different active ingredients;
• the resolutions adopted by AIFA and the Regions regarding the Marketing Authorization of medicinal products, their use and their reimbursement by the SSN (the Italian NHS);
• the inclusion in the so-called “transparency list” of equivalent drugs;
• the measures taken by the Regions and the individual NHS Authorities on the directives and recommendations on the appropriateness of prescriptions;
• the measures for failed or delayed inclusions of medicinal products in the Regional Therapeutic Handbooks;
• the resolutions adopted by the competent Authorities in terms of pharmacovigilance and drug advertising;
• the acts of the tenders launched by the regional purchasing centers and by the SSN (NHS) bodies for the purchase of the medicinal products necessary for their needs;
• the resolutions regarding the marketing and use of homeopathic, traditional and herbal medicines.
The Firm also deals with assisting and representing its Clients – where necessary, also with the support of other professionals with additional specific skills – in the proceedings to be carried out before AIFA (the Italian Medicines Agency) or EMA (the European Medicines Agency) on the matter of Marketing Authorization for new medicinal products, negotiation and renegotiation of the price and reimbursement conditions, pharmacovigilance, promotional strategies, sales licensing, co-promotion and co-marketing. Similarly, the Firm provides legal assistance in proceedings falling under the competence of ANAC (Autorità nazionale anticorruzione, “National Anti-Corruption Authority”), in particular with regard to reference prices, information and registrations in the Registry maintained by the Authority, and so on.
Due to their high specialization and competence, Prof. Vaiano and the Vaiano-Cataldo Law Firm represent an undisputed point of reference in the legal field of Healthcare and Life Sciences, where they received numerous awards from the most famous and authoritative specialized magazines/journals.
Life Sciences – Medical devices
The Firm offers companies that produce and market medical devices advice and assistance in litigation before the Regional Administrative Courts, the Council of State and the ordinary jurisdiction of any degree on issues related to the interpretation and application of the national and community legislation governing the matter, with particular regard to the procedures under the competence of the Ministry of Health, the CE marking, sales licensing, etc., also supporting them in analyzing the current governance system of public expenditure for the purchase of medical devices (the so-called payback) and in examining its critical issues.
The Firm’s professionals also offer assistance to client companies in every phase of the public procedures announced (by CONSIP, by the regional purchasing centers and by the individual Health Authorities) for the supply of the medical devices necessary to meet the needs of the SSN (NHS) bodies/institutions, from the study of the tender deeds to the preparation of the quotation documents, up to the executive phase, assisting them where necessary before the Regional Administrative Courts, the Council of State and the civil courts (Courts, Courts of Appeal and Court of Cassation).