Ateneo - UPO

Module 1 (1 CFU): Intellectual property: Importance of intellectual property, with particular reference to patents. Purpose of patents, historical background, definitions. Prior art searches, novelty, and inventiveness. Filing, examination, publication, registration, maintenance, and claims.
Module 2 (1 CFU): Pharmaceutical policy and market access in major European countries. Pharmaceutical market access steps: approval (specifically, EMA centralized approval). Market access: pricing and reimbursement in major European countries.
Module 3 (2 CFU): Health Technology Assessment (HTA), economic evaluation of medicines, and market access in Italy and for highly complex medicines. Value-based pricing. Market access, pricing, and reimbursement (P&R) in Italy. Critical access areas: rare diseases and access to medicines in low and middle income countries.

There are no textbooks. Reading materials will be suggested lecture by lecture.

Students are expected to learn: how to protect the results of pharmaceutical research and development; the role of regulatory affairs and market access managers; how do the national and European regulatory and HTA agencies work; the organizations that negotiate drug pricing and reimbursement; and the economic evaluation techniques applied to pharmaceuticals.

There are no prerequisites for attending the course.

Lectures, practical applications, exercises, and case discussions.

Students with physical disabilities, Learning Disorders (DAA), or Special Educational Needs (BES) can request specific services through university staff and contact the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti (https://uniupo.it/it/servizi/servizi-studentesse-e-studenti-condizione-di-disabilit%C3%A0-e-dsa). Students with physical disabilities, Learning Disorders (DAA), or Special Educational Needs (BES), after having contacted the Staff, may get in touch with the course instructor regarding the exam details and the teaching issues.

Written exam with open- questions and exercises, covering the entire programme

Module 1: Intellectual property rights (utility models, industrial designs, trademarks, copyright, patents). International regulation and patenting strategies. Patentability criteria. Applications to pharmaceuticals.
Module 2: Role of regulatory affairs and market access; regulation of the pharnaceutical market, international guidelines, marketing approval, role of regulatory agencies; price negotiation and reimbursement in major European countries.
Module 3: Introduction to HTA and economic evaluation; pricing and reimbursement in Italy; managed entry agreements (MEAs); regional and local policies; focus on orphan drugs and advanced therapies. Access to medicines in low- and middle-income countries.

By the end of the course, the student will be familiar with the main regulations of medicines for human use, the economic evaluaitons techniques within HTA, and the market access pathway - from pricing and reimbursement to regional access.