Ateneo - UPO

Module 1 (1 CFU): intellectual property.
This module will deal with intellectual property protection, giving the student sufficient information to be able to undergo a prior art search, write a patent and evaluate the solidness of patents. The topics covered will be: the importance of intellectual property and trademarks, the scope of patents, brief history and definitions, prior art searches, novelty and inventiveness, the person skilled in the art, databases used, filing, examination, publication, approval, maintenance, claims, unitary patent, SPC waiver, classification of patents in the pharmaceutical sciences, litigations. Several examples will be shown.

Module 2 (1 CFU): regulation of the pharmaceutical market and market access in the main European Countries.
This module aims at describing the main phases of market access for pharmaceuticals: approval (with a specific focus on centralised marketing authorisation managed by the European Medicines Agency) and market access (mainly pricing and reimbursement) in the main European Markets.

Module 3 (2 CFU): Pharmacoeconomics, Health Technology Assessment (HTA), Market Access in Italy and for critical drugs. This module will describe (i) the main methodologies that determine the drug value and the relevant prices, within a general overview on HTA; (ii) Market access and price and reimbursement (P&R) in Italy (iii) critical access areas (e.g., rare diseases, low-resource contexts)

Ad hoc readings

At the end of the course, the student will understand how to protect the results of the research and development on medicines; will learn the role of regulatory affairs professionals and market access managers, and of national and European regulatory agencies and organisations that negotiate the price and reimbursement status of drugs. Moreover, the student will learn the techniques of economic evaluation applied to drugs within a Health Technology Assessment (HTA) approach.

None

The course includes lectures in the classroom with slide projection, practical applications, and exercises.

Students with physical disabilities, Learning Disabilities or Special Education Needs can request specific services and tools via the Staff Sviluppo e Coordinamento Carriere e Servizi alle Studentesse e agli Studenti, consulting the University webpage: https://www.uniupo.it/en/services/services- students-physical-or-learning-disabilities.
Students with disabilities, learning disabilities or special education needs, once they have contacted the University Staff, can refer to the tutor in charge of the course to define the examination modalities, concerning academic aspects.

The achievement of the learning objectives will be assessed through a final multiple-choice test (32 questions) including also simple exercises. The test will assess the knowledge of the marketing authorisations procedures, market trends, market access, and price and reimbursement processes from a national and international perspective. Moreover, the test will assess the knowledge of the main pharmacoeconomic analysis techniques and the knowledge of HTA.

Module 1 (1CFU): intellectual property.
Intellectual property rights: general information about utility model, industrial design, trademark, copyright. Patent and patentability. Claims and description. Patent convention and protection strategy.
Prior art search and freedom to operate.

Module 2 (1 CFU): regulation of the pharmaceutical market and market access in the main European Countries. Introduction to regulatory affairs and market access.
Medicines regulation and main international guidelines. Types of drug approval (national and European). The role of regulatory agencies, Market access in the international perspective and price and reimbursement (P&R) negotiation in the main European Countries.

Module 3 (2 CFU): Pharmacoeconomics (introduction to basic economic analyses), Health Technology Assessment (HTA), market access in Italy and for critical drugs. Price and reimbursement (P&R) in Italy. Managed Entry Agreements (MEAs). Regional and local policies. Focus on orphan drugs, medicines for advanced therapies (ATMPs) and personalized therapies, neglected tropical diseases and drug access in middle- and low- income countries. Inequalities in drug access according to socio-economic variables (e.g., income, gender, education).

At the end of the course, the student will know the main regulations and laws applied to drugs for human. Also, the student will know the main techniques of pharmacoeconomic analyses and the main HTA, market access and price and reimbursement (P&R) processes from a national and international perspective.