B2972 - Pharmacy Law, Ethics and Regulation

Learning outcomes

Upon completion of the course, the student: - possesses the specific knowledge related to the legislative and ethical rules necessary for carrying out the profession of pharmacist, including the regulation of the new services provided in the pharmacy (la farmacia dei servizi). - possesses the specific knowledge on the national and Community laws which regulate the various activities of the sector in the field of medicinal products and products for health and well-being, aimed at guaranteeing the safety, quality and efficacy requirements required by WHO regulations and by national and European directives; - possesses the basic knowledge on intellectual properties in the pharmaceutical and biomedical fields; - possesses the methodological and regulatory principles relating to the quality control of medicines and other products for health and well-being; - has acquired the principles of regulatory affairs related to the production, distribution, trade and dispensing of medicinal products and products for health and well-being; - have acquired the principles of pharmacoeconomics, with specific reference to the Health Technology Assessment.

Course contents

- Section 1 (4 CFU) PROF. GIAN MARIA ROSSI:

"PHARMACY LAW, ETHICS & INTELLECTUAL PROPERTY"

SUPRANATIONAL PHARMACEUTICAL REGULATION
- Supranational organizations and their functions in the field of health (UN, WHO)
- Regulatory sources of the European Union (Directives, Regulations, Delegated Acts)
- Notes on the institutions of the European Union
- The Agencies of the European Union: EMA, EFSA
- The FDA

ITALIAN PHARMACEUTICAL REGULATION
- Evolution of the concept of health
- The "Pharmacy System"
- Definition of: jurisprudence, doctrine, jurisdiction
- Article 32 of the Italian Constitution
- AIFA

HEALTH CARE PROFESSIONS
- Health professions and arts.
- Professional order
- Enrollment in the Register

PRACTICE OF THE PROFESSION OF PHARMACIST
- Code of medicinal products for human use: Legislative Decree 219/2006

- Regulation of medicinal products for human use manufactured by industry: Directive 2001/83/EC: Code of medicinal products for human use

- Definitions contained in Legislative Decree 219/2006
- Definition of medicine by presentation and by function

- Towards the revision of pharmaceutical legislation

- EU Pharma package

- Dispensing of Medicines
- The medical prescription (the types)
- The dematerialized prescription

- REV (veterinary electronic prescription)

- Regulation of medicinal products for veterinary use manufactured by industry: Regulation 2019/6/EU
- The health card
- Off-label prescription
- Medicines that do not require a prescription (SOP and OTC)
- Medicines with narcotic and psychotropic action: Presidential Decree 309/1990
- Anti-doping legislation
- Innovative medicines
- Generic/Equivalent Medicines
- FDA Orange-book
- Biosimilars
- FDA Purple-book
- Delivery of medicines in cases of urgency in the absence of a medical prescription
- Galenic medicines (magistral and officinal) definitions and specific discipline: Law 94/1998
- NBP
- Current legislation and management of dangerous substances (poisons) in Pharmacy
- Special table for Pharmacy Owners
- Official Pharmacopoeia XII and its Tables

- Official definitions of products other than medicines dispensed/sold in pharmacies and notes on the respective legislation: medical devices, medical-surgical aids, cosmetics, foods intended for particular diets (dietary, supplements)

- ISO standard for products other than medicines: cosmetics, medical devices. (hints)

-Note AIFA

-Hospital/Territory Formulary

- Treatment Plans with prescribing restrictions.

-package leaflet and summary of product characteristics

- Pan-European project to combat the spread of falsified medicines in Europe, Dir. 2011/62/EU
- Difference between counterfeit medicine and falsified medicine
- Regulating the online sale of medicines in Europe by European pharmacies

RESPONSIBILITY OF THE PHARMACIST
- Civil, penal, administrative and deontological

ARTICULATION OF THE PHARMACEUTICAL SERVICE
- Territorial distribution of Pharmacies: the organic plan
- Urban and rural pharmacies, ordinary and seasonal dispensaries, branch pharmacies
- Ownership and management of the pharmacy
- Eligibility for pharmacy ownership
- Evolution of the "Pharmacy system" due to law 69/2009: the Pharmacy of services

- telemedicine in the pharmacy
- The day and night shifts of the Pharmacies

-Direct Distribution, Distribution on Behalf (DPC), Reimbursed Distribution through Community Pharmacies

- Deblistering: the ruling of the Italian Council of State.

 

-2025 Budget Law: the "Pharmacy of Services" is established as a permanent feature of the Italian National Health Service (SSN).

ETHIC CODE OF THE PHARMACIST ANDOath OF THE PHARMACIST

 - Comment on some rules

- Sent. Court of Cassation No. 26810, 12.20.2007

ELEMENTS OF INTELLECTUAL PROPERTY
- Industrial property: Patent
- Literary and artistic property: Copyright
- Pharmaceutical invention patentability requirements
- European patent: Classic, Unitary patent
- Complementary Certificate of Protection of Medicines, and Pediatric Extension
- Incremental search
- Biotechnological patent.

-meaning of infringment and imminent infringment of a patent

 

Module 2 (4 credits) Professor Leonardo Marchitto:"REGULATORY AFFAIRS, HEALTH TECHNOLOGY ASSESSMENT & PHARMACOECOMICS"

 Regulatory Activities (Regulatory Science)

• Marketing Authorization (MA) and related procedures: national, mutual recognition, centralized, and decentralized;

• The European and Italian Medicines Regulatory System, the CTD (Common Technical Document), and the legal bases, procedures, and regulatory activities for the registration and maintenance of registration dossiers.

• European Public Assessment Report (EPAR);

• Regulation of medicinal products for human use manufactured by industry: Directive 2001/83/EC: Code of Medicinal Products for Human Use

• Technical Regulations and Guidelines for Pharmaceutical Development (ICH and EMA guidelines)

• Advanced techniques and procedures for the quality assessment of pharmaceutical raw materials for the formulation of medicinal products: APIs and Excipients

• Strategic approach to the development of a medicinal product: ICH Q8A Pharmaceutical Development Procedure.

• Authorization for the manufacturing of medicinal products

• GMP (Good Manufacturing Practices), SOPs (Standard Operating Procedures); technical documentation for manufacturing and pharmaceutical production sites

• Clinical trials (outline);

 

Pharmacoeconomics/Health Technology Assessment (HTA)

• Preamble: What is Pharmacoeconomics?

• Definitions and general approach, pharmaceutical indicators, Health Technology Assessment (HTA), and applications in the world of medical devices.

• Market Access (MA), drug pricing and reimbursement procedures; transparency lists.

• Pharmacoeconomic techniques, drug utilization, Osmed reports

• The Pharmaceutical Market and Patient Integrity; Antitrust issues in the pharmaceutical sector; Importation and parallel trade of medicinal products.

 

Readings/Bibliography

ADVISED TEXTS SECTION 1

MAURIZIO CINI – PATRIZIA RAMPINELLI:

Principi di Legislazione farmaceutica - Ed. Minerva Medica (Torino).

PAOLA MINGHETTI:

Legislazione Farmaceutica - Casa Editrice Ambrosiana (Milano).

BRUNO RICCARDO NICOLOSO - LAURA GIORDANI - MICHELE JOMMI:

1) Le responsabilità del Farmacista nel "Sistema Farmacia"

2) La pianificazione territoriale del "Sistema Farmacia"

3) L'ordinamento e la deontologia nel "Sistema Farmacia”

ADVISED TEXTS SECTION 2

“Pharmacoeconomics : From Theory to the practice” edited by RENÉE J. G. ARNOLD - CRC Press Taylor & Francis Group 2010

The Pharmaceutical Regulatory Process: Second Edition edited by Ira R. Berry , Robert P. Martin 2008 by Informa Healthcare USA, Inc

Teaching methods

FRONTAL LESSONS

Assessment methods

Oral Examination with Grading – Pharmacy Law, Ethics and Regulation (Integrated Course)

• In order to take the examination, the student must have attended at least 80% of the laboratory exercises and 70% of the lectures. Students are reminded to check the prerequisites listed in the course structure diagram.
• Students with learning disorders and\or temporary or permanent disabilities: please, contact the office responsible (https://site.unibo.it/studenti-con-disabilita-e-dsa/en/for-students) as soon as possible so that they can propose acceptable adjustments. The request for adaptation must be submitted in advance (15 days before the exam date) to the lecturer, who will assess the appropriateness of the adjustments, taking into account the teaching objectives.
• For the purposes of assessment, students may make limited, declared, and non-substantive use of generative AI for support activities. The substantive use of AI to complete any part of the assessment is prohibited.

 

Teaching tools

Generative AI may be used as a support tool for individual study, including to deepen understanding of course topics, produce summaries, clarify concepts, and support self-assessment and exam preparation. Students remain responsible for critically evaluating AI-generated content and ensuring the accuracy and reliability of the information used.

Office hours

See the website of Gian Maria Rossi

See the website of Leonardo Marchitto