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. PATRIZIA RAMPINELLI:

"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
- Hierarchy of Italian regulatory sources
- 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
- Dispensing of Medicines
- The medical prescription (the types)
- The dematerialized prescription
- 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
- Consultation of the Martindale
- 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)

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": the Pharmacy of services
- The day and night shifts of the Pharmacies

ETHIC CODE OF THE PHARMACIST ANDOath OF THE PHARMACIST

 - Comment on some rules

- Sent. Court of Cassation No. 26810, 12.20.2007

PHARMACEUTICAL REGULATION
- Regulation of medicinal products for human use manufactured by industry: Directive 2001/83/EC: Code of medicinal products for human use
- Regulation of medicinal products for veterinary use manufactured by industry: Regulation 2019/6/EU -
- Definitions contained in Legislative Decree 219/2006
- Definition of medicine by presentation and by function
- Marketing authorization for medicinal products (MA) and related procedures: national, mutual recognition, centralized and decentralized
- Common Technical Document
- The EPAR report
- Clinical trials (outline)
-Good manufacturing practices (GMP)
- 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
- ISO standard for products other than medicines: cosmetics, medical devices. (hints)

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

 

Section 2 (4 CFU) PROF. LEONARDO MARCHITTO:

"REGULATORY AFFAIRS, HEALTH TECHNOLOGY ASSESSMENT & PHARMACOECOMICS"

Regulatory Activities (Regulatory Science):

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

- Technical Regulations for Pharmaceutical Development (ICH and EMA guidelines) Notes on the European and Italian Regulatory System for Medicines, the CTD (Common Technical Document) and the legal bases, procedures and regulatory activities for the registration and maintenance of registration dossiers,

- Advanced quality assessment techniques and procedures for the formulation of medicines: APIs and Excipients Strategic approach to drug development ICH Q8A Pharmaceutical development procedure. GMP

Pharmacoeconomics/ Health Technology Assessment (HTA):

- Preamble, what is Pharmacoeconomics?

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

- Market Access (MA), pricing and reimbursement procedures for medicines; transparency lists. Pharmacoeconomic techniques, drug utilization,

- Pharmaceutical Market and «Patient Integrity» Antitrust issues in the pharmaceutical sector; Import and parallel trade of medicines.

- Technical Regulations for Pharmaceutical Development (ICH and EMA guidelines)

- Notes on the European and Italian Regulatory System for Medicines the CTD (Common Technical Document) and the legal bases

- Procedures and regulatory activities for the registration and maintenance of registration dossiers

Advanced quality assessment techniques and procedures for the formulation of medicines

- APIs and Excipients Strategic approach to drug development ICH Q8A Pharmaceutical development procedure

- GMP

Pharmacoeconomics/HTA:

- Preamble, what is Pharmacoeconomics?

- Definitions and general approach, pharmaceutical indicators

- Health Technology Assessment (HTA) and applications to the world of medical devices

- Market Access (MA), pricing and reimbursement procedures for medicines; transparency lists

- Pharmacoeconomic techniques, drug utilization

- Pharmaceutical Market and «Patient Integrity» Antitrust issues in the pharmaceutical sector

- Import and parallel trade of medicines.

 

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

EXERCISES:

REGULATORY RESEARCH OF INTEREST

Assessment methods

ORAL EXAMINATION

WITH THE POSSIBILITY OF STARTING THE EXAMINATION WITH A pptx PRESENTATION of a topic chosen by the student

complete with bibliography

Office hours

See the website of Patrizia Rampinelli

See the website of Leonardo Marchitto