Pharmaceutical Law

Study Course Description

Course Description Statuss:Approved

Course Description Version:9.00

Study Course Accepted:02.02.2024 12:30:28

Study Course Information
Course Code:		JF_048		LQF level:		Level 6
Credit Points:		2.00		ECTS:		3.00
Branch of Science:		Law; Civil Rights		Target Audience:		Juridical Science
Study Course Supervisor
Course Supervisor:		Olita Staņislavska
Study Course Implementer
Structural Unit:		Faculty of Social Sciences
The Head of Structural Unit:
Contacts:		Dzirciema street 16, Rīga, szfrsu[pnkts]lv
Study Course Planning
Full-Time - Semester No.1
Lectures (count)		12	Lecture Length (academic hours)		2	Total Contact Hours of Lectures		24
Classes (count)		4	Class Length (academic hours)		2	Total Contact Hours of Classes		8
Total Contact Hours								32
Part-Time - Semester No.1
Lectures (count)		4	Lecture Length (academic hours)		2	Total Contact Hours of Lectures		8
Classes (count)		1	Class Length (academic hours)		2	Total Contact Hours of Classes		2
Total Contact Hours								10
Study course description
Preliminary Knowledge:
Legal Theory, Human Rights, Introduction to Civil Law, Civil Procedural Law, Administrative Law, Administrative Process, Criminal Law. General Part, Criminal Law. Special Part, Criminal Process. General Part, Criminal Process. Special Part.
Objective:
Provide and assist in understanding of information that will contribute to the development of a body of theoretical knowledge, in particular: 1. To form, develop and strengthen students’ theoretical knowledge in the field of pharmaceutical law. 2. To develop understanding of pharmaceutical law and in application of legal norm interdisciplinary context. 3. To deepen students' understanding and analytical skills by solving current issues in pharmaceutical law. This course provides students with knowledge on pharmaceutical law, from the founding thereof to current issues, provides insights into how pharmaceutical law is directly related to other areas of law, and provides knowledge about the legal framework for drug manufacturing and distribution from the viewpoints of all those involved.
Topic Layout (Full-Time)
No.	Topic			Type of Implementation		Number	Venue
1	Pharmaceutical Law and its development. The role of the state in enacting pharmaceutical legislation. Legal entities of pharmacy and their interests.			Lectures		1.00	auditorium
2	Medicinal products – subject-matter of pharmacy. Borderline products. Distinction between medicinal products and borderline products according to their characteristics.			Lectures		1.00	auditorium
3	General conditions for the quality of medicinal products. Counterfeit medicinal product.			Lectures		1.00	auditorium
4	Legal conditions for the admissibility of the use of medicinal products in health care.			Classes		1.00	auditorium
5	Legal aspects of the development of medicinal products and pre-clinical research.			Lectures		1.00	auditorium
6	Legal aspects of clinical trials on medicinal products.			Lectures		1.00	auditorium
7	Exclusive data protection for medicinal products.			Lectures		1.00	auditorium
8	Legal aspects of patent protection for medicinal products. Supplementary protection certificate.			Lectures		1.00	auditorium
9	Competition aspects in pharmaceutical law.			Classes		1.00	auditorium
10	Free movement of medicinal products and restrictions thereof. Legal aspects of wholesale and retail trade. Vertical and horizontal integration.			Lectures		1.00	auditorium
11	Aspects of price formation of medicinal products, conditions for compensation and dispensing procedure.			Lectures		1.00	auditorium
12	Legal aspects for medicinal product advertising.			Lectures		1.00	auditorium
13	Interaction between compensation for medicinal products and price formation.			Classes		1.00	auditorium
14	Supervision of medicinal products. Pharmacovigilance and vigilance systems, basic principles and participants.			Lectures		1.00	auditorium
15	Legal aspects of the patient-community benefit relationship.			Lectures		1.00	auditorium
16	Legal evaluation of benefit/risk ratio of the patient and the community relationship.			Classes		1.00	auditorium
Topic Layout (Part-Time)
No.	Topic			Type of Implementation		Number	Venue
1	Pharmaceutical Law and its development. The role of the state in enacting pharmaceutical legislation. Legal entities of pharmacy and their interests.			Lectures		0.25	auditorium
2	Medicinal products – subject-matter of pharmacy. Borderline products. Distinction between medicinal products and borderline products according to their characteristics.			Lectures		0.25	auditorium
3	General conditions for the quality of medicinal products. Counterfeit medicinal product.			Lectures		0.25	auditorium
4	Legal conditions for the admissibility of the use of medicinal products in health care.			Lectures		0.25	auditorium
5	Legal aspects of the development of medicinal products and pre-clinical research.			Lectures		0.25	auditorium
6	Legal aspects of clinical trials on medicinal products.			Lectures		0.25	auditorium
7	Exclusive data protection for medicinal products.			Lectures		0.25	auditorium
8	Legal aspects of patent protection for medicinal products. Supplementary protection certificate.			Lectures		0.25	auditorium
9	Competition aspects in pharmaceutical law.			Lectures		0.25	auditorium
10	Free movement of medicinal products and restrictions thereof. Legal aspects of wholesale and retail trade. Vertical and horizontal integration.			Lectures		0.50	auditorium
12	Legal aspects for medicinal product advertising.			Lectures		0.25	auditorium
14	Supervision of medicinal products. Pharmacovigilance and vigilance systems, basic principles and participants.			Lectures		0.50	auditorium
15	Legal aspects of the patient-community benefit relationship.			Lectures		0.50	auditorium
16	Legal evaluation of benefit/risk ratio of the patient and the community relationship.			Classes		1.00	auditorium
Assessment
Unaided Work:
• 2 home assignments with a specific task for seminar preparation: analyse a court judgement, express own reasoned opinion, presentation and justification of the own opinion (assessment on a 10-point grading scale: analysis of a court judgement and reasoning: 50%; quality of the content of the presentation: 20%; speaking in public: 20%; opposing: 10%); • 2 practical assignments with a specific task (corresponding to the lecture plan): prepare a reasoned opinion on a case (assessment on a 10-point grading scale: reasoned opinion: 50%; design, style and grammar of the reasoned opinion: 30%; participation in the discussion: 20%); • draft and write an essay (the topic of the essay: liability of legal entities and its determination in pharmaceutical law (possibility to choose another topic according to the topics covered in the course); the essay should include: a problem, causal link of the problem, solution to the problem) (assessment on a 10-point grading scale: content: 60%; style and grammar: 20%; layout of the essay: 20%). In order to evaluate the quality of the study course as a whole, the student must fill out the study course evaluation questionnaire on the Student Portal.
Assessment Criteria:
Four tests during the study course: 20%, participation in classes: 20%; practical tasks: 20%; essay: 10%, written examination: 30%.
Final Examination (Full-Time):		Exam (Written)
Final Examination (Part-Time):		Exam (Written)
Learning Outcomes
Knowledge:		After completing the study course, students are able to demonstrate the basic and specialized knowledge characteristic to the particular field of pharmaceutical law and critical understanding of this knowledge; are able to demonstrate understanding of the most important concepts and regularities of the field of pharmaceutical law.
Skills:		Able to demonstrate a scientific approach to problem solving; to independently structure their learning; able to make decisions and find creative solutions in changing or uncertain circumstances; to take responsibility and initiative by doing work individually, in a team or by leading other people; able to direct own further learning and professional development; able to formulate, analytically describe and discuss information, problems, and solutions within the discipline of pharmaceutical law; using the theoretical knowledge and skills acquired, to reasonably discuss them with professionals and non-specialists; able to carry out professional, artistic, innovative or research activities on the basis of theoretical knowledge and skills acquired.
Competencies:		Able to assess the impact of their professional activities on the environment and society; able to demonstrate understanding of professional ethics; to independently acquire, select, analyze and use information; able to participate in the development of the relevant professional field; to make decisions and solve problems in pharmaceutical law.
Bibliography
No.	Reference
Required Reading
1	Ārstniecības likums.
2	Farmācijas likums.
3	Pacientu tiesību likums
4	Patentu likums
5	Fizisko personu datu apstrādes likums
6	Konvencija par Eiropas patentu piešķiršanu
7	Direktīva par Kopienas kodeksu, kas attiecas uz cilvēkiem paredzētajām zālēm: EEK direktīva Nr. 2001/83/EK,
8	The Rules Governing Medicinal Products in the European Union
9	Eudravigilance
10	ASV: Virginia Board of Pharmacy. Federal and state drug law examination handbook.
11	Medicīnas tiesības. Autoru kolektīvs S.Ašnevicas-Slokenbergas zin.red. Tiesu manu aģentūra. Rīga, 2015.
12	Grodin M.A, Tarantola D., Annas G.J, Gruskin S. (ed.). Health and Human Rights in a Changing World (Taylor & Francis, 2013)
13	Tereskerz P.M. Clinical Research and the Law. (Wiley-Blackwell, 2012)
Additional Reading
1	Eiropas Cilvēktiesību tiesas spriedumi
2	Cilvēkiem paredzēto farmaceitisko produktu reģistrācijas tehnisko prasību starptautisko harmonizācijas konferences (International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use – ICH) izstrādāt
3	Appelbe GE, Wingfield J. Dale and Appelbe`s Pharmacy and Medicines Law. 10th ed. Pharmaceutical Press. 2013.
4	Boozang K.M., Coleman C., Miller T.E, Greenvood K., Gutmann V., Handler Hutchinson S., Finizio C. Conflicts of Interests in Clinical Trial Recruitment & Enrollment: a Call for Increased Oversight (Seton Hall 2009)
5	den Exter A; Földes ME. Casebook on European Union health law. Apeldoorn. Maklu, 2014.
6	Merrills J, Fisher J. Pharmacy Law and Practice. 3rd ed. Bleckwell Science, 2001.
7	Sonnedecker G. Kremers and Urdang`s History of Pharmacy. (J.B.Lippincott company 1976)
8	Weissman FG, Pinder J, Berns MR. Pharmacy Practice and Tort Law. McGraw Hill. 2016.
9	Armstrong K. Methods in comparative effectiveness research. Journal of Clinical Oncology. 2012 Dec 1; N30(34): pp.4208 4214.
10	Iacono T, Carling Jenkins R. The human rights context for ethical requirements for involving people with intellectual disability in medical research. Journal of Intellectual Disability Research. 2012 Nov; N56(11): pp.1122–1132.
11	Laventhal N, Tarini B, Lantos J. Ethical Issues in Neonatal and Pediatric Clinical Trials. Pediatric Clinics of North America. 2012 Oct; N59(5): pp.1205–1220.
12	Lundh A, Krogsbøll L, Gøtzsche P. Sponsors` participation in conduct and reporting of industry trials: a descriptivestudy. Trials. 2012; N13(146): pp. 1–6.
13	Marley J. Efficacy, effectiveness, efficiency. Australian Prescriber. 2000; N23: pp.114 115.
14	Miller FG. Clinical research before informed consent. Kennedy Institute of Ethics Journal. 2014 Jun; N24(2): pp.141 157.
15	Rid A, Wendler D. Risk benefit assessment in medical research – critical review and open questions. Law, Probability and Risk. 2010; N9: pp.151 177.
16	Swaroop Vedula S, Li T, Dickersin K. Differences in reporting of analyses in internal company documents versus published trial reports: comparisons in industry sponsored trials in off label uses of gabapentin. PLOS Medicine. 2013 Jan; N10(1): pp. 1–1
17	Taylor T. The Nuremberg Doctors Trial. Opening Statement of the Prosecution (9 Dec 1946).
18	Thomas M, Menon K. Consenting to pediatric critical care research: understanding the perspective of parents. Dynamics. 2013; N24(3): pp. 18–24.