AU kursuskatalog arkiv

6970 European Pharmaceutical Law ( efterår 2011 - 10 ECTS )

Rammer for udbud

• Uddannelsessprog: engelsk
• Niveau: Masters
• Semester/kvarter: Autumn 2011
• Timer per uge: 3
• Deltagerbegrænsning: 30
• Undervisningssted: Århus
• Hovedområde: Det Samfundsvidenskabelige Fakultet
• Udbud ID: 32552

Tid og sted

Tuesday 10-13 in building 1323, room 130
first lessons on the 30th August 2011

Formål

Development and placement of a drug on the European market is a long process. It starts from research and continues through clinical trials, patent registration, drug registration, pricing and setting of the reimbursement from the health insurance, marketing, distribution, prescription, dispensing and using of the drug. Pharmaceutical industry is therefore characterized by a complex system of interrelations between different subjects involved in each stage of the process. These subjects include governments, pharmaceutical companies, patients, insurance companies, physicians and pharmacists. Each of the actors has a different interests and bargaining power. The wide scope and the interplay between activities of all the actors create dynamical system of relationships that has to be strictly regulated in order to maintain its stability and functionality.

The aim of the course is to provide students with the comprehensive horizontal overview of the legal regulations and principles governing pharmaceutical business in Europe. Knowledge of the relevant legal regulations and understanding of the balance of interactions between relevant subjects is essential for everybody working within pharmaceutical industry regardless of his or her position (scientist, physician, lawyer, accountant, product manager, government officer etc.). The students will acquire the ability to identify and analyze important legal issues within pharmaceutical business activities, to find the relevant sources of European law governing these matters and propose optimal measures to be taken under the applicable legal instruments while solving different problems.

Indhold

The course is designed to give the students a solid understanding of the EU legal regulation of the pharmaceutical market mainly from the perspective of a pharmaceutical company. The course is designed as a case study of a drug's lifecycle and will mainly cover the following issues:

• ethical issues and legal regulation of clinical trials (privacy and data protection, contracts with clinical research organizations);
• EC directive 2001/83/EC and guidelines on drug registration (types of registration procedure - national, mutual recognition, decentralized, centralized, transfer and change of registration);
• specifics of drug patents (supplementary protection certificate, regulatory data protection, patent litigations between original and generic companies, relevant competition law concerns - patent settlements, misuse of patent protection against entrance of new drugs on the market);
• legal regulation of drug advertising (advertisement aimed at healthcare professionals and at patients, advertisement v. information to patient, EU Pharmaceutical Package - proposal for new regulation);
• introduction to different pricing systems in EU (comparison of chosen national regulations, generic prescription);
• distribution relationships (license and distribution contracts, distribution schemes, parallel trade, relevant competition law concerns - exclusive distributorship, vertical agreements);
• overview of ethical issues in pharmaceutical industry (relationship between pharmaceutical companies and healthcare professionals, anti-bribery regulations, codes of conduct, CSR, compulsory licensing).

The teaching method is based on lectures combined with class discussion and exercises. The topic will be approached mainly by analyzing relevant case law of the European Court of Justice. The students will have the chance to meet with guest lecturers from pharmaceutical companies, law offices and law professionals who will be invited to present some of the topics.

Faglige forudsætninger

None

Underviser

Katerina Peterkova

Undervisnings- og arbejdsform

The instruction is based on lectures and seminars combined with open-class discussion, case studies and exercises.

English

Litteratur

(The main text is Elias Mossialos, Monique Mrazek, Tom Walley (ed.): Regulating pharmaceuticals in Europe: striving for efficiency, equity and quality (2004) [1] .)

Additional reading materials will be handed out and referred to during the course.

[1] Subject to change; searching for more suitable course book.

Bedømmelse

Oral examination, 7-point grading scale, with external co-examiner.