SFKKIF006U  Pharmaceutical Policy – an International Perspective

Volume 2017/2018
Education

MSc Programme in Pharmacy or Pharmaceutical Sciences (Danish programmes cand.pharm and cand.scient.pharm) - elective

MSc Programme in Medicinal Chemistry - elective

MSc Programme in Pharmaceutical Sciences (English programme) - elective

Content

Pharmaceuticals are one of the most regulated products in society. The policies influencing the use of pharmaceuticals are international, intranational, national and local. Decision makers must make policy decisions from the earliest preclinical stages through all phases of drug development, production, distribution and drug use. These decisions affect the supply and use of medicines and impact on public health as well as the health and welfare of groups and individuals.

The course focuses on how pharmaceutical policies are made, how regulations are formulated and administered and, finally, the effects of policy making, particularly with regard to drug utilization and ultimately health. The course introduces the key issues and central aspects of various pharmaceutical policy approaches and policy decision-making, including the central actors and institutions on international, intranational and national levels. Case studies are selected from the areas of drug distribution, financing, drug safety, drug use and health to illustrate the dynamics and consequences of pharmaceutical policy.

The aim of the course is to give participants insight into and understanding of current developments affecting pharmaceutical policy making today. The course also aims to give participants a better understanding of the theories and methods available for analyzing the effects of policy interventions.

Learning Outcome

On completion of the course participants should be able to:

Knowledge

  • describe pharmaceutical policy processes on the international, intranational and national levels

  • describe and explain various approaches to pharmaceutical policymaking; how regulations are formulated and administered as well as the difference between these two

  • explain how pharmaceutical policy affects and creates a framework for the supply and the use of pharmaceuticals

  • identify and describe typical and important pharmaceutical policy issues

  • identify major actors associated with pharmaceutical policymaking and the potential conflicts between them

  • explain, reflect upon, and discuss the effects of policymaking on drug use on the international, intranational and national levels

Skill

  • evaluate the relationship and dynamics of pharmaceutical policies, regulations and their implications for drug use and health

  • assess and discuss the contribution and perspectives of major actors associated with pharmaceutical policymaking

Competence

  • participate in professional multi-disciplinary groups and be able to contribute with a policy perspective on pharmaceuticals in a health policy context

  • independently transfer a policy perspective to specific international, intranational and/or national pharmaceutical issues and/or challenges

Abbott FM, Dukes G. Global Pharmaceutical Policy.Edward Elgar, Cheltenham UK. 2009

Almarsdóttir AB, Morgall Traulsen J. Rational use of medicines – an important issue in pharmaceutical policy. Pharmacy World & Science 2005; 27: 76-80

Almarsdóttir AB, Morgall Traulsen J. Studying and evaluating pharmaceutical policy – becoming a part of the policy and consultative process. Pharmacy World & Science 2006; 28: 6-12

Almarsdóttir AB, Morgall Traulsen J. Multimethod research into policy changes in the pharmacy sector – The Nordic case. Research in Social and Administrative Pharmacy 2009; 5: 82-90

Almarsdóttir AB, Morgall Traulsen J. Cost-containment as part of pharmaceutical policy. Pharmacy World & Science 2005; 27: 144-148

Eichler H-G, Abadie E, Baker M & Rasi G. Fifty years after thalidomide; what role for drug regulators?. British Journal of Clinical Pharmacology.(2012) 74:5; 731-733.

Larsen JB, Vrangbaek K, Traulsen JM. Advocacy coalitions and pharmacy policy in Denmark – Solid cores with fuzzy edges. Social Science & Medicine 2006; 63: 212-224

Morgall Traulsen J, Almarsdóttir AB. Pharmaceutical policy and the lay public. Pharmacy World & Science 2005; 27: 273-277

Morgall Traulsen J, Almarsdóttir AB. Pharmaceutical policy and the pharmacy profession. Pharmacy World & Science 2005; 27: 359-363

Morgall Traulsen J, Almarsdóttir AB. The argument for pharmaceutical policy. Pharmacy World & Science 2005; 27: 7-12

Noerreslet M, Larsen JB, Traulsen JM. The medicine user – Lost in translation? Analysis of the official political debate prior to the deregulation of the Danish medicine distribution system. Social Science & Medicine 2005; 61: 1733-1740

 

A bachelor's degree in health, natural or technical sciences
Seminars, lectures, oral presentations and field trips.
Credit
7,5 ECTS
Type of assessment
Course participation
Course certificate.
Term paper presenting a case study on a topic approved by the course leader.
Students individually write a paper on a case of pharmaceutical policy with international implications. The paper should be based on literature from the curriculum and other sources of data specific for the case. The papers will be presented during seminars, giving students the opportunity to discuss and critique each other’s work. Relevant critique should then be incorporated in the final version of the paper.
Exam registration requirements

Active participation and a minimum of 80% attendance.

Aid
Written aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Criteria for exam assesment

To pass the course the student should be able to:

Knowledge

  • describe a pharmaceutical policy process on international, intranational and/or national levels

  • describe and explain at least one approach to pharmaceutical policymaking; how regulations are formulated and administered

  • explain how pharmaceutical policy affects and creates a framework for the supply and/or the use of pharmaceuticals.

  • identify and describe an important pharmaceutical policy issue

  • identify major actors associated with pharmaceutical policymaking and the conflicts between them

  • explain, reflect upon, and discuss the effects of policymaking on drug use on the international, intranational and/or national levels

Skill

  • evaluate the relationship and dynamics of pharmaceutical policies, regulations and their implications for drug use and/or health

  • assess and discuss the contribution of major actors associated with pharmaceutical policymaking

Competence

  • independently transfer a policy perspective to a specific international, intranational and/or national pharmaceutical issues

  • Category
  • Hours
  • Lectures
  • 20
  • Study Groups
  • 30
  • Field Work
  • 10
  • Guidance
  • 5
  • Seminar
  • 14
  • Preparation
  • 127
  • Total
  • 206