SMIMIF115U Market Access for Pharmaceutical Products – trends and challenges

Volume 2026/2027
Education
Content

This course will provide insight into the key principles and a practical understanding of ‘market access’ as it relates to the pharmaceutical industry. The course starts with an overview of the key stakeholders and current trends in the global market access of pharmaceuticals followed by a review of the challenges and relevant issues through a combination of lectures, discussions, group work, and case studies.

The topics include:

  • Introduction to market access - marketing trends, defining global market access for the 21st century, its importance for optimizing product launches and its implications for the entire organization.
  • Core concepts of market access – defining the concepts, theories and methods relevant for the pharmaceutical industry.
  • Value generation – the role of clinical trials, real-world evidence, life-cycle management and health economics.
  • Stakeholders – who they are, their perspectives, how and when to engage with ‘payers’.
  • Health economic aspects of market access – economic and financial considerations, core concepts and vocabulary.
  • Pricing and reimbursement – global vs. local optimization, reference pricing systems in various markets.
  • Important decision makers in selected countries 
  • Trends in key markets 
  • Patient centricity – the importance of understanding that the end-user must be the focal point of the entire process.
Learning Outcome

After the course, you will have strengthened your capacity to understand and deal with crucial market access issues. You will have learned about key trends in market access and how market access decisions are made and how the decision frameworks affect requirements for evidence for new health care interventions. You will have:

  • Acquired a basic market access vocabulary.

  • Gained insight into the toolbox of the market access methodologies.

  • Gotten an overview of the key challenges of market access.

  • Identified the key stakeholders and their influence on the drug reimbursement and prescription process in some of the most important markets (e.g.: US, UK, Germany and Denmark).

  • Gained an understanding of payers’ perspective of key markets and of new reimbursement models which are impacting market access.

  • Developed skills that will allow you to generate, apply and present real world evidence to maximize market access strategy.

  • Integrated competencies on how to demonstrate product value.

The compulsory syllabus comprises a collection of scientific articles, review papers and case studies corresponding to approximately 500 pages (extra 200 pages self-selected literature for the optional exam).

The course is designed as continuing professional development for professionals in the pharmaceutical industry, particularly in regulatory affairs, medical affairs and sales and marketing, including decision-makers and administrators in the public and private sectors. The course offers an excellent introduction for those less familiar with market access and will provide a deeper understanding for those with experience within administration and marketing. Please note, the course is not an advanced course for market access specialists.
The course comprises lectures, group work, case studies and discussions.
  • Category
  • Hours
  • Class Instruction
  • 40
  • Preparation
  • 22.5
  • Exam
  • 20
  • Total
  • 82.5
Oral
Collective
Continuous feedback during the course of the semester
Credit
3 ECTS
Type of assessment
Home assignment
Type of assessment details
A set written assignment. Individual written assignment based on a relevant set of questions provided by the course managers and based on an extended literature list.
Examination prerequisites

Active participation in the course is a prerequisite for assessment.

Aid
All aids allowed
Marking scale
passed/not passed
Censorship form
No external censorship
Exam period

Deadline for submission of exam: See exam schedule.

Re-exam

Same as ordinary.

Criteria for exam assesment

To achieve a pass, the student must be able to perform at a sufficient level to:

Knowledge

  • Explain how health policy affects and creates a framework for market access and the use of pharmaceuticals.
  • Identify and describe the key challenges of obtaining market access.
  • Identify major stakeholders & their influence on the drug reimbursement and prescription process.
  • Explain, reflect upon, and discuss the importance of market access and its relation to the entire pharmaceutical organization.

 

Skill

  • Evaluate the relationship and dynamics of regulatory policies, and their implications for reimbursement of new pharmaceutical products.
  • Describe, assess and discuss the various perspectives and potential conflicts of major actors associated with pharmaceutical market access.

 

Competence

  • As a professional, be able to participate in multi-disciplinary groups and contribute with a market access perspective on pharmaceuticals