SMIM25002U The European Health Technology Assessment (HTA) process – get on the learning curve

Volume 2025/2026
Education

Master of Industrial Drug Development (MIND) - elective

The course is preapproved as an elective in the   Master Medicines Regulatory Affairs (MRA) programme. It is also open to single course students who meet the admission criteria.

 

See course webpage for course dates.

Content

What is the European HTA process?

The European HTA process has developed over the last >10 years through voluntary cooperation of HTA agencies during the EUnetHTA joint action programs. The HTA Regulation creates a permanent framework of collaboration involving all 27 member states. The objective is to avoid duplication of work, align evidence requirements for health technologies across the European Member states and ultimately accelerate access for patients. The key pillars for the joint work involve a EU level Joint Clinical Assessment (JCA) of the technology that will support appraisal at member state level. The process came into effect on 12th January 20025 for new oncology products and cell & gene therapies and will be expanded to orphan drugs in 2028 and in 2030 the process will cover all health technologies. In addition, there will be the opportunity for HT developers to ask for joint scientific consultations (JSC) for pipeline assets.

This course will provide insight into the terminology, key principles and key players in the field of the European HTA process. It will provide a practical understanding of the guidelines and the “rules of the road” from JSC to JCA.

The following themes will be addressed:

  • What is HTA?
  • What is the European HTA process?
  • Who are the key stakeholders?
  • What is covered under the EU HTA process?
  • How to prepare for a successful EU HTA/JCA dossier
  • What is JSC and how to prepare for it?
  • How are national HTA bodies expected to incorporate the JCA?
Learning Outcome

 

Upon completion of the course, participants will have gained the following: 

Knowledge

  • Understand key concepts, terminology, and the overall structure of Health Technology Assessment (HTA).
  • Gain insight into the EU HTA process, including key deliverables, milestones, and decision-makers.
  • Comprehend the Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) processes and their impact.
  • Recognize how EU HTA interacts with national HTA, pricing, and reimbursement systems.

 

Skills

  • Analyze and interpret EU HTA procedures and outcomes.
  • Apply JCA and JSC insights to national and organizational contexts.
  • Engage effectively with key stakeholders in the EU HTA landscape.
  • Navigate the link between EU and national HTA processes to support decision-making.

 

Competences

  • Strategically apply HTA knowledge to healthcare innovation and market access.
  • Influence evidence-based decision-making in regulatory and reimbursement frameworks.
  • Collaborate with policymakers, clinicians, and industry experts in HTA processes.
  • Drive impactful contributions to EU and national HTA discussions.

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).

Applicants must meet the following criteria:
• A bachelor's degree, a professional bachelor’s degree, a diploma degree, a master’s degree or equivalent within chemistry, biochemistry, pharmacy, medicine, biomedicine, human biology, molecular biology, veterinary sciences, health sciences, nursing, engineering or equivalent.
• At least two years of relevant work experience related to development of medicines
• Proficiency in English
Applicants must meet the following criteria:
• A relevant bachelor degree or equivalent
• A minimum of 2 years of relevant job experience
• Proficiency in English
This is an intensive 3-day course. Teaching methods consist of a combination of lectures, group discussions, case studies, presentations, exercises and panel discussions.
  • Category
  • Hours
  • Class Instruction
  • 18
  • Preparation
  • 35
  • Exam
  • 15
  • Total
  • 68
Written
Oral
Continuous feedback during the course of the semester
Credit
2.5 ECTS
Type of assessment
Written assignment
Type of assessment details
A written assignment. Individual written assignment based on a relevant set of questions provided by the course managers and based on an extended literature list.
Aid
All aids allowed

All aids allowed for preparation including access to internet and the use of Generative AI.

It is the responsibility of the student to ensure the accuracy, integrity, and originality of the text, including ensuring that the text is not factually incorrect, plagiarized, or contains copyrighted material. AI/LLM’s may not be used as an actual author or a scientific source cf. Vancouver Guidelines.

Marking scale
passed/not passed
Censorship form
No external censorship
Exam period

See exam schedule.

Re-exam

The exam form for the reexam is the same as the ordinary exam. See dates in the exam schedule.

Criteria for exam assesment

To achieve the grade passed, the participant shall (in an adequate level) be able to demonstrate:

Knowledge

  • Understand key concepts, terminology, and the overall structure of Health Technology Assessment (HTA).
  • Gain insight into the EU HTA process, including key deliverables, milestones, and decision-makers.
  • Comprehend the Joint Clinical Assessment (JCA) and Joint Scientific Consultation (JSC) processes and their impact.
  • Recognize how EU HTA interacts with national HTA, pricing, and reimbursement systems.

 

Skills

  • Analyze and interpret EU HTA procedures and outcomes.
  • Apply JCA and JSC insights to national and organizational contexts.
  • Engage effectively with key stakeholders in the EU HTA landscape.
  • Navigate the link between EU and national HTA processes to support decision-making.

 

Competences

  • Strategically apply HTA knowledge to healthcare innovation and market access.
  • Influence evidence-based decision-making in regulatory and reimbursement frameworks.
  • Collaborate with policymakers, clinicians, and industry experts in HTA processes.
  • Drive impactful contributions to EU and national HTA discussions.