Pharmaceutical policy analysis

Course goals

After this course the student is able to

1. Interpret commonly used frameworks for access to medicines;
2. Explain which factors and which stakeholders are involved in ensuring timely access to medicines;
3. Analyse enablers and barriers of access to medicines in different settings (e.g. income level, geographical region, jurisdiction), especially with respect to regulation, pricing and reimbursement and responsible use of medicines;
4. Understand different analytical approaches to assess access to medicines;
5. Develop a research protocol for a pharmaceutical policy analysis.

Content

Medicines are among the most regulated products in society. From the earliest pre-clinical stages onward, policy makers want to foster the development of safe, effective and affordable medicines for patients in need of pharmacotherapy. When a drug reaches the market, it is the beginning of a process of complex interactions between patients, prescribers, insurers, pharmaceutical companies and governments.
Inequity in access to medicines is still a defining characteristic of the global pharmaceutical market place. Access to medicines is part of the fulfillment of the right to health, but worldwide many people lack appropriate access. Pharmaceutical policy analysis may provide the much needed evidence to inform policy and decision makers involved in ensuring access to medicines from bench to bedside.
 
In this course, students will gain insight in the framework(s) defining access to medicines and all stakeholders involved. The course will specifically focus on Regulation, Pricing & reimbursement and Responsible use. Furthermore, students will develop a better understanding of analytical approaches in pharmaceutical policy analysis using these three themes as learning devices.