Tagged with Assessment

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What is the definition of an orphan drug in your country? According to Art. 4 para. 1 lit. adecies TPA, an orphan drug is a medical product for human use for which it has…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What is the definition of a vaccine in your country? In Switzerland, most of the regulations related to vaccines are contained in the Federal Act on Controlling Communicable Human Diseases (EpidA; Epidemiengesetz, EpG, SR.…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.  1. Please make a general introduction to the public health sector in your country and its organization   The Danish healthcare system The Danish public healthcare system is universal – all registered Danish residents are…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? As mentioned, the Danish public healthcare system operates across three levels: the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What are the pricing principles and processes in your country? As mentioned above, there are two main markets for medicines in Denmark: the primary healthcare sector (prescription medicines) and the secondary sector (hospitals).…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The Danish Medicines Council New medicines (or product with new indications) that are intended for the Danish hospital market,…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Please describe the main cost containment policies in place in your country and their fundamental principles  On an overall level, control of healthcare expenditures is based on budget laws and annual agreements between…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Have local authorities published recommendations/guidelines surrounding value assessment dossiers? (If yes please add link) The Danish Medicines Agency has published two main guidelines: i) The Danish Medicines Council’s process guide for assessing new…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Are there any Managed entry agreements in place in your country? (If so, please list them) There have been examples of use of managed entry agreements in Denmark. For example, Amgros may enter…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Which are the main actors involved in public procurement and tendering? During the tender: The main actors involved in a public tender are the contracting authority, i.e., the authority that needs to procure…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. Has an essential or priority drug list been published in your country? (If so provide the link) The guideline process of the Danish Medicines Council results in recommendations with prioritized list of medicines…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Denmark.    1. What is the definition of an orphan drug in your country? The term “orphan drug” usually refers to medicins used for rare diseases – i.e. diseases where the prevalence of the condition in…