Tagged with HEalth

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Are there any Managed entry agreements in place in your country? (If so, please list them) 2. Describe the fundamentals of the Managed entry Agreement, its rationale and the process for implementing it. 3.…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Which are the main actors involved in public procurement and tendering? The main actors involved are usually the awarding body on the one hand and a private tenderer on the other hand. For the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Please describe the main cost containment policies in place in your country and their fundamental principles: a. Pricing and impact of generic/biosimilar approval Based on a price comparison with 15 reference countries (containing among…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes, Switzerland publishes such a list in the annex to the ordinance on the Essential Human Medicines…

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…