Tagged with IT

Europe PharmaBoardroom was delighted to attend DIA Europe 2024 in Brussels earlier this month, bringing together a veritable who’s-who of the European and global regulatory community. The politicians, regulators, payers, patient advocates, industry representatives, and service providers in attendance were treated to a three-day buffet of engaging panels and townhalls with…

UK Last year the UK-based pharma industry warned against the country’s waning competitiveness, condemning the government’s statutory scheme designed to control drug prices. UK-headquartered AstraZeneca joined the battle cry, claiming it would be choosing Ireland over Britain, a decision the company has now more than revised with a GBP 650 million…

Switzerland The biggest pharma news from Switzerland, including the industry’s cautious reaction to a new free trade deal with India; the drop in Roche’s share prices; Novartis’ acquisiton of MorphoSys, and the licence agreement between EraCal Therapeutics and Novo Nordisk.   Swiss industry welcomes agreement with India, pharma more cautious (Le…

India Clinical trials will be a pivotal part of India’s attempts to scale the global pharmaceutical value chain. Following a series of well-publicised scandals in the early 2010s, the country tightened up its clinical research regulations and saw a significant drop in trial numbers. However, with a revised regulatory landscape, a…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Please make a general introduction to the public health sector in your country and its organization The Swiss healthcare system is shaped by the federal structure of Switzerland. That is, federal government (in particular…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Which are the administrations, bodies and institutions in charge of public health in your country and what are their respective responsibilities? a. Federal Office of Public Health (FOPH; Bundesamt für Gesundheit) The FOPH is…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. What are the pricing models, processes and principles for originator drugs? An original drug is defined as a drug approved by Swissmedic as the first drug with a specific active ingredient, including all dosage…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Price Control 1.1. How does price control at ex-factory prices work in your country? Price control is regulated in Art. 65d HIO. Triennially, the FOPH reviews whether the medicinal products included in the LS…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Which are the health technology assessment (HTA) evaluation bodies and their responsibilities in your country? The National HTA program is overseen by the Health Technology Assessment Section (HTAS) of the HIBD (see above chapter…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. Have local authorities published recommendations and guidelines surrounding value assessment dossiers? (If yes please add link) No official guidelines or recommendations are published. However, all pending and completed HTA projects are published on the…

Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Switzerland.  1. In addition to the clinical data obtained through clinical studies please list the data required for: a. Market approval According to Art. 11 TPA, an application for marketing authorisation must contain all of the…

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.…