Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Portugal. 1. What are the pricing models, processes and principles for originator drugs? Prices of medicinal products are regulated by the System of Assessment of Health Technologies (SiNATS), approved by Decree-Law 97/2015, 1 June 2015, which…
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 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 Romania. 1. What are the pricing models, processes and principles for originator drugs? The main enactment setting out the pricing models and approval procedures for medicines is Ministry of Health’s Order no. 368/2017 approving the Norms…
Pharma Legal Handbook Join industry executives in staying informed on the market access and HTA process in Brazil. 1. What are the pricing models, processes and principles for originator drugs? To set the price of originator drugs, CMED uses Health Technology Assessment (“HTA”) to evaluate whether a drug provides an additional therapeutic benefit…
Pharma Legal Handbook 1. What are the pricing models, processes and principles for originator drugs? Originator medicinal products must go through price and reimbursement proceedings (P&R Procedure) where it is decided if they are to be reimbursed or not. If reimbursed, the PVL is also fixed. To determine whether a medicinal product is…
Europe Rainer Westermann, chairman of the Life Sciences Acceleration Alliance e.V. (LSAA), which lobbies on behalf of European venture capitalists in the life sciences space, launches a critique of current pharmaceutical policies across the EU, arguing that constant cost-containment measures, over-regulation, and bureaucracy are leading to drug shortages and acting as…
Europe Edward Mc Gettrick and Sharon Gorman of Pfizer, writing in the January 2023 edition of DIA’s Global Forum magazine, examine the scope and impact of the European Union’s new Regulation on Health Technology Assessment. In December 2021, the European Commission (EC) adopted the Regulation on Health Technology Assessment (EU HTA…
Portugal Part of PharmaBoardroom’s new country-focused series on market access and health technology assessment (HTA), this piece gives the lowdown on post-market approval processes and regulations in Portugal. Buy The Pharma Legal Handbook: Market Access & HTA – Portugal here for £359. What are the pricing principles and processes in your…
Egypt Internationally renowned healthcare quality and safety expert Dr Ashraf Ismail explains the concept behind the Egyptian General Authority for Healthcare Accreditation and Regulation (GAHAR), its work in setting and implementing standards as well as accrediting healthcare institutions in Egypt, and his hopes for the country’s transformational rollout of universal health…
Asia-Pacific Asia has experienced a biotech boom in the past five years. In 2020, almost 50 percent of the region’s clinical trials were led by biotechs and by 2025, biotech-led clinical trials will far exceed those led by Big Pharma, according to IQVIA. However, the region’s biotechs face a myriad of…
Asia-Pacific Writing in the April edition of DIA’s Global Forum magazine, Dhiraj Behl, Janine Jamieson, and Harikesh Kalonia highlight some of the regulatory challenges for drug-device combination products in APAC, including the lack of an international body dedicated to harmonisation in this field. In the current innovation era and in the wake…
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