Pharma Legal Handbook 1. Are there any Managed entry agreements in place in your country? (If so, please list them) Yes, there are managed entry agreements in Spain. The most frequent Managed Entry Agreements (MEAs) are financial and performance-based agreements (both at patient and population level). 2. Describe the fundamentals of the…
Pharma Legal Handbook 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 The entry of generics/biosimilars into the market affects the price of original drugs by three main mechanisms: (i) homogeneous groups (“HG”), (ii) reference groups (“RG”), (iii)…
Pharma Legal Handbook 1. Has an essential or priority drug list been published in your country? (If so provide the link) Yes. Three types of lists have been published by the AEMPS: “Essential medicinal products”: according to the WHO definition, these are the necessary medicinal products for a basic health system. “Critical medicinal…
Pharma Legal Handbook 1. What is the definition of an orphan drug in your country? In Spain there is no particularity in relation to the definition of “orphan drug” derived from the Regulation (EC) No 141/2000. Under Regulation (EC) No 141/2000 a medicinal product shall be designated as an orphan medicinal product if…
Pharma Legal Handbook 1. What is the definition of a vaccine in your country? The AEMPS defines a vaccine as an antigen-containing preparation capable of inducing specific and active immunity in humans against an infecting agent or the toxin or antigen elaborated by it. Immune responses include the induction of innate and adaptive…
Pharma Legal Handbook 1. Which are the main actors involved in public procurement and tendering? There is a high degree of decentralisation in public procurement in Spain. Regarding the public procurement and tendering services of medicinal products there are actors involved at a national level (MOH), regional level (the governments of the Autonomous…
Middle East & Africa Diginova Health Solutions is a platform that incubates and invests in digital health startups and collaborates with governments and regulators to bring digital solutions to the Middle East and North Africa (MENA) region. Healthcare management veteran, founding partner & CEO, Sarper Tanli, discusses the opportunities and challenges posed by digitilisation…
Norway Norway, known more for its expertise in oil and gas and marine biology than in health innovation, is home to increasing numbers of innovative medical technology start-ups. Here are five of the most exciting such companies, as selected by Kathrine Myhre, founder and CEO of Oslo-based innovation cluster Norway Health…
China Charles Bark, CEO and founder of HiNounou, shares the touching personal story of what inspired him to establish HiNounou as a complete remote healthcare solution package for elderly people; how HiNounou’s solutions cover the key genetic, lifestyle and environment factors affecting healthcare; their unique ‘gamification’ system to encourage patient adherence;…
Spain Melqui Calzado, general secretary of Catalonia Bio and Health Tech, highlights the association’s strategy to establish the region as an international reference centre for innovation and entrepreneurship, as well as giving an overview of the steps required to see a new wave of Catalan pharmaceutical companies. Many large international…
See our Cookie Privacy Policy Here
