Tagged with P

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…

Morocco Recently rebranded from its former name, AMIP, the Moroccan Federation of Pharmaceutical Industry and Innovation (FMIIP) represents the local manufacturers operating in Morocco, which hold a domestic market share of 75 percent. Executive Director Layla Laassel Sentissi highlights some of the key trends in the Moroccan pharma market today, how…

LatAm A roundup of some of the latest news from Latin American pharma, including Acino’s acquisition of M8 Pharmaceuticals; AstraZeneca’s growth in Mexico; Neuraxpharm’s expansion into Brazil and Mexico, and Columbia’s decision to issue a compulsory license for GSK/ViiV’s HIV treatment.   Colombia set to issue a compulsory license for an…

USA The US Inflation Reduction Act (IRA) passed last year by the Biden administration and hotly contested by the innovative pharma industry, has started to look more like a reality since the first ten drugs subject to price negotiations under the IRA were announced in August. The negotiated prices will not…

UAE Over the past few decades, the UAE has worked hard to attract top global talent to fill the gaps that its small local population was unable to. While the high salaries on offer were previously the main attractor to the country, with workers often staying for a couple of years…

Global Claudia Martínez, generic & biosimilar medicines programme manager at the Access to Medicine Foundation, draws from a recent AMF report to outline what more generics companies can be doing to ensure greater access to their essential products. Martinez argues that for people living in low-and middle-income countries (LMICs), generic and…

Morocco Dr Rochdi Talib, President-Director General of Morocco’s leading private healthcare group, AKDITAL, on the impressive growth trajectory that brought it to a USD 100 million revenue milestone in 2022. He also discusses how the Group has extended its presence across the country and evolved along with Morocco’s improving healthcare landscape…

UAE With cutting-edge hospital infrastructure being put in place, government authorities rolling out evermore supportive regulatory upgrades, big pharma championing ‘clinical trial diversity’ with greater non-Caucasian representation in trial cohorts, and a high regional prevalence of genetic diseases, it seems that the stage is set for the UAE to assume a…