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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…

Morocco The Moroccan National Social Security Fund (CNSS) has taken on a transformational mandate in recent years, spearheading the highly ambitious national campaign to expand universal health insurance to the entire Moroccan population. In a wide-ranging and in-depth conversation, CNSS Director General Hassan Boubrik lays out the scope and scale of…

Morocco A highly experienced stalwart of the North African pharma industry, Amine Sekhri today heads up AstraZeneca’s operations in Morocco. In his latest PharmaBoardroom conversation, Sekhri shares his delight at the positive healthcare transformations taking place across Morocco and Africa, gives his insight into the market access landscape for AstraZeneca’s most…

Morocco Last year, the USA surpassed France as Morocco’s largest source of foreign direct investment, and Morocco is the only country in Africa to boast a free trade agreement with the US. AmCham Morocco’s Rabia El Alama outlines some of the major trends underpinning the US-Morocco trading relationship, the weighting of…

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…

Taiwan As a part of the World Health Organisation’s (WHO) COVID-19 Technology Access Pool (C-TAP), the Medicines Patent Pool has signed a worldwide license with Medigen Vaccine Biologics (MVC) for its COVID-19 vaccine, representing a debut on two fronts. Not only is this the first time a COVID-19 vaccine developed by…

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…

China A decade on from its launch, the Guangdong-Hong Kong-Macao Greater Bay Area (GBA) initiative has made some significant wins but remains some way from fulfilling the vision of a fully integrated internationally competitive bay area to rival that of its US west coast namesake.   Staggering Fundamentals Home to 87…