Pharma Legal Handbook 1. What are the regulatory authorities with jurisdiction over drugs, biologicals, and medical devices in your country? Ministry of Health, Welfare and Sport (Ministerie van Volksgezondheid, Welzijn en Sport) The policy and regulation of drugs (‘medicinal products’), biologicals and medical devices falls under the jurisdiction of the Ministry of Health,…
USA In late 2023, The Wall Street Journal published the article Generic Drugs Should Be Cheap, but Insurers Are Charging Thousands of Dollars for Them. This article examined interactions between patient health insurance prescription benefits, pharmacies, and pharmacy benefit managers (PBMs), and their collective impact on the prices that patients pay for their prescription…
Belgium Diane Kleinermans leads the reimbursement commission at Belgium’s medicines payer, the National Institute for Health and Disability Insurance (NIHDI). With Belgium currently undergoing a landmark reform of its reimbursement procedure, Kleinermans discusses the access picture in the country today, international HTA collaborations, and the delicate balance between maintaining the stability…
Belgium Belgium’s drug reimbursement system has become increasingly lengthy and complex, compromising patient access to innovative medicines. The roadmap recently presented by the Minister of Health and the Belgian National Institute for Health and Disability Insurance (INAMI) proposes a series of measures to speed up access, limit the duration of reimbursement…
Pharma Legal Handbook An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in China. Prepared in association with Fangda Partners, one of China’s most prestigious and well-regarded law firms. This is an extract from The Pharma Legal Handbook: China, which can be purchased here for GBP 119. 1. What are…
Pharma Legal Handbook An insight into regulatory, pricing and reimbursement overview in Polish Pharma. Prepared in association with DLA Piper, a leading law firm in Poland, this is an extract from The Pharma Legal Handbook: Poland, available to purchase here for GBP 119. 1. What are the regulatory authorities with jurisdiction over…
Pharma Legal Handbook A brief overview of the situation regarding regulation, pricing and reimbursement of drugs in Canada. Prepared in association with Fasken, a leading global law firm, this is an extract from The Pharma Legal Handbook: Canada, available to purchase here for GBP 119. 1. What are the regulatory authorities with…
Pharma Legal Handbook Need to know about regulation, pricing and reimbursement in Colombian pharma? Read on! Prepared in association with Cavelier Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Colombia, available to purchase here for GBP 119. 1. What are the regulatory authorities with jurisdiction over…
Pharma Legal Handbook The legal framework for regulatory, pricing and reimbursement in Romanian Pharma. Prepared in association with Mușat & Asociații, a leading global law firm, this is an extract from The Pharma Legal Handbook: Romania, available to purchase here for GBP 119. 1. What are the regulatory authorities with jurisdiction over…
Pharma Legal Handbook An intro to the regulatory, pricing and reimbursement scenario for pharmaceuticals in Peru. Prepared in association with Osterling Abogados, a leading global law firm, this is an extract from The Pharma Legal Handbook: Peru, available to purchase here for GBP 119. 1. What are the regulatory authorities with jurisdiction…
Pharma Legal Handbook The legal framework for regulatory, pricing and reimbursement of drugs in Denmark. Prepared in association with Gorrissen Federspiel, a leading law firm in Denmark, this is an extract from The Pharma Legal Handbook: Denmark, available to purchase here for GBP 119. 1. What are the regulatory authorities with jurisdiction…
Pharma Legal Handbook Key legal info on regulatory, pricing and reimbursement in Spain. Prepared in association with Faus Moliner Abogados, a leading law firm in Spain, this is an extract from The Pharma Legal Handbook: Spain. The guide is available to purchase here for GBP 119. 1. What are the regulatory…
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