P4A experts regularly share their unique perspectives that inform and challenge the norm through articles and white papers.

BeNeLuxA and FiNoSe joint initiative

Are they as beneficial to manufacturers as they seem? By Joana Fernandes & Ashkay Kumar What are the research aims? Products that are being reviewed by the BeNeLuxA and FiNoSe joint initiatives often generate a lot of media attention and interest for those in the pharma world. But what do these initiatives actually entail, and…

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Expanded Access Programs (EAPs) in Europe

Are they right for your therapy? By Maximus Rex & Nicola Allen Drug development is a long and costly process. It is not uncommon for a new drug candidate to take more than 13 years to progress from discovery to being commercially available, w i t h costs often exceeding $1 billion for the manufacturer…

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Treatment without borders for Cell & Gene Therapies: Are we there yet?

“Cross border access”, “hub models”, “highly centralised access models” are only a few buzz words to refer to the pathway that enables European Union (EU) citizens to access reimbursed treatments in another member state. This pathway is particularly relevant for Advanced Therapy Medicinal Products (ATMPs) like cell & gene therapies where specialist infrastructure, controlled distribution,…

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Orphan Drugs in Colombia: Practical Limitations to Access

By Ciaran Cassidy, Analyst Email: ccassidy@partners4access.com Colombia, like much of Latin America, is receiving attention from the pharmaceutical industry as an emerging market (1). Through the introduction of a universal healthcare system, it seems to provide an attractive opportunity for manufacturers. In this article we will review the Colombian healthcare system from an orphan drugs…

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Scaling the healthcare wall: is Mexico an attractive market for high cost drug makers?

By Jack Rawson, Analyst Email: jrawson@partners4access.com At first glance Mexico presents a significant opportunity for drug manufacturers, with a large population of over 126 million, a developing economy and universal access to reimbursed healthcare. The aging population is also placing an increased need for healthcare services and statistics on the demand for drugs are favourable.…

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Rare Diseases: A New Purpose

How drug repurposing could help drive orphan drug access if pharma can accept the risks By Nader Murad, Senior Analyst Email: nmurad@partners4access.com The US National Institutes of Health describes drug repurposing as “studying drugs that are already approved to treat one disease or condition to see if they are safe and effective for treating other…

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Partners4Access Briefing: November 2018 update on the European Commission regulation proposal on health technology assessment

By Christina Poschen, Consultant Email: cposchen@partners4access.com Background Since 2004, the European Union’s centralised drug approval is in place, allowing manufacturers to submit just one application to gain marketing authorisation in all European Union Member States. Although there were voluntary agreements and working groups to further harmonize health technology assessment, so far, there are 28 different systems…

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