With two billion people globally – predominantly in low and middle-income countries – having little or no access to medicine, a select group of service providers have emerged to try and further dialogue between pharmaceutical companies, regulators, healthcare professionals and patients on the issue of expanding access to medicines. At the forefront of this group is the Swiss-based FarmaMondo, which draws on over 100 years of history to help provide access to medicines to patients with unmet medical needs around the world.
A Unique Business Model
“The whole world is moving toward patient-centricity and our efforts to facilitate patient access to medicines are at the core of this.”
Jaron Spigel, FarmaMondo
FarmaMondo was set up in 1915 in the Italian-speaking Swiss canton of Ticino – where the company remains based today – initially as a small community pharmacy. Over the last 100 years, and especially during the last decade, FarmaMondo has grown to become a service provider to various international stakeholders in the niche of unmet patient needs. Jaron Spigel, FarmaMondo’s French-born CEO notes, “The whole world is moving toward patient-centricity and our efforts to facilitate patient access to medicines are at the core of this.” FarmaMondo operates through two distinct lines of business: Global Early Access, helping provide fast-tracked access to unlicensed medicine in over 65 countries worldwide across all continents and Named Patient programs, whereby certain patients can access products prior to their approval. The company is continuously developing its methodologies for patient access to medicine specific to each country or region in which it operates, with activities in the established markets, such as the EU, as well as new frontiers in Asia, Russia / CIS countries and Latin America as key markets.
A key tenet of FarmaMondo’s business model is that the access to medicine that it helps facilitate must be ‘Responsible’ and ‘Ethical.’ The 2013 case of Josh Hardy in the USA – where social and traditional media launched a campaign to pressure Chimerix to allow access to a novel, yet unapproved therapy, despite the patient not fitting the drug maker’s access requirements – further highlighted the need for more ‘Responsible’ and ‘Ethical’ access. Manufacturers, biotech companies, regulators and healthcare professionals alike called for more stringent guidelines for providing access in a responsible manner, separate from societal or media pressure; an area in which FarmaMondo specializes.
In terms of the advantages of being based in Switzerland, Spigel highlights that “Providing responsible access to medicine is a concept that indisputably fits the Swiss DNA – a combination of being compassionate towards other people, exporting products and services, strict regulatory compliance and international scope.” Furthermore, given its unique business model, “FarmaMondo could only have developed in a country like Switzerland; a regulated, innovation-driven, well-established market where quality infrastructure for distribution, imports and exports is in place to an extremely high standard,” Spigel notes.
Spigel also highlights the fact that SMEs in Switzerland are able to go global without the need to become significantly bigger. He posits that “Thanks to the same great business infrastructure that larger companies enjoy, a privately-owned SME business in Switzerland can enjoy the possibility of looking at world markets and considering them as opportunities that are within reach. Our size also brings operational agility, enabling us to take better advantage of this infrastructure.” Additionally, Swiss pharmaceutical MNCs such as Novartis and Roche are appreciative of the quality of smaller Swiss-based service providers; “they remain Swiss even though they are global giants” he opines.
Close working relationships with the major Swiss companies are, however, just one part of FarmaMondo’s international success story and of Swiss solutions to patient access issues across the world. SwissMedic, the Swiss pharmaceutical regulator, is also of key importance in this effort. Spigel points out that “Swiss innovators are becoming major powers in the effort to provide early access to medicines to address unmet patient need through FarmaMondo, utilizing the unique regulatory frameworks that exist globally. In parallel, SwissMedic is providing precious guidance to allow us, as a Swiss-licensed service provider, to navigate through the jungle of regulations that are in place intentionally governing access to unlicensed medicines.” He concludes, “We are playing a key role in the industry’s effort to expand access to medicines to wherever unmet patient need exists … This is a global task, but Switzerland is at the forefront.”
A Class Apart
Despite occupying a very specific niche – as evinced by the fact that its genuine global competitors can be counted on one hand – FarmaMondo’s service offering places it at the crux of several of the core challenges facing the modern healthcare industry. Spigel elaborates these challenges as “the need to expand access to medicine, the fight against the substandard distribution of drugs, the influence of social media on pharmaceutical companies’ decisions, and the need to navigate through multiple regulatory landscapes.” Moreover, he highlights that FarmaMondo’s business model puts the company firmly in line with the three major trends of the modern industry; namely “Patient-centric initiatives, enhanced access to medicine early in the product life cycle, and innovative regulatory mechanisms that are flexible enough to accommodate individual patient needs.”
Writer: Patrick Burton