Unlicensed Medicines
unlicenced medicine

For more than 100 years, the Group provide to HCPs access to pharmaceutical products that are commercially unavailable in their home territories.

We offer named patient paid access to new therapies when launch is delayed, and cohorts’ access to established products to replace therapies undergoing supply shortages. We address global unmet patient needs by deploying our localized access solutions and by navigating through the complex supply environments of unlicensed pharmaceutical products.

FarmaMondo’s business services for access to unlicensed medicines cover:

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    Staggered launch of innovative products

While market access plans of research-based pharmaceutical companies may not cover all countries equally, their patient-centric launch strategies should allow access for patients with unmet medical needs also in non-launched countries. It may take months or even years before their treatments are approved for commercial supply in certain countries. But patients cannot wait. During this lag time, FarmaMondo responds to global HealthCare Providers’ requests to access such medicines, and supply them via national Named Pateint  regulatory routes in place. Having a well-sounded and consolidated strategy on early access possibilities represents an important part of the social responsibility for research-based pharmaceutical companies. FarmaMondo establishes Managed Access Programs on behalf of innovators to capture and serve HealthCare Providers’ named patient requests for access in non-launched markets.

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    Shortages of established products

Medicine shortages are a growing and complex global challenge. Shortages of essential drugs are becoming increasingly frequent globally, burdening health systems with additional costs and posing risks to the health of patients who fail to receive the medicines they need. More than 85% of EU hospitals report medicine shortages as an acute problem. Commonly prescribed hospital medicines undergoing shortages have significant negative impacts on patient care. A hospital facing medicine shortages without having a locally-available licensed- replacement therapy, can only find a solution by utilizing unlicensed medicine routes to source and import an alternative treatment commercially available in another country. serves HealthCare Providers globally with safe and uninterrupted supply of alternative to those on shortage products.

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    Market exit and product discontinuation of supply

Market exit of a drug is a valid strategic direction for biopharmaceutical companies. Therapy discontinuation could potentially result in an unmet medical need for those patients unable to find suitable replacement therapies. The solution for pharmaceutical manufacturers to mitigate such implications for patients, is to put in place a Managed Access Program allowing patients to have access to the required medicine beyond product discontinuation at an unlicensed status.