Jazz Pharmaceuticals is focused on improving patients’ lives by identifying, developing and commercializing meaningful products that address unmet medical needs. To do this, we conduct clinical trials to assess the safety and efficacy of investigational medicines, and the data generated from these trials allows us to obtain the necessary approvals from regulatory bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA), which allow for broad access to medicines.
At Jazz, we believe that wherever possible, use of an investigational medicine for a patient as part of a clinical trial is preferable because clinical trials can generate data that may lead to the approval of products and, consequently, to wider availability. Conducting clinical trials is extremely complex and challenging. The ultimate goal is the rigorous testing of the clinical product with the aim of securing regulatory approval and enabling the medicine to be available to as many patients as possible as quickly as possible. Jazz complies with good clinical practices and takes steps to help ensure the quality and integrity of our clinical trials and to minimize risks to current research participants and future patients. For a list of clinical trials currently recruiting patients, please visit www.clinicaltrials.gov.
However, we also recognize that in some extreme circumstances, when participating in a clinical trial is not possible, patients facing serious or life-threatening conditions may seek special access to investigational medicines outside of a clinical trial setting.
Consistent with applicable laws and regulations, Jazz may provide patients with access to investigational medicines through Expanded/Early Access Programs (EAPs) when there is sufficient evidence of the safety and effectiveness of the investigational medicine to support its use in the particular circumstance.
It is important to note that terminology used can vary from country to country and dependent on the way that the medicine is accessed. Although often referred to as Expanded Access Programs or Early Access Programs, these types of access can also be known as Compassionate Use, Pre-approval Access, Named Patient Access and Emergency Use.
EAPs do not apply to the use of a currently marketed medicine for an indication outside of the approved label.
In general, there are two ways that Jazz can grant Early Access to an investigational medicine. The type of program available may be dependent on local laws and regulations. It is important to note that terminology used can vary from country to country and in some instances different countries use identical terminology to describe different approaches.
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