i3 Consult Press Releases

Despite billions of Euros being spent each year in the pharmaceutical industry on research, development and gaining approval for licensed use of ethical medicines, there are still broad areas of clinical needs not being met. Patients who are challenged by relapsed cancer states, a rare genetic disorder or has a life threatening disease yet the preferred drug candidate has not yet been approved by regulatory authorities are just some of the cases where CUPs have potential use. In particular for the latter case, early access for such a cohort of patients who fail to meet clinical trial inclusion criteria and are faced with few other treatment options, may benefit from the CUP. It stipulates in Article 83.2 of European Union Regulation (EC) No 726/2004 that drug sponsors are permitted to conduct a CUP on a patient only if that patient is faced with a “life-threatening, long-lasting or seriously disabling illnesses” who has not responded successfully to licensed medica

Pharmaceutical companies still invest billions of dollars over several years in order to get their drug pipeline of product(s) approved, registered and patent protected to maximise profits from such brand ownership in a highly competitive global market. However, the revenue stream of a pharmaceutical company can be quickly impacted by the patent expiry of their prescription brand(s) owing to the competition of new generic medicines entering the market. Generic Drugs A generic drug is a copy of a brand-name drug that has exactly the same dosage, safety, use, strength, quality, performance, effects and side effects. These drugs are developed by other pharmaceutical companies once the patent for the original product has run out and the pharmaceutical company who developed the original (branded) medicine no longer has the exclusive right to produce and distribute the medicine. Generic drugs contain the same active ingredient which acts to cure the condition the medicine is used