Regulatory Focus™ > News Articles > Reimbursement Hurdles Focus of EU Consultation on Post-Authorization Studies

Reimbursement Hurdles Focus of EU Consultation on Post-Authorization Studies

Posted 29 November 2012 | By Louise Zornoza

The European Commission has launched a consultation on the "situations" in which post-authorization studies would be imposed, something required by the 2010 legislation that revamped the EU pharmacovigilance system.

The Commission's reflection paper notes in the section on "Efficacy Versus Effectiveness" that the criteria used by the European Medicines Agency (EMA) for a marketing approval recommendation have been the subject of some debate in recent years.  The practical reality is that in order for a new drug to gain market access in Europe, it must obtain positive national reimbursement decisions.

In other words, EMA's criteria of quality, safety and efficacy are just three of four hurdles to market access for a new drug, with the fourth hurdle - cost effectiveness - being the key that opens the door to market access.

A European marketing authorization without national reimbursement approval denies patients access to the new drug.  This raises a conundrum that the Commission does not specifically address: without market access there is no basis for carrying out post-authorization studies for a given new drug that has cleared EMA's three regulatory hurdles. 

The deadline for comments on the Reflection Paper is 18 February 2013.

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