Masterstudiengang "Drug Regulatory Affairs"
Master-Thesis
Regulatory Approval options in emergency situations - a comparison between EU and US on the example of the Ebola virus ***
Dr. Florian Diwischek (Abschlußjahr: 2015)
Summary
Language: English
The Ebola virus causes an acute, serious illness which is fatal in humans if no treatment is applied. The corresponding disease was noticed for the first time in 1976 in outbreaks in Sudan and in the Democratic Republic of Congo. The current outbreak starting in December 2013 is the largest since the discovery of the virus and more people have did therein than in all others combined. A total of 27049 cases and 11149 deaths have been reported up to 24th May 2015. There are no approved drugs or vaccines against Ebola so far (May 2015). The WHO declared Ebola a public health emergency on 8th August 2014 as a result of the first meeting of the IHR Emergency Committee. The EMA and the FDA commited themselves on the 16th WHO International Conference of Drug Regulatory Authorities (ICDRA) on 3rd September 2014 to accelerate the development and assessment processes of possible new Ebola medical products. Both agencies implemented several new, but also offer established measures for acceleration of the development of new compounds in case of the declared emergency situation of the Ebola Virus Disease. The EMA established an Ad-hoc Task Force, Rapid Scientific Advice, a proactive review of currently available treatments of Ebola (due to Article 5 (3) of regulation 726/2004), a Rolling Review of data and encourages the use of the orphan designation for possible new compounds against Ebola. In a similar way, the FDA installed an Ebola Task Force, advices and cooperations and can rely also on already established measures as the orphan designation, but in addition to many more options than the EMA with the FDA´s designations for Expedited Programs for serious conditions.
Regarding early access options of possible new Ebola medicines, both agencies offer similar possibilities as Compassionate Use/Expanded Access and a named-patient basis-access/EIND.
As regulatory approval options in emergency situations such as the current Ebola outbreak, the EMA has the possibility of the Article 58 procedure or a conditional approval (with also accelerated assessment), whereas the FDA has the possibilities of the Accelerated Approval, the Animal Rule or the Emergency Use Authorisation.
In general, the FDA has better, faster and more flexible options for an emergency situation such as the 2014 Ebola crisis compared to the EMA - with regard to the tools of accelerating the development but even more so in case of the regulatory emergency approval options. Other national regulatory health authorities including the EMA therefore should think about taking over these options from the FDA, particularly the regulatory approval options in emergency situations.
It should also be considered to take these possibilities into account in the currently undergoing structural reforms - initiated due to the current Ebola outbreak - at the WHO (e.g. into the PQP programme) regarding emergencies and disease oubreaks to achieve streamlined and harmonized regulatory pathways in public health emergencies of international significance. The health authorities of the concerned countries of the emergencies also must not be neglected in such processes as they know the situation best and have to include all measures into their local processes.
Pages: 63