EC mulls changes to Orphan Drug rules

By Gareth Macdonald contact

- Last updated on GMT

Related tags: Pharmaceutical drug, Pharmacology

European Commission looks at revising OD requirements
European Commission looks at revising OD requirements
Tweaks to EU orphan drug rules (OD) may be needed to accommodate Ebola treatment development and block industry attempts to delay generic entry says the European Commission.

The Commission mooted revisions last week​, calling for feedback on proposals to tighten ‘significant benefit’ rules, lower prevalence thresholds and place stricter controls on the transfer of OD designations between companies.

According to the Commission, the changes would stop sponsors claiming to have met the legislation's ‘significant benefit’ requirement on the basis their product would increase the availability of treatments in Europe, instead of demonstrating clinical superiority.

The changes would also encourage development of medicines for diseases like Ebola which do not occur often enough in Europe to meet the requirements for an orphan drug designation – a condition affecting not more than 5 in 10000 persons in the EU.

Generic delays

The final major issue raised by the Commission is the practice of transferring orphan designations between sponsors.

If a company has an orphan marketing authorisation for an active substance it cannot seek a second authorisation for the same substance in a new pharmaceutical form. According to the Commission, some firms try to get around this by asking a third party to apply and then transfer the designation.

The Commission says that: “This practice can be considered as an attempt to circumvent the intention and the purpose of this provision. In addition, experience shows that this process has also delayed the placing on the market of generic medicinal products​.”

To address this, the Commission suggests “it may be envisaged to lay down control mechanisms for the transfer of orphan designations between companies in that respect​.”

The call for feedback is timely given the increase in OD applications and designations in Europe. According to European Medicines Agency (EMA) data​, there were 327 applications for OD status in 2014, up from 201 in 2013 and 197 the year before that.

Related topics: Markets & Regulations, Regulations

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