On 18 November 2016, the European Commission published a notice on the application of certain key
provisions within Regulation (EC) No. 141/2000 on orphan
medicinal products (the "Orphan Regulation"). Orphan
medicinal products are medicinal products that are used for the
diagnosis, prevention or treatment of rare diseases. An orphan
designation allows a pharmaceutical company to benefit from EU
incentives to develop a medicinal product, such as fee waivers for
the regulatory procedures or a ten year market exclusivity.
Under Article 3 of the Orphan Regulation, an orphan designation
is subject to the following two conditions:
The product is intended for the
diagnosis, prevention or treatment of a rare condition
("prevalence criterion"), or the marketing of
the product intended for the diagnosis, prevention or treatment of
a life-threatening or serious condition would not generate
sufficient return to cover the investment made ("financial
There is no satisfactory treatment
for the condition in the EU, or if there is, the future
medicinal product will be of significant benefit to patients
affected by that condition ("significant benefit").
The Notice, inter alia, specifies that a
"significant benefit" may no longer be based on a
possible increased availability due to shortages of existing
authorized products; or a new pharmaceutical form, a new strength
or a new route of administration, unless it brings a major
contribution to patient care. The Notice further reiterates that
treatments for communicable diseases with very low or close-to-zero
prevalence in the EU, such as the Ebola and the Zika virus
diseases, are also eligible for orphan designation in the EU. The
eligibility is based on the risk of EU residents becoming affected
by the disease.
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