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 criterion”); and
- 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.
Click here to read the full Mayer Brown Legal Update on the Commission’s Notice.
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