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.
here to read the full Mayer Brown Legal Update on the
Mayer Brown is a global legal services provider
comprising legal practices that are separate entities (the
"Mayer Brown Practices"). The Mayer Brown Practices are:
Mayer Brown LLP and Mayer Brown Europe – Brussels LLP, both
limited liability partnerships established in Illinois USA; Mayer
Brown International LLP, a limited liability partnership
incorporated in England and Wales (authorized and regulated by the
Solicitors Regulation Authority and registered in England and Wales
number OC 303359); Mayer Brown, a SELAS established in France;
Mayer Brown JSM, a Hong Kong partnership and its associated
entities in Asia; and Tauil & Chequer Advogados, a Brazilian
law partnership with which Mayer Brown is associated. "Mayer
Brown" and the Mayer Brown logo are the trademarks of the
Mayer Brown Practices in their respective
Mayer Brown article provides information and comments on legal
issues and developments of interest. The foregoing is not a
comprehensive treatment of the subject matter covered and is not
intended to provide legal advice. Readers should seek specific
legal advice before taking any action with respect to the matters
To print this article, all you need is to be registered on Mondaq.com.
Click to Login as an existing user or Register so you can print this article.
After studying bioengineering and completing a PhD in the San Francisco Bay Area and a two-year postdoctoral research fellowship in London, Mark has spent the past four years analysing global health policy.
World AIDS Day, held on the 1st December each year, provides an opportunity for people to unite in the fight against HIV and show their support for people living with, or having died as a result of, HIV.
Since the enactment of Directive 2001/83/EC ("Community Code Directive") the European Community has conducted a comprehensive review of its legislation on medicinal products. It is not only that the Community since then has adopted Directive 2004/27/EC amending the Community Code. In fact, several other acts of legislation have been issued.
Register for Access and our Free Biweekly Alert for
This service is completely free. Access 250,000 archived articles from 100+ countries and get a personalised email twice a week covering developments (and yes, our lawyers like to think you’ve read our Disclaimer).