When you lose in court, you may appeal the decision, or
you may choose to just change the rules that made you lose. The
latter seem to be the case for the Norwegian Medicines Agency
(NOMA) in a case regarding automatic substitution of
In 2010 NOMA decided automatic substitution for
Ratiograstim, Tevagrastim and Amgen's
Neupogen. Amgen took the decision to court, claiming that it
was invalid. The court decided in favour of Amgen in March
2011 and the decision was not appealed. The medicines had been
taken off the substitution list already after an interlocutory
injunction which immediately followed NOMA's placing of the
medicines on the list.
However, after the final court decision, the Ministry of Health
and Care requested a report from NOMA regarding biosimilars. In
short, the Ministry wanted an evaluation of the need for new rules
regarding pricing and substitution, and possibly a proposal for new
The report from NOMA became public today (15th November
2012). Like in several recent reports from the agency,
economy is a prominent theme. Safety aspects are also dealt with,
however the depth of the discussions leave something to be
NOMA's proposal is that automatic substitution shall no
longer be available only for generics. It shall be a general
possibility for all medicines, and be decided by the Ministry of
Health and Care. To accomplish this, the Act on pharmacies
Section 6-6, second paragraph has to be amended.
NOMA also suggests that the prerequisites for placing products
on the substitution list should appear in a regulation. The
main proposed prerequisites are that the active ingredient is the
same, that there is a Norwegian marketing authorisation and that
the medicinal products are medically equivalent. If these
conditions are met, the products shall be placed on the
substitution list, according to the proposal.
The proposal states medical equivalence should be evaluated.
It is noteworthy that nothing is mentioned about risks
related to changing from one of the medicines in the group to
another. Some aspects of such risks may be picked up by criteria
mentioned, like pharmacokinetics, bioequivalence etc.
However, the patients may have reason to feel safer if the risk
regarding changing are mentioned and evaluated specifically. There
is limited scientific knowledge in this area, and omitting
evaluation of the possibility of adverse effects from the changing
between medicines could mean that lack of knowledge in this area
will not have the impact it should have on the decision of
About the author:
Inga Kaasen is an attorney-at-law and partner at the Norwegian
law firm Grette. She also holds a PhD. in biotechnology. She is the
leader of Grette's Life Sciences team, and has extensive
experience with patent disputes, pharmaceutical law, IP
transactions and R&D agreements.
The content of this article is intended to provide a general
guide to the subject matter. Specialist advice should be sought
about your specific circumstances.
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.
2017 has started with a bang on the data protection front. There have been several developments these past few months, ranging from updates on the new EU General Data Protection Regulation ("GDPR"), coming into force in May 2018, to the establishment of a Swiss-EU Privacy Shield.
The recent Avian Flu outbreak across Europe has been raising cholesterol across the industry since December of last year when the government issued a prevention order requiring farmers to keep their birds inside to help prevent the spread of the disease.
Some comments from our readers… “The articles are extremely timely and highly applicable” “I often find critical information not available elsewhere” “As in-house counsel, Mondaq’s service is of great value”
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).