E-DRUG: Ceiling for drug registration (6)
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Dear Gamal Khalafalla
In Iceland (and Norway) the 'need clause' was in our drug legal base for such limitation you are talking about. However, it was against the EU legislation so when we made the EEA agreement with the EU (Iceland and Norway are not EU members) we had to follow the EU directives and therefore abolish the need clause.
Best regards,
Einar Magnusson
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Einar Magnusson,
Director
Department of Pharmaceutical Affairs,
Directorate of Health Policy and Health Management
IS-150 Reykjavik, Iceland
Tel. +354 545 8700, fax +354 551 9165
einar.magnusson@hbr.stjr.is
[The message received by the moderator had problems with the formatting so I hope I have 'translated' it correctly. In Norway the clause was abolished in 1994. We regret that, and so do (did?) WHO. You do need some generics to ensure competition, but the effect on price after a certain number is rather small. If you ensure quality and use of generic names (not brand names) it will ease confusion. To reduce number of me-toos may also help. There has been some discussion on the need clause previously on E-drug. I copy one message here, written by a Norwegian colleague of mine. In the archive around that date (April 1999) you will find more messages on criteria for approval. Moderator]:
http://www.essentialdrugs.org/edrug/archive/199904/msg00032.php
E-drug: Re: Drug approval criteria (cont'd)
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- The late need clause
To Peter Lurie
Kirsten Myhr made a very good comment on your posting. Just some additional
words on the need clause, which has been abandoned as part of the Norwegian
harmonisation with the European Union rules.
In Norway there used to be three criteria for approval: Efficacy, safety and need (I suppose pharmaceutical quality was taken for granted, or was seen as part of efficacy and safety).
If there was a drug on the market within a specific category, a newcomer on
the market would have to document superiority in efficacy or safety;
otherwise the need was already covered, and the application would be
rejected. This would be applied on me-too drugs, but also on synonyms.
However, if there was a sufficient price advantage in a new synonym, a need for this particular product could be proclaimed, and approval granted.
This clause effectively limited the number of me-toos and synonyms on the
market. But it also provided protection for innovation, actually stimulated
innovation (within the obvious limitations of this tiny market of 4 million
people), because those first on the market were protected against competition except when competitors could document an advantage.
The approval/rejection process was rather simple, and based mainly on
medical considerations performed by the regulatory authority and adopted by
the specialties commission.
The last few years has seen a breakdown of Norwegian drug policy, which used to be rather strict.
Gaut Gadeholt, MD, PhD
Dept of Clinical Chemistry
Rikshospitalet (The National Hospital)
N-0027 OSLO, Norway
E-mail (private) gaut@online.no
[Note from moderator: WHO recommends the use of a need clause, unfortunately there is no longer a model country to refer to. Kirsten Myhr]