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 biologicals.

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 rules.

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 desired.

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 interchangeability.

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.

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