[Ip-health] Norwegian parliament turns down proposal to issue Spinraza compulsory license

Jens Plahte jens at plahte.info
Wed May 30 00:54:46 PDT 2018

On Thursday last week a majority vote in the Norwegian parliament 
Stortinget turned down a proposal to request that the Government issue a 
compulsory license for the drug Spinraza (nusinersen), which is used to 
treat the serious congenital condition Spinal muscular atrophy (SMA). 
Recently, Norwegian health authorities concluded drawn-out negotiations 
with Spinraza manufacturer Biogen to purchase the drug for use in less 
than 18 year old patients, but not in adults, at a non-disclosed price. 
Biogen's initial offer was NOK 1 million per dose (USD 121 000), or NOK 
7 million per patient for the initial year of treatment.

The bill, which was submitted by representatives of the Socialist Party 
and supported by the Christian Democratic Party, made reference to the 
TRIPS regulations, and proposed that Norway should seek ways to 
establish national manufacturing capacities, or alternatively to 
parallel import the drug. The bill also mentioned that US authorities 
had succeeded in lowering the price of Bayer's antibiotic ciprofloaxacin 
by threatening to compulsory licence the drug as a defense against the 
anthrax attacs in 2001.

During the debate the bill received strong opposition and criticism from 
the Conservative Party representative, and his fellow party member the 
Minster og Health Mr. Bent Høie pointed out that 1) the current 
situation represents no public health emergency that could justify 
issuance of a compulsory license, 2) there is no production facility 
available that could manufacture nusinersen, and 3) due to the data 
exclusivity regulations new clinical trails would have to be conducted. 
The Labor Party added weight to the Government coalition's votes to 
reject the bill.


Jens Plahte

Plahte Research & Consulting
Bølerveien 12e
0690 Oslo

Mob.: +47 915 888 56
Skype: jensplahte

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