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Healthy Skepticism Library item: 18924

Warning: This library includes all items relevant to health product marketing that we are aware of regardless of quality. Often we do not agree with all or part of the contents.

 

Publication type: Journal Article

Roos JCP, Hyry HI, Cox TM
Orphan drug pricing may warrant a competition law investigation
BMJ 2010 Nov 16; 341:
http://www.bmj.com/content/341/bmj.c6471.extract


Abstract:

EU legislation offers an exclusive marketing period as an incentive for companies to develop drugs for rare diseases. But pricing for orphan drugs hinders access and may warrant a competition law investigation, say Jonathan C P Roos, Hanna I Hyry, and Timothy M Cox

Orphan drug legislation in the European Union has promoted the development of treatments for very rare diseases by bestowing 10 year marketing exclusivity. This market monopoly is one of the benefits that comes under the European Union’s Regulation EC No 141/2000 (see webtable 1) and has enabled manufacturers to charge what many consider “exorbitant” prices for orphan drugs1 (table 1⇓).

View this table: In this window In a new window
Table 1
Orphan drugs and their approximate costs

These necessary drugs, which are very costly, profoundly affect the wellbeing of patients who2 struggle to persuade national health systems, operating under significant constraints,3 to finance their treatment.4 5 Orphan drug costs already consume 5% of the Belgian national drug budget6 and are predicted soon to consume 6-8% of healthcare budgets of larger EU countries such as France5—an unsustainable position.

Current high pricing thus hinders access to treatment7 and contravenes the aim of the Orphan Regulation: “Patients suffering from rare conditions should be entitled to the same quality of treatment as other patients”.8

Why are orphan drug prices so high in Europe?
The regulation did not create an oversight body to regulate prices and protect consumers from market abuse, by contrast with other state sanctioned monopolies (for example, OFWAT regulates water prices in England 9). However, if the product is deemed sufficiently profitable, the exclusivity period can be reduced to six years under Article 8(2). But a recent EU-commissioned investigation has noted fears that it could “substantially” reduce investment incentives.10 Thus this “claw-back” provision seems never to have been invoked and is unlikely to be …

 

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Far too large a section of the treatment of disease is to-day controlled by the big manufacturing pharmacists, who have enslaved us in a plausible pseudo-science...
The blind faith which some men have in medicines illustrates too often the greatest of all human capacities - the capacity for self deception...
Some one will say, Is this all your science has to tell us? Is this the outcome of decades of good clinical work, of patient study of the disease, of anxious trial in such good faith of so many drugs? Give us back the childlike trust of the fathers in antimony and in the lancet rather than this cold nihilism. Not at all! Let us accept the truth, however unpleasant it may be, and with the death rate staring us in the face, let us not be deceived with vain fancies...
we need a stern, iconoclastic spirit which leads, not to nihilism, but to an active skepticism - not the passive skepticism, born of despair, but the active skepticism born of a knowledge that recognizes its limitations and knows full well that only in this attitude of mind can true progress be made.
- William Osler 1909