Impact of Market Exclusivity on Follow-on Orphan Medicinal Products in Europe
Author Information
Author(s): Brabers Anne EM, Moors Ellen HM, van Weely Sonja, de Vrueh Remco LA
Primary Institution: NIVEL, Netherlands Institute for Health Services Research
Hypothesis
Does the market exclusivity incentive of the European Orphan Drug Regulation result in a market monopoly or is the absence of follow-on OMPs a matter of time or market size?
Conclusion
The study concludes that the absence of follow-on OMP development is more related to time or market size rather than the creation of a market monopoly by the market exclusivity incentive.
Supporting Evidence
- The likelihood of obtaining a follow-on OMP was strongly associated with disease prevalence and turnover of the first OMP.
- Only one follow-on OMP was discontinued upon approval of the first OMP, indicating that market exclusivity does not create a monopoly.
- Manufacturers that continued development of follow-on OMPs predominantly assumed improved efficacy compared to the first approved OMP.
Takeaway
This study looks at whether having a special rule that gives companies exclusive rights to sell rare disease drugs stops other companies from making similar drugs. It found that it's more about how many people have the disease and how big the market is.
Methodology
The study compared rare disorders with an approved OMP and at least one follow-on OMP to those with an approved OMP and no follow-on OMP, analyzing various market, product, and disease-related characteristics.
Limitations
The study was limited to rare disorders with an approved treatment and relied on public domain data.
Participant Demographics
The study included rare disorders affecting a total of 55 million patients in Europe and the US.
Digital Object Identifier (DOI)
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