European Union market exclusivity

In order to encourage pharmaceutical companies to invest in orphan drug development, legislation provides for a number of incentives. These include application fee waiver (the extent of reduction varies with the region of the world, and in the European Union it is 50% for all fees since 2002), market exclusivity and protocol assistance. In the European Union, there is 100% reduction in the fee applicable to the provision of any scientific advice. The fund made available by the Community for fee exemptions for orphan medicinal products amounts to= 3 700000 in 2005. 

The period of market exclusivity is 10 years from authorisation of the product. In the context of market exclusivity in the European Union, a Member State must not accept another application for a marketing authorisation or grant a marketing authorisation or accept an application to extend an existing marketing authorisation for the same therapeutic indication in respect of a similar medicinal product. However, exclusivity may be lost by the first applicant consenting to a second application from another applicant, if the first is unable to meet demand, if a similar product is found to be clinically superior, if the criteria are no longer met or if, at the end of 5 years, a Member State can show that the product is (excessively) profitable. 

Markets for fresh and frozen mnssels are almost exclusively in the European Union. France, Italy, Belginm, and Germany are the main importers in quantity terms. Also, Netherlands imported certain qnantities in times of low prodnction snch as 1991,1992, 2003, and 2004, to supplement the domestic prodnct. The United States has entered the group of top importers of fresh/frozen or live mussels only in recent years these imports are almost equally distributed between frozen and fresh imports. Total value of fresh/frozen or live mussels is around US 374 million in volume of exportation, which gives a unit value of around US 1.57/kg. 

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