Local view for "http://purl.org/linkedpolitics/eu/plenary/2002-12-17-Speech-2-214"
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"en.20021217.7.2-214"2
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". – Mr President, orphan medicinal products are so called because they are used in the treatment or diagnosis of conditions that occur so rarely. The cost of developing and marketing orphan medicinal products would not be recovered by their expected sales. For this reason, the pharmaceutical industry has been unwilling to develop such products under normal market conditions. The regulation on orphan medicinal products which entered into force in January 2000 provides a system of incentives for sponsors to develop and market designated orphan medicinal products.
One of these incentives is market exclusivity for a period of 10 years. This is granted if a designated orphan medicinal product obtains a marketing authorisation in all Member States. To obtain this, the sponsor must conduct a series of tests and studies to demonstrate that the product meets the rigorous standards of quality, safety and efficacy required of all medicinal products marketed in the EU. Since 2000, 123 products have been designated as orphan medicinal products and placed on the Community register.
In a very small number of cases this involves a commonly available chemical that has been supplied by the manufacturer to hospitals which have prepared the chemical for administration to patients. The great majority of these orphan medicinal products contain new innovative ingredients. In a few cases it has been common practice for some time to supply the raw ingredients to treat the patient. However, this chemical has not been tested for its purity and safety and the product is not authorised. Indeed the chemical is not of pharmaceutical quality and may contain unspecified and unquantified impurities. In this situation, it is not surprising that an authorised medicinal product developed to meet rigorous standards of quality, safety and efficacy costs more than the base chemical.
The Commission has no powers with respect to either the price or reimbursement of medicines. However, the orphan regulation contains a provision to reduce the period of market exclusivity to six years, if after five years it can be shown that the product is sufficiently profitable not to justify the maintenance of market exclusivity."@en1
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