News Patents and designs 2000

Orphan medicinal products regulation (EC) No 141/2000 of the European Parliament and of the Council of 16 December 1999.

Regulation (EC) No 141/2000 establishes incentives in order to promote the research, development and availability on the market of the pharmaceutical and health products called Orphan Medicinals
June 16, 2000.

It establishes incentives in order to promote the research, development and availability on the market of the pharmaceutical products called Orphan Medicinal

Article 3

It concerns the criteria for designating a medicinal product as an Orphan Medicinal

Two conditions are necessary: a + b

a. medicinal product has to be intended for the diagnosis, prevention or treatment of a life-threatening or chronically debilitating condition affecting not more than five in 10 thousand persons

or

medicinal product has to be intended for the diagnosis, prevention or treatment of a life-threatening, seriously debilitating or serious and chronic condition in the Community and that without incentives it is unlikely that the marketing of the medicinal product in the Community would generate sufficient return to justify the necessary investment

b. no satisfactory method of diagnosis, prevention or treatment of the condition in question exists that has been authorised in the Community or, if such method exists, the medicinal product will be of significant benefit to those affected by that condition

Article 8

It concerns the Market exclusivity for Orphan Medicinal

Who obtains a marketing authorisation in respect of an orphan medicinal product (Art. 3) will have, without prejudice to intellectual property law or any other provision of Community law, the exclusivity for a period of 10 years

In fact, the Community and the Member States shall not, for a period of 10 years, 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.

Exceptions according to that another authorisation can be granted:

the holder of the marketing authorisation for the original orphan medicinal product has given his consent to the second applicant

the holder of the marketing authorisation for the original orphan medicinal product is unable to supply sufficient quantities of the medicinal product

the second applicant requests authorisation for a second medicinal product safer, more effective or otherwise clinically superior with respect to the orphan medicinal product already authorised.
Finally, the exclusivity period may be reduced to six years if evidences exist that the product is sufficiently profitable not to justify maintenance of market exclusivity.

 

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