Regulation 1992/1768 - Creation of a supplementary protection certificate for medicinal products - Main contents

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Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products

Official Journal L 182 , 02/07/1992 P. 0001 - 0005

Finnish special edition: Chapter 13 Volume 23 P. 0078

Swedish special edition: Chapter 13 Volume 23 P. 0078

COUNCIL REGULATION (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products

THE COUNCIL OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Economic Community, and in particular Article 100a thereof,

Having regard to the proposal from the Commission (1),

In cooperation with the European Parliament (2),

Having regard to the opinion of the Economic and Social Committee (3),

Whereas pharmaceutical research plays a decisive role in the continuing improvement in public health;

Whereas medicinal products, especially those that are the result of long, costly research will not continue to be developed in the Community and in Europe unless they are covered by favourable rules that provide for sufficient protection top encourage such research;

Whereas at the moment the period that elapses between the filing of an application for a patent for a new medicinal product and authorization to place the medicinal product on the market makes the period of effective protection under the patent insufficient to cover the investment put into the research;

Whereas this situation leads to a lack of protection which penalizes pharmaceutical research;

Whereas the current situation is creating the risk of research centres situated in the Member States relocating to countries that already offer greater protection;

Whereas a uniform solution at Community level should be provided for, thereby preventing the heterogeneous development of national laws leading to further disparities which would be likely to create obstacles to the free movement of medicinal products within the Community and thus directly affect the establishment and the functioning of the internal market;

Whereas, therefore, the creation of a supplementary protection certificate granted, under the same conditions, by each of the Member States at the request of the holder of a national or European patent relating to a medicinal product for which marketing authorization has been granted is necessary; whereas a Regulation is therefore the most appropriate legal instrument;

Whereas the duration of the protection granted by the certificate should be such as to provide adequate effective protection; whereas, for this purpose, the holder of both a patent and a certificate should be able to enjoy an overall maximum of fifteen years of exclusively from the time the medicinal product in question first obtains authorization to be placed on the market in the Community;

Whereas all the interests at stake, including those of public health, in a sector as complex and sensitive as the pharmaceutical sector must nevertheless be taken into account; whereas, for this purpose, the certificate cannot be granted for a period exceeding five years; whereas the protection granted should furthermore be strictly confined to the product which obtained authorization to be placed on the market as a medicinal product;

Whereas a fair balance should also be struck with regard to the determination of the transitional arrangements; whereas such arrangements should enable the Community pharmaceutical industry to catch up to some extent with its main competitors who, for a number of years, have been covered by laws guaranteeing them more adequate protection, while making sure that the arrangements do not compromise the achievement of other legitimate objectives concerning the health policies pursued both at national and Community level;

Whereas the transitional arrangements applicable to applications for certificates filed and to certificates granted under...

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