Council Regulation (EEC) No 1768/92 of 18 June 1992 concerning the creation of a supplementary protection certificate for medicinal products
Modified by
Actconcerning the conditions of accession of the Kingdom of Norway, the Republic of Austria, the Republic of Finland and the Kingdom of Sweden and the adjustments to the Treaties on which the European Union is founded(94/C 241/08)
Decision of the Council of the European Unionof 1 January 1995adjusting the instruments concerning the accession of new Member States to the European Union(95/1/EC, Euratom, ECSC), 11994N31995D0001, August 29, 1994
Decision of the Council of the European Unionof 1 January 1995adjusting the instruments concerning the accession of new Member States to the European Union(95/1/EC, Euratom, ECSC), 31995D0001, January 1, 1995
Actconcerning the conditions of accession of the Czech Republic, the Republic of Estonia, the Republic of Cyprus, the Republic of Latvia, the Republic of Lithuania, the Republic of Hungary, the Republic of Malta, the Republic of Poland, the Republic of Slovenia and the Slovak Republic and the adjustments to the Treaties on which the European Union is founded, 12003T, September 23, 2003
Actconcerning the conditions of accession of the Republic of Bulgaria and Romania and the adjustments to the treaties on which the European Union is founded, 12005S, June 21, 2005
Regulation (EC) No 1901/2006 of the European Parliament and of the Councilof 12 December 2006on medicinal products for paediatric use and amending Regulation (EEC) No 1768/92, Directive 2001/20/EC, Directive 2001/83/EC and Regulation (EC) No 726/2004(Text with EEA relevance), 32006R1901, December 27, 2006
Regulation (EC) No 469/2009 of the European Parliament and of the Councilof 6 May 2009concerning the supplementary protection certificate for medicinal products(Codified version)(Text with EEA relevance), 32009R0469, June 16, 2009
Council Regulation (EEC) No 1768/92of 18 June 1992concerning the creation of a supplementary protection certificate for medicinal productsTHE 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 CommissionOJ No C 114, 8.5.1990, p. 10.,In cooperation with the European ParliamentOJ No C 19, 28.1.1991, p. 94 and OJ No C 150, 15.6.1992.,Having regard to the opinion of the Economic and Social CommitteeOJ No C 69, 18.3.1991, p. 22.,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 national legislation prior to the entry into force of this Regulation should be defined;Whereas special arrangements should be allowed in Member States whose laws introduced the patentability of pharmaceutical products only very recently;Whereas provision should be made for appropriate limitation of the duration of the certificate in the special case where a patent term has already been extended under a specific national law,HAS ADOPTED THIS REGULATION: