Since the publication of Review 2001 in the European Union, comprehensive changes to pharmaceutical legislation have led to a considerable modernization of the legal framework for medicinal products developed and commercialized within the European Union. By analyzing the community law, it becomes evident that the principles of ‘free movement of goods’ and ‘protection of public health’ constitute the key determinants of the actual and future development of legislation for pharmaceuticals in Europe.
This article reviews the recent changes in the regulation of pharmaceutical products, including important case law decisions within the European Union. Focusing on the question of how far the pharmaceutical market has been harmonized up until now, different areas of pharmaceutical entrepreneurship are analyzed: the situation for innovative medicines, conditions for generic products, the market of parallel importation and parallel distribution, and the role of public health concerns in the future regulatory process.
Academy of European Law.Free Movement of Pharmaceutical Products and Public Health: more variations or essential similarity? Available at: http://www.era.int/www/en/a_press_11783.htm. Accessed April 8, 2004.
6.
European Parliament and Council Directive 2001/20/EC of 4 Apr 2001. OJ. May 1, 2001; L121/34 of 7.
7.
CMS Cameron McKenna and Andersen Consulting.Evaluation of the Operation of Community Procedures for the Authorisation of Medicinal Products. November 17, 2000. Available at: http://pharmacos.eudra.org/F2/review/index.htm. Accessed April 8, 2004.
8.
European Union Commission.Proposal for a Regulation of the European Parliament (and the Council) laying down Community procedures for the authorisation and supervision of medicinal products for human and veterinary use and establishing a European Agency for the Evaluation of Medicinal Products (2001/0252/COD) & amending Directive 2001/83/EC on the Community code relating to medicinal products for human use (2001/0253/COD) & amending Directive 2001/82/EC on the Community code relating to veterinary medicinal products (2001/0254/COD). COM (2001) 404 final. November 26, 2001.
9.
European Parliament and Council Directive 2001/83/EC of 6 Nov 2001. OJ. November 28, 2001; L311/67.
10.
European Parliament and Council Directive 2001/82/EC of 6 Nov 2001. OJ. November 28, 2001; L311/1.
11.
Council Regulation(EEC) No 2309/93 of 22 July 1993. OJ. August 24, 1993; No L214/1.
12.
European Parliament and Council Regulation (EC) No 726/2004 of 31 Mar 2004. OJ. April 39, 2004; L136/1.
13.
European Parliament and Council Directive 2004/27/EC of 31 Mar 2004. OJ. April 30, 2004; L136/34.
14.
Council Regulation (EEC) No 1768/92 of 18 June 1992. OJ. July 2, 1992; L182/1.
15.
European Parliament and Council Regulation (EC) No 141/2000 of 16 Dec 1999. OJ. January 22, 2000; L18/1.
16.
Commission Regulation (EC) No 847/2000 of 27 Apr 2000. OJ. April 28, 2000; L103/5.
17.
Commission of the European Communities v. Artegodan and others. C-39/03, ECR, 2003: 1-07885 (European Court of Justice 2003).
18.
European Medicine Evaluation Agency. CPMP/1CH/2887/99 Rev 2—Topic M4: Common Technical Document for the Registration of Pharmaceuticals for Human Use.London, UK: European Medicine Evaluation Agency; November 20, 2003.
19.
Commission Directive 2001/63/EC of 25 June 2003. OJ. June 27, 2003; L159/46.
20.
G10 Medicines Report.High Level Group on innovation and provision of medicines. May 7, 2002. Available at: http://pharmacos.org/F3/g10/p9.htm. Accessed April 17, 2004.
21.
European Union Commission.Commission consultation on a draft proposal for a European Parliament and Council Regulation (EC) on medicinal products for pediatric use. March 8, 2004. Available at: http://pharmacos.eudra.org/F2/pharmacos/new.htm. Accessed April 16, 2004.
22.
European Parliament and Council Directive 2004/24/EC of 31 Mar 2004. OJ. April 30, 2004; LT36/85.
23.
European Parliament and Council Directive 2003/94/EC of 8 Oct 2003. OJ. October 14, 2003, L262/22.
24.
European Parliament and Council Directive 2004/9/EC of 11 Feb 2004. OJ. February 20, 2004; L050/28.
25.
European Parliament and Council Directive 2004/10/EC of 11 Feb 2004. OJ. February 20, 2004; L050/44.
26.
AstraZeneca v. Laegemiddelstyrelsen. C-223/01, ECR, 2004, not yet published (European Court of Justice, 2003).
27.
The Queen v. The Licensing Authority established by the Medicines Act 1968. C-368/96, ECR, 1998:1–07967 (European Court of Justice, 1998).
28.
The Queen on the application of Novartis Pharmaceuticals v. The Licensing Authority established by the Medicines Act 1968 and SangStat UK Ltd and Imtix-SangStat UK Ltd. C-106/01, ECR, 2004: not yet published (European Court of Justice, 2004).
29.
Centrafarm v. Sterling Drug. C-15/74, ECR. 1974:1147 (European Court of Justice, 1974).
30.
Council Directive 89/104/EEC of 21 Dec 1988. OJ. February 11, 1989; L40/1.
31.
ForresterIS. The repackaging of trademarked pharmaceuticals in Europe: Recent developments. In European Intellectual Property Review.London, UK: Sweet & Maxwell, Ltd.2000;11: 512–519.
32.
Hoffmann-La Roche & Co. v. Centrafarm. Case C-102/77, ECR, 1978:1139 (European Court of Justice, 1978).
33.
European Union Commission.Communication from the Commission on parallel imports of proprietary medicinal products for which marketing authorisations have already been granted. COM (2003) 839 final. December 30, 2003.
34.
Bristol-Myers Squibb and others v. Paranova. C-436/93. July 11, 1996. ECR, 1996:03457 (European Court of Justice, 1996).
35.
Pharmacia & Upjohn v. Paranova. C-379/97, ECR, 1999:06927 (European Court of Justice, 1999).
36.
Merck, Sharp & Dohme v. Paranova. C-443/99, ECR, 2002:03703 (European Court of Justice, 2002).
37.
Boehringer Ingelheim and others v. Swingward and others. Case C-143/00, ECR, 2002:03759 (European Court of Justice, 2002).
38.
Aventis Pharma Deutschland v. Kohlpharma. C-433/00, ECR, 2002:07761 (European Court of Justice, 2002).
39.
Paranova Läkemedel and others v. Läkemedelsverket. C-15/01, ECR, 2003:1–04175 (European Court of Justice, 2003).
40.
Sandoz Prodotti Farmaceutici v. Commission. C-277/87, ECR, 1990:1–00045 (European Court of Justice, 1990).
41.
Commission Decision No 2001/791/EC of 8 May 2001. Glaxo Wellcome, Aseprofar and Fedifar, Spain Pharma, BAI and EAEPC. OJ. November 17, 2001;L302/1.
42.
Bundesverband der Arzneimittel-Importeure e.V. and Commission of the European Communities v. Bayer AG. C-2/01 and C-3/01, ECR, 2004, not yet published (European Court of Justice, 2004).
43.
Deutscher Apothekerverband e.V. v. DocMorris NV, Jacques Waterval. C-322/01, ECR, 2003, not yet published (European Court of Justice, 2003).
44.
Criminal proceedings against Jean-Marie Delattre. C-369/88, ECR, 1991:1–01487 (European Court of Justice, 1991).
45.
Criminal proceedings against B. Keck and D. Mithouard. C-267/91 and C-268/91, ECR, 1993:1–06097 (European Court of Justice, 1993).
46.
Guidelines on Good Distribution Practice of Medicinal Products for Human Use (94/C 63/03). Available at: http://pharmacos.eudra.org/F2/EudraLex. Accessed April 27, 2004.
47.
Freistaat Bayern v. Eurimpharm. C-347/89, ECR, 1991:1–01747 (European Court of Justice, 1991).
48.
European Union Commission.Commission Communication on the Single Market in Pharmaceuticals. COM (98) 588 final. November 25, 1998.
49.
European Union Commission.Communication from the Commission to the Council, the European Parliament, the Economic and Social Committee and the Committee of the Regions. A stronger European-based pharmaceutical industry for the benefit of the patient—a call for action. COM (2003) 383 final. July 1, 2003.
50.
Council Directive 89/105/EC of 21 Dec 1988. OJ. February 11, 1989; L40/8.
