Recent Developments in European Pharmaceutical Law 2004: A Legal Point of View
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.
European drug legislation; Regulatory affairs; European pharmaceutical law; Pharma Review 2004; Pharmaceutical case law
Since the compilation of the "Review 2001" report (1), European pharmaceutical law has undergone extensive revisions and amendments. Numerous initiatives and decisions have came into force by means of legislation and case law, giving at present the image of a complex and rapidly changing legal puzzle in the sector of pharmaceuticals.
Two introductory remarks might be helpful in seeking to understand how European law develops. First, the European Community treaty (2) remains the key determinant for all evolution in the area of pharmaceutical law. Articles 28 and 30 of the European Community (EC) treaty lay down the twin foundation stones on which the body of European pharmaceutical legislation is built, namely, the general principle of free movement of goods (Article 28 EC) and the partly conflicting principle of protection of public health (Article 30 EC), which limits the scope of Article 28 EC and defines limitations to the achievement of the single market. Article 28 EC prohibits all forms of restrictions on importations of goods, including medicinal products, and all measures have equivalent effect between Member States. However, Article 30 EC allows for exceptions which may be justified on certain grounds, such as the protection of the health and life of humans and animals. On the basis of this provision, Member States of the EC have maintained and in many cases modernized their national legislation on medicinal products, thus restricting the free movement of medicinal products within the EC.
Second, regulations, directives, decisions, and-to a minor extent-recommendations, communications, and guidelines express the current state of pharmaceutical law in Europe. It is important to emphasize that within these texts, which together constitute the body of 'European pharmaceutical law/different obligations and intentions are incorporated, ranging from quasi-immediate European-wide binding legal instruments to texts which are issued to assist applicants in interpreting and following procedures within the EC. Today, the distinction between 'legally binding law' and 'soft law' is often used to allow a classification of the various texts that are published by the institutional axis Brussels-Luxembourg-Strasbourg and enforced by the Member States (Table 1).
In some areas, for example, procedural aspects of classical regulatory activities related to the approval and renewal of marketing authorization applications, the directives and regulations together with the corresponding 'notice to applicants' and detailed guidelines form an increasingly detailed framework which can be reviewed and studied by viewing the institutional home pages (3,4). In other areas, the legal codex is enhanced primarily by decisions of the European Court of Justice and driven as well by nonharmonized public health modernization acts at the Member State level.
Although the diversity of texts and information makes it difficult to provide a rapid overview, especially in view of the huge range of economic, regulatory, and legal aspects covered, some issues in the area of pharmaceutical activity remain constant hot-spots of interest and modernization:
* The procedures regulating the manufacturing, development, marketing authorization (MA), and distribution of drugs and their tremendous importance for the availability of patentprotected new chemical and biological drug entities,
* The mechanisms limiting intellectual property rights allowing generic products (hereby named 'generics') to enter either the internal market or, more frequently, segments of the common European market,
* The effects which can be seen as a result of a not completely harmonized common market: parallel distribution and parallel importation of medicinal products due to different pricing schemes that are, in most cases, triggered by the existence and variety of national price fixing systems, coupled with different forms of reimbursement of the costs of medicines, and
* The impact of new information technologies that create new channels of drug information for healthcare professionals as well as for consumers and allow inter alia the setting-up of information technology-based drug distribution systems across national borders.
A conference in European pharmaceutical law hosted by the Academy of European Law on February 12-13, 2004 in Trier (Germany) was dedicated to the above mentioned issues. Some of the proceedings of this conference are presented in this paper (5).
The present paper aims to summarize the recent developments in European pharmaceutical law. In particular, it provides information on the latest case law developments and an up-to-date analysis of the legislative process at the very moment when European Union (EU) enlargement introduces additional questions and issues requiring resolution. However, the complex legal process of enlargement and integration of most of the Collaboration Agreement of Drug Regulatory Authorities in EU Associated Countries into the EU on May 1,2004 is too intricate to be handled within this review. Discussion of another important process, the implementation of the Clinical Trials Directive 2001/20/EC (6), which must be implemented by May 1, 2004, cannot be done at this time as many Member States are still in the process of transposing the directive into their national law.
REVIEW OF MARKETING AUTHORIZATION PROCEDURES: RECENT EUROPEAN COMMUNITY LEGISLATION
In addition to the two procedures allowing European-wide marketing approval of medicines, the centralized procedure with the European Medicines Evaluation Agency (EMEA) as the competent authority, and the mutual recognition procedure (MRP) for approvals by the medical agencies network, additional aspects of the European legislation were also evaluated by Review 2001. Based on the Cameron McKennaAnderson report (7), the EU Commission in November 2001 transmitted to the European Council and the European Parliament two comprehensive legislative proposals concerning the review of the pharmaceutical legislation on medicines for human use (8):
* A proposal for a regulation of the European Parliament and the European Council laying down community procedures for the authorization and supervision of medicinal products for human (and veterinary) use and establishing a European Agency for the Evaluation of Medicinal Products (Proposal 2001/0252/COD), and
* A proposal for a directive of the European Parliament and the European Council amending Directive 2001/83/EC (9) on the Community code relating to medicinal products for human use (Proposal 2001/0253/COD).
Both proposals as well as the proposal requesting an amendment of the Veterinary Medicines Codification Directive 2001/82/EC (10) have been subject to discussion by the respective institutions and have been re-amended several times since the end of 2001. The European Parliament held its second reading on December 17, 2003. In March 2004, the finalized proposals intended to amend Regulation (EEC) No 2309/93 (11) and Directive 2001/83/EC were passed by the European Council and published on April 30, 2004 as Regulation (EC) No 726/2004 (12) and Directive 2004/27 (13) in the Official Journal of the European Communities (Figure 1).
It must be mentioned that Figure 1 focuses only on the major legislative acts enforced since the year of the publication of Review 2001. Other directives and regulations issued before 2001 continue to be valid, for example, the regulation laying down the provisions of a supplementary protection certificate (EEC No 1768/92) (14) or the orphan medicinal products regulations (EC No 141/2000 and EC No 847/2000) (15,16), though the codifying Directive 2001/83/EC contains no direct references to these acts.