Protecting patients, either in medical interventions or as consumers of medicinal products or as participants in clinical trials, and facilitating access to innovative medicinal products are two distinct but interacting regulatory processes. Through the implementation of the Pharmaceuticals Review 2001, taking the form of a package of revised pharmaceutical legislation that entered into force in November 2005, the European Union (EU) set new standards for both processes—including a new European pediatrics regulation as part of the implementation measures.
One year on from the introduction of the new EU legislation, this article provides an overview of the most recent developments of pharmacovigilance and summarizes the ongoing political and legal activities intended to achieve an equal and rapid access to medicinal products across the EU. The review incorporates an analysis of the objectives and outcomes of the much-discussed Clinical Trials Directive as well as recent judgments of the European Court of Justice on patient mobility and health care services.
European Parliament and Council Directive 2004/27/EC of 31 Mar 2004. OJ. April 30, 2004; L136/34.
2.
European Parliament and Council Directive 2004/24/EC of 31 Mar 2004. OJ. April 30, 2004; L136/85.
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European Parliament and Council Regulation (EC) No 726/2004 of 31 Mar 2004. OJ. April 30, 2004; L136/1.
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EU Commission. Communication from the Commission—follow up to the high level reflection on patient mobility and healthcare developments in the European Union. COM (2004) 301 final; April 20, 2004.
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EMEA. European risk management strategy: progress to date and next steps. EMEA, London; May 2005 (Doc.Ref.EMEA/136253/2005). Available at: http://www.emea.europa.eu/pdfs/human/phv/13625305en.pdf. Accessed November 30, 2006.
EU Commission. Guideline on the definition of a potential serious risk to public health in the context of Article 29(1) and (2) of Directive 2001/83—March 2006. (2006/C133/05) OJ. June 8, 2006;C133/5.
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EMEA.Guideline on risk management systems for medicinal products for human use. London, November 2005 (Doc.Ref. EMEA/96268/2005). Available at: http://www.emea.europa.eu/pdfs/human/euleg/9626805en.pdf. Accessed November 30, 2006.
EMEA.Draft guideline on the conduct of pharmacovigilance for medicines used by the paediatric population. EMEA, London; May 2005 (Doc. Ref. EMEA/CHMP/235910/2005). Available at: http://www.emea.europa.eu/pdfs/human/phvwp/23591005en.pdf. Accessed November 30, 2006.
15.
European Parliament and Council Regulation (EC) No 1901/2006 of 12 December 2006. OJ. December 27, 2006;L 378/1.
European Parliament and Council Regulation (EC) No 141/2000 of 16 Dec 1999. OJ. January 22, 2000;L18/1.
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Commission Regulation (EC) No 847/2000 of 27 Apr 2000. OJ. April 28, 2000;L103/5.
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EMEA. Guideline on the procedure for accelerated assessment pursuant to Article 14 (9) of Regulation (EC) No 726/2004 (Doc. Ref. EMEA/419127/05). Available at: http://www.emea.europa.eu/pdfs/human/euleg/41912705en.pdf. Accessed November 5, 2006.
28.
Commission Regulation (EC) No 507/2006 of 29 Mar 2006. OJ. March 30, 2006;L92/6.
29.
EMEA. Guideline on procedures for the granting a marketing authorisation under exceptional circumstances, pursuant to Article 14(8) of Regulation (EC) No 726/2004 (Doc. Ref. EMEA/357981/2005). Available at: http://www.emea.europa.eu/pdfs/human/euleg/35798105en.pdf. Accessed November 5, 2006.
30.
EMEA. Guideline on compassionate use of medicinal products, pursuant to Article 83 of Regulation (EC) No 726/2004 (Doc. Ref. EMEA/27170/2006/Draft). Available at: http://www.emea.europa.eu/pdfs/human/euleg/2717006en.pdf. Accessed November 5, 2006.
31.
EU Commission. Commission staff working document on the experience acquired as a result of the application of Regulation (EC) No 141/2000 on orphan medicinal products and account of the public health benefits obtained. Posted June 27, 2006. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/doc/orphan_en_06–2006.pdf. Accessed November 5, 2006.
32.
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EU Commission.Inventory of community and Member States’ incentive measures to aid the research, marketing, development and availability of orphan medicinal products. Revision 2005. Posted September 7, 2006. Available at: http://ec.europa.eu/enterprise/pharmaceuticals/orphanmp/doc/inventory_2006_08.pdf Accessed November 5, 2006.
Council Regulation (EEC) No 1408/71 of 14 June 1971 on the application of social security schemes to employed persons and their families moving within the Community. OJ. July 5, 1971;L. 149.
36.
Charter of fundamental rights of the European Union. OJ. December 5, 2000;C 364/1.
37.
EU Commission. Commission communication to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions—modernising social protection for the development of high-quality, accessible and sustainable health care and long-term care: support for the national strategies using the “open method of coordination.” COM (2004) 304; April 20, 2004.
38.
EU Commission. Commission Communication to the Council, the European Parliament, the European Economic and Social Committee and the Committee of the Regions—healthier, safer, more confident citizens, a health and consumer protection strategy. COM (2005) 115 final; April 6, 2005 (not yet published). Available at: http://ec.europa.eu/health/ph_overview/Documents/com_2005_0115_en.pdf. Accessed December 1, 2006.
39.
Decker v. Caisse de maladie des employés privés. C-120/95, ECR 1998: 1–1831 and Kohll v. Union des caisses de maladie. C-158/96, ECR 1998: 1–1931 (European Court of Justice, 1998).
40.
B.S.M. Geraets-Smits and Peerbooms. C-157/99, ECR 2001: 1–5473 (European Court of Justice, 2001).
41.
Abdon Vanbraekel e.a. and Alliance nationale des mutualités chrétiennes (ANMC). C-368/98, ECR 2001: 1–5363 (European Court of Justice, 2001).
42.
V. G. Müller-Fauré and Onderlinge Waarborgmaatschappij OZ Zorgverzekeringen UA and E.E.M. and van Riet and Onderlinge Waarborgmaatschappij ZAO Zorgverzekeringen, C-385/99, ECR 2003: 1–4509 (European Court of Justice, 2003).
43.
Yvonne Watts v. Bedford Primary Care Trust, Secretary of State for Health. C-372/04, ECR 2006: I-4325 (European Court of Justice, 2006).
44.
Héritiers d'Annette Keller against Instituto Nacional de la Seguridad Social (INSS), Instituto Nacional de Gestión Sanitaria (Ingesa). C-145/03, ECR 2005: 1–2529 (European Court of Justice, 2005).
45.
EU Commission. Communication from the Commission to the Council, the European social and economic committee parliament and the committee of the regions on the annual policy strategy for 2007, COM (2006) 122 final; March 14, 2006.
46.
EU Commission. Communication from the commission on the consultation regarding community action on health services, SEC (2006) 1195/4; September 26, 2006.
EMEA. Rules of involvement of Members of Patients’ and/or consumers’ organisations in committees related activities (Doc. Ref. EMEA/ 161660/2005 corr.). Available at: http://www.emea.europa.eu/pdfs/human/patientgroup/16166005.pdf. Accessed December 7, 2006.
Heads of Agencies Working Group.Establishing a European risk management strategy: summary report of the heads of agencies ad hoc working group. Available at: http://hma.eu/uploads/media/ERMS_summary_report.pdf. Accessed May 25, 2007.
