Mail-order trade in medicines in europe - A guide for legislators to protect consumers

European Journal of Health Law

Volumn 16, Issue 4, 2009, Pages 351-366

  Seeberg Elverfeldt, Niels J ^a  

^a German Federal Ministry of Health   (Germany)

Author keywords

Illegal internet sales; Mail order trade; Medicines; Safety standards

Indexed keywords

DRUG;

ARTICLE; COMMERCIAL PHENOMENA; EUROPE; HUMAN; INTERNET; LEGAL ASPECT; SAFETY;

COMMERCE; CONSUMER PRODUCT SAFETY; EUROPE; HUMANS; INTERNET; PHARMACEUTICAL PREPARATIONS;

EID: 73349091566     PISSN: 09290273     EISSN: 15718093     Source Type: Journal    
DOI: 10.1163/092902709X12506817652856     Document Type: Article

References (104)

1. Resolution ResAP(2007)2 on good practices for distributing medicines via mail order which protect patient safety and the quality of the delivered medicine, adopted by the Committee of Ministers on 5 September 2007(hereinafter COE Resolution). The author chaired the COE working group which prepared the resolution. https://wcd.coe.int/ViewDoc.jsp?id=1179467&Site= CM&BackColorInternet= 9999CC&BackColorIntranet= FFBB55&BackColorLogged=FFAC75
2. ECJ judgement of 11 December 2003, C-322/01 ("DocMorris")
3. Ibid., No. 104: ". . . national rules or practices likely to have a restrictive effect, or having such an effect, on the importation of pharmaceutical products are compatible with the Treaty only to the extent that they are necessary for the effective protection of health and life of humans."
4. Opened for signature on 23 November 2001, entry into force on 1 July 2004, as of 29 July 2009 total number of ratifications/accessions by 26 countries, also by the United States of America as non-member of the Council of Europe.
5. Supra, fn. 1.
6. Supra, fn. 2, No. 63, 103, 104.
7. Act on Medicinal Products No. 378 of 31 December 2007; Compilation of Laws no. 378/2007, p. 5408 et seq.
8. Regulation on proper pharmaceutical practice, and on further conditions for handling medicines in pharmacies, medical facilities and other operators and facilities which dispense medicines; Compilation of Laws no. 84/2008, p. 1112 et se.
9. See for detail: Law on the modernisation of the statutory health insurance system - (GMG) of 14 November 2003 (Bundesgesetzblatt I p. 2190).
10. http://www.dimdi.de/static/de/amg/var/index.htm.
11. Publication of 16 June 2005 in the Federal Journal (Bundesanzeiger) on 21 June 2005.
12. Announcement of 29 April 2009 in the Federal Journal (Bundesanzeiger) on 15 May 2009.
13. Judgement of 20 December 2007, I ZR 205/04: http://www.bundesgerichtshof. de/.
14. Judgement of 13 March 2008, 3 C 27/7: http://www. bundesverwaltungsgericht.de/media/archive/ 6264.pdf.
15. Art. 3 para. 1 No. 8 of the Law amending the Medicines Act no. 93/1994, in force since 1.10.2008; http://eng.heilbrigdisraduneyti.is/media/ Laws%20in%20english/The-Medicinal-Products-Act-No- 93-1994.pdf.
16. Regulation No. 1065 of 6 November 2008.
17. Nederlandse Apotheeknorm (NAN) of 23 March 2006: http://www.knmp.nl/ vakinhoud/kwaliteit-szorg/nederlandse-apotheeknorm-2006.
18. See for the German conclusion, supra, text to fn. 12.
19. Geneesmiddelenwet, in force since 1 July 2007; http://wetten.overheid.nl/ BWBR0021505/geldig-heidsdatum-20-08-2009.
20. Medicines Act 1968 (c.67); http://www.statutelaw.gov.uk/content.aspx? activeTextDocId=1662209.
21. The Code of Ethics and the Professional Standards and Guidance for Internet Pharmacy Services can be accessed at http://www.rpsgb.org/pdfs/ coepsgintpharm.pdf.
22. The NHS (Pharmaceutical Services) Regulations 2005 can be accessed via this link: http://www. dh.gov.uk/PolicyAndGuidance/MedicinesPharmacyAndIndustry/ NHSPharmaceuticalRegulations/ NHSPharmaceuticalRegulationsArticle/fs/en?CONTENT- ID=4113501&chk=2Ymb69.
23. Art. 29 of the Royal Decree of 21 January 2009 with regulations for pharmacists, in force since 9 February 2009; Bulletin of Acts, Orders an Decrees of 30 January 2009, pages 7229-7280.
24. Regulation S. I. No. 510/2005 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005; http://www.irishstatutebook.ie/ 2005/en/si/0510.html.
25. Regarding the Import, Export and Distribution of Medicinal Products and Requirements for the Opening and Operation of Medicinal Product Wholesalers, last amended on 27 April 2004.
26. Regulation No. 416 of 26 June 2007.
27. Polish Medicines Act; in force since 6 September 2001.
28. Ordinance of the Minister of Health of 14 March 2008 on conditions of mail-order sale of medicinal products dispensed without doctor's prescription; http://www.departamenty.gif.gov.pl/img/Deparament-Nadzoru/Rozporzdzenia/Roz. sprzedazy-wysy%C5%82kowej.pdf (Polish version).
29. Official Gazette of the Republic of Slovenia, No. 31, p. 3217, entry into force on 8 April 2006; http:// www.firdpc.com/en/Legislation/Medicinal-Act- March-2006/.
30. Article 234(4) of the Law of Medicinal Products on Human Medicine, in force since 13 April 2007.
31. Pharmacy Act Nr. 279 of 6 July 1984 in the consolidated version of 28.7.2006, Nr. 657; Executive Order no. 155 of 20 February 2007 on Prescriptions; Executive Order no. 933 of 5 October 2006 on the dispensing of OTC medicines outside of pharmacies.
32. Article 1 of the Act Number 1963 of 20 September 1991, Official Journal of the Government of the Hellenic Republic, version number 145, p. 4072 and Article 14 of the Presidential Decree 340/1993, Official Journal of the Government of the Hellenic Republic, version number 157, p. 2895.
33. Section 21/A of a regulation issued by the Ministry of Health which entered into force on 1 June 2004.
34. Act on Medicinal Products 29/2006. Article 2 para. 5.
35. Notification of the EU Commission SG(2008) D/51366, notification-number: 2008 / 9020 / IS 902. Iceland furthermore refers to the relevant provisions in the United Kingdom and the DocMorris judgement of the ECJ.
36. Statistics "Die Apotheke; Zahlen, Daten, Fakten 2008" (The Pharmacy: Figures, Data, Facts for 2008", Federal Association of German Pharmacists (ABDA); http://www.abda.de/fileadmin/downloads/ZDF/72dpi-ABDA-ZDF- Broschuere-100x210.pdf; ( (number without value added tax).
37. Information from the Federation of German Mail-Order Pharmacists (BVDVA), dated March 2009: http://www.bvdva.de/fileadmin/content/pdf/Daten-und-Fakten- zum-Versandhandel-Maerz-09.pdf
38. Bill presented by the Free States of Saxony and Bavaria to reduce mail-order trade in medicines to the extent allowed under European law, Federal Council document 538/08 dated 1 August 2008.
39. Bill presented by DIE LINKE: For a quality-assured, nation-wide supply of medicines - Limiting mail-order trade to non-prescription medicines; Official Parliamentary Records 16/9754 of 25 June 2009.
40. Supra, fn. 40.
41. Ibid,.
42. See, supra, text to fn. 10.
43. Summary based on communications of the Dutch Ministry of Health and the Dutch Health Inspectorate to the author in August 2009.
44. See, supra, text to fn. 19.
45. Supra fn. 2, No. 119; see e.g., the statement of Prof. Dr. Michael Uechtritz in the hearings of the Committee of Health of the German Bundestag on 25 March 2009 regarding a legislative proposal to prohibit mail-order trade in prescription-only medicines: http://www.bundestag.de/bundestag/auss-chuesse/a14/ anhoerungen/115/Prot.pdf at 23.
46. Supra, text to fn. 1.
47. As regards counterfeit medicines, the WHO International Medical Products Anti-Counterfeit Task-force (IMPACT) was formed within the World Health Organization (WHO) in 2006. The Council of Europe is discussing the draft of an international agreement which is expected to be opened for signature in 2010, see for details: http://www.coe.int/t/dghl/standardsetting/pharmacrime/default- EN.asp?. On 10 December 2008 the EU Commission proposed a Directive on the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source. At national level in Germany new legislation entered into force on 23 July 2009. It entitles customs not only to confiscate any illegal imports of medicines but also to give notice to the relevant health authorities. Such import is punishable even for those who have bought a potentially counterfeit piece of medicine which gave reason to suspect its illegal origin be it because it was extremely cheap or available without prescription while being subject to prescription in Germany (see sections 73 para. 1b, 74 and 96 of the Law on Medical Products).
48. See http://www.intgovforum.org/cms/.
49. See presentation of Dr. Niels-J. Seeberg-Elverfeldt, LL.M., on "Legal v. illegal trade in medicines", 2007 Chairman of the Committee of Experts on Pharmaceutical Questions, Council of Europe, at the UN Internet Governance Forum - Brazil 2007 on 14 November 2007, Rio de Janeiro/Brazil.
50. According to the COE Resolution the only way to protect the public from illegal offers is to help differentiate these easily from legal offers which bear a clearly identifiable legal imprint, and that information on a pharmacy website should therefore be understandable, reliable and specific.
51. See, supra, text to fn. 11.
52. http://www.rpsgb.org/registrationandsupport/registration/ internetpharmacylogo.html.
53. Resolution ResAP(2007)2 on good practices for distributing medicines via mail order which protect patient safety and the quality of the delivered medicine, adopted by the Committee of Ministers on 5 September 2007(hereinafter COE Resolution). The author chaired the COE working group which prepared the resolution. https://wcd.coe.int/ViewDoc.jsp?id=1179467&Site= CM&BackColorInternet= 9999CC&BackColorIntranet= FFBB55&BackColorLogged=FFAC75
54. ECJ judgement of 11 December 2003, C-322/01 ("DocMorris")
55. Ibid., No. 104: ". . . national rules or practices likely to have a restrictive effect, or having such an effect, on the importation of pharmaceutical products are compatible with the Treaty only to the extent that they are necessary for the effective protection of health and life of humans."
56. Opened for signature on 23 November 2001, entry into force on 1 July 2004, as of 29 July 2009 total number of ratifications/accessions by 26 countries, also by the United States of America as non-member of the Council of Europe.
57. Supra, fn. 1.
58. Supra, fn. 2, No. 63, 103, 104.
59. Act on Medicinal Products No. 378 of 31 December 2007; Compilation of Laws no. 378/2007, p. 5408 et seq.
60. Regulation on proper pharmaceutical practice, and on further conditions for handling medicines in pharmacies, medical facilities and other operators and facilities which dispense medicines; Compilation of Laws no. 84/2008, p. 1112 et se.
61. See for detail: Law on the modernisation of the statutory health insurance system - (GMG) of 14 November 2003 (Bundesgesetzblatt I p. 2190).
62. http://www.dimdi.de/static/de/amg/var/index.htm.
63. Publication of 16 June 2005 in the Federal Journal (Bundesanzeiger) on 21 June 2005.
64. Announcement of 29 April 2009 in the Federal Journal (Bundesanzeiger) on 15 May 2009.
65. Judgement of 20 December 2007, I ZR 205/04: http://www.bundesgerichtshof. de/.
66. Judgement of 13 March 2008, 3 C 27/7: http://www. bundesverwaltungsgericht.de/media/archive/ 6264.pdf.
67. Art. 3 para. 1 No. 8 of the Law amending the Medicines Act no. 93/1994, in force since 1.10.2008; http://eng.heilbrigdisraduneyti.is/media/ Laws%20in%20english/The-Medicinal-Products-Act-No- 93-1994.pdf.
68. Regulation No. 1065 of 6 November 2008.
69. Nederlandse Apotheeknorm (NAN) of 23 March 2006: http://www.knmp.nl/ vakinhoud/kwaliteit-szorg/nederlandse-apotheeknorm-2006.
70. See for the German conclusion, supra, text to fn. 12.
71. Geneesmiddelenwet, in force since 1 July 2007; http://wetten.overheid.nl/ BWBR0021505/geldig-heidsdatum-20-08-2009.
72. Medicines Act 1968 (c.67); http://www.statutelaw.gov.uk/content.aspx? activeTextDocId=1662209.
73. The Code of Ethics and the Professional Standards and Guidance for Internet Pharmacy Services can be accessed at http://www.rpsgb.org/pdfs/ coepsgintpharm.pdf.
74. The NHS (Pharmaceutical Services) Regulations 2005 can be accessed via this link: http://www. dh.gov.uk/PolicyAndGuidance/MedicinesPharmacyAndIndustry/ NHSPharmaceuticalRegulations/ NHSPharmaceuticalRegulationsArticle/fs/en?CONTENT- ID=4113501&chk=2Ymb69.
75. Art. 29 of the Royal Decree of 21 January 2009 with regulations for pharmacists, in force since 9 February 2009; Bulletin of Acts, Orders an Decrees of 30 January 2009, pages 7229-7280.
76. Regulation S. I. No. 510/2005 - Medicinal Products (Prescription and Control of Supply) (Amendment) Regulations 2005; http://www.irishstatutebook.ie/ 2005/en/si/0510.html.
77. Regarding the Import, Export and Distribution of Medicinal Products and Requirements for the Opening and Operation of Medicinal Product Wholesalers, last amended on 27 April 2004.
78. Regulation No. 416 of 26 June 2007.
79. Polish Medicines Act; in force since 6 September 2001.
80. Ordinance of the Minister of Health of 14 March 2008 on conditions of mail-order sale of medicinal products dispensed without doctor's prescription; http://www.departamenty.gif.gov.pl/img/Deparament-Nadzoru/Rozporzdzenia/Roz. sprzedazy-wysy%C5%82kowej.pdf (Polish version).
81. Official Gazette of the Republic of Slovenia, No. 31, p. 3217, entry into force on 8 April 2006; http:// www.firdpc.com/en/Legislation/Medicinal-Act- March-2006/.
82. Article 234(4) of the Law of Medicinal Products on Human Medicine, in force since 13 April 2007.
83. Pharmacy Act Nr. 279 of 6 July 1984 in the consolidated version of 28.7.2006, Nr. 657; Executive Order no. 155 of 20 February 2007 on Prescriptions; Executive Order no. 933 of 5 October 2006 on the dispensing of OTC medicines outside of pharmacies.
84. Article 1 of the Act Number 1963 of 20 September 1991, Official Journal of the Government of the Hellenic Republic, version number 145, p. 4072 and Article 14 of the Presidential Decree 340/1993, Official Journal of the Government of the Hellenic Republic, version number 157, p. 2895.
85. Section 21/A of a regulation issued by the Ministry of Health which entered into force on 1 June 2004.
86. Act on Medicinal Products 29/2006. Article 2 para. 5.
87. Notification of the EU Commission SG(2008) D/51366, notification-number: 2008 / 9020 / IS 902. Iceland furthermore refers to the relevant provisions in the United Kingdom and the DocMorris judgement of the ECJ.
88. Statistics "Die Apotheke; Zahlen, Daten, Fakten 2008" (The Pharmacy: Figures, Data, Facts for 2008", Federal Association of German Pharmacists (ABDA); http://www.abda.de/fileadmin/downloads/ZDF/72dpi-ABDA-ZDF- Broschuere-100x210.pdf; ( (number without value added tax).
89. Information from the Federation of German Mail-Order Pharmacists (BVDVA), dated March 2009: http://www.bvdva.de/fileadmin/content/pdf/Daten-und-Fakten- zum-Versandhandel-Maerz-09.pdf
90. Bill presented by the Free States of Saxony and Bavaria to reduce mail-order trade in medicines to the extent allowed under European law, Federal Council document 538/08 dated 1 August 2008.
91. Bill presented by DIE LINKE: For a quality-assured, nation-wide supply of medicines - Limiting mail-order trade to non-prescription medicines; Official Parliamentary Records 16/9754 of 25 June 2009.
92. Supra, fn. 40.
93. Ibid,.
94. See, supra, text to fn. 10.
95. Summary based on communications of the Dutch Ministry of Health and the Dutch Health Inspectorate to the author in August 2009.
96. See, supra, text to fn. 19.
97. Supra fn. 2, No. 119; see e.g., the statement of Prof. Dr. Michael Uechtritz in the hearings of the Committee of Health of the German Bundestag on 25 March 2009 regarding a legislative proposal to prohibit mail-order trade in prescription-only medicines: http://www.bundestag.de/bundestag/auss-chuesse/a14/ anhoerungen/115/Prot.pdf at 23.
98. Supra, text to fn. 1.
99. As regards counterfeit medicines, the WHO International Medical Products Anti-Counterfeit Task-force (IMPACT) was formed within the World Health Organization (WHO) in 2006. The Council of Europe is discussing the draft of an international agreement which is expected to be opened for signature in 2010, see for details: http://www.coe.int/t/dghl/standardsetting/pharmacrime/default- EN.asp?. On 10 December 2008 the EU Commission proposed a Directive on the prevention of the entry into the legal supply chain of medicinal products which are falsified in relation to their identity, history or source. At national level in Germany new legislation entered into force on 23 July 2009. It entitles customs not only to confiscate any illegal imports of medicines but also to give notice to the relevant health authorities. Such import is punishable even for those who have bought a potentially counterfeit piece of medicine which gave reason to suspect its illegal origin be it because it was extremely cheap or available without prescription while being subject to prescription in Germany (see sections 73 para. 1b, 74 and 96 of the Law on Medical Products).
100. See http://www.intgovforum.org/cms/.
101. See presentation of Dr. Niels-J. Seeberg-Elverfeldt, LL.M., on "Legal v. illegal trade in medicines", 2007 Chairman of the Committee of Experts on Pharmaceutical Questions, Council of Europe, at the UN Internet Governance Forum - Brazil 2007 on 14 November 2007, Rio de Janeiro/Brazil.
102. According to the COE Resolution the only way to protect the public from illegal offers is to help differentiate these easily from legal offers which bear a clearly identifiable legal imprint, and that information on a pharmacy website should therefore be understandable, reliable and specific.
103. See, supra, text to fn. 11.
104. http://www.rpsgb.org/registrationandsupport/registration/ internetpharmacylogo.html.