Abstract
The European Commission (EC) continues to move towards transforming healthcare in Europe by making use of information and communication technologies (ICT) to improve the quality and access to healthcare for all European Union (EU) citizens. ICT is seen as the enabler of growth and development in the EU, by facilitating the interoperability of healthcare systems (to enable patient mobility and provide medical services at any place and time) and cross-border commerce. This chapter focuses on the phenomenon of Internet pharmacies and the increasing use of the Internet by EU citizens to obtain pharmaceutical drugs either in their own Member State, in other Member States, or further afield. It discusses the legislative framework regulating the cross-border sale of pharmaceutical drugs within the EU. It argues that as a result of recent EU regulatory reforms, technological developments, the increasing interoperability of EU healthcare systems, and the increase in use of cross-border medical services and electronic commerce, there may be very little justification for restricting cross-border online prescription drugs sales within the EU. Furthermore, that EU citizens who are at risk from prescription drugs purchased from online sellers located outside the EU, may be best protected by the provision of a safe and open EU online market for all pharmaceutical drugs. The chapter discusses possible measures and legislative reform that could provide a safe and open EU market for online prescription drugs. It ends by advocating for all EU citizens to be allowed the freedom to purchase cross-border online prescription drugs within the EU.
This is a preview of subscription content, log in via an institution.
Buying options
Tax calculation will be finalised at checkout
Purchases are for personal use only
Learn about institutional subscriptionsNotes
- 1.
eEurope: An Information Society For All. Communication on a Commission Initiative for the Special European Council of Lisbon, 23 and 24 March 2000. http://europa.eu/legislation_summaries/information_society/strategies/l24221_en.htm
- 2.
eEurope 2005: An information society for all. An Action Plan to be presented in view of the Sevilla European Council, 21/22 June 2002. COM(2002) 263 final.
- 3.
EU (2004a), e-Health—making healthcare better for European citizens: An action plan for a European e-Health area, {SEC(2004)539}.
- 4.
The EU’s eEurope Initiative involved the widespread use of ICT as a driver for growth and development.
- 5.
EU (2004b), Follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM(2004) 301.
- 6.
Actions included: the provision of better and clearer information about mobility rights, the provision of better legal certainty regarding the authorisation regime for reimbursement of costs incurred for healthcare; improved decision-making; simplifying rules regarding the coordination of social security systems; the deployment of a European health insurance card; simplifying procedures to facilitate mobility of citizens.
- 7.
Directive 2011/24/EU of the European Parliament and of the Council of 9th March 2011 on the application of patients’ rights in cross-border healthcare http://www.eahm.eu.org/files/2011/EUDirective_patientsRight_EN_l_08820110404en00450065.pdf
- 8.
eHealth Action Plan 2012-2020 public consultation http://ec.europa.eu/information_society/activities/health/ehealth_ap_consultation/index_en.htm
- 9.
Ibid.
- 10.
EU(2005), “i2010—A European Information Society for growth and employment” {SEC(2005) 717}.
- 11.
- 12.
EU (2010), A Digital Agenda for Europe, COM(2010)245 http://ec.europa.eu/europe2020/pdf/digital-agenda-communication-en.pdf
- 13.
Much of the focus on eHealth relates to “Sustainable healthcare and ICT-based support for dignified and independent living”, See Ibid.
- 14.
Directive 2009/110/EC on the taking up, pursuit and prudential supervision of the business of electronic money institutions (e-Money Directive).
- 15.
Directive 2011/24/EU of the European Parliament and of the Council of 9th March 2011 on the application of patients’ rights in cross-border healthcare http://www.eahm.eu.org/files/2011/EUDirective_patientsRight_EN_l_08820110404en00450065.pdf
- 16.
“ePrescription” means a medicinal prescription, as defined by Article 1(19) of Directive 2001/83/EC, issued and transmitted electronically’. COM(2008) 3282, Official Journal L 190, 18/07/2008 P. 0037 - 0043.
- 17.
See Directive 2005/36/EC which combined a number of earlier directives. In January 2011 a public consultation on modernizing Directive 2005/36/EC was launched (ending in November 2011) with a view to updating this directive.
- 18.
Internet pharmacies refer to online businesses that sell a variety of products ranging from beauty products, over-the-counter drugs (not requiring a prescription) and prescription drugs.
- 19.
The Internet’s first full-service Internet Pharmacy was the United States-based online pharmacy “Soma.com” which was launched in January 1999. See: Sonnenfeld and Hurlow (2000), pp. 105–110(6). The first UK Internet Pharmacy, “Pharmacy2u.co.uk” began operations in November 1999: See Pharm-line (1999), p. 849.
- 20.
This may be subject to various restrictions, for example the medicine should have been prescribed by a medical professional.
- 21.
See: George (2009).
- 22.
Ibid.
- 23.
In response to the global challenges posed by counterfeit drugs, in 2006 the World Health Organisation (WHO) launched a global coalition of stakeholders (from industry, international organisations, law enforcement and non-governmental organisations) called the International Medical Products Anti-Counterfeiting Taskforce (IMPACT), See: http://www.who.int/impact/en/. IMPACT has been actively working internationally, to seek solutions to the challenges raised by counterfeit drugs as well as raising global awareness of the dangers posed by counterfeit drugs.
- 24.
- 25.
Eaasm (2008).
- 26.
WHO (2010), pp. 241–320.
- 27.
NABP(2011) Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: July 2011. Available at: http://www.nabp.net/news/assets/IDOIReportJuly11.pdf
- 28.
Ibid.
- 29.
MHRA (2011).
- 30.
H.R. 6353: Ryan Haight Online Pharmacy Consumer Protection Act of 2008. Available at: http://www.govtrack.us/congress/bills/110/hr6353
- 31.
Protect IP Act 2011: http://leahy.senate.gov/imo/media/doc/BillText-PROTECTIPAct.pdf
- 32.
For example in the UK, in 2007, Dr Julian Eden was suspended by the General Medical Council (GMC) for prescribing drugs over the Internet, in breach of the GMC code of conduct.
- 33.
EU ResAP (2007), Resolution ResAP(2007)2: on good practices for distributing medicines via mail order which protect patient safety and the quality of the delivered medicine, 5th September 2007. Available at: https://wcd.coe.int/wcd/ViewDoc.jsp?id=1179467%26Site=CM
- 34.
Standards listed in the Appendix to Resolution ResAP(2007)2 concerned: delivery methods and related responsibilities; counselling and information for the patient; mandatory notification; conditions for sale and distribution; exclusion of unsuitable medicines from mail order trade; marketing and advertising; handling of prescriptions for mail orders of prescription-only medicines; establishment of focal points and their role and contribution to international co-operation; measures to follow up on offences.
- 35.
Directive 2011/83/EC amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products. Available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2011_62/dir_2011_62_en.pdf
- 36.
EPHA(2009), “EPHA releases its Position on Counterfeit Medicines”, Available at http://www.epha.org/a/3775
- 37.
Ibid.
- 38.
NABP (2010), World Customs Organization Members Unite to Ban Counterfeit Drugs. http://www.nabp.net/news/world-customs-organization-members-unite-to-ban-counterfeit-drugs/
- 39.
The Consolidated Version of the Treaty Establishing the European Community, consists of the original 1957 founding treaty of the European Economic Community (The Treaty of Rome), combined with various amendments by subsequent treaties including: the 1986 Single European Act; the 1992 Maastricht Treaty, the 1997 Treaty of Amsterdam and the 2003 Treaty of Nice.
- 40.
Article 5 states that: “the Community shall take action … only if and in so far as the objectives of the proposed action cannot be sufficiently achieved by the Member States and can therefore, by reason of the scale or effects of the proposed action, be better achieved by the Community” and that this “shall not go beyond what is necessary to achieve the objectives of this Treaty.”
- 41.
Article 152(1) also states that: “Community action, which shall complement national policies, shall be directed towards improving public health, preventing human illness and diseases, and obviating sources of danger to human health. Such action shall cover the fight against the major health scourges, by promoting research into their causes, their transmission and their prevention, as well as health information and education. The Community shall complement the Member States’ action in reducing drugs-related health damage, including information and prevention.”
- 42.
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 “on the Community code relating to medicinal products for human use” is a consolidation into a single act of the following previous directives: Directive 65/65/EEC; Directive 75/319/EEC; Directive 75/318/EEC; Directive 92/25/EEC; Directive 92/26/EEC; Directive 92/27/EEC; Directive 92/28/EEC. Subsequently, it has also been amended by various directives and regulations (including Directives 2002/98/EC, 2003/63/EC, 2004/24/EC, 2004/27/EC, 2009/53/EC, 2010/84/EU, 2011/62/EU). Directive 2001/83/EC does not apply to medical products prepared in pharmacies in accordance with a medical prescription for an individual or prescriptions of a pharmacopoeia (Article 3). Directive 2001/83/EC is available at: http://ec.europa.eu/health/files/eudralex/vol-1/dir_2001_83_cons2009/2001_83_cons2009_en.pdf
- 43.
Article 1(2) of Directive 2001/83/EC defines a medicinal product as: “(a) Any substance or combination of substances presented as having properties for treating or preventing disease in human beings; or (b) Any substance or combination of substances which may be used in or administered to human beings either with a view to restoring, correcting or modifying physiological functions by exerting a pharmacological, immunological or metabolic action, or to making a medical diagnosis.”
- 44.
Regulation (EEC) No 2309/93 provides for a centralised Community authorisation for technologically advanced medical products (e.g. derived from biotechnology) or medical products containing new active substances for use in humans or in food-producing animals.
- 45.
Parenteral administration of a drug involves injecting the drug into a vein, muscle or other body tissue. The drug is absorbed faster then with oral administration.
- 46.
Psychotropic and narcotic substances are classified by international conventions.
- 47.
C115/47-199 (2008) Consolidated Version of the Treaty on the Functioning of the European Union, Official Journal of the European Union, Brussels, 9.5.2008.
- 48.
Directive 2000/31/EC on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market (Directive on electronic commerce).
- 49.
Directive 97/7/EC (The Distance Selling Directive).
- 50.
Directive 2011/83/EU of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council.
- 51.
Directive 2011/83/EC must be implemented into Member States national laws by December 2013.
- 52.
Article 3(3)(b) of the Directive on Consumer Rights states that the Directive does not apply to contracts: “for healthcare as defined in point (a) of Article 3 of Directive 2011/24/EU, whether or not they are provided via healthcare facilities”. Article 3(a) of Directive 2011/24/EC states that: “‘healthcare’ means health services provided by health professionals to patients to assess, maintain or restore their state of health, including the prescription, dispensation and provision of medicinal products and medical devices”. Hence, the Consumer Rights Directive does not apply to the online sale of medicines.
- 53.
Recital 8 of the Directive.
- 54.
Article 1(2) of Directive 98/34/EC as amended by Directive 98/48/EC.
- 55.
As noted earlier the Distance Selling Directive will be replaced by the Directive on Consumer Rights (Directive 2011/83/EC) and it does not apply to the online sale of medicines. It must be implemented in the national laws of Member States by December 2013.
- 56.
ECJ Judgment of 11 December 2003 in Case C-322/01 Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval.
- 57.
This means that the German prohibition was not a measure that had an equivalent effect to a quantitative restriction on imports within the meaning of Article 28 (EC Treaty).
- 58.
Article 30 (EC Treaty) states that “The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on the grounds of public morality, public policy, public security; the protection of health and life of humans, animals or plants....” and that “Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.”
- 59.
The Distance Selling Directive, Article 14 allows member states to introduce a higher level of consumer protection such as a ban, “on the marketing of certain goods and services, particularly medicinal products, within their territory by means of distance contracts, with due regard to the Treaty”.
- 60.
Note that Directive 2005/36/EC contains provisions for on the mutual recognition of professional qualifications (including for pharmacists) across the EU and coordination of activities in professional fields. Provisions specific to pharmacists were previously detailed in the Directive 85/432/EEC and Directive 85/433/EEC, which were replaced by Directive 2005/36/EC.
- 61.
Article 88, Directive 2001/83/EC.
- 62.
Non-prescription medicines can be further classified into those sold under the supervision of a pharmacist (Pharmacy medicines) and others sold without the supervision of a pharmacists (General sales list medicines).
- 63.
ECJ Judgment of 26 May 2005 in Case C-212/03 Commission of the European Communities V French Republic.
- 64.
This means that medicines are not transported into a Member State personally by a citizen but are delivered via courier or by post.
- 65.
Opinion of Advocate General Geelhoed, delivered on 21 October 204, Case C-212/03 Commission of the European Communities v French Republic.
- 66.
ECJ Judgment of 2 December 2010 in Case C-108/09, Ker-Optika bt v ÀNTSZ Dél-dunántúli Regionális Intézete.
- 67.
This was in response to the argument that the activity of selling contact lenses required a physical examination, and therefore was not an information society service (as defined in Recital 18 of Directive 2000/31/EC), hence it did not fall within the scope of Directive 2000/31/EC.
- 68.
At paragraph 114 of the judgment.
- 69.
ECJ Judgment of 13 October 2011 in Case C-439/09, Pierre Fabre Dermo-Cosmétique SAS v Président de l’Autorité de la Concurrence & Ministre de l’Économie, de l’Industrie et de l’Emploi
- 70.
Article 81 EC or Article 101 TFEU prohibits agreements that could disrupt free competition in the European Economic Area’s internal market.
- 71.
As decided in Case C-212/03—Commission of the European Communities V French Republic , discussed in Sect. 6.4.3.2.
- 72.
In this context, a legal purchase means that the customer is in possession of a valid prescription (or can have one delivered to the Internet pharmacy) and that the prescription drug is authorised in the purchasing Member State and the importing Member State (or the customer in the importing Member State has been granted an individual import authorisation). The Internet Pharmacy is licensed.
- 73.
With an individual import authorisation supported by their doctor.
- 74.
C115/47-199 (2008) Consolidated Version of the Treaty on the Functioning of the European Union, Official Journal of the European Union, Brussels, 9.5.2008.
- 75.
Directive 2011/24/EU of the European Parliament and of the Council of 9th March 2011 on the application of patients’ rights in cross-border healthcare.
- 76.
Article 30 (EC Treaty) states that “The provisions of Articles 28 and 29 shall not preclude prohibitions or restrictions on imports, exports or goods in transit justified on the grounds of public morality, public policy, public security; the protection of health and life of humans, animals or plants....” and that “Such prohibitions or restrictions shall not, however, constitute a means of arbitrary discrimination or a disguised restriction on trade between Member States.”
- 77.
On the other hand, shifts may be occurring towards a greater coherence (or “harmonisation”) of approaches to human health e.g., through examining such domains as health and security. Member States are being increasingly encouraged to examine the commonality of situations rather than their own individual needs.
- 78.
H.R. 4954: SAFE Port Act (Title VIII—Unlawful Internet Gambling Enforcement) http://www.govtrack.us/congress/bills/109/hr4954
References
Eaasm (2008) The Counterfeiting Superhighway. http://www.a-cg.org/guest/pdf/reportEAASM08.pdf
George C (2009) Internet pharmacies: global threat requires global approach to regulation. Telehealth Law 9(3)
Irish J (2010) Customs group to fight $200 bln bogus drug industry, Reuters, June 10th, 2010. http://www.reuters.com/article/idUSTRE65961U20100610
MHRA (2011) Press release: UK medicines watchdog plays vital role in £5 million international fake drugs bust, 29 September 2011. http://www.mhra.gov.uk/NewsCentre/Pressreleases/CON129237
Pharm-line (1999) Britain’s first Internet Pharmacy opens. Pharmaceu J 263(7073):p849
Sonnenfeld S, Hurlow R (2000) Launching America’s first full-service Internet pharmacy. Int J Med Market 1(2):105–110 (6)
The Economist (2010) Poison pills: Counterfeit drugs used to be a problem for poor countries. Now they threaten the rich world, too, September 2nd 2010, New York
WHO (2010) Growing threat from counterfeit medicines. Bull World Health Org 88(4):241–320
Documents
C115/47-199 (2008) Consolidated Version of the Treaty on the Functioning of the European Union, Official Journal of the European Union, Brussels, 9.5.2008
COM (2008) 3282, Commission Recommendation of 2 July 2008 on cross-border interoperability of electronic health record systems. Official Journal L 190, 18/07/2008 P. 0037–0043
Council Regulation (EEC) No 2309/93 of 22 July 1993 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. http://ec.europa.eu/health/files/eudralex/vol-1/reg_1993_2309/reg_1993_2309_en.pdf
Directive 97/7/EC of the European Parliament and of the Council of 20 May 1997 on the protection of consumers in respect of distance contracts. (The Distance Selling Directive)
Directive 98/34/EC of the European Parliament and of the Council of 22 June 1998 laying down a procedure for the provision of information in the field of technical standards and regulations as amended by Directive 98/48/EC
Directive 2000/31/EC of the European Parliament and of the Council of 8 June 2000 on certain legal aspects of information society services, in particular electronic commerce, in the Internal Market ('Directive on electronic commerce')
Directive 2001/83/EC of the European Parliament and of the Council of 6 November 2001 “on the Community code relating to medicinal products for human use”
Directive 2005/36/EC of the European Parliament and of the Council of 7 September 2005 on the recognition of professional qualifications
Directive 2009/110/EC of the European Parliament and of the Council of 16 September 2009 on the taking up, pursuit and prudential supervision of the business of electronic money institutions amending Directives 2005/60/EC and 2006/48/EC and repealing Directive 2000/46/EC Text with EEA relevance. (The E-Money Directive)
Directive 2011/24/EU of the European Parliament and of the Council of 9th March 2011 on the application of patients’ rights in cross-border healthcare
Directive 2011/62/EC amending Directive 2001/83/EC on the Community Code relating to medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products
Directive 2011/83/EU of the European Parliament and of the Council of of 25 October 2011 on consumer rights, amending Council Directive 93/13/EEC and Directive 1999/44/EC of the European Parliament and of the Council and repealing Council Directive 85/577/EEC and Directive 97/7/EC of the European Parliament and of the Council
ECJ Judgment of 11 December 2003 in Case C-322/01, Deutscher Apothekerverband eV v 0800 DocMorris NV and Jacques Waterval
ECJ Judgment of 26 May 2005 in Case C-212/03 - Commission of the European Communities V French Republic
ECJ Judgment of 2 December 2010 in Case C-108/09, Ker-Optika bt v ÀNTSZ Dél-dunántúli Regionális Intézete
ECJ Judgment of 13 October 2011 in Case C-439/09, Pierre Fabre Dermo-Cosmétique SAS v Président de l'Autorité de la Concurrence & Ministre de l’Économie, de l’Industrie et de l’Emploi
eEurope: An Information Society For All. Communication on a Commission Initiative for the Special European Council of Lisbon, 23 and 24 March 2000. http://europa.eu/legislation_summaries/information_society/strategies/l24221_en.htm
eEurope 2005: An information society for all. An Action Plan to be presented in view of the Sevilla European Council, 21/22 June 2002. COM(2002) 263 final
eHealth Action Plan 2012-2020 public consultation. http://ec.europa.eu/information_society/activities/health/ehealth_ap_consultation/index_en.htm
EPHA (2009), “EPHA releases its Position on Counterfeit Medicines”. http://www.epha.org/a/3775
EU (2010), A Digital Agenda for Europe, COM(2010)245. http://ec.europa.eu/europe2020/pdf/digital-agenda-communication-en.pdf
EU(2005), “i2010 – A European Information Society for growth and employment” {SEC(2005) 717}
EU (2004a), e-Health – making healthcare better for European citizens: An action plan for a European e-Health area, {SEC(2004)539}
EU (2004b), Follow-up to the high level reflection process on patient mobility and healthcare developments in the European Union, COM(2004) 301
EU ResAP (2007), Resolution ResAP(2007)2: on good practices for distributing medicines via mail order which protect patient safety and the quality of the delivered medicine, 5th September 2007. https://wcd.coe.int/wcd/ViewDoc.jsp?id=1179467%26Site=CM
H.R. 6353: Ryan Haight Online Pharmacy Consumer Protection Act of 2008. http://www.govtrack.us/congress/bills/110/hr6353
H.R. 4954: SAFE Port Act (Title VIII - Unlawful Internet Gambling Enforcement). http://www.govtrack.us/congress/bills/109/hr4954
NABP (2010), World Customs Organization Members Unite to Ban Counterfeit Drugs. http://www.nabp.net/news/world-customs-organization-members-unite-to-ban-counterfeit-drugs/
NABP(2011) Internet Drug Outlet Identification Program Progress Report for State and Federal Regulators: July 2011. http://www.nabp.net/news/assets/IDOIReportJuly11.pdf
Opinion of Advocate General Geelhoed, delivered on 21 October 2004, Case C-212/03 Commission of the European Communities v French Republic. Protect IP Act 2011: http://leahy.senate.gov/imo/media/doc/BillText-PROTECTIPAct.pdf
Author information
Authors and Affiliations
Corresponding author
Editor information
Editors and Affiliations
Rights and permissions
Copyright information
© 2013 Springer-Verlag Berlin Heidelberg
About this chapter
Cite this chapter
George, C. (2013). The Internet and Pharmaceutical Drugs in the Era of Interoperable eHealth Systems Across the European Union. In: George, C., Whitehouse, D., Duquenoy, P. (eds) eHealth: Legal, Ethical and Governance Challenges. Springer, Berlin, Heidelberg. https://doi.org/10.1007/978-3-642-22474-4_6
Download citation
DOI: https://doi.org/10.1007/978-3-642-22474-4_6
Published:
Publisher Name: Springer, Berlin, Heidelberg
Print ISBN: 978-3-642-22473-7
Online ISBN: 978-3-642-22474-4
eBook Packages: Humanities, Social Sciences and LawLaw and Criminology (R0)