(2001; 76 pages)
Internet purchase of pharmaceuticals: a review of regulatory experience*
* Compiled and commented by Harri Ovaskainen, Director for Pharmaceutical Affairs, Finnish Pharmacists’ Association, Helsinki, Finland
Countries vary considerably with regard to regulation of medicines sold over the Internet. Because of the cross-border nature of the Internet, regulations at international level should be favoured whenever possible particularly if these are seen to enhance harmonization of drug legislation. Notwithstanding this trend to globalization, there is always a risk of over regulation - and regulations which are too aggressive or restrictive will only deter innovative Internet pharmacy practices. In this environment, regulation can be seen as a powerful and positive tool to enable practitioners to engage in professional responsibilities towards patients by improving outcomes.
The Internet pharmacy can enhance and enable the practice of pharmaceutical care. Routine questions about medication can be answered by online pharmacists using e-mail or other electronic real-time video connections. Knowledge of a patient’s diagnosis, results of laboratory tests, and established drug monitoring parameters, largely unavailable to pharmacists at present, could be made accessible through the Internet. The vision of an e-enhanced pharmacy within the health care system is soon to become a reality.
The status of e-commerce of pharmaceuticals
In 2000, a survey was carried out to determine whether differences in the provision of pharmacy services exist among different types of US-based Internet pharmacies. This involved 5 chain pharmacy extensions, 6 mail order pharmacies, 14 online pharmacies and 8 independent pharmacy extensions allowing patients to purchase prescription medications online. There was significant variation among the four types of pharmacies. Patients were required to provide their own prescription at 88% of the sites. However several sites - particularly online pharmacies - either allowed the patient to obtain the prescription from the site’s online physician or made provisions for contacting the patient’s physician directly (1).
According to the data obtained, the most interesting finding was the variation in privacy and confidentiality policies. Chain pharmacy extensions were the most sensitive to this issue: such sites alerted users to their privacy policies during the ordering process and VIPPS-certified sites were more likely to do this. There was also a significant variation in availability of drug information - for example, only eight sites (24%) provided an electronic newsletter for patients but more than two-thirds provided a toll-free number for contacting a health care professional (1).
A study carried out in 1999 tested 46 websites selling prescription pharmaceuticals over the Internet. Thirty-seven sites (33 based in the USA and 4 based outside the United States) required a prescription from a personal physician or through an Internet physician consultation. Nine sites based outside of the United States did not require a prescription or physician consultation. The median cost of an Internet physician visit was US$ 70, which was considered to be 15% higher than the general practice visit locally. Median price per pill of two most commonly offered medications (sildenafil and finasteride) was 10% higher on the Internet (before shipping charges) than at local pharmacies in Philadelphia, USA (2).
A further study (3), used search engines (Altavista, HotBot, and WebCrawler) and identified 86 sites that offered to deliver sildenafil directly to consumers without a visit to a physician. In the 10-day interval between identification and data collection, nine sites operating within the United States ceased to exist. Forty-two (55%) of the 77 remaining sites required consumers to undergo an on-line medical evaluation, consisting of a questionnaire. Four sites (5%) offered, but did not require, such an evaluation and 31 sites (40%) did not offer such an evaluation. The average cost of an on-line evaluation was US$ 64 (IMF exchange rates were used to convert costs into dollars) and was separate from the cost of the drug. The average cost of a 50-mg tablet of sildenafil was US$ 12.60 (range: $5 to $40), and that of 100-mg tablet was US$ 13.50. Shipping and handling charges (range: $5 to $48) were added by 26 sites (34%) and all sites accepted credit-card payment for all costs.
The content and design of the questionnaire differed among the 46 sites (60%) that offered a questionnaire to their customers. Thirty-four of the sites required information about the use of nitrates before the respondent could submit the questionnaire, and 10 merely requested such information. Forty sites included questions about whether the respondent had been given a diagnosis and 33 of these sites required this information. On the other hand, at 52 websites (68%), consumers were required to consent to release the companies from any liability, and at 12 sites consumers were required to waive their need for physical examination (3).
To assure patient safety and avoid liability, many on-line pharmacy sites reject an order if a buyer’s questionnaire suggests that the drug may be medically inappropriate. However, on many sites, the process of analysing the questionnaire appears to be quite haphazard. For example, a newspaper reporter in Seattle contacted an Internet site, claimed normal weight, but was still able to order a prescription weight loss drug. Equally, a TV reporter ordered and got sildenafil for her 6-month-old son, using his actual height, weight, and birth date. Another investigator received the same drug after giving vital data for his cat. Though there are sites that do cull through questionnaires and reject inappropriate buyers, these systems remain ripe for abuse (4).
Two people working at the Austrian Health Institute (Österreichisches Bundesinstitut für Gesundheitswesen, ÖBIG) spent 6 months ordering 27 different prescription drugs through 20 online pharmacies. The results were not promising. One-third of all medicines ordered and paid for by credit card did not even arrive. Those that did, arrived with delays of up to 73 days only after several recalls. Even the prices were higher than in regular pharmacies - partly because of online consultation charges and shipping and handling fees. When delivered, the pills were never adequately packed in terms of mechanical and thermal protection. There were also deficiencies in the inclusion of information leaflets and in selling medications for incorrect indications (5).
A Swiss consultancy firm carried out a study of Internet purchase of prescription-only medicines or medicines not officially licensed in Switzerland. The study involved ordering, a total of 20 medicines from 9 different suppliers over the Internet. Seventeen medicines were delivered by mail within six weeks. They were sent in envelopes up to 8 cm thick, unopened and without having been inspected by customs. Five of the 17 medicines had been damaged during transport, leaving individual capsules or tablets open and unprotected in the envelope. Only two medicines were not supplied on the grounds that the person ordering them had not provided a doctor’s prescription. One medicine was not delivered for six weeks (6).
When products were analysed by the Swiss regulatory authority, the Intercantonal Medicines Bureau, they showed shortcomings in quality and quantitative composition. The products had excessive abrasion (brittleness), inadequate active ingredient content, unidentifiable impurities and misleading descriptions. In one case, the active ingredient was not exactly as declared, while another product contained the D-isomer instead of the L-isomer. No more than six of the medicines delivered contained a package insert, of which only one was in German. All other patient information leaflets were in English, Dutch, French, Italian or Spanish (6).
WHO questionnaire on the Internet and international regulatory control
To gain more information concerning the promotion and sale of medicines via the Internet, WHO distributed a questionnaire, in March 2000, to regulatory authorities controlling the sale and promotion of pharmaceuticals in each WHO Member State. The total number of replies was 58, representing just over one-third of Member States. Geographical distribution of these answers was Africa 8, America 6, Asia 26 and Europe 18.
Upon evaluation, it was evident that countries vary substantially in their regulations on the sale and promotion of medicines via the Internet. The outcome of the survey may not be statistically representative, but it does give a useful overview.
According to responses to the questionnaire, Denmark, Japan, Malaysia, Netherlands, New Zealand, Sweden, Switzerland, United Kingdom and United States of America have specific or general regulations on promotion and sale of medicines via the Internet. In some countries like Denmark, New Zealand and Sweden, the same general regulations on medicines apply to Internet sale, distribution and advertising as apply to usual commercial activity. In Israel and South Africa, regulation was planned and in Vanuatu legislation was under development.
Inspection of on-line pharmacies has so far only been carried out by the US Food and Drug Administration, although the number of inspections was not disclosed. The type of action taken for non-compliant premises was: convictions 12, arrests 28, warning letters 23, letters to foreign sellers 13, and import alerts 3.
National sanctions for patients importing medicines without a marketing authorization
Countries have different positions concerning patients importing pharmaceutical products which do not have marketing authorization in their country (excluding substances under international control). In some countries, such as the Czech Republic, this situation is not covered by law. More often, patients are free to import small quantities of medicines without a marketing authorization if these are for their personal use and/or their household. Countries that fall in this category are Bahrain, Brunei, Cyprus, Denmark, Estonia, Fiji Islands, Germany, Hungary, Japan, Malaysia, Mexico, Myanmar, Netherlands, Oman, Senegal, Spain, Sweden, Switzerland, United Kingdom, USA, Vanuatu, Venezuela. However, there may be some restrictions, for example, that the product should be prescribed by a physician in Brazil, India, Israel, Maldives and Philippines, while permission is required to import for personal use in India, Iran, Jordan, Lithuania, New Zealand, Singapore, Slovak Republic, Zimbabwe.
Many countries such as Antigua and Barbuda, Bangladesh (for large quantities), Hong Kong, Indonesia, Latvia, Mauritius, Mongolia, Nigeria, Samoa, South Africa, and Vietnam, reported sanctions for importing products without a marketing authorization. The minimum penalty varied between a fine or a fine and/or imprisonment up to seven years (Indonesia).
Companies/individuals engaging in commerce of pharmaceuticals without being licensed
This question seeks to determine if there are loopholes in legislation where companies/individuals can either import or wholesale pharmaceuticals without being licensed to do so. A country where export of pharmaceuticals is poorly controlled allows criminals to establish rogue Internet sites and operate with ease. Bangladesh, India, Jordan, Micronesia, Tonga and United Arab Emirates did not report on sanctions concerning this type of act. In most other countries, this is a criminal act subject to prosecution leading to either a fine and/or imprisonment. The seizure of stock and some other type of regulatory action can also exist. In some countries such as Estonia and the Slovak Republic, sanctions can vary depending on whether the offender is a physical or legal entity.
Companies/individuals involved in the retail and sale of prescription drugs without a valid prescription
This question indicates potential countries which either do not have strong control mechanisms for classifying prescription and OTC-medicines separately, or countries which have a loophole in their legislation. Countries not having sanctions for companies/individuals carrying out illegal retail selling of prescription medicines were Bangladesh, Jordan, Nigeria, Oman, Tonga and United Arab Emirates. The countries which accept that they do have difficulties in controlling this or have a culture of expanded self-medication are Brazil, Brunei, Malaysia and Myanmar. Sanctions for selling prescription drugs without valid prescriptions seem to consist of either a monetary fine or imprisonment. For licensed pharmacies or licensed practitioners, sanctions can include suspension or revocation of licensure.
In the perspective of Internet sales of pharmaceuticals, New Zealand identified a loophole in its legislation allowing online pharmacies to sell prescription drugs overseas without a valid prescription. This was challenged in court and tighter regulations were introduced in November 2000. These regulations now prohibit sales of prescription medicines to overseas consumers who do not have a prescription from a New Zealand authorized prescriber. The Medical Council of New Zealand has issued strict guidelines for doctors prescribing medicines over the Internet. These guidelines require the doctor and patient to have met on at least one occasion, and for the patient to be under that doctor’s care.
Companies/individuals exporting pharmaceuticals without enquiring whether the products have a marketing authorization in the importing country or whether the importing company/individual is authorized.
This question provides information on potential sources of pharmaceuticals for online ‘rogue’ sites. It can give hints as to how the illegal Internet sellers can import their products - whether licensed or unlicensed in the importing country - without breaking the laws in the exporting country. The countries that did not have sanctions for exporting pharmaceuticals to an unauthorized importer and/or without enquiring from the importer before exporting whether the products have a marketing authorization in the importing country were Antigua and Barbuda, Bangladesh, Brazil, Czech Republic, Fiji (except substances under international control), Iceland, India, Indonesia, Israel, Japan, Jordan, Hungary, Maldives, Netherlands, Nigeria, Oman, Philippines, Singapore (except substances under international control), South Africa, Sweden, Switzerland, Tonga, United Arab Emirates, Vietnam and Zimbabwe.
Some countries, such as the UK have declared that the only control is the WHO Certification Scheme. However, New Zealand replied that there was no law ordering that WHO Certification must be obtained. Many countries (for example Hungary) stressed that at the moment it is up to the importing country to punish illegal actors. Most countries have enacted legislation that companies/individuals must be licensed in the exporting country to be able to start exporting in general.
Countries having export regulations for unapproved products were Belgium, Estonia, Latvia, Micronesia, Mongolia and the USA. The USA answered that for approved products, licensed wholesalers and registered distributors were responsible for assuring compliance with foreign laws. According to export law of 1996, unapproved products may be shipped by a US manufacturer either under an IND for a clinical study or to 25 countries (Europe, Japan, Canada, etc.) without FDA prior approval.
Some specific cases concerning pharmaceuticals and the Internet
In this section some countries are looked at more closely. The section begins with a short description of the policies in the European Union and three examples (Denmark, Germany and UK) of different approaches in EU member countries. The other countries that are introduced are Japan, New Zealand and USA.
The European Union
In December 1999, the European Commission launched the eEurope initiative. The goal of this initiative was to accelerate Europe’s transition to an “information” society. As requested by the Lisbon Summit in March 2000, the Commission prepared an eEurope Action Plan (7). The eEurope 2002 Action Plan was developed as a road map to where Europe should be by 2002 if it wanted to engage with competitors and meet the challenges of the new economy. The plan has three major topics: a cheaper, faster, and more secure Internet; stimulating use of the Internet, including e-commerce; and investing in people and skills (8).
In the European Union (EU), member countries have sovereignty over healthcare and, as a result, they can decide how they will organize the supply of medicines to the general public. The European Directives recognize two basic categories: prescription and non-prescription medicines. Depending on the category and the particular member country, different regulations of advertising and sale apply. Moreover, the legal status of some medicines differs between one member country and another.
In 1998, a legal consultant firm prepared a report and study for the Commission on the “Impact of electronic commerce on the European pharmaceutical sector”. A part of this study was a questionnaire which was sent to approximately 180 organizations across Europe with an interest in electronic commerce of pharmaceuticals. The survey indicated that pharmacist organizations were strongly opposed to e-commerce because of the possible threats to the patients’ health. Wholesalers, however, showed little interest in the subject and manufacturers were largely in favour of e-commerce with expectations that on-line sale of pharmaceuticals to consumers would become considerable. Regulators views were largely determined by their attitudes to regulation and free-market in general, so that regulators followed either a pro-free-market or pro-regulation line in their answers (9).
Self-prescription was difficult to argue, because some medicines are regarded as OTC-drugs in some EU countries and as prescription-only medicines in others. This was not regarded as a clear option since health is at risk through purchase and use of prescription medicines without the required medical diagnosis, oversight and follow-up. In this context, it is important to note that the Internet might be misused for this purpose and that the existing heterogeneity among different member countries on the prescription-only status of some medicines could potentially influence this situation. Consumers may purchase a medicine as non-prescription in a member state whereas they need a medical prescription for it in another member state (10).
In some EU member countries (for example, Denmark and UK) national regulations permit community pharmacies to provide services on-line. According to the EU Directive on electronic commerce (2000/31/EEC) information on the Internet pharmacy site should meet the following requirements:
• Name of the pharmacy providing the service.
• The geographic addresses at which the pharmacy is established and its details (telephone and fax numbers) including e-mail address which allows rapid communication in a direct and effective manner.
• Professional title of the pharmacist responsible and country where granted.
• Professional body with which the pharmacist responsible is registered and the relevant supervisory authority (where applicable).
• Reference to the applicable professional rules in the country of establishment and means to access them.
A European Commission working group on information, advertising and e-commerce for medicinal products was set up in 2000.
Denmark has general regulations on pharmaceutical products which include Internet sale. Denmark was the first Nordic country to allow pharmacy customers to purchase non-prescription (OTC) medicines on-line. The Danish Government plans to set up a working group to look into Internet sales of drugs, and it is anticipated that customers will eventually also be able to choose and purchase prescription-only medicines (11).
In Germany, there are no regulations concerning the promotion and sale of medicines via the Internet. However, the Dutch e-pharmacy DocMorris operates a service for mailing of medicines to Germany. As a result of this practice, the regional civil court in Frankfurt-am-Main has submitted three questions concerning cross-border e-pharmacy to the Court of Justice of the European Communities (ECJ). The first question is whether national bans on cross-border commercial shipment of individually ordered, pharmacy-only medicines contravene the free movement of goods provisions of Article 28 of the EC Treaty or is such ban a measure equivalent to a restriction of trade (12).
The second question relates to advertising through distance selling of pharmaceuticals. The Frankfurt court asks whether the Internet presentation of pharmacy services, or parts of this presentation, should not be considered as promotion of human pharmaceuticals under the meaning of the pharmaceutical advertising Directive (92/28/EEC), in order to give practical expression to society’s need for information on the provision of services.
The third question is whether parts of an Internet presentation of a pharmacy infringe the rules on medicines advertising. Articles 28 and 30, nonetheless, require that cross-border trade developed with the aid of this presentation be treated as legal in order that the principle of free movement of goods is given a more practical expression.
The first online pharmacy in the UK - Pharmacy2U - was launched in November 1999. As a consequence, the Royal Pharmaceutical Society of Great Britain has issued guidance on the electronic commerce of pharmaceuticals (13) and the UK government has stated its support for online pharmacies (14). The UK Government’s view is that if proper safeguards and professional standards are in place, there is no reason in principle why medicines should not be sold or dispensed electronically, or by other forms of distance sale and supply, like mail order or home delivery. At the moment online pharmacy services are offered to people for purchasing of OTC medicines and dispensing of private prescriptions. The UK Government believes that this choice should also be available to people with National Health Service prescriptions and will be bringing this service to cover routine electronic transmission of prescriptions by 2004.
Under the Japanese Pharmaceutical Affairs Law, pharmaceuticals should be sold face-to-face by a pharmacist or under his/her supervision. However, under certain conditions and for a limited scope of pharmaceuticals, direct mail and Internet sale is permitted. These conditions are:
1) The website must belong to a registered pharmacy or first-class drug seller.
2) Information on pharmaceuticals should be provided independently of that on other goods.
3) Name, address, licence number and date, owner and/or managing pharmacist of the pharmacy or first-class drug seller should be provided.
4) Dosage form, name and amount of active ingredients, indication, number of tablets per package, precautions, price and the name of manufacturer or importer should be provided.
5) General advice such as “Use this pharmaceutical product after carefully reading precautions” should be provided.
6) The telephone number for consultation should be shown.
7) A sufficient number of telephones and personnel should be available for callers.
8) Pharmaceuticals should not be mixed with other goods during delivery.
9) Pharmaceuticals should be provided in a solid container, with stable ingredients, few adverse drug reactions and their scope is uncomplicated, for example, antihemorrhoidals (except those containing steroids), dental analgesics and gastrointestinal agents (except gastrointestinal analgesics and antispasmodics).
New Zealand regulations prohibit sales of prescription medicines to individuals overseas who do not have a prescription from a New Zealand authorized prescriber. The requirement to have a New Zealand based prescription will restrict the ability of overseas consumers to purchase medicines pharmacies (15). Since November 2000, there has also been an Internet pharmacy accreditation system organized by the Pharmaceutical Society of New Zealand. The programme was introduced to officially recognize pharmacy sites that meet the prescribed professional standards for operating on the Internet. To be accredited, a pharmacy must comply with the ethical and legislative requirements and quality standards of a registered pharmacy. In addition, Internet sites displaying the accreditation seal must demonstrate compliance with patient rights to privacy and confidentiality, compliance with codes and legislative requirements for the advertising of medicines and the provision of factual and understandable information about all medicines advertised. The site must also provide the opportunity for meaningful consultation between patient and pharmacist. More information on this New Zealand accreditation system can be found at http://www.psnz.org.nz/
United States of America
The USA has a long history of mail-order pharmacies and many of them have extended their services to the Internet. The International Pharmaceutical Federation (FIP) Task Force Group on Internet pharmacies noted that the on-line pharmacies have come to resemble mail-order pharmacies. The Internet is a potentially interesting and interactive channel for customers, (16). In parallel to the true Internet pharmacies, many chain pharmacies have developed a cyberspace extension of brick-and-mortar stores, sometimes through alliances with existing online pharmacies (17). Other independent pharmacies have entered the Internet, as they believe it combines the convenience of the Internet with the trust associated with local pharmacists (18).
In July 1999, the FDA adopted, and has since implemented, an Internet Drug Sales Action Plan to expand and improve its activities in addressing the unlawful sale of drugs over the Internet. This was followed in December 1999, by proposals to protect US consumers when buying prescription drugs from online ‘rogue’ sites and gave the FDA authority to identify, investigate and prosecute web sites that do not comply with existing FDA and Pharmacy Board regulations (19).
Federal legislation has since been introduced to expand FDA authority over online pharmacies. The Internet Pharmacy Consumer Protection Act proposed amending the Food, Drug & Cosmetic Act (“FDCA”), which is under FDA implementation and enforcement authority. The bill prohibits online pharmacies from dispensing prescription drugs unless the website discloses information about who is selling the drugs. It also requires the identities of the pharmacist and medical consultant, and where those persons are licensed to practice, to be disclosed (20). The FDA’s testimony gives a good detailed explanation of what that Act aims to do. It will require:
• online pharmacies to be licensed in each State in which they operate or to which they deliver prescription drugs;
• compliance with all applicable Federal and State laws governing the practice of pharmacy, including those laws that require proper storage and handling of prescription drugs, proper record keeping, and other consumer protections;
• online pharmacies to post on their website a notice of their physical location, a list of States in which the online pharmacy is licensed to dispense prescription drugs and a list of applicable license numbers, the name, degree, and license of the pharmacist in charge; a telephone number for contacting a licensed pharmacist associated with the website, and a statement that the online pharmacy shall dispense prescription drugs only upon a valid prescription by a licensed practitioner (21).
In 2001, the FDA was provided with a budget of US$ 55 million to police the Internet. According to the Director of Pharmacy Affairs in the FDA, priorities are preventing unapproved new drugs from entering the US, dealing with health fraud: where patients have been deceived in some way, and preventing the sale of drugs without a valid prescription (19). The FDA has issued “cyber letters” (letters sent electronically via the Internet operators of foreign-based Internet sites that offer to sell online prescription drugs to US citizens without a valid - or in some cases without any - prescription (22).
Online pharmacies should be licensed and operated under the same regulatory system as traditional pharmacies. However, many countries still need to develop their legislation and guarantee the implementation of regulations which should also cover pharmacy inspections, including those of drug preparation and dispensing facilities and of controlled substance records (20).
Electronic prescribing is a technological prerequisite for effective e-commerce of prescription pharmaceuticals. However, regulations should allow only the dispensing of prescriptions that are valid in the country and/or state where the online pharmacy is licensed. Regulations and guidelines should also be developed for online prescribing so that the doctors will not prescribe medicines over the Internet for patients they have never met. Reimbursement, together with the issues of product categorization and pricing affect the development of e-commerce of pharmaceuticals. That is an especially important question when prescribing pharmaceuticals in countries that have reimbursement systems (9).
Until the e-commerce of pharmaceuticals has been satisfactorily regulated and organized, consumers should be warned of the risks of purchasing medicinal products via the Internet and especially the dangers of purchasing from illegal sites. They should also learn how to recognize nationally/locally accredited online pharmacies from illegal sites selling either prescription or OTC medicines.
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21. Posner, E, Deputy Associate Attorney General Ethan M. Posner testified before the Subcommittee on Oversight and Investigations of the House Committee on Commerce on the subject of Online Pharmaceutical Drug Sales. 25 May, 2000 http://www.US$oj.gov/criminal/cybercrime/posner.htm
22. FDA Talk Paper, T00-8 2 February 2000 http://www.fda.gov/bbs/topics/ANSWERS/ANS01001.html,
23. Myhr, K. Problems with the selling of medicines by Internet. Speech at the Council of Europe seminar in Strasbourg at 21 October 1999 http://www.coe.fr/soc-sp/actes/procsem.htm
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