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Advertising, Promotion, and Sale of Medical Products Across Borders Using the Internet

Martijn TEN HAM <tenhamm@who.ch>
World Health Organization
Switzerland

Abstract

Marketing of medical products is covered by a number of regulations in order to ensure their safe and rational use. Safety, efficacy, and quality of medical products require careful technical assessment of scientific documentation and in many countries such products require marketing authorization.

Most countries allow promotion of prescription medical products only in the professional media and directed to the health professionals, not to the consumers.

With the advent of electronic information systems, in particular the Internet, information about all kinds of medical products has become accessible to the public.

The use of the Internet for promotion and sales of medical products is expanding rapidly, and the consequences of these activities for individual and public health are significant. It is important to address issues regarding the promotion and sale of medical products through the Internet as soon as possible in order to avoid unregulated situations with potential harmful outcomes.

Consumers and patients can buy medical products over the Internet and have them mailed to their home. Consumer protection may be undermined because there is no assurance of efficacy, safety, quality, or proper information for products that have not been licensed for marketing. Even if the medicinal products themselves may not be dangerous, consumers may compromise their health by not seeking proper medical treatment from a qualified health professional.

Medical products promoted and sold over the Internet do not meet product quality standards if they are not sold by authorized distributors. First, the stability and integrity of the product may be jeopardized if the product is shipped without proper packaging and handling. Second, tampering may become more of a concern if products are shipped to consumers without proper precautions.

For proper prescription, the physician carries out a careful examination and obtains some basic information about the patient, including concurrent disease and any other medication he or she is taking. Uncontrolled use of strong-acting pharmaceuticals may be associated with adverse effects that are not recognized and with interaction with other prescription or nonprescription medication or with food components.

In many countries, pharmacists have a very important role in providing information to the patient about prescription medical products and managing the prescription process for patients. Sale of prescription medical products over the Internet to patients leaves the pharmacist out of the pharmacotherapeutic treatment process.

Information on the Internet for health care professionals is also available to the public, unless the Web site contains a password-protected area for professionals only. Although in some countries all product information for consumers must be provided by a health care professional, including pharmacists, in other countries the Internet has proven to be a good source of product information or even a viable way to promote to consumers. Although patients can receive counseling from their health care providers, they can also use the Internet to look up information about the products they use. The quality of that information cannot be guaranteed, however, so that any medical product information received through the Internet should be compared with counseling from a health care professional.

It is technically impossible to prevent people from putting anything they want, including promotional material for medical products, on the Internet. Complete control of electronic information transport is unrealistic, and probably undesirable, but some understandable and reasonable measures should be taken to limit misuse of the Internet.

Any individual, company, or enterprise using the Internet for promotion or sale of medical products should be required to be authorized by the local authorities. The authorities should maintain a register of such authorizations which is easily accessible through the Internet.

To avoid receiving insufficient or incorrect information or fraudulent products through the Internet, any Internet user must be able to verify and identify the person or institution responsible for the information.

Codes such as The WHO Ethical Criteria for Medicinal Drug Promotion would also provide guidance for the quality of the information provided on the Internet. Several parties have proposed core standards for information to be provided on the Internet. In general they are straightforward and not too difficult to adhere to. They include authorship, attribution, disclosure of any financial arrangements, and dates, including updates. Other code principles, such as the Health on the Net code, are more specific for medical products and require supportive evidence for any claims, together with information sources, and, importantly, a clear statement which countries or state laws apply to the information and the product. One could give those providers of information that have their material satisfactorily checked against the code the right to carry a logo on their output.

It is not possible to prevent individuals from putting information on the Internet. It may be feasible to close servers and access providers who pass violative information on to potential customers, but several practical problems arise.

It would be useful to know the volume of their sales and how often "common" patients are involved. International exchange of information between relevant parties would save work and enable rapid international action.

Possibly the best place for control is at the receiving end. Professional societies should inform, through the medical press, their members of the dangers of uncontrolled sales of nonregulated medical products. Physicians should inform their patients about the possibility of obtaining medical products through the Internet, but also indicate the risks associated with this practice. The existence and meaning of the logo should be explained.

A positive step would be for governments to start promotion campaigns, both over the Internet and in the classic media, to increase awareness of potential problems.

Contents

Introduction

In the classical triangle of patient, physician, and pharmacist, it is the physician who examines the patient and prescribes a therapy which the patient obtains from his pharmacy on the basis of the prescription. In this process the diagnosis and choice of the medication are the physician's responsibility, and the role of the responsible pharmacist is to dispense the medication together with relevant instructions on the proper use and storage at home. In some countries the pharmacist is also expected to survey the patient's medication, including potential interaction with other medication, food, or other underlying disease. In fact, it is because of the strong pharmacological activity and potential of adverse reactions that many medical products are available only by medical prescription.

Medical products are covered by a number of regulations in order to ensure their safe and rational use. Safety, efficacy, and quality of medical products require careful technical assessment of scientific documentation, and in many Member States such products require marketing authorization, including approved evidence-based product information.

Most countries do not allow advertising and promotion of prescription medical products aimed at the consumers, but only in the professional media and directed to the health professionals.

With the advent of electronic information systems, in particular the Internet, together with its graphical part, the World Wide Web, information about all kinds of medical products has become accessible to the public.

The Internet is a rapidly expanding medium that has many uses. Individuals use the Internet to find information about a variety of subjects and products more quickly and conveniently than in traditional ways, such as medical journals and textbooks. Organizations and individuals post information about their purpose, activities, or products and sometimes offer these products, including medical products, for sale.

Moreover, the Internet is not bound by national borders, in that information on the Internet is available almost instantly to anyone in the world who has access to it. Therefore, consumers worldwide can use the Internet to find information and, if they wish, to buy products through the Internet. The Internet is not as easily regulated as traditional media, and, therefore, consumers may be at a potentially higher risk due to insufficient or incorrect information or fraudulent products, particularly health products.

The use of the Internet for advertising, promotion, and sales of goods, including medical products, is expanding rapidly, and the consequences of these activities to individual and to public health are significant. Therefore, it is important to address issues regarding the advertising, promotion, and sale of medical products through the Internet as soon as possible in order to avoid unregulated situations with potentially harmful outcomes.

Concerns

Patient health and public health

Safety and efficacy

Consumers and patients can buy medical products over the Internet and have them mailed to their home. Consumer protection may be undermined because there is no assurance of efficacy, safety, quality, or proper information for products that have not been approved or licensed for marketing. Even if the medicinal products themselves may not be dangerous, consumers may compromise their health by not seeking proper medical treatment from a qualified health professional. At a minimum, it may be a concern for some health authorities that consumers risk wasting their money on ineffective, improper, or needless treatments. The greatest danger, however, is that potent prescription-only medicines are taken by consumers for improper purposes.

Quality

Although medicinal products promoted and sold over the Internet may be authorized for marketing, such products may not meet product quality standards if they are not sold by authorized distributors. First, the stability and integrity of the product may be jeopardized if the product is shipped without proper packaging and handling. Second, tampering may become more of a concern if products are shipped to consumers without proper precautions.

Relationship between physician and patient

The pivotal point in the patient's treatment is the physician. For proper prescription, the physician carries out careful examination to obtain some basic information about the patient, including concurrent disease and any other medication he is taking. Uncontrolled use of strong-acting pharmaceuticals may be associated with adverse effects that are not recognized as well as interaction with other, prescribed or nonprescription, medication or with food components.

Relationship between pharmacist and patient

Sale of prescription medical products over the Internet to patients leaves the pharmacist out of the pharmacotherapeutic treatment process. In many countries, pharmacists have a very important role in providing information to the patient about prescription medicinal products and managing the prescription process for patients. In some countries, patients must fill their prescriptions in person with the pharmacist, except in very unusual circumstances, and Internet sales provide a way to bypass that requirement.

Differences between countries in prescription versus over-the-counter policy

Whether a medicinal product is on prescription or not on prescription (over-the-counter, OTC) varies among countries. If an OTC product in one country were on prescription in another, it may be possible for a person in the latter country to order the product without a prescription through the Internet in the country where a prescription is not needed. Not only could this undermine the laws of individual countries, but patients could receive prescription medicinal products without the involvement of a healthcare professional in those countries where this is considered necessary.

Legal and liability issues

Mail-order pharmacy

Mail-order sales of prescription or OTC medicines, including sales using the Internet, are still illegal in some countries.

Manufacturers' liability

Active pharmaceutical compounds may cause adverse effects that may even be fatal. Manufacturers may be held responsible for their products, even when these are consumed in an unauthorized way. Products may be offered on the Internet for sale without providing the name of the manufacturer in the catalogue, but individual manufacturers can usually be easily identified.

Locating sellers on the Internet

It is difficult to find the actual physical location of an organization or responsible person who has posted a Web site, so that identifying a party responsible for an illegal activity on the Web can be a challenging enforcement issue. Additionally, if a Web site is physically located, the site can be easily closed and reopened in another location, even another country, without operational oversight. Consumers, however, would still have access to the information and even possibly be able to buy medical products that would not meet acceptable standards.

Drug diversion/undermining price control

For countries that have price controls, it is possible for individuals to sell products over the Internet at a higher or lower price than the controlled price set by the country. In cases where there is a shortage of a medicine, such drug diversion may cause the shortage of a medicinal product to be more severe. Additionally, because of a shortage, patients who need the product may pay a much higher price for the product to a seller wishing to capitalize illegally on the product shortage.

Advertisements and promotion

Quality of information

The laws regarding what are truthful and not misleading advertisements and promotional material for medical products may vary among countries. Although these differences have generally not become an issue with traditional promotional media, the ease with which individuals may access cross-border advertisements and promotional information may cause this issue to be raised.

Direct-to-consumer advertising

Advertisements or promotional pieces for medical products, food products, and traditional medicine can be viewed on the Internet by anyone with access, unless the sites are password-protected. Countries have different laws regarding what kind of medical products, i.e., prescription, OTC, hormonal, etc., if any, can be advertised or promoted to consumers on the Internet as well as how this can be done. However, consumers from any country can access all information on the Internet, including the direct-to-consumer medicinal product advertisements.

Advantages

Product information on the Internet

Information on the Internet for healthcare professionals is also available to the public, unless the Web site contains a password-protected area for professionals only. Although in some countries all product information for consumers must be provided by a healthcare professional, including pharmacists, in other countries the Internet has proven to be a good source of product information or even a viable way to promote to consumers. Although patients can receive counseling from their healthcare providers, they can also use the Internet to look up information about the products they use. The quality of that information cannot be guaranteed, however, so any medical product information received through the Internet should be compared with counseling from a healthcare professional.

Mail-order sales to remote areas or to special populations

Patients in remote areas may be able to benefit from information and sale of medical products over the Internet, both prescription and OTC, by having easier access to needed medications. Additionally, individuals who may not be able to leave their homes easily may be able to receive more efficient healthcare through easier purchase of medicinal products through the Internet, regardless of their location.

Reduced prices

Patients may be able to purchase medical products over the Internet at a cost savings, particularly in those countries where there is no price control of medical products.

Measures to be taken

From the points above, the need for action emanates clearly. It should, however, be recognized that it is technically impossible to prevent people from putting anything they want, including promotional material for medical products, on the Internet. Complete control of electronic information transport is unrealistic, and probably undesirable, but some measures should be taken to limit misuse of the Internet, and these measures should be understandable and reasonable. Unreasonably strict national measures may result in a tendency to operate from off-shore locations. Several options are open, but none of these, however, provide a panacea.

Authorization and registration

Most countries have legal provisions that require pharmaceutical manufacturers, wholesalers, and retail outlets, including pharmacies, to be authorized by health authorities. This authorization or license includes terms of reference for regarding advertising, promotion, and sale of medical products. The same activities using the Internet should not escape existing regulatory practices. It is therefore logical that any individual, company, or enterprise using the Internet for advertising, promotion, or sale of medical products be required to be authorized by the local authorities. The authorities should maintain a register of such authorizations which is easily accessible through the Internet.

Verification

To avoid receiving insufficient or incorrect information or fraudulent products through the Internet, it is vital for any Internet user to be able to verify and identify the person or institution responsible for such information or products. Registration and authorization of this institution should be clearly and easily verifiable, e.g., by a standard, dated statement such as: "registered Internet company" or "registered by the Ministry of Health."

Code of conduct

Providers of medical products through the Internet should follow and respect the existing national laws and regulations. If such regulations do not exist internationally, accepted criteria and codes such as The WHO Ethical Criteria for Medicinal Drug Promotion can provide guidance for the quality of the information provided on the Internet.

Several parties have proposed core standards for information to be provided on the Internet. In general, these standards are straightforward and not too difficult to adhere to. They include authorship, attribution disclosure of any financial arrangements, and dates, including updates. Other code principles are more specific for medical products and require supportive evidence for any claims, together with information sources, and, importantly, a clear statement about which countries or state laws apply to the information and the product.

One could give those providers of information that have their material satisfactorily checked against the code the right to carry a logo on their output. It is, however, questionable whether this positive approach would work with those sellers of medicines who rather take pride in providing pharmaceuticals for nonapproved indications.

Blocking or closure of servers

It is not possible to prevent individuals from putting information on the Internet. It may be feasible to close servers and access providers who pass violative information on to potential customers. The practical difficulties in localization of the sites through the servers are large, in a technical sense as well as from a legal point of view. Once a site is closed, it is quite easy to establish another one somewhere else.

Clearinghouse and information exchange

Information about the size and nature of the phenomenon is still scarce and scanty.

From the sites on the Internet where medical products are offered for sale, it appears that the majority of the companies limit the range of offered products to some fifty different items.

There is little variation between individual companies, who are predominantly active in the sphere of "smart drugs" products that are supposed to enhance cognitive functions. It would be useful to know the volume of their sales and how often "common" patients are involved. International exchange of information between relevant parties would save work and enable rapid international action.

Legislation

In only a few countries is the trade in pharmaceuticals by mail effectively regulated. In some countries any form of mail order is prohibited; in others only mail order of prescription products is prohibited. In many countries there is no specific legislation. It is recommended that mailing pharmaceuticals across borders should not be permitted in any case.

Publicity and information

Possibly the best place for control is at the receiving end.

Professional societies should inform, through the medical press, their members of the dangers of uncontrolled sales of nonregulated medical products. Physicians should inform their patients about the possibility of obtaining medical products through the Internet, but also indicate the risks associated with this practice. The existence and meaning of the logo should be explained. A positive initial step would be for governments to start promotion campaigns, both over the Internet and in the classic media, to increase awareness.

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