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The Birth of the E-Clinic. Continuity or Transform ation

in the UK Governance of Pharmaceutical Consumption?

Nick Fox, Katie Ward and Alan O’Rourke

University of Sheffield

Address for correspondence:

Dr Nick Fox

ScHARR

University of Sheffield

Regent Court

30 Regent Street

Sheffield S1 4DA

Word Count: 7995

Key Words: Consumption, Governance, Internet, Internet Pharmacy, Pharmaceutical Drugs,

Pharmacy

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Abstract

Traditional arrangements for the prescription and dispensing of pharmaceuticals have been

challenged by the rise of Internet services enabling consumers to acquire these products

online, without a face-to-face contact with a professional. This paper considers three

moments in the emergence of the ‘e-clinic’ as an alternative route to prescription drugs in the

UK. We examine the phenomenon in relation to issues of governance, considering the legal

and voluntary frameworks that govern prescribing. Documentary and interview data suggest

that the Internet has the potential to transform the relations between prescribers, dispensers

and consumers, but that stakeholders seek continuity by applying existing governance

frameworks and codes of conduct. This continuity can be explained by Rosenau’s (1997)

model of a contested and fragmenting process of technology governance.

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The Birth of the E-Clinic. Continuity or Transform ation in the

Governance of Pharmaceutical Consumption?

Introduction

Consumers in the United Kingdom (UK) and elsewhere traditionally have accessed

pharmaceuticals in two ways. Medication has fallen into broad categories: those requiring a

doctor’s prescription (prescription-only medicines or POMs) and those available over-the-

counter in the presence of a qualified pharmacist (pharmacy medicines or PMs). In both

cases, most pharmaceuticals can only be accessed by consumers via a healthcare professional. 1

In this paper, we examine how this familiar landscape of pharmaceutical consumption has

been affected by the arrival of the Internet as a medium both for information access and for

global consumption (Armstrong et al 1999, Eysenbach et al 1999, Eysenbach 2000). Driven

in part by commercial pressures in North America, where pharmaceuticals are regulated

within a context of private health care rather than a socialised public system such as the UK’s

NHS, Internet or ‘e-pharmacy’ has developed alongside traditional community pharmacies.

While such e-pharmacies have been aimed at nationals, the global nature of the Internet has

meant that national boundaries have become far more permeable as far as the marketing of

pharmaceuticals is concerned (Pines 2000). More recently, the online doctor’s surgery or ‘e-

clinic’ has emerged, in which an Internet consultation with a qualified medical practitioner is

a precursor to prescription and sale of prescription-only medications.

Drawing on findings from a wider ESRC study 2 into the dynamics of pharmaceutical

consumption in the Internet age and consequences for governance, we describe here a range

of initiatives concerning prescribing that have been facilitated by electronic networks. These

contribute to the ‘birth of the e-clinic’ as a consumption medium in modern healthcare, and in

this paper we examine challenges for the governance of pharmaceuticals in this form of

consumption. Elsewhere (Authors 2005, in press), we have explored some of the social

relations of Internet-enabled pharmaceutical consumption, as patients become consumers and

the credit card substitutes for the patient record.

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A Framework for Studying Changes in Governance

Governance may be understood as the management of diverse concerns of state and

individual, to sustain both the continuity, security and integrity (and on occasions, cultural,

ethical or religious precepts) of the former and the liberty and rights to self-actualisation of

the latter (Loader 1997: 12, Shore and Wright 1997: 30-31). It is a matter of law and

regulation, but also of responsibility and accountability that goes to the heart of how modern

democratic states and organisations seek to govern themselves and individuals (Rose 1990:

10, Rosenau 1997: 145). At the level of the nation-state and international relations, these

issues have fallen within the purview of political science. However, from a sociological

perspective, governance may be seen more generally as the application of guidance or control

over an activity, in order to achieve a specified outcome (Jewson and Macgregor 1997: 6,

Rosenau 1997: 146).

This paper draws upon the analysis of governance developed by James Rosenau (1995, 1997),

and we have fully developed the application of this approach to the study of technology

governance elsewhere (Authors, submitted a). Rosenau (1997: 14-15) suggests that

governance emerges when those who would control an activity (‘sources of authority’)

achieve a degree of compliance from those who are to be controlled, thereby establishing a

‘system of rule’ that regularises activity. Systems of rule can become established even in the

absence of legal or political authority, and in late modern society, governance is often

voluntaristic, consensual and collaborative (ibid: 147).

In this model, governance is not a final outcome. Rather, environmental changes (for

example, the development of new information technologies) continually challenge systems of

rule, as sources of authority are empowered or disabled (Barry 2001, Cashore 2002). Sources

of authority vie for control, forming coalitions that may range from the relatively stable to ad

hoc alliances that circumvent traditional sources of authority (Rosenau 1997: 171-2).

Moreover, individual or community values, behaviours and prejudices (for example,

individual greed, an increase in people’s analytical skills or a rise in religious bigotry) affect

the stability of systems of rule, and governance is achieved only within highly unstable and

complex cultural contexts (Rosenau 1995: 15). To give an example: the regulation of new

reproductive technologies continue to evolve within a mix of ethical and religious precepts in

a secularising society, falling birth rates and shortage of children for adoption, economic

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prosperity, idealisation of childhood, concepts of human rights, trust in science and so forth,

as well as from technological advances and global variations in regulation (Jones and Salter

2003). The emergent system of rule achieves compliance only so long as these environmental

factors are stable: if one factor strengthens or weakens in intensity, the system of rule must

adapt accordingly.

This dynamic conception of systems of rule suggests that governance is forever in the process

of breaking down and being re-invented to address environmental (societal, economic,

technological, political and cultural) changes (Rosenau 1995: 17-18). In this paper, we apply

this approach to governance to map the effects of a specific environmental change: the rise of

the ‘networked’, information society, specifically, the Internet. Our proposition is that

governance emerges within a nexus of power relations and that the shape of governance

reflects the on-going struggles and conflicts between stakeholders, including states, social

groups, commercial and other interests and individuals.

Global access to information and communication technologies has changed many traditional

relations, opening up possibilities for new social relations and creating new patterns of

inclusion and exclusion (Holderness 1998, Lenk 1997), enhancing participation for some

while creating new systems of surveillance and control (Baym 1995, Freeman 2002: 752,

Queau 2002). Information technologies render government open to scrutiny and promote

democratisation (Kedzie 2002), human rights and transparency (Richards 2002).

Information networks are themselves governance networks. They allow for different

forms of authority to emerge, for concerted action to take place, and for institutional

creation or reinforcement. … Information (makes) governance less hierarchical and

more plural and democratic (Singh 2002: 18)

Our research examined the extent to which information technology has transformed the

system of rule governing pharmaceutical consumption, and how sources of authority adapt to

meet the changed environmental conditions. What happens when an Internet user has the

power to self-prescribe and consume drugs without face-to-face contact with health

professionals? We have considered elsewhere the social role that consumption is playing in

defining doctor-patient relations, notions of being ‘a patient’, and the de-hegemonising of

expertise in relation to diagnosis and treatment of disease (Authors 2005, in press), and

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changes in the governance of consumer advertising of pharmaceuticals (Authors, submitted).

Here we explore the emergence of e-pharmacy and the e-clinic. While governance is

increasingly globalised (Singh 2002), the nation-state retains important legal and regulatory

functions: for this reason, we focus specifically on UK governance, although the findings are

generalisable internationally.

The structure of the paper is as follows. Having briefly described the methods used in our

research, we consider the frameworks within which the prescription of medications are

governed, and explore how stakeholders have responded to the challenges of information

technology for pharmaceutical governance. We then examine the birth of the e-clinic through

three ‘moments’ 3 that demonstrate how the Internet has facilitated new methods of supplying

pharmaceutical drugs to consumers:

• the UK electronic transfer of prescriptions pilot;

• an example of a global ‘e-pharmacy’;

• an example of a UK-based ‘e-clinic’.

In a discussion, we examine the findings within a sociological framework that assesses the

part that a technology such as the Internet can play in transforming governance relations.

Research Objectives, Methods and Contexts

The data reported in this paper emerge from a two-year project within the ESRC Innovative

Health Technologies (IHT) programme. The study addressed the impact of the Internet on

purchasing and use of prescription pharmaceuticals, people’s motivations to seek medication

via Internet pharmacies and the regulation of online pharmacies. It applied a range of

qualitative approaches including in-depth face-to-face and telephone interviews, ethnography,

content analysis of paper- and web-based materials including web sites and discussion fora,

and review of documentary sources including governmental and other publications. The

strand of data collection reported in this paper was based on reviews of published reports and

other literature, and interviews with ‘stakeholders’.

The literature and documentary evidence reviewed included governmental reports, relevant

policy documents, documentation published on official web sites including commercial sites,

advertising materials and other grey literature. We summarised these in a series of working

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papers that informed the data collection with respondents and provided trhe basis for our

understanding of the emerging technological developments in e-enabled pharmacy.

We conducted interviews with a range of stakeholders including government agencies,

professional and commercial organisations and consumers. : This was an exploratory study:

our data provided a mix of background and contextual material and the opportunity to analyse

the perspectives of the different stakeholder organisations and individuals interviewed.

Respondents were selected iteratively to provide a theoretical sample and to enable data

saturation. Thirteen representatives of organisations were recruited directly or by contact with

external relations departments in organisations, and interviewees were senior members of

their organisation with relevant knowledge or responsibility. Eight interviews were with a

single respondent, and two were with two representatives of an organisation interviewed

together. Consumers were recruited via three health discussion forums, 4 usually by asking

questions on a message board followed by private in-depth online interviews. All interviews

were recorded and fully transcribed. The respondents are summarised in Table 1

Table 1: Respondents in the study

Stakeholder Group Affiliation of Respondents N

UK government agencies NHS Modernisation Agency, Medicines Control

Agency

2

Pharmacy professionals Pharmacists, including representatives of the Royal

Pharmaceutical Society of Great Britain, and the

director of an e-clinic

4

Pharmaceutical industry Marketing director of multinational company,

Association of the British Pharmaceutical Industry

3

Patient and consumer groups Consumers’ Association and organisers of two patient

groups

4

Consumers Members of online patient groups 35

Analysis used the software package AtlasTI, and following close reading and loading of

transcripts, data were coded to reflect the main constructs within our research questions and

the theoretical concepts that we applied to make sense of the data. During analysis, data from

earlier interviews and from documentary sources informed and refined the questions asked, a

process that enabled progressive focusing of data collection. In the following section we first

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describe the contexts of pharmaceutical governance, then look at the emergence of e-enabled

prescribing, before finally reporting data from stakeholders.

E-clinics: the Governance Context

To understand the legal and regulatory framework within which the birth of the e-clinic has

emerged, it is helpful to highlight the tension between pharmaceuticals as potentially

dangerous substances and a consumerist perspective that considers medications as

commodities that can be traded on the Internet in much the same way as books, CDs or

refrigerators. Unlike these consumer goods, pharmaceuticals are potent biochemical agents

that may poison or kill. Governments and the scientific community have mediated consumer

demands for effective pharmaceutical treatments for disease in various ways, imposing

safeguards to minimise the risk of inappropriate use.

Most national governments have legal and regulatory frameworks to govern pharmaceutical

use, and the nation-state has traditionally performed this role, although some supra-national

agencies also govern usage (for example, the European Union Drug Regulatory Authorities,

Pan American Network for Drug Regulatory Harmonization). The jurisdiction of such

governance regimes may thus be limited to national or geopolitical boundaries: both

consumers and global pharmaceutical companies operate within the complexities of

regulatory frameworks that vary from nation to nation. In the UK, regulation is under the

auspices of the Medicines and HealthCare Products Regulatory Authority, established under

the Medicine Act 1968 as the executive arm of the Drug Licensing Authority. The licensing

of medicines for use on humans is strictly regulated, and all new drugs must undergo lengthy

trials before they may become available for prescription. The Committee on Safety of

Medicines, an independent committee of experts, advises the Government on the safety,

quality and effectiveness of medicines, and investigates suspected adverse reactions to

medicines already on the market.

Traditionally, medications have been dispensed by pharmacy professionals, within a

regulation framework encompassing a mix of legislation and a self-regulatory code of ethics

to which all UK pharmacists must adhere (RPSGB 2003). In addition to POMs, which

require a prescription by a doctor or nurse-prescriber, PMs can only be dispensed in the

presence of a qualified pharmacist, while the general sales list (GSL) of proprietary

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compounds, herbal remedies and food supplements can be obtained from a variety of other

outlets in addition to pharmacies. Which drugs have been designated for retail without

prescription has been determined largely by evidence on potency, safety and risk of adverse

side effects (Department of Health 1999), or to encourage self-medication for short-term

illnesses (Bosch 2001). Recently in the UK, a prescription statin (cholesterol-lowering

medication) was re-classified from POM to PM to encourage widespread prophylactic use

(Department of Health website 12 May 2004: press release 0186). Such categorisations vary

from nation to nation, and anomalies occur, so that drugs available in one country as

pharmacy medicines or GSL supplements (for example, melatonin) are POMs in others

(Childs et al 1998).

While the 1968 Medicines Act prohibits both the sale on UK territory of unlicensed drugs and

POMs without a prescription, the same Act permits individuals to import medicinal products

other than controlled substances for their own use (Bynoe 1999). There remains little control

over transactions with providers in foreign countries (Henney et al 1999), and travellers and

others have exploited this right to obtain medicines overseas, with or without professional

sanction. However, the UK and EU explicitly ban direct-to-consumer advertising (DTCA) of

POMs, and before the advent of the Internet, UK consumers were limited in the information

they could access on POMs to the technical information provided with drugs and advertising

in media aimed at health professionals. Proposals to permit DTCA have been criticised as

creating a market in pharmaceuticals that may pressure prescribers to meet patient requests for

specific medications (Shaw and Baker 2004).

The governance of pharmaceuticals addresses the following objectives of various parties:

• a need for control over the supply of potentially dangerous chemicals to protect the public,

through licensing and regulation of prescription;

• regulating the supply of pharmaceuticals possessing significant risks on the basis of

judgements by designated professionals including doctors, nurse-prescribers and

pharmacists, rather than by market forces;

• encouraging pharmaceutical innovation by commercial industry, including protection of

inventions and other intellectual property, to improve the public health, combat disease and

enhance the social and economic well-being of the nation;

• enabling individuals opportunities to access pharmaceuticals other than controlled

substances according to national and international legal frameworks;

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This suggests that governing pharmaceutical consumption must balance the interests of a

range of stakeholders, including the government (in its various duties to protect the public,

maximise health, encourage technological innovation and account for its expenditure),

medical and pharmacy professions, patients and consumers (including support and interest

groups) and the pharmaceutical industry. This must be done within a broader environment

that acknowledges frameworks of national and international law and human rights legislation

and convention, the dynamics of the trans-national pharmaceutical market, as well as

scientific and technological innovation and social changes, and contingent of course upon

compliance by the general population including special interests such as patient support

groups. Governance is achieved in a partnership involving a mix of government agencies,

professional bodies and scientific advisory groups. In addition to legal requirements, there is

a strong element of professional and industrial self-regulation and what might be called a

‘fudge-factor’ that allows a light touch where appropriate. We now examine how the

development of the Internet as an information and commercial medium affects the system of

rule governing pharmaceutical consumption, before exploring stakeholder views on these

developments.

Three Moments in the Birth of the E-Clinic

Internet-enabled pharmacy is a relatively new phenomenon, but by 2002, Bessell et al had

been able to survey 104 websites offering medications over the Internet to members of the

public. Since then, the exponential rise in outlets has meant that, internationally, obtaining

both PMs and POMs from sources other than local pharmacists has become straightforward.

In North America and elsewhere, pharmacy chains diversified into online sales, and US e-

pharmacies are now accredited through the National Association of Boards of Pharmacy

(Sellers 2000). E-pharmacy has developed alongside traditional community pharmacies in the

US, and while e-pharmacies primarily target domestic consumers, an Internet user in

possession of a credit card can purchase many prescription drugs such as Viagra, Prozac, anti-

cancer drugs and weight loss drugs from these sites and have them sent internationally by

post. In the UK, ‘home-grown’ Internet-enabled pharmacy has developed within national and

EU governance frameworks. Since we began research in 2002, the shape of UK Internet-

enabled pharmacy has continued to develop, and the three ‘moments’ documented below

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reflect differing degrees of continuity with, and transformation of existing patterns of

pharmaceutical consumption.

Moment 1: Electronic Transfer of Prescriptions

As part of a ‘Pharmacy in the Future’ initiative (DoH 2000) to modernise pharmacy, the UK

Department of Health commissioned a pilot scheme to evaluate electronic transfer of

prescriptions (ETP) between prescribers, pharmacists and the Prescriptions Pricing Authority

(PPA). Previously, POMs could only be legally dispensed against a hand-signed prescription,

however the ETP pilot was justified as a technical advance not prejudicial to public safety.

The Government believes the law permits the distance sale and supply of medicines,

provided that normal safeguards are met. … (I)f 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 (ibid: 12).

Under the pilot, GPs sent prescriptions electronically to one of three pharmacies in the

scheme, while remuneration of these pharmacies by the PPA (following dispensing of a

prescribed medicine to a patient) was also based on e-communication. In two of the pilot

organisations, patients collected drugs from the pharmacy premises, while a third was a ‘mail-

order’ pharmacy using a courier service to dispense prescriptions. The pilot study evaluation

(Sugden 2003) was broadly positive, although it did not appear to significantly free up

pharmacist or prescriber time (ibid: 10), and indeed required additional GP input to

electronically ‘sign’ repeat prescriptions (ibid: 11). Subject to the findings of the pilot, the

roll-out of ETP in the UK is planned for the near future (DoH 2000).

ETP is a technical solution to reduce paperwork and the need for multiple keying of patient

information during the prescribing process, and its implementation will overturn the legal

requirement for a ‘signature’ on a paper prescription (ibid: 12). However, ETP retains a

traditional model for prescribing pharmaceutical drugs, assuming doctors and other licensed

prescribers remain as exclusive gate-keepers to POMs, a principle strongly supported by

European Union member states (Stanberry 2002: 605) and the US (Charatan 2000).

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Moment 2: E-Pharmacy and the ‘virtual’ pharmacist

While ETP exploits Internet technology to facilitate dispensing of POMs, the establishment of

online pharmacies enables consumers to purchase PM and GSL pharmaceuticals from a web-

site, for delivery by mail or courier service. Some traditional pharmacies have established

web-sites enabling online purchase of PMs, subject to a short questionnaire assessed by a

qualified pharmacist. These include Boots in the UK, Amcal in Australia and Walgreens in

the US. Other pharmacies without a high-street presence, including Pharmacy2U, also

operate online in a way analogous to a traditional pharmacist. These pharmacies also permit

consumers to purchase POM medicines on submission of a valid, signed prescription either in

person or by mail, and also enable repeat prescriptions to be ordered.

This model of e-pharmacy moves beyond a technical solution to transferring information, to

establish a ‘virtual’ pharmacist as a legitimate alternative to a face-to-face professional

contact. Thus, for example, Pharmacy2U asserts on its website that it

… has developed unique procedures and protocols that allow our pharmacists to check

the suitability of a medicine for a particular patient and ensure its safe delivery.

Qualified pharmacists supervise our service and we are members of the Royal

Pharmaceutical Society of Great Britain and the National Pharmaceutical Association.

Typically, customers purchasing PMs will be asked to complete a product-specific

questionnaire. According to Pharmacy2U, this is ‘checked by a registered pharmacist prior to

dispatch’ to assess the suitability of the drug for the profile elicited by the questionnaire.

The e-pharmacy marks a break from tradition by establishing the legitimacy of the e-

pharmacist, and of creating a market-place for PM drugs via internet promotional materials.

As will be seen in the next section, this virtual model of patient/pharmacist interaction has

been defended as acceptable by pharmacy professionals, and has been incorporated within

self-regulation codes of conduct. However, as with the electronic transfer of prescription

data, this second moment does not challenge the basic assumption that, in relation to POMs,

prescriptions are originated from a face-to-face consultation between patient and prescriber.

Moment 3: the E-clinic and the virtual prescriber

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The third moment in the birth of the e-clinic establishes the online of virtual medical

consultation as an alternative mode of accessing POMs. In the market-driven US pharmacy

business, there has been a proliferation of websites offering access to prescription medicines.

Following federal regulation (Charatan 2000), most now offer these medications subject to an

online consultation with a registered physician. For UK residents, it is possible to obtain

POMs from e-pharmacies retailing internationally such as AmerimedRX or Epharmacist.com

based in the US, Canada and elsewhere. Typically, a physician employed by the pharmacy or

acting as a consultant reviews an online order. Thus for example, customers of AmerimedRX

must

… complete an online medical questionnaire which is thoroughly reviewed by a

licensed AmeriMedRx physician, and if found suitable for treatment, the prescription

will be dispensed and shipped by our licensed pharmacy. If the consulting physician

has any questions or concerns regarding your medical history or needs more

information, he or she will contact you … (extract from web site)

Most of these e-pharmacies promote a limited range of pharmaceuticals, predominantly ‘life-

style’ drugs such as sildenafil (Viagra), the weight-loss drug orlistat (Xenical), adjunct

therapies such as the pain relief drug celecoxib (Celebrex), and anti-virals such as acyclovir.

Many sites are consumer-orientated, promoting products according to US regulatory

frameworks that permit direct-to-consumer advertising (DTCA). Some US websites will not

retail to overseas consumers, but it is easy to access e-pharmacies that will ship

pharmaceuticals to any address: UK citizens may import POMs other than controlled

substances for personal use. The quality and authenticity of products available from some

sites has been questioned by commentators, as has the safety of trading POMs without

medical advice (Burgermeister 2004).

The ban on consumer advertising of POMs in the UK has been the constraining factor in the

emergence of UK equivalents to these outlets. We interviewed the director of one

organisation that operates legally within the UK as a self-styled ‘online clinic’, offerings a

small number of ‘lifestyle’ treatments for obesity, impotence and male pattern baldness (with

an aspiration to extend this range in the future). It operates as one of three ‘compliant sites’ in

the UK under the Medicines (Advertising) Regulations 1994 and European Directive

2001/83/EC. Unlike US websites, these regulations prevent UK e-clinics from giving details

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of treatments or costs prior to a free online consultation with a UK-registered doctor. Their

mode of operation was negotiated in discussions with the Medicines and HealthCare

Regulatory Authority (MHRA) during 2003. According to the online clinic director

… their main concern was that you cannot mention POM names on your website as

this is considered advertising. They define a website as an advertising mechanism.

Also, they required a period of consideration for the doctor - they described this as

being similar to going to see your own doctor. For example, you would not go to your

doctor and say 'I would like Viagra please' instead, you would go and discuss your

condition, the doctor considers the facts before selecting a drug or range of drugs.

This principle is one that they feel would need to be replicated and considered

acceptable on the web.

Accordingly, it is only after an online consultation that consumers are e-mailed details of their

diagnosis and suggested treatments, and provided with a web address from which to buy the

treatment from the range of those recommended by the consultant, while repeat orders are

subject to confirmation by the consumer of their medical details. In an interview, the director

of the e-clinic suggested their service offered the security of a UK-regulated and compliant

website and genuine UK-licensed drugs, in contrast with overseas suppliers of POMs that

may be counterfeit or not manufactured to UK standards.

This third moment marks the most radical break with traditional modes of accessing POMs in

the UK, and by branding itself as an online clinic establishes a new model for consultation

with the medical profession. From a governance perspective, it was the issue of promoting

POMs to consumers that was a major stumbling block in the creation of a fully-fledged e-

clinic, rather than the need for face-to-face contact with a medical professional. In terms of

the social relations of prescribing, the e-clinic establishes a consumer model of POM

dispensing, bolstered by a subtle use of language that avoids the term ‘patient’ and an un-

moderated forum that allows consumers to discuss treatments directly with each other,

independent of medical intervention.

Stakeholder Responses to the Birth of the E-Clinic

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The data from documentary evidence and interviews with stakeholder groups explored the

ways in which UK regulatory frameworks have been applied to address changing patterns of

supply and consumption of prescription medicines. Interviews with those tasked with

regulation and other stakeholders suggested a mix of reliance on established frameworks and

a hint of complacency concerning the extent of the emerging trends.

In the UK, no new legislation has been passed to regulate e-pharmacy, and developments

have been managed within codes of conduct developed by professional bodies (Anonymous

1999, Hansard 2000). Both documentary and interview data suggest a conservative response

to e-pharmacy, with the 1968 Medicines Act (which sets out the requirement for POMs to be

obtained only by valid prescription) judged adequate to address e-pharmacy developments. A

European Commission report on the electronic sale of pharmaceuticals (Muscardini 2001: 57)

assumes that ‘… prescription-only medicines are delivered to patients who can provide a

prescription that reflects meaningful contact with a qualified medical professional’. A

respondent from the Medicines and HealthCare Products Regulatory Agency (MHRA)

confirmed in an interview that in the UK, this has been interpreted to encompass ‘online

consultations’.

… on the question of … the need for a doctor to consult with a patient prior to issuing

a prescription, there is no requirement under medicines legislation for this to be face-

to-face. Therefore, there is nothing to prevent a doctor prescribing or supplying a

medicine on the basis of for example, an on-line questionnaire. That said, we would

take the view that it should contain sufficient information for the doctor to make a

decision about whether or not any proposed treatment was appropriate.

Concerning the ETP initiative, stakeholder reactions saw this as a technical advance in

communication (as one pharmacist respondent commented: ‘its just e-mailing prescriptions in

a secure system, isn’t it?’). Similarly, on the potential for POMs to be acquired from overseas

e-pharmacies, a member of the NHS Modernisation Board felt

… It’s a small problem, but it’s this debate as to whether it’s going to become a bigger

one. And, I wouldn’t like to say actually. I mean it’s probably going to slowly

increase but I’m not sure it’s going to suddenly expand exponentially. Because, if you

think that fifty per cent of medicines are for the over 75s … we’re really talking about

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more than half of this being for older people and you know, it’s a limited market at the

moment.

The reaction of the MHRA has been to ensure that e-pharmacies based in the UK do not flout

DTCA legislation. This has had consequences for the emergence of fully-fledged e-clinics.

According to the director of an e-clinic, compliance with MHRA guidelines has cost it

business in the global Internet market, but has benefits as

‘… our customers appreciate being on the right side of the law … fraud is reduced and

people buy with more confidence therefore resulting in buying more quantity. … We

are disadvantaged, but there is not much we can do about it as the laws on the

promotion of POMs is different from country to country. We now see it as an

opportunity to establish ourselves in the knowledge that we will not be shut down.

This suggests pragmatism in the face of challenges to governance of e-pharmacy. Wherever

possible, new legislation is to be avoided, and voluntary consensus achieved to manage

environmental changes. In response to the development of e-pharmacy, the Royal

Pharmaceutical Society of Great Britain (RPSGB) updated its code-of-practice to

accommodate new practices, including the potential future use of electronic prescriptions

(RPSGB 2003). An editorial in the profession’s Pharmaceutical Journal reflects a view that

nothing has really changed:

As with all professional services, online pharmacy services must be provided

within the legislative framework for pharmacy and in compliance with existing

professional requirements detailed in the code of ethics. … all requirements of the

Medicines Act 1968 and Regulations must be complied with, including the

requirements for the supplying pharmacy to hold a valid prescription (Anonymous

2000: 9).

The RPSGB argue that the ‘remote patient’ is not new or unique: pharmacists are often

required to dispense medicines to family and friends on a patient’s behalf, and this way of

working can be replicated online using questionnaires and emailed advice as modes of

communication. Many aspects of e-pharmacy such as compliance with marketing

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regulations, provision of drug information, record keeping and accountability transfer directly

from traditional to online environments (Appelbe and Wingfield 2001).

Thus the Royal Society’s approach is to work within existing legislation and regulatory

guidelines where possible, but to acknowledge that in a developing information-oriented

environment, there was a need for new alliances between government, professional and

patient organisations and the industry in order to govern the technology effectively and

appropriately. A pharmacist respondent voiced anxieties about the constraints that the use of

communication technology for ETP might place on patients.

The idea sounds brilliant in practice, but I would dread to think what would happen if

technology failed. (At present), quite often, the prescription generated is wrong, or

missing the odd item - through the fault of the practice … pharmacy staff spend a lot

of time chasing the surgeries for missing items - I wonder what would happen if this

happened via the internet? … It may mean that patients have to agree to staying with

one pharmacy, and at present this is something that isn't allowed, as patients should be

free to choose where they go.

The pharmaceutical industry is in a position to benefit commercially from environmental

changes that will enable a closer engagement between provider and consumer, including

direct advertising and opening up markets for non—NHS prescription. However, as our

respondents from the Association of the British Pharmaceutical Industry (ABPI) noted, the

pharmaceutical industry is one of the most regulated industries in the UK, and in such a

climate, companies are cautious about overstepping the line. Some multinational

pharmaceutical companies have adapted their web presence to avoid any implication that they

are advertising directly to consumers in countries in which DTCA is illegal. While web

surfers can access US pharmaceutical company sites, many companies provide separate web

sites for US and other visitors and point non-US citizens to web-pages where product

information is couched in language that reduces the sense of marketing.

Respondents from the pharmaceutical industry offered a cautious response to e-pharmacy.

The ABPI supported government efforts to establish electronic prescription transfer as an

example of how the Internet could be used to enhance the development of pharmaceutical

practice. The three respondents from the industry that we interviewed expressed concern over

18

e-pharmacy, which they perceived primarily as a means to market counterfeit products,

undercutting legitimate sales. Illegal selling of pharmaceuticals was a major risk for the

industry as it creates mistrust and potential misuse of drugs such as sildenafil and orlistat. In

addition, they argued that while many drugs sold without prescription on the Internet are

counterfeit, people seem willing to take risks. These responses suggest a stakeholder that is

keen to embrace developments arising from e-technology, but aware that they must work in

collaboration with more influential stakeholders if a more liberal governance regime is to be

realised, and to ensure that their livelihood is not undermined by deregulating intellectual

property and patent rights over products, or by challenging consumer trust in POMs.

While members of the public do not constitute a source of authority concerning

pharmaceutical governance, clearly their compliance with governance is critical to its success.

During our research, we interviewed consumers of a range of pharmaceuticals including

lifestyle drugs such as Viagra and Xenical, as well as correspondents to health chat rooms

(Authors, 2005, in press). Some of these respondents had used e-pharmacy to obtain

pharmaceuticals and other products, while others were strongly opposed, citing safety and

lack of knowledge as hazards of e-pharmacy. One respondent argued against the use of an e-

clinic:

There is a danger of someone ordering the drugs because they might have similar

symptoms to their next-door neighbour, relative, friend and thinking the same drugs

would cure them. A wide number of illnesses and conditions have symptoms which

are very similar but the drugs which would treat one condition won't necessarily treat

another condition even though they have similar or even the same symptoms. …

Prescription drugs should only be prescribed by a doctor after he/she has given a good

examination of the patient.

However, another respondent disagreed, but only for repeat prescriptions.

I think that if a patient knows the medication they should take (based on their own past

experience with the drug) then they should be allowed to purchase the drug over the

Internet without having to wait for a prescription from the GP. For example, women

who take oral contraceptives, people who are on long-term treatment, when an allergy

flares up, etc. … It is a great idea to have an Internet Pharmacy if the patient gets their

19

prescription (for the first time) from their GP and then can obtain the medicine via the

web instead of having to find the time to get to the (pharmacy).

These consumer perspectives must be acknowledged in managing governance of

pharmaceuticals in the Internet age. Elsewhere we have described the ways in which

consumers of POMs have subverted the traditional model of pharmaceutical consumption in

the quest to acquire drugs that can assist in achieving lifestyle objectives (Authors 2005, in

press, submitted b). In an international market-place, governance must balance the demands

for drugs against the need for public safety and the protection of business interests.

Discussion

We have documented three changes to pharmaceutical consumption in the UK that emerge

from the exploitation of Internet technologies. The first, ETP, is primarily a technical fix to

enable more efficient management of pharmaceutical dispensing, while the second and third

are more radical consequences of commercial exploitation of these technologies. These latter

two moments mark changes in the consumer-pharmacist and consumer-prescriber relationship

respectively, replacing face-to-face interaction with virtual encounters. The governance

issues are summarised in Table 2

Table 2: Challenges and Responses to Changes in Prescribing

Challenge to Governance Governance Response

ETP Legal requirement for a physical

prescriber signature on a prescription

Existing law amended to permit

electronic signatures

E-pharmacy No face-to-face opportunity for a

pharmacist to check that a patient is

suitable for a medication; direct-to-

consumer advertising of PMs

Pharmacy code of conduct on

acceptability of pharmacist advice by

phone or to a relative adapted to

cover Internet communication;

similarly for advertising PMs

E-clinic Non-UK

POMs available without prescription

from some websites

UK

Non-UK

Non-UK business lies beyond UK

jurisdiction, and consumers can

import for their own personal use

UK

20

No face-to-face consultation between

prescriber and patient; potential for

direct-to-consumer advertising of

POMs

Following negotiation between

regulator and business, e-

consultation with a GMC-registered

doctor deemed acceptable, but

available POM treatments and prices

not available to consumers until after

diagnosis.

The emergence of global e-pharmacy and the e-clinic has the potential to change the way in

which pharmaceuticals are considered by the public, equating these products with other goods

to be marketed and consumed, and reducing the gate-keeper role of a professional to that of an

online reviewer of a consumer and their self-reported ‘symptoms’. Health care consumers

perceive pharmaceutical technology as an adjunct in the pursuit of a better lifestyle and

experience of embodiment (Authors, 2005), and in a nation where the National Health Service

(NHS) has dominated the way in which POMs are used, the e-clinic provides a new route for

private prescription of drugs, circumventing the evidentially-based guidance provided to NHS

clinicians by the National Institute for Clinical Excellence (NICE). Together, these

developments affect some fundamental power relations between consumers, commerce and

professionals, and may upset a precarious balance between the objectives of ensuring public

safety and freedom of choice and autonomy (Walley et al 2000). The role of professional

expertise in sustaining this balance has been a key component of pharmaceutical governance,

and the e-pharmacy and e-clinic have the potential to undermine the extent to which this

expertise is exerted in the prescribing of pharmaceuticals (Bessell et al 2003: 90).

However, our research suggested a highly conservative response by UK regulators to these

innovations, depending upon established legislation to cover emergent technological changes

to pharmaceutical consumption and online consulting. Data from interviews and

documentary analysis suggest that in the view of regulators and professionals, minor changes

to data protection legislation and modifications to voluntary codes of conduct by professional

bodies and industry can address the emergence of e-prescribing. Thus, for example, Internet

media are to be included in DTCA codes, with online communication confirmed as an

adequate and legitimate method to assess patient suitability for POMs. Our data suggests a

strong tendency towards continuity, despite transformational pressures, with the impact of

21

new communication technology is down-played, and managed ‘at the margins’. How can we

understand this low-key reaction?

We would suggest that, following Rosenau’s (1995) model of governance, the under-stated

response to the birth of the e-clinic may be best understood as efforts by stakeholders to

sustain an existing system of rule in the face of an environmental change (the emergence of

global Internet commerce) rather than overturn existing systems and begin from scratch.

This, we have suggested elsewhere (Authors, forthcoming), is a feature of technology

governance: stakeholders manage environmental change incrementally, until pressure from

one quarter (for example, from consumers or from commercial interests, public morals and so

forth) is so significant that the system of rule must adapt. Governance is a process that is

continually breaking down, and must balance stakeholder interests. This explains the

emphasis on self-regulation in many systems of rule, and efforts to retain a lightness of touch

in terms of legal coercion.

Successful governance depends upon compliance, and with the emergence of the e-clinic, the

motor of change in pharmaceutical use comes from consumers. Given the right of the UK

citizen to import pharmaceuticals for personal consumption, UK regulators have no control

over consumer rights to obtain non-controlled medications from overseas, nor can they

regulate the advertising activities of non-UK companies, except in relation to EU legislation

that applies regulatory controls across member-states. We found a consensus of opinion

among government regulators, industry and professionals, and sustaining this consensus may

be more important than a radical response to alter governance arrangements. Only in the non-

controversial area of electronic prescription transfer have Parliamentary statutory instruments

(2001/2887-2890) been effected to ensure the legality of e-prescriptions. In the radical case

of the e-clinic, negotiations have established the online consultation as valid, so long as it

precedes any discussion or promotion of treatment options.

Currently, we observe the emergence in the UK of an e-clinic managed within existing

systems of rule. A mixture of fudge, strategic alliances between industry, professionals and

government and slightly modified codes of conduct has allowed the UK e-clinic to develop as

a distinct phenomenon, different from its overseas counterparts in terms of scale of operation,

and mimicking a traditional model of patient-prescriber interaction despite the lack of face-to-

face contact. While elsewhere, different cultures of prescribing and pharmaceutical

22

commerce, and of course, differing governance arrangements have led to a burgeoning

provision of online clinics, the analysis of governance applied in this paper suggests that for

the time being, the UK e-clinic will develop as a curiosity. UK e-clinics will subsist within

the interstices of established governance, meeting the demands for some lifestyle treatments

and ensuring a medical overview of pharmaceutical consumption is sustained, albeit at a

distance. Whether these governance arrangements can be maintained will depend upon the

success of the system of rule in balancing consumer demand and commercial enterprise

against public safety and consumer protection.

Notes

1. PMs can only be retailed in the presence of a qualified pharmacist. A general sales (GSL)

that includes proprietary compounds, herbal remedies and food supplements can be obtained

from a variety of other outlets in addition to pharmacies.

2. ESRC project L218252057, funded within the Innovative Health Technologies

programme.

3. We have used the notion of the sociological ‘moment’ to give a sense of development as

the opportunities to exploit Internet technology are recognised and operationalised.

4. Twenty interviews were with respondents in an anorexia forum, 12 in a weight loss forum

and three from a BBC health discussion forum. We followed ethical guidelines that prohibit

covert online data collection (Marx 1998; Reid 1996): all interviewees were fully aware that

their responses to the researcher’s questions were to be used in research.

23

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