Global consumption and the challenge to pharmaceutical governance in the United Kingdom
1 School of Health and Related Research, University of Sheffield, Sheffield S1 4DA
Analysis of governance, based on research into the views of stakeholders, can show the ways in which systems for regulation of technology evolve in the face of changes such as globalisation
Introduction
The globalisation of production and consumption challenges the ways in which potentially harmful yet essential technologies such as pharmaceuticals are governed. In modern liberal democracies, governance (a term whose Greek root implies control) depends not only on law and regulation but also on successfully engaging a wide range of interests within society—industry, professionals, and the public—as responsible and accountable. With the emergence of the internet, consumers' access to information and opportunities to purchase goods online may destabilise the established processes regulating prescription drugs.
, 百拇医药
Technology, governance, and globalisation
For democratic societies, the challenge of governance is to balance and reconcile the differing interests of the state and of individuals in an effort to sustain the continuity, security, and cultural integrity of the state and the liberty and rights of individuals.1 Governance systems can be established in the absence of legal or political authority and often depend on voluntary and consensual processes. A good example is the governance of professions, such as the medical profession, which have applied self regulation and codes of conduct alongside legal frameworks.
, 百拇医药
A hundred years ago, local pharmacies had no competition from the internet, and governance was more straightforward
Credit: MEPL
Scientific and technological developments such as nuclear power, genetic engineering, food safety, and pharmaceutical innovation all demand regulation for reasons of public health, safety, and security.2-4 These developments require policy makers and professionals to balance a paternalistic responsibility for others against individual freedoms and rights and the commercial interests of industry. New technologies gradually acquire regulatory frameworks as policy makers assess and weigh different interests among innovators, professionals, consumers, and ethicists. For drugs, national governments determine how they may be supplied and consumed. The Medicines and Healthcare Products Regulatory Authority (MHRA) controls the marketing of pharmaceuticals and regulates the sale of pharmacy and prescription only medicines in the United Kingdom, while permitting individuals to import medicinal products other than controlled substances for their own use.5
, http://www.100md.com
Globalisation threatens governance, requiring control mechanisms to become either more inclusive or less comprehensive.6 In a global economy without barriers to trade across borders, the internet offers both an information resource for potential consumers and a commercial medium for suppliers to trade in commodities.7
Our research on the regulation of pharmaceutical consumption in the UK explores how globalisation of information and communication technologies (in particular, the internet) poses challenges for national systems of governance. We gathered data from "stakeholders" with interests in governance changes, using in-depth face to face and telephone interviews with respondents from UK government agencies, pharmacies and e-clinics, the pharmaceutical industry, and consumer groups and email interviews with consumers set up through internet health forums, plus documentary analysis of paper based and web based materials, including government publications. We concluded that globalisation of information has created two critical challenges for pharmaceutical regulation: online "e-pharmacy," which circumvents the traditional gatekeeping of pharmaceutical consumption by health professionals, and challenges to European bans on direct to consumer advertising arising from consumers' access to transnational industry websites.8 9
, 百拇医药
Globalisation and the growth of e-pharmacy
The pharmacy profession dispenses prescription only medicines and pharmacy medications within a governance context of legislation and its professional self regulatory code of practice.10 Categorisations of drugs as "over the counter" or prescription only medicines vary from country to country and anomalies (exploited by travellers) occur, so that drugs such as melatonin are available in one country as pharmacy medicines or food supplements and only by prescription in others.11
, 百拇医药
The internet offers a means for UK residents to purchase drugs from an overseas e-pharmacy or from a handful of outlets registered in Britain that have sprung up in the past few years. We interviewed consumers of a range of pharmaceuticals, including lifestyle drugs such as sildenafil (Viagra) and orlistat (Xenical), who had used e-pharmacy to obtain pharmaceuticals and other products. They considered this an appropriate way to obtain drugs, especially when they did not wish to approach their general practitioner.
, 百拇医药
In legal British and American e-pharmacies, pharmacy medicines are dispensed after the customer completes an online questionnaire, which is assessed by a registered pharmacist. The Royal Pharmaceutical Society of Great Britain updated its code of practice in 2003 to accommodate e-pharmacy, arguing that a remote patient is nothing new: 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 by using questionnaires and emailed advice as a means of communication.10
, http://www.100md.com
For prescription only medicines, e-pharmacies require some form of online consultation with a doctor. During our research, the MHRA confirmed that it considers this kind of interaction between patient and doctor as an acceptable medium for diagnosis, and it had agreed to UK pharmacies using this approach to sales of prescription only medicines. To overcome regulations on advertising, the MHRA requires that e-pharmacies based in the United Kingdom do not provide details of the available prescription only medicines before an online consultation. According to the director of one UK e-pharmacy, compliance with these MHRA guidelines has cost it business in the global market but has increased trust among consumers.
, http://www.100md.com
Globalisation and consumer advertising
Prescription only medicines can be marketed to the public in the United States and New Zealand, but in European Union countries direct to consumer advertising of prescription only medicines is explicitly banned, and healthcare professionals worry that such advertising may pressure prescribers to meet patients' requests for specific drugs.12 13 The internet has created an ambiguity for regulators: like the websites of many commercial organisations, pharmaceutical companies' websites describe the products the companies manufacture. Do these descriptions amount to marketing, and where does legitimate information about a drug become advertising Given the global reach of a website authored in a country where direct to consumer advertising is legal, does this contravene advertising regulations elsewhere
, 百拇医药
As the UK regulator of pharmaceutical consumption, the MHRA has declared that pharmaceutical websites that are not intended exclusively for healthcare professionals may not publish details of their products beyond technical data on use and drug interactions.14 According to a respondent from the MHRA, voluntary self regulation by the pharmaceutical industry has ensured that, at least on their UK websites, pharmaceutical manufacturers do not flout UK legislation. Our respondent accepted that UK consumers could access fuller information from websites originating overseas, over which the MHRA has no legal control. This, she argued, was acceptable, as it represented a "pull" rather than a "push" in relation to accessing drug information, a distinction also made by a respondent from the Royal Pharmaceutical Society.
, http://www.100md.com
The pharmaceutical industry self regulates its advertising, with companies informing on competitors who infringe the code of practice. Recent guidelines from the European Federation of Pharmaceutical Industries and Associations restricted online information for patients to technical data but permitted sites to provide further information for health professionals.15 Some transnational companies erect "Chinese walls," asking Europeans not to visit the pages on their websites that are aimed at US consumers and contain more overt marketing. Our data suggest that although companies do not wish to "rock the boat" by overtly advertising to consumers on their websites, a groundswell of opinion supports liberalisation. Respondents from the industry were hopeful that the ban on advertising would be lifted in the longer term, arguing that technical data could not adequately inform patients. We learnt of collaboration between the pharmaceutical industry and patient support groups, using non-industry websites to provide more comprehensive information to patients about drugs. A respondent from a patient group told us how pharmaceutical companies sponsored her group's website: detailed information about prescription only medicines on these non-commercial sites does not transgress rules on direct to consumer advertising.
, 百拇医药
Flexibility in the face of challenge
Our study indicates that global information and communication technology threatens existing pharmaceutical regulation. However, processes of governance are fluid and responsive, as shown in the two aspects of pharmaceutical consumption we reported here. In relation to the emergence of a global market in pharmaceuticals enabled by the internet, UK governance agencies have been conservative, underplaying the challenge while adapting existing regulations to address the emergent practices. A respondent from the NHS Modernisation Board argued that because internet access was low among the older age groups, who consume most prescription only drugs, use of overseas e-pharmacies was not an important problem in the United Kingdom. Meanwhile, the MHRA recognised the "online consultation" as a legitimate interaction between patient and doctor, thus enabling UK internet pharmacies to supply prescription only drugs to consumers.
, 百拇医药
Similarly, pharmacy stakeholders have subtly adapted their guidelines to permit the operation of UK internet pharmacies, protecting their members against competition from overseas outlets. The industry supports continued regulation as a way to prevent piracy of their copyright on pharmaceutical products. The broad outline of governance remains intact, leaving consumers free to purchase from overseas outlets, accepting that regulation across national borders is hard to police.
, 百拇医药
Sustaining existing bans on direct to consumer advertising in the face of the globalisation of communication may be less straightforward, with stakeholders taking more extreme positions. Respondents from industry, the pharmacy profession, and some consumer interests all doubted the viability of current strict controls on consumer-oriented information as the internet extends its global reach. On the other hand, both Which (the consumers association, a self proclaimed protector of patients against commercial exploitation) and medical professionals voice anxiety over relaxing these regulations, as this could create a market for prescription only medicines and allow pressure by patients for particular drugs.
, 百拇医药
Summary points
Governance of technologies such as pharmaceutical medications is achieved by legislation and by consent among different interests
Globalisation challenges systems of governance as markets and consumption cross national frontiers
The rise of e-pharmacy in the United Kingdom has been achieved without adapting legislation and has sustained existing systems of governance
, 百拇医药
The internet challenges European Union bans on direct to consumer advertising
Alliances between the pharmaceutical industry and consumer groups may affect future regulation
At present, regulators strongly support the status quo on direct to consumer advertising, but as a consequence of new information and communication technology they may have to readjust the balance of arguments concerning safety, consumer protection, and the public good; professional claims to authoritative knowledge; commercial interests; and citizens' rights to information and autonomy. The differing positions of governments around the world on this issue may exacerbate the tensions in this aspect of pharmaceutical governance.
, 百拇医药
The adaptability of UK regulations in relation to an emergent e-pharmacy may reflect in part the ultimate power of consumers to choose whether or not to purchase drugs online: where there is demand a market will emerge, and consumers may accept a degree of regulation to protect their rights. When it comes to accessing pharmaceutical information, both sides of the provider-consumer partnership are involved. Different stakeholders have interests in ensuring dependable information is available to consumers. The future shape of governance of pharmaceutical information may depend more on alliances between the pharmaceutical industry and patient groups than on consumer sovereignty.16
, 百拇医药
Contributors and sources: NF led the research leading to this article and is lead author and guarantor. KW was the research officer on the study and contributed to the writing of this article.
Funding: Economic and Social Research Council (Grant L218252057).
Conflict of interest: None declared.
References
Rosenau JN. Along the domestic-foreign frontier. Cambridge: Cambridge University Press, 1997.
, 百拇医药
Jones M, Salter B. The governance of human genetics: policy discourse and constructions of public trust. New Genet Soc. 2003;22: 21-41.
Kerr A. Governing genetics: reifying choice and progress. New Genet Soc 2003;22: 111-26.
Smart A. Reporting the dawn of the post-genomic age: Who wants to live for ever Sociology Health Illness 2003;25: 408-28.
Bynoe R. M'Learned Web: drugs on the net—viagra. ZDNet 6 April 1999. http://news.zdnet.co.uk/story/0,t269-s2071446,00.html (accessed 16 Jun 2005).
, http://www.100md.com
Rosenau JN, Johnson D. Information technologies and turbulence in world politics. In: Allison JE, ed. Technology, development and democracy. Albany: State University of New York Press, 2002.
Lenk K. The challenges of cyberspatial forms of human interaction to territorial governance and policing. In: Loader BD, ed. The governance of cyberspace. London: Routledge, 1997: 126-35.
Fox NJ, Ward KJ, O'Rourke AJ. The birth of the e-clinic. Continuity or transformation in the governance of pharmaceutical consumption Soc Sci Med (in press).
, 百拇医药
Fox NJ, Ward KJ, O'Rourke AJ. A sociology of technology governance for the information age: the case of pharmaceutical consumption. Sociology (in press).
Royal Pharmaceutical Society of Great Britain. Code of ethics and standards. London: RPSGB, 2003, updated 6 April 2005. www.rpsgb.org/pdfs/coe050406.pdf (accessed 16 Jun 2005).
Childs M, Ellison L, Prayle D. Drugs and the internet. New Law Journal 1998;148(6868): 1840.
, 百拇医药
Shaw J, Baker M. Expert patient: dream or nightmare BMJ 2004;328: 723-4.
Pines WL. Direct-to-consumer advertising. Ann Pharmacother 2000;34: 1341-4.
Medicines Control Agency. Advertising and promotion of medicines in the UK. London: Stationery Office, 1999.
European Federation of Pharmaceutical Industries and Associations. Guidelines for internet web sites available to health professionals, patients and the public in the EU. 2001. www.efpia.org/6_publ/Internetguidelines.pdf (accessed 16 Jun 2005).
Queau P. Global governance and knowledge societies. Development 2002;45(4): 10., 百拇医药(Nick Fox, Katie Ward)
Analysis of governance, based on research into the views of stakeholders, can show the ways in which systems for regulation of technology evolve in the face of changes such as globalisation
Introduction
The globalisation of production and consumption challenges the ways in which potentially harmful yet essential technologies such as pharmaceuticals are governed. In modern liberal democracies, governance (a term whose Greek root implies control) depends not only on law and regulation but also on successfully engaging a wide range of interests within society—industry, professionals, and the public—as responsible and accountable. With the emergence of the internet, consumers' access to information and opportunities to purchase goods online may destabilise the established processes regulating prescription drugs.
, 百拇医药
Technology, governance, and globalisation
For democratic societies, the challenge of governance is to balance and reconcile the differing interests of the state and of individuals in an effort to sustain the continuity, security, and cultural integrity of the state and the liberty and rights of individuals.1 Governance systems can be established in the absence of legal or political authority and often depend on voluntary and consensual processes. A good example is the governance of professions, such as the medical profession, which have applied self regulation and codes of conduct alongside legal frameworks.
, 百拇医药
A hundred years ago, local pharmacies had no competition from the internet, and governance was more straightforward
Credit: MEPL
Scientific and technological developments such as nuclear power, genetic engineering, food safety, and pharmaceutical innovation all demand regulation for reasons of public health, safety, and security.2-4 These developments require policy makers and professionals to balance a paternalistic responsibility for others against individual freedoms and rights and the commercial interests of industry. New technologies gradually acquire regulatory frameworks as policy makers assess and weigh different interests among innovators, professionals, consumers, and ethicists. For drugs, national governments determine how they may be supplied and consumed. The Medicines and Healthcare Products Regulatory Authority (MHRA) controls the marketing of pharmaceuticals and regulates the sale of pharmacy and prescription only medicines in the United Kingdom, while permitting individuals to import medicinal products other than controlled substances for their own use.5
, http://www.100md.com
Globalisation threatens governance, requiring control mechanisms to become either more inclusive or less comprehensive.6 In a global economy without barriers to trade across borders, the internet offers both an information resource for potential consumers and a commercial medium for suppliers to trade in commodities.7
Our research on the regulation of pharmaceutical consumption in the UK explores how globalisation of information and communication technologies (in particular, the internet) poses challenges for national systems of governance. We gathered data from "stakeholders" with interests in governance changes, using in-depth face to face and telephone interviews with respondents from UK government agencies, pharmacies and e-clinics, the pharmaceutical industry, and consumer groups and email interviews with consumers set up through internet health forums, plus documentary analysis of paper based and web based materials, including government publications. We concluded that globalisation of information has created two critical challenges for pharmaceutical regulation: online "e-pharmacy," which circumvents the traditional gatekeeping of pharmaceutical consumption by health professionals, and challenges to European bans on direct to consumer advertising arising from consumers' access to transnational industry websites.8 9
, 百拇医药
Globalisation and the growth of e-pharmacy
The pharmacy profession dispenses prescription only medicines and pharmacy medications within a governance context of legislation and its professional self regulatory code of practice.10 Categorisations of drugs as "over the counter" or prescription only medicines vary from country to country and anomalies (exploited by travellers) occur, so that drugs such as melatonin are available in one country as pharmacy medicines or food supplements and only by prescription in others.11
, 百拇医药
The internet offers a means for UK residents to purchase drugs from an overseas e-pharmacy or from a handful of outlets registered in Britain that have sprung up in the past few years. We interviewed consumers of a range of pharmaceuticals, including lifestyle drugs such as sildenafil (Viagra) and orlistat (Xenical), who had used e-pharmacy to obtain pharmaceuticals and other products. They considered this an appropriate way to obtain drugs, especially when they did not wish to approach their general practitioner.
, 百拇医药
In legal British and American e-pharmacies, pharmacy medicines are dispensed after the customer completes an online questionnaire, which is assessed by a registered pharmacist. The Royal Pharmaceutical Society of Great Britain updated its code of practice in 2003 to accommodate e-pharmacy, arguing that a remote patient is nothing new: 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 by using questionnaires and emailed advice as a means of communication.10
, http://www.100md.com
For prescription only medicines, e-pharmacies require some form of online consultation with a doctor. During our research, the MHRA confirmed that it considers this kind of interaction between patient and doctor as an acceptable medium for diagnosis, and it had agreed to UK pharmacies using this approach to sales of prescription only medicines. To overcome regulations on advertising, the MHRA requires that e-pharmacies based in the United Kingdom do not provide details of the available prescription only medicines before an online consultation. According to the director of one UK e-pharmacy, compliance with these MHRA guidelines has cost it business in the global market but has increased trust among consumers.
, http://www.100md.com
Globalisation and consumer advertising
Prescription only medicines can be marketed to the public in the United States and New Zealand, but in European Union countries direct to consumer advertising of prescription only medicines is explicitly banned, and healthcare professionals worry that such advertising may pressure prescribers to meet patients' requests for specific drugs.12 13 The internet has created an ambiguity for regulators: like the websites of many commercial organisations, pharmaceutical companies' websites describe the products the companies manufacture. Do these descriptions amount to marketing, and where does legitimate information about a drug become advertising Given the global reach of a website authored in a country where direct to consumer advertising is legal, does this contravene advertising regulations elsewhere
, 百拇医药
As the UK regulator of pharmaceutical consumption, the MHRA has declared that pharmaceutical websites that are not intended exclusively for healthcare professionals may not publish details of their products beyond technical data on use and drug interactions.14 According to a respondent from the MHRA, voluntary self regulation by the pharmaceutical industry has ensured that, at least on their UK websites, pharmaceutical manufacturers do not flout UK legislation. Our respondent accepted that UK consumers could access fuller information from websites originating overseas, over which the MHRA has no legal control. This, she argued, was acceptable, as it represented a "pull" rather than a "push" in relation to accessing drug information, a distinction also made by a respondent from the Royal Pharmaceutical Society.
, http://www.100md.com
The pharmaceutical industry self regulates its advertising, with companies informing on competitors who infringe the code of practice. Recent guidelines from the European Federation of Pharmaceutical Industries and Associations restricted online information for patients to technical data but permitted sites to provide further information for health professionals.15 Some transnational companies erect "Chinese walls," asking Europeans not to visit the pages on their websites that are aimed at US consumers and contain more overt marketing. Our data suggest that although companies do not wish to "rock the boat" by overtly advertising to consumers on their websites, a groundswell of opinion supports liberalisation. Respondents from the industry were hopeful that the ban on advertising would be lifted in the longer term, arguing that technical data could not adequately inform patients. We learnt of collaboration between the pharmaceutical industry and patient support groups, using non-industry websites to provide more comprehensive information to patients about drugs. A respondent from a patient group told us how pharmaceutical companies sponsored her group's website: detailed information about prescription only medicines on these non-commercial sites does not transgress rules on direct to consumer advertising.
, 百拇医药
Flexibility in the face of challenge
Our study indicates that global information and communication technology threatens existing pharmaceutical regulation. However, processes of governance are fluid and responsive, as shown in the two aspects of pharmaceutical consumption we reported here. In relation to the emergence of a global market in pharmaceuticals enabled by the internet, UK governance agencies have been conservative, underplaying the challenge while adapting existing regulations to address the emergent practices. A respondent from the NHS Modernisation Board argued that because internet access was low among the older age groups, who consume most prescription only drugs, use of overseas e-pharmacies was not an important problem in the United Kingdom. Meanwhile, the MHRA recognised the "online consultation" as a legitimate interaction between patient and doctor, thus enabling UK internet pharmacies to supply prescription only drugs to consumers.
, 百拇医药
Similarly, pharmacy stakeholders have subtly adapted their guidelines to permit the operation of UK internet pharmacies, protecting their members against competition from overseas outlets. The industry supports continued regulation as a way to prevent piracy of their copyright on pharmaceutical products. The broad outline of governance remains intact, leaving consumers free to purchase from overseas outlets, accepting that regulation across national borders is hard to police.
, 百拇医药
Sustaining existing bans on direct to consumer advertising in the face of the globalisation of communication may be less straightforward, with stakeholders taking more extreme positions. Respondents from industry, the pharmacy profession, and some consumer interests all doubted the viability of current strict controls on consumer-oriented information as the internet extends its global reach. On the other hand, both Which (the consumers association, a self proclaimed protector of patients against commercial exploitation) and medical professionals voice anxiety over relaxing these regulations, as this could create a market for prescription only medicines and allow pressure by patients for particular drugs.
, 百拇医药
Summary points
Governance of technologies such as pharmaceutical medications is achieved by legislation and by consent among different interests
Globalisation challenges systems of governance as markets and consumption cross national frontiers
The rise of e-pharmacy in the United Kingdom has been achieved without adapting legislation and has sustained existing systems of governance
, 百拇医药
The internet challenges European Union bans on direct to consumer advertising
Alliances between the pharmaceutical industry and consumer groups may affect future regulation
At present, regulators strongly support the status quo on direct to consumer advertising, but as a consequence of new information and communication technology they may have to readjust the balance of arguments concerning safety, consumer protection, and the public good; professional claims to authoritative knowledge; commercial interests; and citizens' rights to information and autonomy. The differing positions of governments around the world on this issue may exacerbate the tensions in this aspect of pharmaceutical governance.
, 百拇医药
The adaptability of UK regulations in relation to an emergent e-pharmacy may reflect in part the ultimate power of consumers to choose whether or not to purchase drugs online: where there is demand a market will emerge, and consumers may accept a degree of regulation to protect their rights. When it comes to accessing pharmaceutical information, both sides of the provider-consumer partnership are involved. Different stakeholders have interests in ensuring dependable information is available to consumers. The future shape of governance of pharmaceutical information may depend more on alliances between the pharmaceutical industry and patient groups than on consumer sovereignty.16
, 百拇医药
Contributors and sources: NF led the research leading to this article and is lead author and guarantor. KW was the research officer on the study and contributed to the writing of this article.
Funding: Economic and Social Research Council (Grant L218252057).
Conflict of interest: None declared.
References
Rosenau JN. Along the domestic-foreign frontier. Cambridge: Cambridge University Press, 1997.
, 百拇医药
Jones M, Salter B. The governance of human genetics: policy discourse and constructions of public trust. New Genet Soc. 2003;22: 21-41.
Kerr A. Governing genetics: reifying choice and progress. New Genet Soc 2003;22: 111-26.
Smart A. Reporting the dawn of the post-genomic age: Who wants to live for ever Sociology Health Illness 2003;25: 408-28.
Bynoe R. M'Learned Web: drugs on the net—viagra. ZDNet 6 April 1999. http://news.zdnet.co.uk/story/0,t269-s2071446,00.html (accessed 16 Jun 2005).
, http://www.100md.com
Rosenau JN, Johnson D. Information technologies and turbulence in world politics. In: Allison JE, ed. Technology, development and democracy. Albany: State University of New York Press, 2002.
Lenk K. The challenges of cyberspatial forms of human interaction to territorial governance and policing. In: Loader BD, ed. The governance of cyberspace. London: Routledge, 1997: 126-35.
Fox NJ, Ward KJ, O'Rourke AJ. The birth of the e-clinic. Continuity or transformation in the governance of pharmaceutical consumption Soc Sci Med (in press).
, 百拇医药
Fox NJ, Ward KJ, O'Rourke AJ. A sociology of technology governance for the information age: the case of pharmaceutical consumption. Sociology (in press).
Royal Pharmaceutical Society of Great Britain. Code of ethics and standards. London: RPSGB, 2003, updated 6 April 2005. www.rpsgb.org/pdfs/coe050406.pdf (accessed 16 Jun 2005).
Childs M, Ellison L, Prayle D. Drugs and the internet. New Law Journal 1998;148(6868): 1840.
, 百拇医药
Shaw J, Baker M. Expert patient: dream or nightmare BMJ 2004;328: 723-4.
Pines WL. Direct-to-consumer advertising. Ann Pharmacother 2000;34: 1341-4.
Medicines Control Agency. Advertising and promotion of medicines in the UK. London: Stationery Office, 1999.
European Federation of Pharmaceutical Industries and Associations. Guidelines for internet web sites available to health professionals, patients and the public in the EU. 2001. www.efpia.org/6_publ/Internetguidelines.pdf (accessed 16 Jun 2005).
Queau P. Global governance and knowledge societies. Development 2002;45(4): 10., 百拇医药(Nick Fox, Katie Ward)