• Intended Use Add reagents directly to the bottom of the tube while avoiding contact between the reagents and the pipet tip . This will For the ultra-sensitive detection and quantitation of 17β-help assure consistent quantities of reagent in the test mixture. Estradiol in water (groundwater, surface water, well water). For Polystyrene tubes (33) are packaged in a bag. other appli
Eis.mdx.ac.ukGeneral Editor: Domenic A. Crolla, Gowling Lafleur Henderson LLP, Ottawa
• INTERNET PHARMACIES: GLOBAL THREAT REQUIRES
GLOBAL APPROACH TO REGULATION •
tion of Internet Pharmacies in the United Kingdom (“UK”) and the United States (“US”), to illustrate This paper investigates the growing phenomenon some of the challenges related to differences. Some of selling drugs and medical services over the Inter- of these comparisons relate to regulatory structure, net via Internet Pharmacies. It discusses some of the advertising of prescription drugs, online prescribing, benefits of Internet Pharmacies and some serious data protection, policy on importing drugs for per- concerns that they bring for regulators, governments sonal use and self-regulation/certification of web- and global consumers. In addition, the paper com- sites. In assessing reasons for differences in the two pares regulatory frameworks governing the opera- jurisdictions, the paper concludes that these are due to various historic, economic, geographic and politi-cal factors. The paper argues that continuing regula- • In This Issue •
tory challenges arise due to the nature of the Inter- net, jurisdiction issues, economic realities, and a lack of harmonisation of regulatory policy at an interna- tional/global level. The paper further argues that a global approach is needed to regulate online medical services, because of the potential threat to the health STIMULATING THE ECONOMY BY INVESTING IN HEALTH INFORMATION TECHNOLOGY: AN The widespread use of the Internet for commer- cial activities (electronic commerce) has resulted in the global access to drugs and medical services at the click of a button. The borderless nature of the Internet, however, creates difficulty in regulating electronic commerce within a physical jurisdiction, especially when websites originate outside that ju- risdiction. In the absence of appropriate harmonised laws, treaties and cooperative agreements between nation states, online sellers can evade regulation in TELEHEALTH LAW
certain jurisdictions by engaging in regulatory arbi- trage (i.e. operating websites in a jurisdiction which Telehealth Law is published quarterly by LexisNexis
has the least restrictive regulatory framework). In Canada Inc., 123 Commerce Valley Drive East, Markham, Ontario L3T 7W8 many instances those evading regulation do so in order to engage in illegal activities. There is need for Design and Compilation LexisNexis Canada Inc.,
a concerted global approach to address such (illegal) 2009. Unless otherwise stated, copyright in individual
activities relating to electronic commerce, especially articles rests with the contributors.
where health and medical issues are concerned. The All rights reserved. No part of this publication may be seriousness of this issue is encapsulated in a 2005 reproduced or stored in any material form (including speech to the 108th Congress given by US Senator photocopying or storing it in any medium by electronic means and whether or not transiently or incidentally to some other use of this publication) without the written Rogue internet pharmacies continue to pose a seri- permission of the copyright holder except in accordance with the provisions of the Copyright Act. ous threat to the health and safety of Americans … Simply put, a few unethical physicians and pharma- ISBN: 0-433-43038-9
cists have become drug suppliers to a nation. They ISBN: 0-433-44400-2 (Print & PDF)
provide pharmaceuticals — including powerful nar- ISBN: 0-433-44711-7 (PDF)
cotics and anti-depressants — to patients without an Subscription rates: $185 plus GST per year (print or PDF) in-person examination, based solely on an online $240 plus GST per year (print & PDF) questionnaire. The longer we wait to take action, Please address all editorial inquiries to: the more people will be killed orusly injured as a result of this unethical behaviour. Unfortunately, the problem of ‘rogue’ pharma- Tel. (905) 479-2665; Toll-Free Tel. 1-800-668-6481 cies (and the illegal online selling of drugs) is not Fax (905) 479-2826 Toll-Free Fax 1-800-461-3275 confined to a ‘few unethical physicians and phar- Internet e-mail: firstname.lastname@example.org. macists’, but exists on a wider scale. Examples in- EDITORIAL BOARD
clude: In the UK, the National Audit Office (2003) reported that one per cent (1%) of the public sur- veyed had bought prescription medicines on the Domenic A. Crolla, Gowling Lafleur Henderson LLP,
Internet (without a prescription) for various condi- tions such as obesity, prostate cancer, hair loss, or erectile dysfunction , In 2004, according to Pfizer (the world’s largest pharmaceutical company and Professor Martha Bailey, Queen’s University,
Kingston Dr. Patrick Ceresia, Canadian Medical
makers of the drug Viagra) approximately 350,000 Protective Association, Ottawa Dr. Robert Filler,
websites sold fake Viagra or directed users to a site Hospital for Sick Children, Toronto Patricia A.
that sold fake Viagra , In 2005 the US Drug En- MacLean, Canadian Nurses Protective Society, Ottawa
forcement Administration (“DEA”) launched opera- Joseph P. McMenamin, McGuireWoods LLP,
tion Cyber X which led to the shutdown of more Richmond, Virginia Gilbert Sharpe, Fasken Marti-
This paper focuses on the selling of drugs and Note: This newsletter solicits manuscripts for
medical services via Internet Pharmacies. It first consideration by the General Editor, who reserves the gives a brief introduction to Internet Pharmacies, right to reject any manuscript or to publish it in revised form. The articles included in Telehealth Law reflect the then discusses some benefits and concerns regarding views of the individual authors. This newsletter is not the operation of Internet Pharmacies. It then gives a intended to provide legal or other professional advice comparison of some aspects of the regulatory and readers should not act on the information contained in this report without seeking specific independent frameworks of two major jurisdictions, with a view advice on the particular matters with which they are to discussing the challenges that some differences bring. The paper attempts to give reasons for some of the differences seen, and argues that a global ap- proach is needed to regulate Internet Pharmacies (especially those engaged in illegal activities), be- cause of the potential threat to the health of the check and verify the advice and treatment Privacy and anonymity. Consumers buy- Various drugs and medical services can be ac- cessed online, via businesses known as ‘Internet Pharmacies’ , also called ‘cyberpharmacies’, may otherwise be embarrassed to ask in a ‘ePharmacies’, and ‘online pharmacies’ among other names. An Internet Pharmacy is used to sell a variety Generally cheaper costs. Some studies have of products including beauty products, over-the- found that US residents import drugs into counter drugs (which do not require a prescription) and prescription drugs (which require a prescription issued by a licensed health professional) . Some Availability of alternative treatments. The li- Internet Pharmacies also provide a variety of online censing of drugs can be a very slow process services (e.g. advice on medications). In the US, (due to testing requirements) but the Internet Internet Pharmacies have been in existence since January 1999 (with the opening of Soma.com) , fol- licensed drugs that patients with terminal lowing a long history (from 1872) of selling drugs illness (e.g. Cancer, AIDS) may be willing via mail-order . In the UK, Internet Pharmacies be- to use on an experimental basis. This how- gan operations a few months later (November 1999) ever, may not always be a benefit since there are many fraudulent treatments and drugs While many Internet pharmacies operate within the law, some ‘rogue’ pharmacies, are involved in various illegal acts such as selling prescription drugs without a valid prescription, selling fake or poor quality drugs, and providing online medical consul- Online prescriptions without prior physi- tations for prescribing and dispensing drugs. These cal examination by a doctor. Some Inter- ‘rogue’ Internet Pharmacies present a great danger to the public due to the potential harm which can be (questionnaires) to issue prescriptions to dispense drugs. There are many risks as-sociated with this practice such as: the potential for misdiagnosis or drug interac- There are many benefits as well as concerns related to the operation and use of Internet Pharmacies. false information; the possible absence of Ease, convenience and increased choice. a legitimate (or licensed) consulting phy- Online services allow 24-7 access and easy comparison of products. This is especially naire; loss of confidentiality; and diffi- relevant to consumers who live in sparsely culty in establishing duty of care (liabil- populated areas where there are no pharma- ity) as arises in a traditional doctor– ceutical services and disabled people who have difficulty in travelling to a Pharmacy, Dispensing prescription drugs without a prescription. Some of the risks with this Increased consumer information and in- formation exchange. Through online taining unsuitable drugs; and gaining ad- searches, consumers can investigate issues such as the effectiveness of different drugs, Purity and quality of drugs. Some online side/adverse effects of medications, and drugs can be either: past their expiry date; new/alternative treatments among others; above, as well as the possibility of non- nated in storage or during shipping. It is also difficult to ascertain the origin of Drug resistance. An important concern is some antibiotics (drugs used to fight in- fection caused by bacteria) via Internet cies were manufactured in other countries Pharmacies. Indiscriminate use of antibi- such as China, Pakistan, Thailand, India, otics can lead to bacteria developing re- sistance/immunity to such drugs resulting drugs is an important issue, since drugs of (sometimes called ‘superbugs’). For ex- may be ineffective for treatment leading ample, in the UK hospital deaths related to the worsening of a medical condition. Foreign labels and different drug names. tance to commonly used antibiotics) have different labelling requirements and dos- per cent in a decade . In February 2005, Differences in drug classification. The lished in February 2006 stated that in the to 1,168, an increase of 22 per cent on the The concerns above make a compelling case for Availability of unapproved or illegal sub- the effective regulation of Internet pharmacies to stances and fraudulent products. Many ensure that consumers are not adversely affected by illegal acts or practices. Since Internet Pharmacies are accessible to global consumers, they can have a global effect, and therefore a global approach to ‘miracle cures’ and fraudulent treat- regulation is needed. This is perhaps even more relevant since currently there are many differences in regulatory frameworks for Internet Pharmacies in Medical and financial privacy concerns. different jurisdictions. The next section will examine two major jurisdictions namely the United Kingdom the US) do not adhere to their assurances (“UK”) and United States (“US”) to illustrate how, although some similarities in regulating Internet pharmacies exists, there are important differences. These differences impact on the operation of Internet sonal, financial or medical information. Pharmacies and the behaviour of consumers in the Direct to consumer advertising of pre- scription drugs. While this practice is il- legal in the UK, it is legal in the US. Such advertising may have the effect of stimu-lating the use of prescription drugs and This section will compare some aspects of the regulation of Internet Pharmacies in the UK and US Risks of buying drugs online. These with a view to discussing some similarities and dif- risks may include all of the issues raised ferences. The aspects of regulation compared are: standards and authorisations; regulatory structure; the main federal agency responsible for the regula- personal importation policy; advertising of drugs; tion of online drug sales. It has jurisdiction over online prescribing of drugs; protection of personal matters regarding interstate commerce, which in- cludes the sale of prescription drugs either between states or through importation from outside the US. With regard to Internet pharmacies, the main body The standards of pharmaceutical and medical of legislation enforced by the FDA is the Federal practice are similar in both UK and US jurisdictions. Food, Drug and Cosmetic Act (“FFDCA”) 1938 (as All drugs are subject to safety and quality regula- amended) . Under the FFDCA, new drugs intro- tions. Pharmacists and medical practitioners are sub- duced or delivered into interstate commerce must ject to regulatory control by government bodies and be FDA-approved (21 USC s. 355) . This means professional organisations. Both jurisdictions require that drug manufacturers must meet various quality a need for prescriptions to be issued by licensed and safety standards, are subjected to inspections, practitioners and dispensed by licensed pharmacists. and must comply with the FDA’s Good Manufac- In both jurisdictions, there are similar authorisa- turing Practice. , Further the shipment and stor- tions for pharmaceutical and medical practice, which age of drugs need to be clearly documented and involve licensing by appropriate government au- subject to inspection. Even if a drug is approved thorities (or their affiliated organizations). In the in the US, a foreign version of the drug is generally UK, pharmacists and pharmacies must be registered not considered FDA-approved because FDA ap- with the Royal Pharmaceutical Society of Great proval is manufacturer-specific, product-specific, Britain (“RPSGB”) , and doctors with the General and requires detailed information about the pro- Medical Council (“GMC”). In the US, all pharma- duct (listed in the Code of Federal Regula- cies and pharmacists are required to be licensed in tions ). Various other provisions of the FFDCA the (US) state where they are resident. Further- directly relate to the sale of drugs over the Internet. more, over 40 states require that out-of-state US The FFDCA prohibits the introduction or delivery pharmacies (or non-resident pharmacies) need to be into interstate commerce of drugs that are: adulter- licensed or registered in their state (i.e. the non- ated or misbranded; unapproved; or counterfeit (21 resident state) if they are shipping prescription drugs USC s. 331 (a), (d), (i)). Pharmacists are prohibited to state residents. All physicians practicing in a US from dispensing prescription drugs without a valid state are required to be licensed by that state. Each prescription issued by a licensed practitioner (21 state has a State Medical Board that is responsible USC s. 353(b)(1)). Also pharmacists are prohibited for regulating physicians according to state medical from dispensing prescription drugs without proper practice laws, investigating complaints, and uphold- ing professional standards among other require- ments. All State Medical Boards belong to a repre-sentative organisation called the Federation of State The regulatory structure impacting on Internet Medical Boards (“FSMB”), which is committed to Pharmacies in the two jurisdictions have some dif- developing and promoting high standards of medical ferences mainly due to different political structures. In the UK, there is a centralised control by a na- In the UK and US, the marketing and selling of tional government that sets policy whereas in the medical products are subject to control through a US, control is shared among federal, state and pro- system of licences. In the UK under s. 58, of the fessional bodies. The UK system is very reliant on Medicines Act 1968 (as amended) (MA), it is il- state licensed self-regulation (e.g. GMC, RPSGB) legal to supply prescription drugs except through a and independent self regulation (e.g. BMA ). The registered pharmacist with a prescription issued by US has many governmental bodies (e.g. federal an appropriate practitioner. Also UK-based phar- agencies — FDA, FTC and State Boards) enforc- macies can only legally sell pharmaceutical prod- ing legislation in addition to self-regulation (e.g. ucts licensed by the Medicines and Healthcare Products Regulatory Agency (“MHRA”) . In the structure creates conflict between individual states US, the Food and Drug Administration (“FDA”) is and the federal government. While individual US states can regulate pharmacies, pharmacists and such foreign drugs on the Internet. The controls in medical practice, state legislators have limited the US are more rigid than in the UK, since US citi- powers to regulate activities which impact on inter- zens cannot import drugs that are already marketed state commerce. The Commerce Clause of the in the US. Citizens in the UK, however, are not re- United States Constitution, gives the federal gov- stricted from importing drugs (for personal use), ernment the power to regulate interstate trade, and except where a drug is on the controlled drugs list. therefore makes any state legislation which affects interstate commerce unconstitutional. This creates difficulty for US States seeking to effectively con-trol some activities related to Internet Pharmacies. The advertising of prescription drugs to the gen- eral public is illegal in the UK under the Medicines (Advertising) Regulations 1994 (as amended). Regulatory provisions regarding the importation However, in the US, the First Amendment to the of drugs for personal use have some differences in US Constitution generally protects the advertising the two jurisdictions and hence different implica- of prescription drugs (directly to the public) as a tions. The UK allows individuals to import medici- form of commercial speech. The legality of any nal products (except controlled drugs) for personal advertising regulation is subject to the Central or family use (MA, s. 13) without needing authorisa- Hudson Test , and it has been difficult for the Fed- tion or a licence. Controlled drugs are listed in the eral Government to regulate the advertising of pre- Misuse of Drugs Act 1971 (as amended) and include scription drugs to the same extent that it has regu- some prescription drugs. However, not all prescrip- lated the distribution of prescription drugs. In an tion drugs are on the controlled drugs list. In the US, effort to tighten advertising requirements in Janu- however the FDA only allows personal importation ary 2004, the FDA released new draft guideline under very strict conditions. Under the FDA’s ‘per- proposals for direct-to-consumer drug advertising sonal importation’ policy, a patient or his doctor is which encourages greater disclosing of risk infor- allowed to import a small amount of an unapproved drug into the US, from another country, under cer- With regard to advertising, Internet Pharmacies tain conditions. The conditions are that: located outside of the UK (such as in the US) can circumvent UK law by advertising prescription the patient must have a serious condition drugs to UK residents. This difference in regulation can exacerbate the problems which UK regulatory authorities face when trying to control access to the drug must not present an unreasonable the patient seeking to import the product In both jurisdictions, regulators have issued guidelines to address the practice of issuing prescrip- tions online. This practice is not seen as consistent with good medical care and is not encouraged in ei- the patient must give the name and ad- ther jurisdiction. There are however, subtle differ- ences in the scope of regulation of this practice for The UK has taken a more relaxed attitude to this is used to continue a treatment started in a issue (compared to the US), although there has been one case of suspension of a doctor for conduct re- lated to prescribing online (after the first publication The ‘personal importation’ policy does not cover of this article in 2006, the GMC suspended another foreign versions of FDA-approved drugs, therefore doctor Dr Julian Eden in 2007, for prescribing drugs under the FFDCA it is illegal for US residents to buy over the Internet) . In the UK, medical guidance given by the GMC does not expressly prohibit re- with the patient’s doctor), a policy which is different mote (online, email, telephone, video link) prescrib- from the UK position. In addition to the above, in ing but instead gives doctors guidelines according to February 2005, the “The Ryan Haight Act” was in- particular circumstances. Specific guidelines are troduced in the US Congress to address ‘rogue given where the doctor: has responsibility for the pharmacies’ and to prevent Americans from obtain- patient; is deputising for the patient’s doctor; or has ing drugs without a prescription (or with a prescrip- prior knowledge and understanding of the patient’s tion based solely on an online questionnaire). condition(s)/medical history, and is authorised to In addition, where a doctor is not providing con- Internet Pharmacies based in the US are less tinuing care to a patient, or does not have a patient’s likely to offer privacy protection requirements medical records, or is not deputising for the patient’s compared to those based in the UK. In the UK the doctor, the following guidelines are given: Data Protection Act 1998 , stipulates legal re- quirements to ensure that personal data collected on Give an explanation to the patient of the consumers are safeguarded from abuse and remain processes involved in remote consultations confidential. It plays a role in regulating Internet pharmacies, in terms of stipulating controls for the processing, storage and transfer of personal data Establish a dialogue with the patient, using collected during online transactions. In the US, the a questionnaire, to ensure that you have culture of privacy and data protection legislation sufficient information about the patient to are not as strong. The US takes a sector based ap- Make appropriate arrangements to follow proach to privacy which consists of mixed legisla- Monitor the effectiveness of the treatment Inform the patient’s general practitioner or In both the UK and US, some degree of self- regulation/certification exists, however, the extent to prescribing medicines] if the patient objects which this is done remains questionable. In the UK, to the general practitioner being informed. medical websites can apply for HONcode accredita- tion to display the HONcode seal , which signifies a UK doctors are advised not to prescribe via re- pledge to respect and honour the eight principles of mote means if the conditions set out in the GMC the Health on the Net Foundation Code of Conduct . Legitimate Internet Pharmacies in the UK must regis- In the US, various regulatory bodies have issued ter their premises with the Royal Pharmaceutical So- guidelines for prescribing via the Internet. These ciety of Great Britain (“RPSGB”), and are listed on include the FSMB (“Federal State Medical Boards”) guidelines of 2002 and the American Medical As- the RPSGB online register . The US regulatory sociation (“AMA”) guidelines of 2003 .The US model provides a means for Internet pharmacies to guidelines and regulatory approach go further than self-certify themselves, for example, via the Verified in the UK. In the US, the guidelines insist that a pre- Internet Pharmacy Practice Sites (“VIPPS”) pro- scriber/practitioner must have a qualifying medical gram . The VIPPS program confers the VIPPS- relationship with the patient at the time of issuing a certification on Internet pharmacies that comply with prescription (The AMA guidelines makes an excep- licensing and inspection obligations in its resident tion where a doctor is in consultation with the pa- state and in all states where it dispenses medication. tient’s doctor). Such a relationship entails conduct- An internet pharmacy displaying a VIPPS seal pub- ing a face-to-face physical examination of the pa- licly indicates that it adheres to certain VIPPS criteria tient and having knowledge of the patient’s medical including: respect for privacy rights, verification and history. This implies that in the US a doctor is only security of prescriptions, meeting recognised quality legally entitled to prescribe online, if he has already assurance and providing meaningful consultation be- carried out a physical examination of the patient and tween patients and pharmacists. This enables con- knows the patient’s medical history (or is consulting sumers to have confidence that the pharmacy is bona fide, and that it adheres to certain standards and crite- size of the UK with less inaccessible regions com- ria. At the date of writing only 12 Internet Pharmacies pared to the US have meant a smaller market de- are listed on the VIPPS online database. mand for distance selling of medicines in the UK. The effect of this may be that regulators in the UK perhaps until lately have not been very focused on The different frameworks in the two jurisdictions the potential problems that Internet pharmacies stem from historic, geographic, economic, and po- may pose, especially those not located within the From a historic perspective, Internet pharmacies From an economic perspective, the provision of are essentially an extension of mail-order pharma- medical services in the UK is completely different cies. Unlike the UK, the US has a long history of from the US. The UK has a single dominant state mail-order pharmacies. In fact the UK pharmaceu- run National Health Service (“NHS”) largely funded tical profession is reported to have resisted mail- by taxation. Medical services (and doctors) are free order pharmacies for the past 150 years. This is and the NHS generally provides free or subsidised because typical UK community pharmacies earn medicines depending on the circumstances of the most of their revenue from dispensing medicines patient. In the US, there is no single healthcare sys- and mail-order pharmacies would have essentially tem, but rather a pluralist system, driven by the state processed large numbers of prescriptions from a and also by markets. Medical services are funded central site, undermining the community pharmacy privately or by private insurance, federal Medicare network. In the US, before the advent of the or state Medicaid. Most doctors are self employed Internet, many laws were in place to regulate mail- and the cost of consulting a doctor is generally order pharmacies. Such laws were useful in focus- high. Unregulated drug prices and strong patent ing US legislative thinking on the relevant issues laws have resulted in high drug costs (compared to related to the distance selling of drugs. This is not its neighbour Canada where regulated prices and the case in the UK as seen by the way in which UK weaker patent laws have meant comparatively lower authorities have viewed Internet Pharmacies in the costs ). The economic imperative to seek cheaper past. In 2000, the Department of Health (“DoH”) sources of drugs has therefore increased the popular- did not appear to think that there was a problem in ity of Internet Pharmacies. This popularity may have the UK, when called upon to crack down on illegal contributed to the US regulatory authorities being Internet prescriptions. The DoH responded that more acutely aware of potential regulatory issues the UK did not have a history of mail-order drug and hence shaping their regulatory policies accord- sales like the US, and that UK online pharmacies ingly. This may perhaps further explain two of the were required to have a prescription to dispense differences raised previously: (i) The direct-to- drugs. This response was criticised by the BMA consumer advertising of prescription drugs in the US as being a naive view and a failure to grasp the may have the beneficial effect of informing patients fundamental issue, that Internet pharmacies tran- about drugs and empowering them to seek cheaper medications either from their doctors or dispensing Geographic differences between the two juris- pharmacies; (ii) the tighter controls on Internet pre- dictions may account for the rate of growth of scribing in the US may be due to the high demand Internet Pharmacies within the respective jurisdic- for such online services because of the high costs of tions, and hence the perception of the problems that they may pose. In the UK, most people live Different political cultures in the UK and US may within a short distance of a pharmacy. A 2003 account for regulatory differences. In the US the in- OFT report concluded that seventy-nine percent fluence of interest groups and reactions to various (79%) of people in the UK live within one kilome- national medical disasters such as: Sulfanilamide tre of a pharmacy and forty-seven percent (47%) (1937), Thalidomide (1961) and AIDS (1980s), have have a pharmacy within 500 metres. In the US, significantly shaped US regulatory policy. Political remoteness has been cited as a major reason for pressure for change to address these disasters (espe- consumers using Internet pharmacies. This cially from interest groups) led to government action therefore suggests that the comparatively smaller in passing legislation and instituting strong regula- tory controls. For example, the strict legal rules pro- lenge to regulators. Owners of such websites will hibiting the importation (into the US) of drugs that continue to engage in regulatory arbitrage and are not FDA-approved may be explained by the hence evade enforcement actions in countries like presence of a more protectionist political culture, the UK and US that have high regulatory standards. resulting from a fear of unsafe medicines entering The need for a global approach to address drug the US, bearing in mind previous medical disasters. sales on the Internet (especially Internet Pharmacies In the UK, however, change has been instituted by a engaging in illegal activity) is indeed compelling in more consensus-based political culture which is light of the preceding discussions. The use of a driven by scientific and medical experts. global approach to address matters which are of global significance has been successfully imple- mented in the past. For example UNCITRAL has a The preceding sections highlight the many prob- mandate from the United Nations to progressively lems that may arise with Internet Pharmacies and by harmonise and unify the law of international trade extension bring regulatory challenges to authorities. (hence reducing or removing obstacles to the flow of These challenges are compounded by the nature of trade due to disparities in national laws). the Internet itself and the existence of different regu- UNCITRAL Model Law on areas such as ‘electronic latory structures in various jurisdictions, as demon- signatures’, ‘electronic commerce’, and ‘interna- strated by the examples of the UK and US. These tional credit transfers’ have resulted in the harmoni- differences imply a lack of a global approach to sation of laws (affecting international trade) across tackle various illegal acts carried out by some Inter- nation states. It must be noted that the regulation of net Pharmacies. Enforcement of regulatory rules is Internet Pharmacies is more complex (than the latter mainly possible within a legal jurisdiction. Busi- examples) and some may argue that it is difficult or nesses that operate outside the scope of that legal undesirable to regulate Internet-based entities (that jurisdiction present difficult problems for regulators. transcend national boundaries). Nonetheless, nation The nature of the Internet means that residents of states can begin to harmonise their laws, have coop- one state/country are exposed to global online com- erative agreements, and develop new institu- merce, except where country-specific filtering soft- tions/organisations to collectively address the con- ware is used to block certain sites (from outside the cerns that Internet Pharmacies bring. Technological jurisdiction). Internet filtering is not in widespread solutions (where possible) and public education pro- use for commercial Internet activity in Western grams can also be implemented at national levels. countries (such as the UK and US) as seen in other A global approach can include a UN-lead programme (possibly by the World Health Organisation–WHO) to jurisdictions like China and Singapore. It is also develop international agreements, and help harmonise unlikely that the democratic ethos of the UK and US national legislation to result in common policies (that will tolerate the censoring of commercial activity on reflect international standards) on areas such as: online medical consultations (without a physical examination It is difficult or impossible for regulatory bodies by a doctor); online prescribing; the advertising of pre- to control advertising of prescription drugs from scription drugs to the public; the certification of medical Internet sites beyond their legal jurisdiction. This is websites; the naming of drugs and dosage instructions; especially true for the UK where national rules pro- the classification of drugs, especially prescription drugs; hibit the advertising of prescription drugs to the pub- and the hosting (by Internet Service Providers) of phar- lic unlike in the US. It is highly unlikely, however macies (and other websites) involved in illegal activities. that the advertising of prescription drugs will ever be made illegal in the US, due to fact that it is constitu- tionally protected. This therefore will continue to Although the Internet continues to bring many create a challenge for regulators in jurisdictions benefits to the global community, the widespread where the advertising of prescription drugs (to the availability of drugs and medical services via the Internet (especially through illegal activity) has the Tracing web site servers which may be mobile or potential to result in problems of a global nature. located in certain countries presents a major chal- Examples of such problems include: widespread drug addiction which may have consequences for the wider society; harm (or death) from drugs that may <http://www.usdoj.gov/dea/pubs/pressrel/pr121905.html>. be contaminated, counterfeit, sub-potent or above 5 S. Crawford, Internet Pharmacy: Issues of Access, potency; the development of new strains of bacteria Quality, Costs and Regulation. Journal of Medical (and hence new diseases) due to indiscriminate use of antibiotics; and increased criminal activity related Note that drugs in the UK are placed into three cate- to illegal medical practice and the supply of drugs; gories under the Medicines Act 1968 (as amended) These potential problems are further compounded by namely: (i) Prescription-only (s. 58) — which can only be sold with a valid prescription; (ii) Pharmacy the inability of nation states to effectively control only (s. 60) — which can must be sold in consulta- websites not located within their physical jurisdic- tion with a pharmacists; and (iii) General Sales List tion. There is a pressing need for nation states to de- (s. 5) — which do not require any prescription or velop a global approach/strategy to collectively ad- consultation before sale. In the US only two catego- dress the issue of online drugs and medical services. ries exists namely: prescription drugs and over-the- This global approach/strategy should entail coopera- counter drugs (not requiring a prescription). In this tive agreements (e.g. for enforcement), and the har- paper drugs requiring a prescription are simply called monisation of national policy and legislation, to re- flect internationally agreed standards. Failure to ad- S. Crawford, Internet Pharmacy: Issues of Access, Quality, Costs and Regulation. Journal of Medical dress this problem may result in serious conse- quences (in the future) for the health and well-being 8 As early as 1872, Americans began purchasing goods via mail order, after the world’s first general mer- chandise mail-order company was started in the US [Editors’ note: This article is a reprint of a piece originally published in the Hertfordshire Law <http://www.graveyards.com/rosehill/ward.html>. 9 Britain’s first Internet pharmacy opens. The Phar- Dr Carlisle George is a lawyer and computer scien- maceutical Journal, Vol. 263, No. 7073, p. 849, tist. He holds a Masters degree (LLM) in Information Technology & Communications Law from the London 10 C.E. George, Online healthcare — Internet School of Economics, and a Doctorate (PhD) in Com- Pharmacies may not be good for your health. IFIP puter Science from the University of London (Gold- WG 9.2 Conference on Landscapes of ICT and Social smiths). He has been called to the Bar of England and Accountability, June 27-29, 2005, University of Wales at Lincoln’s Inn (London) and the Bar of the Eastern Caribbean Supreme Court. He is a Senior Lec- Consumer advice: buying drugs online. Harv Health turer at Middlesex University and currently leads the ALERT (Aspects of Law and Ethics Related to Tech- J. Henney, Cyberpharmacies and the role of the US nology) research group. He is also a visiting lec- Food and Drug Administration. J Med Internet Res. turer/'Guest Teacher' in the Department of Law at the London School of Economics. Dr George is the author A study reported in the British Medical Journal, of many academic publications in information technol- March 6, 2004 (p. 564) concluded that some cancer ogy law and a member of several professional bodies.] patients were able to use the Internet verify their treatment and advice, which helped them to better <http://www.senate.gov/~feinstein/05releases/r- C. Fung, H. Woo and S. Asch, Controversies and legal Issues of Prescribing and Dispensing Medicines Using The NAO study surveyed 2000 members of the pub- the Internet. Mayo Clinic proc. 2004; 79: 188-194. lic aged 15 years or over. See: NAO Report. Safety, quality, efficacy: regulating medicines in the UK, M. Korcok, Internet Pharmacy: the tug-of-war inten- <http://www.nao.org.uk/system_pages/search.aspx?& J. Henny, Online Pharmacies — Maintaining the Safety Net. Medscape Pharmacists 1(1), 2000. J. Libbenga, Rogue Pharmacies still thriving, The S. Kahan, A. Seftel and M. Resnick, Sildenafil and the Internet. The Journal of Urology. Vol. 163, 919- <http://www.theregister.co.uk/2004/12/21/rogue_phar In 2001, a young UK (London) male drug abuser committed suicide after suffering from addiction to drugs bought online. At one point he was receiving 30 T. Bessell et al, Quality of global e-pharmacies: can 300 anti-depressant tablets in the post every day at we safeguard consumers? Eur J Clin Pharmacol his East London home and had tried 23 types of pre- scription drugs. See: A. Barnett, Deadly cost of the 31 Methicillin-resistant Staphylococcus aureus. See: trade in online prescription drugs. The Observer Sun- <http://www.netdoctor.co.uk/diseases/facts/mrsa.htm>. 32 Superbug MRSA deaths up 1400% in a decade <http://observer.guardian.co.uk/drugs/story/0,11908,1 <http://www.medicalnewstoday.com/medicalnews.ph In 2003, the FDA estimated that ten per cent of the global medicines market was counterfeit and that over US$32 <http://news.bbc.co.uk/1/hi/health/2572841.stm>. billion was being earned annually from the sale of coun- Deaths Linked To MRSA Rose Significantly In Eng- <http://www.who.int/mediacentre/factsheets/2003 <http://www.medicalnewstoday.com/healthnews.php Giuliani Partners LLC, Examination and Assess- ment of Prescription Drug Importation from For- The RPSGB, is a regulatory and professional body eign Sources to the United States. Interim Findings, founded in 1841, consisting of pharmacists in Eng- land, Scotland and Wales. It receives its authority <http://www.heartland.org/policybot/results/17220/Examinat from the Pharmacy Act 1954 and the Medicines Act ion_and_Assessment_of_Prescription_Drug_Importation_fr om_Foreign_Sources_to_the_United_States.html>. The GMC (<http://www.gmc-uk.org/>) was established by the Medical Act 1983 (as amended). For example an ulcer medication named Prilosec in US General Accounting Office. Internet pharmacies — Adding Disclosure Requirements Would Aid State The US and Canada have slightly different dosage in- and Federal Oversight, Washington, DC: October structions for the anticonvulsant drug called Dilantin. Drug Classification: Prescription and OTC drugs, <http://www.paho.org/english/ad/ths/ev/CM- Medicines Act 1968 has been amended 24 Narcotic drugs are those which produce numbness or stu- many times due to new policies and EU directives. por. They are often taken for pleasure or to reduce pain, and This means a doctor, dentist or other person author- prolonged use can lead to addiction (e.g. Cocaine). ised to prescribe such as a nurse prescriber. Psychotropic drugs affect the mind or mood or other mental processes e.g. Diazepam (Valium) — a seda- 43 <http://www.access.gpo.gov/uscode/title21/ tive and muscle relaxant; Alprazolam (Xanax) — an anti-anxiety agent. These drugs are controlled under FFDCA is otherwise known as Title 21 of the The United Nations Convention on Psychotropic Designer drugs are derived from making minor altera- detailed in the Quality System Regulation (passed tions to approved drugs in an effort to circumvent legal into law by the FFDCA s. 520) and contained in Title restrictions. They are intended for recreational use to give 21, Part 820 of the Code of Federal Regulations hallucinogenic experiences. (e.g. KAT, Special K, Cloud (“CFR”). <http://www.access.gpo.gov/cgi- 9, Sextasy — Viagra combined with Ecstasy). 27 Examples of claims: A cure for arthritis with a fatty 46 National Association of Boards of Pharmacy, Position acid derived from beef tallow, and a treatment for Paper on the Importation of Foreign Prescription cancer and AIDS with a Peruvian plant derivative. See: Buying Drugs Online: It’s convenient and pri- <http://www.nabp.net/ftpfiles/NABP01/foreigndrug.pdf>. vate, but beware of ‘rogue sites’, FDA Consumer <http://www.fda.gov/fdac/features/2000/100_online.html>. Letter from William K. Hubbard, Associate Commis- sioner for Policy and Planning, FDA to Robert P. Online Pharmacies Settle FTC Charges, FTC Report, <http://www.fda.gov/ora/import/kullman.htm>. <http://www.ftc.gov/opa/2000/07/iog.htm>. <http://www.access.gpo.gov/nara/cfr/waisidx_99/21c 63 Note that some US prescription drugs may be classed as controlled drugs in the UK and therefore UK indi- 50 A label is required to contain the name and address of viduals are prohibited from importing them for per- the dispenser, the serial number and date of the pre- scription or of its filling, the name of the prescriber, 64 BBC (2007), Internet drug GP suspended by GMC and, if stated in the prescription, the name of the pa- tient, and the directions for use and cautionary state- <http://news.bbc.co.uk/1/hi/health/6380135.stm>. ments, if any, contained in such prescription.
65 In January 2002 Dr Richard Franklin was found 51 The British Medical Association (“BMA”), is a vol- guilty of serious professional misconduct by the untary association founded in 1832, consisting of GMC after prescribing drugs online. The GMC found that he did not carry out an adequate assessment of his patients’ conditions, and therefore did not act in 52 The Federal Trade Commission (“FTC”) is a US fed- the best interests of his patients, BBC News, Viagra eral agency primarily responsible for protecting con- sumers from fraud, deception and unfair business <http://news.bbc.co.uk/1/hi/england/1752670.stm>. 66 Model Guidelines for the Appropriate use of the 53 The National Association of Boards of Pharmacy Internet in Medical Practice. Accessed via the FSMB (“NABP”) is an independent professional associa- tion established in 1994, consisting of member <http://www.fsmb.org/pdf/2002_grpol_Use_of_Inter Boards of Pharmacy of all 50 States and some 54 The American Medical Association (“AMA”), founded in 1847, is the national professional or- 68 <http://www.senate.gov/~feinstein/05releases/r- ganisation for all physicians. It functions as an ad- vocate for both patients and physicians. 69 <http://www.data-protection-act.co.uk/>. US General Accounting Office. Internet pharmacies — Adding Disclosure Requirements Would Aid State and Federal Oversight, Washington, DC: October <http://www.ukcia.org/pollaw/lawlibrary/updatedMo DA1971.html>. Individuals wishing to import con- trolled drugs for personal use may need to get a li- cence. This however may be subject to the amount of 72 The eight principles of the HONcode address: Au- thority, Complementarity, Confidentiality, Attribu- <http://www.britainusa.com/faq/guide_for_clinics.doc>. tion, Justifiability, Transparency of authorship, FDA, Coverage of Personal Importations, Transparency of sponsorship, and Honesty in adver- <http://www.fda.gov/ora/compliance_ref/rpm/default.htm>. <http://www.hon.ch/HONcode/Conduct.html>. 73 Buying Medicines over the Internet: MHRA website: <http://www.legislation.hmso.gov.uk/si/si1994/Uksi_ <http://www.mhra.gov.uk/home/idcplg?IdcService=S 60 L. Walters, Legal Issues Associated With Online program: <http://www.nabp.net/vipps/intro.asp>. <http://www.ainews.com/Archives/Story6548.phtml>. 75 The Implications of e-commerce for community 61 “Central Hudson’s four-part test [to analyse commer- pharmacy, The Pharmaceutical Journal Vol. 265 No. cial speech regulation] asks (1) whether the speech at 7118, page 580, Plenary session, October 14, 2000. issue concerns lawful activity and is not misleading and (2) whether the asserted governmental interest is 77 BBC News, Crackdown on Internet Prescriptions, Sat substantial; and, if so, (3) whether the regulation [in question] directly advances the governmental interest <http://news.bbc.co.uk/1/hi/health/765117.stm>. asserted and (4) whether it [the regulation] is not more extensive than is necessary to serve that inter- est.” See: <http://www.law.cornell.edu/supct/html/98- Consumer advice: buying drugs online, Harv Health A. Daemmrich, Regulatory Laws and Political Cul- ture in the United States and Germany in J. Abraham 82 M. Moran and B. Wood, States, Regulation and the and H. L. Smith (Eds), Regulation of the Pharmaceu- Medical Profession, 1993, Open University Press. M. Froomkin, The Internet As A Source Of Regula- 85 V. Paris and E Docteur (2006), “Pharmaceutical Pric- ing and Reimbursement policies in Canada”, OECD <http://www.law.miami.edu/~froomkin/articles/arbitr.htm>. 90 Health Working Papers, No. 24, OECD Publishing The United Nations Commission on International Trade <http://www.uncitral.org/uncitral/en/about/origin.html>. Patented Medicines Regulations, SOR/94-688 • STIMULATING THE ECONOMY BY INVESTING IN HEALTH INFORMATION
TECHNOLOGY: AN OPPORTUNITY FOR EHR PROGRESS •
Health Insurance Portability and Accountability Act (“HIPAA”). While Canada’s federal government is Historically, public investment in infrastructure not alone able to regulate health-specific privacy projects has been an important component of any matters, there are a number of recent provincial leg- government initiative to stimulate the economy. En- islative initiatives aimed at addressing electronic hancing our national infrastructure has traditionally medical record systems. The advent of the EHR as included building roads, bridges, and other means of an infrastructure project represents a significant op- public transit. On January 28, 2009, the Government of Canada announced an economic stimulus plan that will fund such “shovel-ready” projects, but will also provide significant funding to support our In Canada’s Economic Action Plan, Budget 2009, “knowledge infrastructure”. In particular, the federal the Federal Government claims its investment in government has committed an additional $500 mil- Canada Health Infoway “will not only enhance the lion to Canada Health Infoway , to further the goal safety, quality and efficiency of the health care sys- of having 50 per cent of Canadians with an Elec- tem, but will also result in a significant positive con- tronic Health Record (“EHR”) by 2010. tribution to Canada’s economy, including the crea- In the United States, health information technol- tion of thousands of sustainable, knowledge-based ogy also formed a strategic part of the economic jobs throughout Canada”. The Canadian Medical stimulus package. The America Recovery and Rein- Association has also predicted that investing in vestment Act of 2009 (“ARRA”), signed into law by health information technology “will create jobs”, President Obama on February 17, 2009, includes an “improve patient outcomes, system efficiency and investment of more than $19 billion for health in- accountability, and save billions of dollars annu- formation technology. The investment is intended ally”. According to Canada Health Infoway, among to make it possible to have an EHR for each Ameri- Unlike building train stations and airports, creat- Shorter wait times and fewer repeat tests, ing infrastructure for electronic health information thanks to faster lab and radiology results gives rise to a number of complex privacy issues. In addition to appropriating funding for EHR projects New tools to manage chronic diseases, ena- in the United States, the ARRA proposes noteworthy bling patients and health care providers to changes to the federal health privacy legislation, the Better overall care, because health care pro- fessionals will save time on administration, Creating EHRs that will improve healthcare de- giving them more time to devote to patients. livery will likely require more than just a financial Safer drugs prescribing, enabled because commitment. It is generally recognized that EHRs must be created with the support of healthcare pro- information, making it easier for them to viders and their patients. Beyond the efficacy of EHRs, healthcare providers and patients want reas- surances that patient information will not be com- trol, through access to more information In addition to appropriation of funds, the ARRA introduces substantive changes to the U.S. Health Insurance Portability and Accountability Act of 1996. The ARRA amends HIPAA to expand the The expectations are just as high in the United scope of individuals and organizations required to States, where the ARRA is intended to “take a big comply with HIPAA. The ARRA also imposes new step toward computerizing Americans’ health re- privacy breach notification obligations where per- cords, reducing medical errors, and saving billions in sonal health information is subject to unauthorized, use, access or disclosure. The ARRA also proposes Studies have only recently begun to provide some new prohibitions on the sale of personal health in- reassurance, beyond anecdotal evidence , that some formation and electronic health records, unless the of these claims may be achievable. Two of the latest individual has consented. Further, new penalties studies were published in the Archives of Internal have been introduced where entities have been found Medicine. Virapongse et. al. surveyed a random to have engaged in “willful neglect” of personal sample of 1884 physicians in Massachusetts and health information. These and other changes to concluded it is possible that there may be a connec- HIPAA illustrate an attempt by Congress to address tion between EHR adoption and a reduction in medi- privacy issues associated with electronic health in- cal malpractice claims. The authors stated, how- formation. However, as another author has noted, the ever, that their findings should be considered pre- lack of uniformity in U.S. state requirements may liminary and that confirmatory studies need to be continue to pose difficulties for interstate portability performed. Amarasingham, et. al. conducted a cross- sectional study of urban hospitals in Texas to com- The Government of Canada has not proposed pare a hospital’s level of automation with error rates. changes to the federal Personal Information Protec- They concluded that automating hospital informa- tion and Electronic Documents Act to coincide tion systems may, for certain conditions, reduce hos- with its additional funding for EHRs through Canada pital mortality rates, complications, and costs. Health Infoway. However, funding for Canada However, they also observed that a hospital’s ability Health Infoway is intended to flow to EHR projects to reduce error rates will depend not only on invest- across the country. In many provinces, personal ment in information systems, but whether or not the health information is already regulated by provincial health-specific privacy legislation. A number of As a part of the investment in electronic health provinces, including those with and without existing records, the ARRA (through the Health Information health-specific privacy legislation, have begun to Technology for Economic and Clinical Health Act more carefully consider the importance of a regula- (“HITECH Act”)) requires the creation of the Office tory framework governing health information in of the National Coordinator for Health Information electronic form. A common theme amongst these Technology. The Office is charged with various initiatives is how to protect patient privacy, while at functions including evaluation of the benefits and the same time promoting widespread adoption of costs of the use of EHR. This may facilitate further studies into the correlation between the use of EHRs In May 2008, British Columbia became the first province to pass standalone legislation aimed at the regulation of electronic health records. The E- Committee recommended that s. 73(1)(h) of PHIPA Health (Personal Health Information Access and be amended to allow for the creation of eHealth- Protection of Privacy) Act (“E-Health Act”) pro- related regulations. The need for eHealth-related vides for the establishment of health information regulations has been emphasized in the document, banks and sets out a framework to govern the collec- Ontario’s eHealth Strategy 2009-2012. eHealth On- tion, use, and disclosure of the personal health in- tario is committed to working closely with Ontario’s formation contained in those banks. British Co- Information and Privacy Commissioner and the lumbia’s Minister of Health Services has said that Ministry of Health and Long-Term Care to ensure the E-Health Act will provide British Columbians timely development of regulations required to sup- with “faster, safer [and better] healthcare in a secure electronic environment”. While this is a laudable The Nova Scotia Department of Health recently goal, numerous uncertainties over the language of published a Discussion Paper, Personal Health In- the E-Health Act make it difficult to assess at this formation Legislation for Nova Scotia, which sets time how it will ultimately be interpreted and ap- out the proposed legislative provisions for the pro- plied. For example, the provisions respecting the creation of health information banks are extremely ("PHIA"). It is noted in the Discussion Paper that broad. Most importantly, it is as yet unknown how the development of a provincial electronic health much control patients (and their healthcare provid- record system called “SHARe” (“Secure Health Ac- ers) will have over the patient information that must cess Record”) is well underway and will create an be contributed to a health information bank. EHR for all Nova Scotia residents. The first phase of In November 2008, the Legislative Assembly of the SHARe system is expected to be completed by Alberta introduced Bill 52, the Health Information December 31, 2009. Consequently, the Discussion Amendment Act, 2008. Bill 52 sought to establish a Paper provides that “comprehensive personal health legislative framework for a pan-provincial EHR. It information legislation is a key element in the devel- also provided for the regulation of health informa- opment of the electronic health record”. tion repositories, which may include local systems In October 2008, the Legislative Assembly of or small scale EHRs. However, Alberta’s Informa- New Brunswick sought public comments on a Dis- tion and Privacy Commissioner has expressed con- cussion Paper, Personal Health Information Access cerns that the Bill could permit patient information and Privacy Legislation. The Discussion Paper to be shared without consideration for the patient’s sets out proposed legislation for the regulation of wishes. The Alberta Medical Association has also personal health information including information expressed concerns that Bill 52 does not strike the stored in EHR systems. Provisions are also proposed right balance between protecting patient privacy and with respect to encryption of personal health infor- promoting EHRs. The Bill was referred to the Standing Committee on Health for further considera- In addition to these legislative developments, tion, but died on the Order Paper following proroga- many other jurisdictions in Canada have been ac- tion of Alberta’s legislature on February 10, 2009. At tively considering how best to implement and im- the time this paper was written, the Health Informa- prove the regulation of EHRs at the local and pro- tion Amendment Act had not yet been reintroduced in vincial/territorial level. For example, Newfound- the legislature. If the bill is re-introduced, it is sure land & Labrador’s Centre for Health Information to generate further debate about how best to respect recently published a document subtitled “EHR the confidentiality of patient information, while fa- Governance: If we build it, who will govern it?”. The publication states that consultations are ongo- In Ontario, the Personal Health Information Pro- ing between the government and the health au- tection Act (“PHIPA”) governs personal health in- thorities regarding the appropriate governance formation, whether it is stored in a paper record or in electronic form. The Legislative Assembly of On- tario recently referred PHIPA to the Standing Com-mittee on Social Policy for a scheduled legislative The inclusion of health information technology review. Following its deliberations, the Standing and infrastructure as part of the economic stimulus plans in both Canada and the United States provides 13 Daniel Castro, “Improving Health Care: Why a Does a unique opportunity for the advancement of EHR of IT May be Just What the Doctor Ordered” (2008- systems in both countries. While a significant step forward, funding alone will not resolve many of the 14 Personal Information Protection and Electronic unknowns currently associated with the implementa- tion and regulation of EHRs. Further progress will 15 As of December 31, 2008, Canada Health Infoway require continued efforts to identify appropriate and had approved funding for over 276 projects across workable governance structures and mechanisms for Canada, <http://www.infoway-inforoute.ca/lang-en/about-ehr/ehr-progress-map>. the sharing of patient information without compro- mising privacy. Only once the appropriate structures have health-specific privacy legislation in force. are created will it be possible for EHRs to meet the 17 E-Health (Personal Health Information Access and expectations for improved delivery of healthcare. Protection of Privacy) Act, S.B.C. 2008, c. 38; See also Cappone D’Angelo and Vincent K.S. Yip, “Brit- [Editors’ note: Maureen L. Murphy is a Partner at ish Columbia Enacts E-Health Legislation” (2008-09) Gowling Lafleur Henderson LLP in Ottawa, Ontario] 18 British Columbia, Ministry of Health News Release 1 Canada Health Infoway is an independent, not-for- profit corporation established in 2001. The Members <http://www2.news.gov.bc.ca/news_releases_2005- of Infoway are the 14 Federal/Provincial/Territorial 19 Alberta, Bill 52, Health Information Amendment Act, 2008, 1st Sess., 27th Legis., 2008. Canada’s Economic Action Plan, Budget 20 “Commissioner concerned by amendments to Health Information Act” Office of the Informa- <http://www.budget.gc.ca/2009/plan/bpc3d-eng.asp>. tion and Privacy Commissioner of Alberta, News 3 U.S., Bill H.R. 1, America Recovery and Reinvest- ment Act of 2009, 111th Cong., 2009 (enacted). 21 “Alberta physicians oppose Bill 52: Proposed legisla- Canada’s Economic Action Plan, Budget tion fails to balance patient privacy with need for in- formation”, Alberta Medical Association, News Re- <http://www.budget.gc.ca/2009/plan/bpc3d-eng.asp>. 5 Patrick Sullivan “Spend on health care infrastructure 22 Personal Health Information Protection Act, S.O. to help cure sick economy: CMA”, (January 13, 2009), online: Canadian Medical Association, on Social Policy, “Review of the Personal Health In- formation Protection Act, 2004”, 1st Session, 39th 7 Recovery Accountability and Transparency Board, Parliament, 57 Elizabeth II, October 2008. online: <http://www.recovery.gov/?q=content/act>. 2009-2012, February 2008, Draft for Consultation, EHR Success Stories”, online: <http://www.infoway- inforoute.ca/lang-en/about-ehr/ehr-success-stories>. <http://www.ehealthontario.on.ca/pdfs/News/Ontario 9 Annuta Virapongse, David W. Bates, Ping Shi, et. al. “Electronic Health Records and Malpractice Claims Nova Scotia, Department of Health, Personal Health in Office Practice” Arch Intern Med. 2008; Information Legislation for Nova Scotia Discussion 10 Ruben Amarasingham, Laura Plantinga, Marie Die- <http://www.gov.ns.ca/health/phia/PHIA_%20Discus ner-West, et. al. “Clinical Information Technologies and Inpatient Outcomes: A Multiple Hospital Study” New Brunswick, Personal Health Information Access and Arch Intern Med. 2009; 169(2):108-114. Privacy Legislation, Discussion Paper, September 2008. Newfoundland & Labrador Centre for Health In- 12 U.S., Bill H.R. 1, America Recovery and Reinvest- formation, Electronic Health Record Improved ment Act of 2009, 111th Cong., 2009, Title XIII, ss. health through quality health information: EHR Governance: If we build it, who will govern it? October 2008.
ISSN 0362 1197, Human Physiology, 2012, Vol. 38, No. 5, pp. 541–544. © Pleiades Publishing, Inc., 2012. Original Russian Text © V.M. Pokrovskii, O.G. Kompaniets, 2012, published in Fiziologiya Cheloveka, 2012, Vol. 38, No. 5, pp. 102–107. Influence of the Level of Blood Pressure on the Regulatory–Adaptive State V. M. Pokrovskii and O. G. Kompaniets Kuban State Medical Universi