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LEGAL FOCUS |
Cedric Lam examines the prohibition against direct-to-consumer advertising (DTCA) of prescription medicines in Hong Kong, the mounting pressure to relax such restrictions in light of a recent policy decision of the European Commission and the current realities of DTCA in Hong Kong
Introduction
Hong Kong, like most developed countries, does not allow direct-toconsumer advertising (DTCA) of prescription drug products. At present, DTCA of prescription medicines is permitted in only two jurisdictions (New Zealand and the US), although the extensive DTCA occurring over the internet may lead one to think otherwise. In fact, as in the case of most other countries, DTCA of prescription drugs was outlawed in Hong Kong long before the banning of tobacco advertising.
Legal Framework
Advertising of all medicinal products in Hong Kong is strictly controlled by the Undesirable Medical Advertisements Ordinance (Cap 231) (the UMAO). Section 3 of the UMAO provides for an outright prohibition against the publication of 'any advertisement likely to lead to the use of any medicine … for the purpose of treating … or preventing' any disease, disorder or abnormal physical state specified in the schedules to the UMAO. The schedules include virtually all health conditions that require some degree of medical attention - from diabetes to heart disease to cancer. This general prohibition applies to both drug companies and advertisers. Advertisements directed at health care professionals are, however, exempted by way of a statutory defence provided under s 5 of the UMAO.
Advertisement is defined very broadly under the UMAO to include 'any announcement made orally or by any means of producing or transmitting light or sound'. Therefore, all forms of advertising to the public, whether through traditional media or the internet, would fall within the scope of this prohibition against DTCA. Violation of the UMAO is a criminal offence and may attract a custodial sentence for repeat offenders.
The DTCA prohibition in Hong Kong differs from that of other countries in one important respect. Unlike the UMAO in Hong Kong, which applies to advertisements of all medicines, the ban on DTCA in most other countries focuses primarily on prescription drug products.
Prescription medicines are drugs with potent therapeutic effects and are usually associated with more severe side effects than over-thecounter medications. They hold a special place in the practice of medicine and can only be dispensed pursuant to a prescription issued by a registered medical practitioner.
Prescription medicines available in Hong Kong are listed in Part I, Schedule 3 of the Pharmacy and Poisons Regulations (Cap 138 sub leg A). The Pharmacy and Poisons Ordinance, however, does not contain any prohibition against the advertising of prescription or other medicines. That is a matter within the purview of the UMAO. Nonetheless, the fact that the UMAO makes no distinction between the advertising of prescription drugs and non-prescription drugs in Hong Kong does not make the DTCA experience in other jurisdictions any less relevant.
A Brief History Lesson
Many countries enacted legislation prohibiting DTCA back when most people held the paternalistic view that patients were vulnerable individuals desperate for cures and that 'doctors know best' in managing their health. As a result, protection of the unsophisticated public from quackery by restricting their access to medical information was generally thought to be a good and necessary thing. Also, for a long time pharmaceutical companies were content to focus their marketing efforts on health care professionals rather than the general public.
The general public had no easy access to information on drugs until the late 1970s and early 1980s when medical books for non-professionals started to become available. Following the movement of consumer empowerment in the late 1980s and early 1990s, people began to take greater interest in managing their own medical well being. The explosion of communications technology and advances in medical care during the past two decades, particularly the 'discovery' of many wonder drugs, have also fuelled great public interest in and demand for drug-related information. Despite these developments, the Ethical Criteria for Medicinal Drug Promotion, issued by the World Health Organization (first published in 1988), continues to stipulate that 'advertisements for the general public … should not generally be permitted for prescription drugs'.
Most countries are currently taking a wait-and-see approach on DTCA. While increasing consumer demand for drug-related information has sparked some public consultation (Canada, for example, has held many consultations on this subject since 1996) and resulted in the loosening of some restrictions on prescription drug advertising in a few countries, direct-to-consumer advertising of prescription medicines remains illegal in most developed countries. New Zealand and the United States are exceptions.
The New Zealand and US Experiences
At present, New Zealand and the US are the only industrialised countries that allow DTCA of prescription medicines. New Zealand has never explicitly prohibited advertising of prescription drugs to the public and many drug companies have taken advantage of this permissive regulatory environment. The expenditure on DTCA in New Zealand has grown substantially over the past few years. In 2000, it went up by about 24 percent.
Similarly, the US has never had any legislation specifically disallowing the public advertising of prescription medicines. When the first wave of DTCA hit the US during the early 1980s, the US Food and Drug Administration (FDA) had to issue a 20-month moratorium asking members of the pharmaceutical industry to refrain from advertising prescription drugs directly to the public until some guidelines were developed. Prescription drug advertising in the US took off in August 1997 after the FDA loosened its law, permitting DTCA through the broadcast media. Today, DTCA of prescription medicines is a two billion dollar a year business in the US.
Europe: Latest Impetus for Change
At the moment, DTCA of prescription medicines is not allowed in any member state of the European Union. The existing ban is poised to change, however, following a recent policy decision of the European Commission (EC) to relax this strict prohibition.
On 18 July 2001, the EC announced that 'the current ban on public advertising of prescription medicines in Europe will be complemented by a pilot system aimed to ensure the availability of better, clear and reliable information on authorised pharmaceuticals … for three types of illnesses: AIDS, diabetes and asthma … This will be coupled with strict control measures … This is not direct to consumer advertising …'.
Despite the cautious language adopted in the decision and the limited scope of the proposed pilot project, most people in the industry regarded the EC's decision as the first step in ending the general prohibition against DTCA of prescription drugs in Europe. Opponents of DTCA are, of course, unhappy about the EC's decision. They argue that most consumers are not sophisticated enough to filter promotional claims about prescription medicines and that DTCA will lead to inappropriate demand for and unnecessary consumption of drugs.
On the other hand, proponents of DTCA argue that it will increase consumer knowledge of available treatment options, lead to improved physician-patient relations, increase patient compliance with drug therapy and lower drug prices. Debate on this subject has been gathering momentum since the EC's decision.
The Situation in Hong Kong
Hong Kong has not waited for the EC's decision and the ensuing loosening of the ban in Europe. A number of drug companies have simply 'jumped the gun' and DTCA of prescription drugs is already here. Over the past 24 months, there has been a constant diet of prescription drug advertisements in the mainstream media aimed directly at the general public.
These prescription drug advertisements come in a variety of forms: track-side ads in MTR stations, print advertisements in newspapers and magazines, posters in pharmacies as well as dedicated websites on the internet. There is, however, no DTCA through the broadcast media yet. This, presumably, is due to the restrictions set out in the current advertising standards issued under the Broadcasting Ordinance (Cap 562).
According to the Code of Practice on Advertising Standards, released in June 2001, 'advertisements for medical preparations which are included in Part I of the Poisons List in the Pharmacy and Poisons Ordinance (P&PO) … are not acceptable'. As mentioned, prescription medicines are found in Schedule 3, Part I of the P&PO. Although these standards do not apply directly to drug companies or advertisers, the Broadcasting Authority can impose sanctions on television and radio operators who fail to comply with them. Effectively, they operate as an indirect prohibition against DTCA through the broadcast media in the SAR.
The DTCA in Hong Kong also varies in terms of presentation. Many are 'help-seeking' ads which encourage consumers to consult their doctor in relation to a particular medical condition without identifying any drug product or treatment option. There are also 'product-claim' ads which reveal the name of a specific prescription drug, its indication and effectiveness. More recently, there are 'reminder' ads which showcase only the names of the drugs and the companies which market them.
The prescription drugs being marketed directly to the public in Hong Kong include those indicated for hair loss, obesity and penile dysfunction, all of which are, medically speaking, conditions specified in the schedules to the UMAO. In other words, these drug advertisements are prima facie 'undesirable medical advertisements'. To avoid breaching the DTCA prohibition, lawyers and media specialists were brought in to ensure compliance with the letter of the UMAO and the other relevant legislation. So far the Department of Health has exhibited an openness to these direct-to-consumer advertisements. Save for a few warning letters, such DTCA campaigns have attracted little enforcement action.
Desirable Medical Advertisements
DTCA can be worded so that it complies with the UMAO, but such advertisements are not necessarily 'desirable' medical advertisements. The UMAO only proscribes undesirable advertisements without saying what attributes 'desirable' medical advertisements should have.
This lack of direction regarding the quality of medical advertisements which otherwise comply with the UMAO is unfortunate, as illustrated by some of the DTCA in Hong Kong. Many ads tend to highlight the benefits of treatment but place little or no emphasis on the risks or side effects. Others make broad claims about effectiveness without revealing that the treatment in question is only suitable for selected patient groups. Even the forerunner in DTCA of prescription medicines would not have accepted such advertisements.
In the US, advertisements of all prescription medicines are required to meet a 'fair, balanced and full' disclosure standard. Some of the ads in the SAR could hardly pass muster. Yet these ads still fall short of attracting the operation of the Trade Descriptions Ordinance (Cap 362) or the Public Health and Municipal Services Ordinance (Cap 132), which forbid the publication of advertisements that are likely to mislead as to the nature, substance or quality of any drug product.
Industry Self-Regulation
Like many other countries, Hong Kong relies on industry selfregulation when it comes to the promotion of drug products. In Australia, for instance, the Code of Conduct of the Australian Pharmaceutical Manufacturers' Association provides that 'any activity directed towards the general public which encourages a patient to seek a prescription for a specific prescription-only medicine is unacceptable'.
The Hong Kong Association of the Pharmaceutical Industry (HKAPI) has also put out a similar Code of Pharmaceutical Marketing Practices. These voluntary codes of conduct are, however, only binding on their respective member companies and afford no legal sanctions for infractions. In any event, the anti-DTCA provision in the HKAPI Code was removed from the latest edition published in 1999. Prescription drug advertising in Hong Kong is thus not presently subject to any specific industry selfregulation.
Whether or not the health care consumers in Hong Kong embrace DTCA of prescription drugs, this absence of specific control and lack of clear guidelines regarding the contents of medical advertisements is certainly not helpful in improving the quality and accessibility of drug information available to the general public.
Conclusion
The Undesirable Medical Advertisements Ordinance first entered our statute books in 1953. This antiquated legislation provides for a blanket prohibition against direct-to-consumer advertising of medicines but offers no guidance as to the qualities of desirable medical advertisements. Some drug companies in Hong Kong are attempting to 'push the envelope' by indulging in American-style prescription drug advertising without adopting corresponding quality control measures. The internet has also lured more and more drug companies to distribute their educational and promotional materials on-line.
In light of these developments and the recent international trend in deregulating DTCA, the UMAO and the patchwork of related legislation can no longer provide an effective regulatory environment. Until a new regime is put in place, however, drug companies and advertisers seeking to deliver their messages directly to consumers will have to manoeuvre around the DTCA prohibition with some legal and marketing ingenuity.
Cedric G Lam
Herbert Smith
cedric.lam@herbertsmith.com
林嘉聰認為，現行禁止直接向消費者進行處方藥品廣告宣傳的本地法例，不但有欠完善，而且已不能追上世界各地的大趨勢和互聯網的發展
引言
像大部分已發展國家一樣，香港並不容許就處方藥品而直接向消費者進行廣告宣傳（以下簡稱「處方藥品直銷宣傳」或「直銷宣傳」）。目前只有兩個司法管轄區准許處方藥品直銷宣傳，分別是新西蘭及美國，縱使出現在互聯網上的廣泛直銷宣傳也許令我們認為情況並非如此。事實上，跟大部分其他國家相同，香港法律對於處方藥品直銷宣傳的禁制，遠比煙草廣告宣傳的禁制來得早。
有關的法律架構
在香港，《不良醫藥廣告條例》（第 231 章）（以下簡稱《條例》）對於所有醫藥產品的廣告宣傳活動作出了嚴格的監控。《條例》第 3 條斬釘截鐵地禁止任何人發布「任何相當可能導致他人為…治療…或預防」《條例》各個附表所列明的疾病、功能失調或異常身體狀況「而使用任用藥物」的廣告。《條例》各個附表所列的，幾乎涵蓋一切需要某些程度的治療的疾病和病理情況，包括糖尿病、心臟病和癌症。這項一般「禁令」，同時適用於藥品公司和廣告商。然而，任何向專業醫護人士發布的廣告，可根據《條例》第 5 條的法定免責辯護而獲豁免。
在《條例》下，「廣告」的定義廣泛，包括「任何以口頭方式或藉產生或傳送光或聲音的方式所作出的宣布」。據此，所有形式的直銷宣傳，不論是透過傳統媒介還是互聯網而作出，均受到《條例》禁制。違反《條例》的規定乃屬刑事罪行，屢次犯規者更可能被判處監禁。
香港對於直銷宣傳的禁制，跟其他國家的同類禁制有著一個重大的分別：《條例》適用於所有藥物的廣告，其他國家則主要針對處方藥品直銷宣傳而作出禁制。
處方藥品指具有療效的藥物，但其副作用通常被視為較不用處方購得的藥物為嚴重。處方藥品在醫學界可說是享有特殊地位–顧名思義，任何人只可憑著由註冊醫生發出的處方購買處方藥品。
在香港，《藥劑業及毒藥規例》（第 138 章附例 A）附表 3 第 I 部臚列了可供使用的處方藥品。不過，《藥劑業及毒藥條例》（第 138 章）（以下簡稱《藥劑條例》）內並沒有任何條文禁止處方藥品或其他藥物的廣告宣傳活動，而這事項正落在《條例》的範圍。縱使《條例》沒有在處方藥品的廣告宣傳與其他藥物的廣告宣傳之間作出區分，但我們可從其他司法管轄區的直銷宣傳情況之中得到寶貴的啟示。
一點歷史
很多國家當初制定法例禁止直銷宣傳的時候，大部分人都認為醫者無異於病人的父母，病人渴望接受治療，而醫生是最懂得如何照料他們的人。當時各界普遍贊成限制公眾取覽醫學資料，以保障他們免被庸醫欺騙。此外，醫藥公司向來都安於只向醫護專業醫護人士而不向普羅大眾進行產品推廣活動。
到了 1970 年代末期和 1980 年代初期，以非專業人士為對象的醫學書籍相繼面世，改變了公眾對醫藥資料一無所知的狀況。加上 1980 年代末期至 1990 年代初期的消費者權益運動，公眾對於「自我醫護」概念漸感興趣。此外，醫學界在過去二十年間「發現」了不少神奇藥物，今大眾對醫學資料的興趣和需求大增。縱然如此，世界衛生組織曾在 1988 年首次公布的「醫學藥物宣傳的道德標準」中規定，「就處方藥物而言，一般不應准許【發布】以公眾為對象的廣告」，而該規定現仍存在。
現時不少國家對於直銷宣傳仍採取「靜觀其變」的做法。誠然，公眾對醫藥資料的需求，曾經驅使一些地區進行公開諮詢（舉例說，加拿大自 1996 年以來曾就這個課題進行多次諮詢），並曾導致某些國家放寬有關限制。然而，除了新西蘭和美國外，在大部分已發展國家，處方藥品直銷宣傳仍屬不合法行為。
新西蘭和美國的情況
在現今的工業化國家之中，只有新西蘭和美國容許處方藥品直銷宣傳，而新西蘭更從沒有明文禁止向公眾進行處方藥品廣告宣傳活動。不少藥物公司自然把握了這種環境所帶來的商機。過去數年來，新西蘭當地在直銷宣傳方面的開支大幅增加，單於 2000 年，該等開支已增加約百分之二十四。
同樣地，美國從沒有立例禁止向公眾進行處方藥品廣告宣傳。早於 1980 年代初期，當直銷宣傳在美國興起時，當地的食物及藥品管理局曾訂立為期二十個月的「暫禁」期，並要求藥劑業界避免直接向公眾進行處方藥品宣傳，直至當局制定有關指引為止。到了 1997 年 8 月，上述管理局放寬有關法規，容許透過廣播媒介進行直銷宣傳，這也標誌了直銷宣傳在美國的正式發展。時至今日，處方藥品廣告宣傳每年在美國所帶來的回報可高達二十億美元。
歐洲的最新發展
目前歐盟成員國一律嚴禁處方藥品直銷宣傳。不過，隨著歐洲委員會近期一項決定，上述限制的放寬是指日可待的。
去年 7 月 18 日，歐洲委員會宣布：「一項試點計劃將予以實行，補充現時對於歐洲境內的處方藥品公開廣告宣傳活動的禁制，該計劃旨在確保公眾可就…三種疾病–愛滋病、糖尿病及哮喘病–的獲授權藥品而得到更佳、更清晰和更可靠的資料…這將與嚴格的監控措施一併實行…這不屬於直接向消費者進行廣告宣傳…」。縱使上述宣告的內容字眼頗為審慎，而建議中的試點計劃的範圍有限，但業界普遍將上述宣告視為摒除對歐洲境內的處方藥品直銷宣傳的禁制的第一步。
反對直銷宣傳的人固然不滿意歐洲委員會的決定，他們認為，消費者大多缺乏「過濾」藥品宣傳內容的能力，而直銷宣傳將導致公眾不適當和不必要地依賴和服用藥物。
支持直銷宣傳的人則認為，這類宣傳將有助增加消費者對於各種醫療選擇的認識、從而改善醫者與病人的關係、促進病人遵循醫療規定以及降低藥物價格。自歐洲委員會作出上述決定以來，各界就直銷宣傳問題的辯論正日趨激烈。
香港的情況
香港藥品公司和廣告商看來未有像歐洲般循序漸進。不少本地藥商已乾脆「搶先」進行處方藥品直銷宣傳。
過去兩年來，透過各類媒介進行的處方藥品直銷宣傳活動此起彼落，我們從地鐵月台的大型廣告箱、報章雜誌、海報和互聯網站都可看到林林總總的處方藥品廣告。不過，迄今這類廣告仍未在廣播媒介中出現，這大概是因為《廣播條例》（第 562 章）對廣告宣傳標準訂立了限制。
當局於去年 6 月發出的「廣告標準業務守則」表明：「任何藥品如含有【《藥劑條例》毒藥表第 I 部】所限制出售的藥物，俱不可作廣告宣傳」。正如上文所述，《藥劑條例》附表 3 第 I 部已列明本地各類處方藥品。儘管上述標準不適用於藥品公司和廣告商，但廣播事務管理局有權懲罰不遵守上述標準的電視台和電台。因此，上述標準實際上間接地禁止透過本地廣播媒體進行直銷宣傳活動。
本地處方藥品直銷宣傳的呈現方式亦層出不窮。不少相關廣告屬於所謂「求助」廣告，意指鼓勵消費者就某些醫學情況徵詢醫生，但不識別任何藥品或治療選擇。另一種廣告是「藥物聲稱」廣告，其內容述明某處方藥品的名稱，並包含關於其特徵和功效的聲稱。此外，近期新興一種「提示式」廣告，它們只載有某藥物和其推廣商的名稱。
現時在本地出現的處方藥品直銷廣告，包括了針對脫髮、肥胖及性機能障礙等病症的廣告，而這些病症在醫藥上均屬於《條例》各附表所列明的病理情況。換句話說，這類廣告表面上均屬於「不良醫藥廣告」。一些藥品公司和廣告商為了避免觸犯《條例》的規定，曾經聘請律師和傳媒界專家，以確保有關廣告符合《條例》和其他相關法例的明文規定。迄今衛生署對於這類直銷廣告抱有寬容態度，除了在某些個案中發出警告信外，大致上未有對這類直銷宣傳活動採取強硬的執法行動。
不良醫藥廣告
即使藥物直銷廣告的內容字眼符合《條例》的規定，這些廣告亦不一定是「良好」的醫藥廣告。《條例》在禁止不良醫藥廣告之餘，並沒有述明「良好」醫藥廣告所應具備的特質。
正如一些本地直銷宣傳顯示，法例缺乏有關藥物廣告質量方面的指引，實屬欠妥的情況。目前不少藥物廣告都只著重強調藥物的療效，但甚少（甚或全不）提及藥物的潛在危險或副作用。另一些廣告則只載有藥物效用方面的籠統聲稱，而沒有指出有關治療只適合某類病人。即使是完全准許處方藥品直銷宣傳的國家，相信也不會接受上述的廣告。
事實上，在美國，所有關於處方藥品的廣告，都必須達到「公平、相稱和徹底」的資料披露標準。相信本地一些藥物廣告不會達到這個標準。然而，該些廣告仍未有遭到當局根據《商品說明條例》（第 362 章）或《公眾衛生及市政條例》（第 132 章）而採取行動，這兩項條例禁止任何人發布相當可能在藥品的性質、內容或質量方面帶誤導成分的廣告。
業界自我監管
就藥品宣傳而言，香港像許多其他國家一樣，倚賴業界自律和自我監管。澳洲藥劑製造商協會曾發出業務指引，規定「不得向公眾進行任何鼓勵病人就某處方藥物尋求處方的活動」，而香港藥劑業協會亦曾發出相類的「藥劑推廣業務守則」。不過，這些自願性質的守則只對成員公司具約束力，而不遵守這些守則的成員亦不會受到法律制裁。不管如何，上述守則內關於禁止直銷宣傳的條文，已不再出現於 1999 年守則版本之內。因此，本地的處方藥品廣告宣傳活動，目前不受任何業界規則監控。
不論本地消費者會否接受處方藥品宣傳活動，有關廣告內容不受任何具體指引監管的現況，顯然無助於改善可供公眾取覽的藥物資料的範圍和質量。
結語
早於 1953 年生效的《條例》，全面禁止直接向消費者進行藥物廣告宣傳，但沒有就良好藥物廣告的特質提供任何指引。一些本地藥品公司正試圖在漠視相應的管控措施下強行作美國式的處方藥品廣告宣傳。與此同時，互聯網正驅使愈來愈多的藥品公司在網上發布宣傳資料。
有見及這些發展，加上世界各地正邁向放寬對直銷宣傳的禁制，《條例》和零碎的相關法例已不能提供有效的監管架構。直至當局設立完備的新架構前，有意向公眾作直接宣傳的藥品公司和廣告商，便只好考慮如何訂立巧妙的市場推廣策略，以規避對於直銷宣傳的禁制了。
林嘉聰律師
史密夫律師行
電郵：
cedric.lam@herbertsmith.com