In June 2008, a district court in Guangzhou ruled that Qiqihar No 2 Pharmaceutical Company Ltd, as well as two other companies and a hospital in Guangzhou, were to share responsibility for 14 deaths that resulted from counterfeit drugs. The civil award, a combined RMB 3.5 million, was calculated to cover medical expenses and mental suffering, and comes approximately a year after a Guangzhou Intermediate People's court sent five Qiqihar employees to jail for their involvement in the counterfeit drug operation.

The case, though an illustration of China's commitment to fighting the proliferation of counterfeit pharmaceuticals, highlights a nationwide epidemic. While counterfeit drugs are estimated to occupy approximately 10% of the Chinese market, fakes of certain products are said to exceed 30%, while fakes in certain cities may exceed 40%. Not surprisingly, the prevalence of counterfeits has led to health scares and the loss of life. Recently, in May of 2007, 11 people died after being injected with a medication tainted by a non-standard chemical. That July, six people died and 80 more fell ill after being treated with an antibiotic manufactured using 'substandard disinfectants'.

Like melamine-laced baby formula and lead-tainted toys, China's counterfeit pharmaceutical problems have gone global. In 1996, 89 children in Haiti died after consuming Chinese-produced cough syrup that contained anti-freeze. A few years later, Chinese-made diet pills took the lives of five women in Japan and Singapore. And in 2005, a California resident pled guilty to importing fake Viagra from China for sale in the US market. The imported tablets, combined with his own manufacturing efforts at home, were valued at more than US$5 million.

The problem of fake pharmaceuticals stems from similar institutional and market factors as those of other goods. Yet, there are significant differences. Most plainly, while counterfeiting is viewed by the public and indeed many enforcement authorities as a 'victimless crime', counterfeit drugs exact a harm upon consumers that is beyond traditional anti-counterfeiting statistics, such as lost sales. The counterfeit pharmaceutical problem in China is not an isolated phenomenon, but is exacerbated by a growing global trade in fake drugs. Regulatory amendments and on-the-ground enforcement actions in China must reflect the global nature of the problem, both in their efforts to stem its trade as well as bring its perpetrators to justice.

Counterfeit Pharmaceuticals: A Global Perspective

According to the World Health Organization (WHO), counterfeit pharmaceuticals are medicines which are 'deliberately and fraudulently mislabelled with respect to identity and/or source'. Such products can include drugs with correct ingredients, without any active ingredients, or active drugs sold in fake packaging.

Under such a definition, counterfeit pharmaceuticals currently account for 10% of the world's drugs, and are growing at a rate of 13% annually. By 2010, counterfeit drugs are predicted to bring in approximately US$75 billion in revenue - a value 15% the size of the legitimate industry.

There are several reasons for this substantial growth. First, counterfeiting pharmaceuticals is a very lucrative business. Counterfeiters share none of the enormous research and development costs incurred by legitimate producers, yet are able to exploit continued high demand and low production costs.

Second, detecting counterfeit drugs is complex and costly. Consumers, and sometimes prescribing physicians themselves, cannot tell the difference between the legitimate product and an impostor. For example, if a patient consumes the fake, but recovers naturally, there is no reason to suspect a counterfeit product. If a patient's condition worsens as a result of the fake goods, however, the healthcare professional might incorrectly conclude that other factors, such as drug resistance, are at play. Oftentimes, only after significant harm has occurred are advanced technical means employed to determine the drugs composition, and with it, the drug's counterfeit origins.

Finally, drug counterfeiters are growing more and more sophisticated. In a recent study examining the prevalence of inactive ingredients in counterfeit artesunate (an anti-malarial), investigators discovered that the ability of counterfeit producers to employ advanced printing technology, such as holograms, had improved dramatically between 2001 and 2005. Not only are counterfeiters able to label their products as if they were legitimate goods, but they are also 'chemically competent'. The ingredients of fake drugs are often deliberately chosen to imitate the chemical fingerprint of authentic components, and thereby pass basic quality tests.

In response to the global threat posed by counterfeit pharmaceuticals, in 2006 the WHO created a global partnership known as the International Medicinal Products Anti-Counterfeiting Taskforce (IMPACT), composed of all 193 Member States, including China, as well as enforcement agencies, national drug regulatory authorities, non-governmental organisations and patients' groups. IMPACT's mandate is to improve coordination and harmonisation of anti-counterfeiting efforts across borders, by organising enforcement actions between member States, providing members with effective anti-counterfeiting legislation to adapt to their own needs, and assisting in the development of anti-counterfeiting technologies.

China's Pharmaceutical Market

China is currently the world's top producer of both legitimate and counterfeit pharmaceuticals. An example of China's production capacity: the country can produce over a billion doses per year of over 40 different types of vaccines. This massive inventory is produced by almost 7000 registered drug manufacturers, who reach the domestic market via a network of 341,000 pharmaceutical retailers. Total pharmaceutical output rose from RMB 1.37 billion in 1998 to RMB 667.9 billion in 2007.

Meanwhile the domestic market for pharmaceutical products continues to grow. Several factors have combined to produce demand. First, as the economy develops and incomes increase, people are able to spend more keeping themselves healthy. In addition, the Chinese population has become progressively more aware of the importance of health care generally. As a result, wealthy consumers now spend more on consumer pharmaceuticals, such as diet pills and nutritional supplements. Finally, China's ageing population is growing, and with it, a simultaneous rise in age-related diseases, all of which demand quality pharmaceutical products.

However, lack of consumer education, high medication prices, and protectionist local governments?support for counterfeit industries has created a vast underground market of counterfeit pharmaceuticals. As a result, by some estimates, China is now the world's leading exporter of counterfeit drugs and bulk chemicals.

China's Anti-Counterfeiting Efforts

China's commitment to fighting counterfeit pharmaceuticals is not a new phenomenon. Almost a decade ago, China's food and drug administration officials warned of 'illegal medicine fairs' and the potential for widespread counterfeiting. Since then, the government has made repeated promises to clamp down on the production and distribution of counterfeit drugs.

Early efforts
In 1984, the Standing Committee of the National People's Congress adopted the Law of the People's Republic of China for the Administration of Pharmaceuticals, and introduced legal responsibility for the production and sale of counterfeit and inferior drugs. The law was amended in 2001, further fleshing out the counterfeit drug provisions by providing broad definitions of 'counterfeit' and 'inferior', as well as clear legal liability for production and sale. In 2003, the State Food and Drug Administration (SFDA) was founded on top of the State Drug Administration. While the SDA was under the jurisdiction of the Ministry of Health, the new SFDA exists directly under the State Council, and therefore generally has greater regulatory and legal enforcement powers than its predecessor, in addition to the broader scope of its mandate. In carrying out its supervision of the pharmaceutical industry, the SFDA coordinates with other agencies in the Chinese government, such as the Ministry of Health, the Administration for Quality Supervision, Inspection and Quarantine (AQSIQ) and the State Administration of Industry and Commerce (SAIC). For example, the SFDA and the SAIC jointly oversee the advertising of pharmaceutical products, with the SFDA focused on monitoring and approving drug advertising, while the SAIC is responsible for investigations and punishment. While the two agencies may often split responsibility in this fashion, the SFDA and local FDAs at the provincial, municipal and county-level also staff inspection offices, leading to a fair amount of agency overlap.

Recent court cases
Over the past two years, there have been a number of high-profile anti-counterfeit pharmaceutical enforcement actions and court cases, which demonstrate China's recent emphasis on effective enforcement of pharmaceutical intellectual property, as well as consumer protection.

In 2006, the Beijing No 1 Intermediate People's Court reversed a 2004 decision by the Chinese Patent Review Board that had sided with a group of Chinese generic drug manufacturers and invalidated Pfizer's patent on Viagra. The case was followed a few months later by another decision which upheld the validity of Pfizer's patent, and ordered two Chinese companies to stop sales and pay compensation for trademark infringement.

In July of 2007, Zheng Xiaoyu, the former director of the SFDA, was executed for taking over RMB 6 million in bribes. During his eight-year tenure, the drug regulatory body approved over 150,000 applications for new drugs. The US Food and Drug Administration, by contrast, approves approximately 140 drugs per year. Police and drug administration officials in Heilongjiang Province arrested 15 people in August of 2007 after
busting a nationwide counterfeit pharmaceutical production ring operating out of Harbin. The counterfeiters were responsible for producing and distributing over 100 types of medications under 53 domestic brand names. Analysis of the counterfeit pills and injections, which included rabies vaccines, found that most were produced with inert raw materials such as water and starch.

This past spring, a Higher People's Court in Liaoning Province upheld a 15-year sentence for a former Provincial Food and Drug Administration director who was convicted of embezzlement and bribery. The official, Zhang Shusen, was found guilty of embezzling RMB 300,000 in public funds and accepting more than RMB 400,000 in bribes. The court found that in one instance, Director Zhang had received RMB 50,000 for mitigating the sentence of a drug counterfeiter based in neighbouring Jilin.

Recent regulatory changes
In addition to the increase in high profile cases, a number of recent changes in China's drug regulatory regime have further bolstered the ability of enforcement officials to crack down on counterfeit producers and distributors.

GMP certification becomes mandatory
In 2004, the SFDA announced that the Good Manufacturing Practice (GMP) Certificate, a standards designation designed to promote quality and safety in the pharmaceutical industry, would no longer be optional. A year after declaring that all drug manufacturing plants must be GMP-compliant, the SFDA began conducting 'flying' or unannounced, inspections at all drug manufacturing plants to ensure their compliance. These inspections were seen as largely successful, as many manufacturers had their GMP certification revoked and others still were required to halt production until they met GMP standards.

Advertising
In addition to regulatory oversight of the manufacture of pharmaceuticals, Chinese regulatory authorities also clamped down on false and misleading pharmaceutical advertising. In 2005, the State Administration of Industry and Commerce (SAIC) launched an investigation into the veracity of advertisements in over 80 newspapers nationwide. It discovered a large number of false advertisements, including ads made to look like news reports, claiming to cure AIDS. In 2007, the SFDA created a system for recording the advertising of pharmaceuticals, as well as medical devices and health foods. The system classifies companies as 'creditable', 'discreditable' or 'seriously discreditable' based on their compliance with regulations covering health-related advertising. In September of that same year, the SFDA created the Market Supervision Office to focus on the counterfeit pharmaceutical market and illegal drug-related advertisements. The Office will also be responsible for testing pharmaceutical agents, biological agents and vaccine products.

Detection vans
Chinese authorities have also attacked the counterfeit problem from the ground-level up. In 2006, the State Institute for Control of Pharmaceutical and Biological Products cooperated with a number of provincial-level drug inspection agencies to launch a campaign to track down the distribution channels of counterfeit drugs. The campaign employed over 350 vans equipped with drug detection technologies such as near-infrared spectroscopy, and operating in 28 provinces and municipalities nationwide. The vans toured China's remote rural counties, rooting out counterfeit drug distribution in areas of the country which, because of their size and location, had not received significant enforcement attention.

API producer supervision
In June of 2008, the SFDA announced that it planned to revamp its Active Pharmaceutical Ingredient (API) supervision network. APIs are the building blocks of the drug products sold to consumers, ingredients which are chemically altered during the manufacturing process to produce the desired activity or effect in the final product. API exports from China have grown significantly in the past several years, and were up 22% in 2007. However, the unauthorised use of bulk APIs is a significant contributing factor of the counterfeit pharmaceutical market, and it is estimated that the bulk of APIs produced by China are used in the manufacture of counterfeit pharmaceuticals worldwide. Under the old model, an API producer was regulated by the SFDA only if it chose to register a specific API with the regulatory body. That requirement was triggered only if the API producer declared it was manufacturing an API for use in a finished pharmaceutical product. If the producer did not declare its intentions to produce an API for such a purpose, there was no government agency that possessed the authority to stop them from doing so. As a result, these producers were able to create bulk APIs, unregulated and unchecked.

The new system will require that all API manufacturers, not just those who produce APIs for a final product, register the details of the transaction with the SFDA. Under such a system, the SFDA will have access to information on the buyer, as well as the nature of the particular API involved. On a macroscopic level, this system will allow SFDA to track all API stocks, and quickly verify illegal activity.

SFDA's draft propositions
In addition to the above sighted developments, the SFDA has recently released draft documents for public comment. Two of these documents specifically target counterfeit pharmaceuticals, both by making them harder to distribute and by increasing the likelihood of criminal prosecution.

Drug labelling
Last spring, the SFDA released a draft plan to assist drug monitoring through a system of labelling codes. The draft plan required pharmaceutical manufacturers to include a 14-digit code on their drug packaging. The code would consist of numbers which indicated product type, manufacturer, specification and country of origin. The code would be readable both by machine and by humans, thereby facilitating structural controls as well as providing an additional layer of protection for physicians and consumers.

Criminal sanctions for the production and sale of counterfeit pharmaceuticals
According to Article 141 of the Criminal Law of the People's Republic of China, anyone caught producing or selling counterfeit pharmaceuticals that are sufficient to seriously harm human health will be sentenced to a fixed term of imprisonment of not more than three years. In addition, if counterfeit pharmaceuticals seriously harm human health, the prison sentence for producers and sellers is raised from three to 10 years. Finally, if the fake drugs result in loss of life, or cause exceptionally serious harm to human health, the producer or seller shall be sentenced to at least 10 years, life imprisonment or death.

Despite providing for criminal sanctions, the Criminal Law never defines what terms such as 'seriously harm human health,' or 'exceptionally serious harm' mean. Without a clear definition for these thresholds, enforcement authorities have no guidelines for pursuing criminal sanctions. In November of 2007, the SFDA released a draft of Supreme People's Court (SPC) Interpretations for public comment. These draft Interpretations offer much needed definitions to the above mentioned terms. For example, pharmaceuticals that contain toxic or other substandard ingredients not allowed under national standards are considered 'sufficient to seriously harm human health'. In addition, prescription drugs produced without a manufacturing license or any counterfeit medication whose target demographic is pregnant women, infants or children would also be considered 'sufficient to seriously harm human health'.

The draft interpretations also spell out the situation where capital punishment would be appropriate. Counterfeit medicines which upon use lead to death or severe disability to one individual, cause serious harm to three or more people, or cause minor harm to 10 or more people, are considered to have caused 'especially serious harm to human health'.

Finally, the draft Interpretations entrust county-level food and drug administration officials to make the above listed threshold determinations, where the current system only allows such decisions at the provincial-level.

Other Relevant Issues

Despite substantial progress on drug safety, particularly with respect to creating a mature and efficient regulatory structure, substantial problems still remain. Not surprisingly, many of the issues which continue to frustrate anti-counterfeiting efforts in other industries are relevant to the fake drug problem. Foremost among them is a substantial lack of enforcement.

Weak enforcement
As brand owners in other industries will testify, China's anti-counterfeiting efforts suffer from an over-reliance on ineffective administrative enforcement. While Administration of Industry and Commerce (AIC) officials can investigate counterfeiters and render punishment when appropriate, the fines levied are insufficient to significantly deter counterfeiters. While AIC officials can transfer more serious cases to criminal enforcement authorities, the transfers simply do not happen. For example, in the first six months of 2008, there were only 50 transfers of counterfeit cases to Public Security Bureau (PSB) officers nationwide. There are several reasons for this. First, administrative enforcement bodies simply do not have the ability to meet the criminal thresholds required. The Criminal Law requires cases involving over RMB 50,000 in sales, or RMB 150,000 in seizures. But many administrative enforcement officers lack to the manpower to track down counterfeiters of this scale. As a result, legitimate pharmaceutical producers have to be content with whatever quantities the local authorities are capable of seizing, which will generally result in fines insufficient to deter further production.

Second, administrative officials have a financial incentive to keep cases small. Not only do local officials often receive kickbacks from counterfeiters for looking the other way, but the local governments in some regions are dependent on the tax dollars and spending of counterfeit producers to keep them afloat. Counterfeiters often make significant investments in the areas in which they operate. Administrative officials may be willing to fine producers, but to shut them down completely might eventually result in unemployment. With the support of local government officials, whose influence extends even over the courts, administrative enforcement officers have little motivation for seeking criminal penalties.

Untrained and biased judiciary
Even when cases are transferred to courts for civil and criminal proceedings, drug makers are faced with judges who are biased strongly in favour of counterfeiters supported by the local government. These judges have no tenure, and are removed from their office if they render a verdict at odds with local government priorities. Salaries for People's Court judges are also notoriously low, so that even if the local government isn't guiding the court's deliberations, counterfeiters are often able to bribe their way to favourable decisions.

In addition to the potential for judicial interference, local judges suffer from a lack of experience dealing with intellectual property (IP) cases. While China has made substantial progress in setting training and education standards for People's Court judges, there are simply not enough judges with practical experience handling complex IP litigation in the pharmaceutical practice area. For the time being, many judges are armed with only second-hand knowledge of pharmaceutical issues, gained solely from reading books.

Recommendations

While recent amendments to drug-related regulations and draft Interpretations will help pharmaceutical companies operating in China protect their investment in intellectual property, there is still room for improvement.

Criminal thresholds
Though the draft Interpretations defining 'harm to human health' are a welcome step, if and when they become law, they will not solve the fundamental problem of the thresholds themselves. By requiring thresholds to be met, China takes the position that a certain amount of counterfeiting is acceptable, and can be overlooked. When it comes to counterfeit pharmaceuticals and their deadly potential, adopting this position gambles with the health of Chinese consumers. As stated above, administrative officials lack the manpower to meet criminal case thresholds. The proposed Interpretations, while offering additional channels to criminal sanction, do nothing to remedy the fact that local administrative officers lack the personnel and technical expertise to carry out the required investigations. Only by making a serious commitment to provide technical training and additional resources to local administrative organs will China see any marked increase in the number of criminal trials.

With respect to counterfeit pharmaceuticals, China should adopt a position similar to brand owners: every fake should be treated the same. Counterfeiting pharmaceuticals should be a crime, regardless of whether the producers makes RMB 4000 or RMB 400,000. The distinction of scope should matter only when it comes to sentencing. Instead, China should amend the appropriate provisions of its Criminal Law to criminalise the production, distribution, import and export of any drug product that is intentionally mislabelled with respect to its contents, source, identity or effect.

Inter-agency cooperation
The SFDA is only responsible for the administrative punishment of counterfeit drugs. It cannot dole out criminal punishment. As a result, substantial increases in local FDA enforcement activity might not translate into significant decreases in counterfeit drugs. To remedy this, the SFDA should focus on increasing cooperation and sharing of technical resources between itself and Public Security officers. By sharing its expertise of drug-related investigatory technologies and methods with experienced police officers, both organisations could work together to vastly increase the application of criminal sanctions to counterfeiting activity.

Yet this alone is not enough. The scope of the counterfeit pharmaceutical problem demands that SFDA must also work with the Postal Office to clamp down on the illicit transportation of counterfeit drugs through the mail. In addition, SFDA should also cooperate with Customs officials to ensure that counterfeit pharmaceuticals, and especially bulk APIs, are not exported for unauthorised use abroad. China's anti-counterfeiting efforts must acknowledge the dominant role China's pharmaceutical counterfeiters play in the global market for fake drugs.

International cooperation
Recently, Interpol collaborated with the World Health Organization and scientists from the University of Oxford in an effort to bring down an anti-malarial counterfeiting ring in southern China. The scientists analysed pollen grains and minerals found in the drugs themselves and were able to pinpoint their origin in Yunnan Province. Known as 'Operation Jupiter', this successful operation underscores the fact that while an effective regulatory structure is an important part of the fight against counterfeit pharmaceuticals, combating fake drugs requires significant financial support and resources to be effective. The types of forensic technologies employed in this case simply aren't available in the countries where counterfeit pharmaceuticals are most prevalent.

International collaboration will be critical to the success of China's anti-counterfeit efforts at home. China should continue to work with organizations like IMPACT and the US FDA in order to better equip itself for the fight against counterfeit pharmaceuticals.

Commercial Solutions

Pharmaceutical companies already operating in China do not have the luxury of waiting for China's enforcement bodies and drug-related regulations to become more effective deterrents. As a result, there are a number of strategies companies can take to cut down on counterfeit versions of their pharmaceutical products.

Cooperate with local administrative agencies
Beginning in 2003, Pfizer signed two ground-breaking memoranda of understanding (MOU) in Shanghai, one with the local AIC and the other, in 2004, with the Municipal Food and Drug Administration. In the MOU, Pfizer promised to provide specialised training and support staff to assist them in combating counterfeit pharmaceuticals in the Shanghai area. The initiative was a success. A year later, Chinese officials seized 600,000 counterfeit Viagra labels and 440,000 counterfeit Viagra tablets with an estimated value of US$4.3 million.

Pfizer is not alone. In May of 2004, Chinese authorities coordinated enforcement efforts with several international drug makers, including Bayer and Eli Lilly, and conducted seven operations which netted a cache of counterfeit drugs estimated at US$8 million. By cooperating with local officials and providing technical expertise, pharmaceutical companies can not only increase the likelihood that counterfeit drugs are found, but by supporting local administrative agencies, drug makers can increase the likelihood counterfeit versions of their products receive enforcement attention.

Create anti-counterfeit labelling schemes
As noted above, pharmaceutical counterfeiters are increasingly sophisticated and able to recreate many of the anti-counterfeit technologies that drug makers employ, including holograms. Yet pharmaceutical companies should continue their efforts to develop sustainable anti-counterfeiting technologies. One option is Radio Frequency Identification (RFID), a technology which enables various entities throughout the supply chain to verify a drug package's validity and authenticity. Ideally, RFID would enable drug makers to both fight counterfeiters as well as increase production and distribution efficiency. Unfortunately, RFID is costly to develop and implement, requires complex software and hardware integration, and raises significant privacy concerns. As a result, drug makers will likely remain unwilling to invest in RFID until the technology has been sufficiently vetted.

There are several alternatives to RFID, including security inks, invisible digital graphics, surface fingerprinting, and infrared invisible codes. Whichever technology drug makers adapt, they must take into account the specific needs and counterfeit situation in China, and ensure that their technology of choice is feasible in a country with diverse geographical and regulatory scope.

Register 2D and 3D trademarks
Any brand owner in China has to move quickly to register its new products. Pharmaceutical companies are no different, and should ensure they are the first to register their new products in the PRC. In addition, drug makers should put the word marks on the pills themselves, not only to distinguish their products as legitimate, but also to increase likelihood of finding infringements. In addition to regular word marks, pharmaceutical companies should look into creating unique pill designs and registering those designs as 3D trademarks. Companies should be prepared, however, to move aggressively to both register the designs and protect them in the market. While there is clear support for 3D marks under China's trademark regime, examiners at China's Trademark Office have been extremely strict in approving 3D mark applications. In addition, enforceability of those marks remains as yet unproven.

Conclusion
As one of the leading exporters of counterfeit medicines, China has a responsibility to crack down on the production, distribution and export of fake drugs. In addition, the safety and health of Chinese consumers requires a nationwide and sustained commitment to keeping counterfeit pharmaceuticals off the shelves. Recent regulatory revisions and draft amendments are a step in the right direction.

Several issues still remain. China needs to continue its effort to replace incompetent, biased and poorly trained judges with a new generation of judges capable of adjudicating over complex pharmaceutical issues. And while the SFDA has been busy with structural reforms, only time will tell whether it will be an effective enforcement body. Questions remain as to whether local FDAs, in particular, will be as susceptible to protectionist pressures as their AIC counterparts.

Finally, as with other sectors, until China takes the criminal enforcement of counterfeit pharmaceuticals seriously, progress will be slow and the scale of enforcement limited. The mortal consequences of insufficient deterrence should serve as a motivating force for the necessary regulatory amendments. Whether enforcement officers will be similarly motivated is another issue. Certainly increased cooperation and information sharing between PSB and FDA officials would make the criminal enforcement of pharmaceuticals easier. In the meantime, drug makers should take a proactive approach to protecting their valuable IP in China, by pursuing effective cooperation with local regulatory agencies and creatively enforcing their trademarks. These efforts will not only allow pharmaceutical companies to profit from their significant investments, but also play a substantial role in the health of Chinese and world consumers.



Tan Loke Khoon
Duncan Willson
Baker & McKenzie
lkt@bakernet.com
duncan.willson@bakernet.com

偽冒藥品：難以下咽的苦澀藥
Tan Loke Khoon及Duncan Willson談論中國日益嚴重的偽冒藥品問題和正在採取的打擊措施。

2008年6月，廣州的一個地區法院裁定，齊齊哈爾第二制藥有限公司及位於廣州的另外兩家公司和一家醫院，對於因服用假藥而喪生的14名人士須共同承擔責任。該案的350萬元人民幣民事賠償金額的計算，包括醫療費用及所造成的精神傷害。該項判決，是於廣州中級人民法院判處5名齊齊哈爾員工涉及假藥生產而被判處入獄的大約一年後作出。

該案件雖然說明了中國對打擊偽冒藥品蔓延的決心，但亦暴露了這一惡劣行為正在全國擴散。雖然偽冒藥品估計約佔中國市場的百分之十，但某些贗品據稱已實際超過百分之三十，而在某些城市，更有可能超過了百分之四十。偽冒產品的盛行，導致對人們健康構成威脅及人命的傷亡。2007年5月，11名人士在被注射受不符合規格的化學物品污染的藥物後死亡。同年7月，發生了因為服用以「不符合規格消毒劑」製造的抗生素而導致6人死亡和80人生病的事件。

正如含三聚氰胺的嬰兒配方及含鉛玩具的情況一般，中國的偽冒藥品問題已蔓延至全球。1996年，89名海地兒童在服用了中國生產的含有防凍劑的咳嗽糖漿後死亡。數年後，中國製的減肥藥丸奪去了5名日本和新加坡婦女的性命。2005年，一名加州居民承認從中國進口偽造的威而剛以供在美國市場銷售，並承認控罪。該等進口藥片，連同他自己在本地進行的加工，價值估計超過500萬美元。

雖然偽造藥品問題，源於與其他貨品相類似的制度和市場因素，但兩者之間仍然存在若干重大差別。最明顯的是，雖然公眾人士，甚至很多執法機關，認為偽冒產品是屬於「無受害者的罪行」，但假藥對消費者所造成的傷害，並非可以藉一貫的防止偽冒統計數據（例如銷售損失）來表達。中國的假藥問題並非一個單獨存在的現象，而是因著偽冒藥品交易在全球的泛濫而加劇。中國的法例修訂和當場執法行動，不論是在遏止交易和將犯罪者繩之於法方面，必須能反映該問題的全球性。

偽冒藥品：環球角度

據世界衛生組織所言，偽冒藥品是「蓄意和欺詐性地在特性及／或來源方面貼上不實標簽」的藥物。該等產品可包含正確成份、沒有任何活性成份，或是以偽冒包裝形式銷售的活性藥物。在該定義下，偽冒藥品目前佔全球藥物的百分之十，並以每年百分之十三的速度增長。及至2010年，偽冒藥品預期將會帶來大約750億美元的利潤—其價值是合法行業規模的百分之十五。此等重大增長是基於數項原因。第一，偽冒藥品是一門利潤豐厚的生意，製造偽冒產品的人士完全不須分擔合法生產者所投入的巨額研發費用，但卻可以持續地享有高需求和低生產成品。

第二，偵查偽冒藥品是一項複雜而費用高昂的行動。消費者，有時甚至是處方的醫生本人，均無從識別合法產品和贗品之間的分別。例如，倘一名病人服用了假藥，但卻自然地康復，我們便沒有理由對某一偽冒產品產生懷疑。假如病人因服用了該假藥而導致情況變壞，但衛生保健人員卻可能錯誤地推斷是其他因素，例如抗藥性，導致病人的情況變壞。經常地，只有在發生了重大傷害事故後，當局才會採取先進技術方法來鑒定藥物的成份，並據此確定該藥物的偽冒來源。

最後的一個原因是，假藥製造者的技倆越來越高超。在最近所進行的一項對偽冒青蒿素（一種抗瘧藥）進行檢查的非活性成份研究中，調查人員發現在2001至2005的年間，假藥生產者使用先進印刷技術的能力（例如全息照片）竟有著驚人的進步。他們不單有能力將其產品加上標簽，使其有如合法的產品一般，而且亦具有「化學能力」。假藥製造者經常故意選擇偽冒藥品的成份，將其模仿真確成份的化學指紋，從而通過基本品質測試。

世界衛生組織在對偽冒藥品帶來全球性威脅所作的回應是，於2006年成立了一個名為「國際防止偽冒藥品工作隊」（以下簡稱IMPACT）的全球性伙伴組織。該組織由193個成員國（包括中國），以及執法機構、全國性藥物監管機構、非政府組織及病人團體等組成。IMPACT的宗旨是藉著組織成員國之間的執法行動，加強協調打擊偽冒產品的跨境力量，並向成員國提供有效的打擊偽冒法例以符合其本國需要，並在防偽技術的開發上提供協助。

中國的藥品市場

中國現時是世界上最大的藥品生產者，不論是合法的還是偽冒藥品。關於中國生產能力的一個例子是：她每年可以生產超過10億劑的40種以上不同疫苗。這一龐大的產量，由接近7000家註冊製藥公司來進行生產，並通過一個含341,000家藥品零售商的網絡在國內市場行銷。藥物的產值，從1998年的13.7億元人民幣上升至2007年的6679億元人民幣。

其間，國內的藥品市場持續增長。促成需求的形成，是基於以下幾項因素。第一，由於經濟發展及收入增加，人們有能力花費更多來使自己的身體健康。此外，中國的國民一般而言，已變得更加關注保健的重要性。因此，富有的消費者現時願意付出更多金錢於消費藥品方面，例如減肥藥丸及營養補充劑等。最後，由於中國的老年人口正在增加，導致與年齡相關的疾病同時上升。這種種情形，均需要獲得優質的藥品來應付需求。

然而，基於缺乏消費者教育、高昂的藥物價格，以及地方政府對偽冒產品行業的支持，形成了假藥的龐大地下市場。根據一些估計，中國現時是世界上主要的偽冒藥品及大量化學藥品的出口國。

中國在防偽冒方面的努力

中國對打擊偽冒藥品所作的承諾並非始於今天。大約10年以前，中國的食品藥品管理局官員已提及「非法藥物市集」及藥品偽冒行為的廣泛散播可能。自此，政府多次重申其在打擊偽冒藥品的生產和分銷方面的承諾。

早期努力
1984年，全國人大常務委員會通過了《中華人民共和國藥品管理法》，並訂立了生產和銷售偽冒及劣質藥物的法律責任。該法例於2001年修訂，通過在「偽冒」及「劣質」方面訂立寬泛的定義，以及在生產和銷售方面的清晰法律責任，令有關偽冒藥物的條文得以進一步充實。2003年，中國在「國家藥品監督管理局」（以下簡稱SDA）之上，設立「國家食品藥品監督管理局」（以下簡稱SFDA）。雖然SDA是在衛生部的管轄之下，但新成立的SFDA是直轄於國務院，因而除了具有更廣泛的權力外，亦較其前任機構具有更強的監管和執法權力。SFDA在進行其對製藥行業的監督時，與中國政府的其他機關共同合作，例如衛生部、國家質檢總局(AQSIQ)及國家工商行政管理局(SAIC)。例如，SFDA及SAIC共同監督藥物產品的廣告宣傳，前者集中於對藥物廣告的監控和審批，而後者則負責進行調查和實施處罰。雖然這兩個機關通常以這一方式來各自履行責任，但SFDA及各省市和縣級的食品藥品監督管理局亦有其自身的調查人員編制，這導致各機關在執行工作上出現頗為嚴重的重疊。

近期的法院案例
在過去兩年，曾經出現過若干高調打擊偽冒藥品的執法行動及法院案例，顯示中國在近年相當重視藥品知識產權的有效執法和對消費者的保護。

2006年，北京中級人民法院第一庭推翻了一項由中國專利覆審委員會於2004年所作的裁決。該項裁決有利於中國一些沒有牌子的藥品生產商，因它裁定美國輝瑞藥廠對威而剛所享有的專利無效。數月後，在另一宗案件中，北京中級人民法院所作的這一項裁決獲得遵循。該案裁定美國輝瑞藥廠的專利有效，命令兩家中國公司停止銷售其有關產品，並作出侵犯商標的賠償。

2007年7月，前SFDA局長鄭筱萸因收受超過600萬元人民幣的賄款而被處決。在他的八年任期內，該藥品監管機關批准了超過150萬宗新藥物的申請。相反，美國的食品藥品管理局每年只是大約批准140宗藥物申請。黑龍江省的警方及藥物管理人員於2007年8月搗破了一個在哈爾濱以外地方運作的全國性偽冒藥物生產組織，並拘捕了15人。這些偽冒產品的生產者，生產和分銷涉及53個國內品牌的超過100種藥物。在對偽冒藥丸及注射劑進行分析後（包括狂犬病的疫苗），發現它們大多數是使用惰性原材料來作生產，例如水份及澱粉質。

在剛過去的春天，遼寧省的高級人民法院維持了對一名前省級食品藥品管理局局長的15年刑期判決，他被裁定侵佔公款和受賄罪名成立。該名叫Zhang Shusen的官員，被裁定侵佔30萬元人民幣公帑和收受超過40萬元人民幣賄款的罪名成立。法院發現，Zhang Shusen於收受了5萬元人民幣後，曾減輕了對一名以鄰省吉林為基地的假藥生產者的判刑。

近期的監管改變
除了高資態案件數目的增加外，中國藥物監管制度的若干近期變更，亦進一步顯示了執法人員對打擊偽冒產品的生產者及分銷者的能力。

GMP認證變為強制性
2004年，SFDA公布了藥品生產質量管理規範(GMP)認證（那是專門為了提高製藥業的產品質素和安全而訂立的標準）不再是隨意性的規定。在宣告了所有藥物生產工廠必須符合GMP認證後，SFDA開始對所有藥物生產工廠進行「飛快」或「不予公布」的檢查以確保它們符合規定。該等檢查看來相當成功，因為很多生產商的GMP認證已被撤銷，而其他一些生產商則仍然被要求停業，直至它們能夠符合GMP認證為止。

廣告宣傳
中國的監管機構除了對藥物生產進行監督外，亦對虛假和誤導性的藥品宣傳加以遏制。2005年，SAIC對全國超過80家報紙的廣告的準確性進行了調查，發現了許多虛假的宣傳，包括看去有如新聞報導般的廣告，聲稱能醫治愛滋病。2007年，SFDA建立了一個制度，用以記錄藥品以及醫療裝置和健康食品的宣傳。該制度根據公司是否遵從涵蓋與健康有關的宣傳的規例，將公司分類為「可信」、「不可信」或「嚴重不可信」三類。同年9月，SFDA成立了藥品市場監督辦公室，專門關注偽冒藥品市場及與藥物有關的非法宣傳。該辦公室亦負責對藥物制劑、生物制劑及疫苗產品進行測試。

偵察性裝運車
中國當局亦從最底層來著手處理偽冒問題。2006年，中國藥品生物制品檢定所與各個省級藥物檢查機關合作，進行了打擊偽冒藥物分銷途徑的行動。該行動共動用了超過350輛配備偵查技術（例如近紅外線光譜）的裝運車，於全國28個省市執行任務。該等裝運車巡查至中國的偏遠鄉縣，在基於其規模和所處位置而並未被有力取締的偏遠地區，採取行動根除偽冒藥物的分銷網絡。

對主要藥物成份生產商的監督
2008年6月，SFDA公布其更新其主要藥物成份監督網絡的計劃。主要藥物成份乃銷售予消費者的藥物產品模塊，它的成份在生產過程中進行了化學性的改變，以求在最終產品中形成所欲產生的作用或效果。中國出口的主要藥物成份於過去數年有相當程度的增長，2007年時上升了百分之二十二。然而，對大量主要藥物成份的未經核准使用，是導致偽冒藥品充斥市場的一項主要成因。據估計，中國所生產的主要藥物成份，被大量使用於全球偽冒藥物的生產過程中。在舊有模式下，只有當主要藥物成份生產商選擇向SFDA註冊一種特定的主要藥物成份時，該主要藥物成份的生產商才會受該監管機構的監管。這一規定，只有當該生產商宣布它正在生產一種供制成藥品使用的主要藥物成份時，才會產生作用。假如該生產商並沒有宣布其為該目的而生產某種主要藥物成份的意圖，那麼便沒有任何政府機關有權禁止其如此行事。結果，該些生產商可以不受監管和檢查地大量生產主要藥物成份。在新制度下，所有主要藥物成份生產商（不單是該些為製成品生產主要藥物成份的生產商）均須向SFDA進行有關該業務的詳細登記。在這制度下，SFDA將可取得買家的資料，以及所涉及的主要藥物成份的性質。從宏觀角度看，這一制度可以讓SFDA追蹤所有主要藥物成份產品，並快速地查證涉及非法行為的活動。

SFDA草擬的提案
從了上述可見的發展外，SFDA最近亦發布了文件草稿讓公眾發表意見，而其中兩份文件更特別針對偽冒藥物，旨在讓其更難進行分銷傳播，以及增加對其提出刑事檢控的可能。

藥物標簽
去年春天，SFDA發出了一份規劃草案，計劃透過標簽編碼系統來協助進行藥物監控。該規劃草案要求藥物生產商在其藥物包裝上登錄一個14數位的編碼。該編碼將包含顯示產品種類、生產商、規格以及產地來源等方面的數字。編碼可以由機器或個人閱讀，從而有助實行結構性控制，以及為醫師和消費者提供多一重額外保障。

對偽冒藥品的生產和銷售實施刑事制裁
根據《中華人民共和國刑法》第141條，任何人如被查獲生產或銷售偽冒藥物，足以嚴重傷害人們健康的，將被判處3年以下有期徒刑。此外，假如偽冒藥物嚴重地傷害人們的健康，則生產商和售賣者的刑罰，將會從3年監禁提高至10年監禁。最後，倘假藥導致死亡，或是對人們健康造成份外嚴重的傷害，則生產商或售賣者將會被判處至少10年監禁，又或是無期徒刑或死刑。

除了刑事制裁外，刑法並沒有界定「對人們健康造成嚴重傷害」或「份外嚴重傷害」的意思為何。在此等門檻缺乏清晰定義情況下，執法部門將無法獲得提供尋求刑事制裁的指引。2007年11月，SFDA公布了最高人民法院作出有關解釋的一份草稿，讓公眾對此發表意見。這一份解釋，就上述判刑提供了所須的定義。例如，含有有毒成份，或根據國家標準而不能達標的其他藥物，可視為「足以對人們健康造成嚴重傷害」。此外，未獲生產許可而生產的藥物處方，或是任何偽冒藥物，倘其服用對象是懷孕婦女、幼兒或兒童，亦可視為足以對人們健康造成嚴重傷害」。 該解釋草案亦陳述了在甚麼情況下可判處死刑。即是：該偽冒藥品的使用，倘導致一人死亡或嚴重傷殘，或導致3名或以上人士受到嚴重傷害，或是導致10名或以上人士遭受較輕微傷害，可視為導致「人們健康的份外嚴重傷害」。最後，該解釋草案授權縣級食品藥品管理局人員作出以上所列的門檻決定，而在現行體制下，只有省級人員才有權作出如此決定。

其他相關議題

除了藥物安全的重大進展，除別是建立了一個成熟和有效的監管架構外，目前仍然存在若干嚴重問題。令人不感驚訝的是，對於持續地令其他產業在打擊偽冒產品方面的努力無法湊效的許多問題，在偽冒藥物問題上亦同樣相關，而當中最主要的問題是強制執行的嚴重不足。

執法力度不足
正如其他產業的品牌擁有人所證實的，中國的打擊偽冒產品的努力，因過度依賴效力不彰的行政執法而受損。雖然工商行政管理局(AIC)的人員有權調查偽冒產品，並於適當情況下施予懲罰，但所判處的罰款不足以有效阻嚇偽冒者。雖然AIC人員可以將較為嚴重的案件移送刑事執法當局，但此等案件的移送實際並沒有發生。例如，在2008年的首6個月，全國只有50宗偽冒案件被移送公安局人員偵辦。其中的原因有數項：第一，行政執法部門並不具備足夠能力達到所須的刑事門檻。刑法所規定的情況為，銷售方面須超過5萬元人民幣，查封方面須超過15萬元人民幣。但許多行政執法人員缺乏人手打擊這樣規模的偽冒者。因此，合法的藥品生產商只有接受地方當局所能查封的不論多少的數量，以致所處的罰款不足以阻嚇該等生產的繼續進行。

第二，行政部門人員有金錢動機將案件維持在較少規模。不單是地方官員時常因網開一面而獲得偽冒者提供報酬，一些地區的地方政府更是倚賴偽冒者所繳納的稅項和他們所作的消費來維持地方的運作。偽冒者通常在所經營的地區作出重大投資。行政部門人員可能希望對生產商處以罰款，但將場地完全查封，最終可能會導致失業。在地方官員的支持下（其影響力甚至伸延至法院），行政執法人員並沒有太大動機尋求對偽冒者施予刑事制裁。

培訓不足及不能持平的司法機構人員
即使案件被移送至民事和刑事法庭處理，藥物生產者所面對的法官，其立場是強烈偏向獲地方政府支持的偽冒者。該些法官並沒有任期保障，假如他們所作的裁決與地方政府的傾向有所抵觸，他們將可能被辭退。人民法院法官的薪酬嚴重偏低，因此即使地方政府並沒有對法院的裁量施加影響，偽冒者亦往往能夠向他們行賄而取得對其有利的裁決。

除了可能發生的司法干預外，地方法官亦囿於處理知識產權案件的經驗不足。雖然中國在為人民法院法官制訂培訓和教育標準方面，已經取得了很大的進展，但仍然缺乏在處理藥品問題上具複雜知識產權訴訟的實務經驗的法官。目前，許多法官所具有的，只是從書本上得來的有關藥品問題的二手知識。

建議

雖然最近對藥物相關法規所進行的修訂以及公布解釋草案等舉措，有助在中國經營的藥業公司保護其在知識產權方面的投資，但仍存在須加以改進的地方。

刑事門檻
雖然解釋草案對「人們健康造成傷害」作出了界定是受人歡迎的一步，但假如它們成為了法例，其本身將不能解決門檻方面的基本問題。要符合門檻的規定，中國的立場是﹕在某程度數量之內的偽冒是可以接受的，並可以加以忽視。但遇到偽冒藥品方面的問題時，當中涉及有可能會導致死亡的情況發生，故假如接納上述立場的話，這是拿中國消者的健康來作賭注。如以上所述，行政部門人員缺乏人手達至刑事案件的門檻。所建議的解釋，雖然為刑事制裁提供了額外的途徑，但無助於解決地方行政部門缺乏人手及專門技術知識來進行所須調查的問題。只要中國對於提供技術性培訓，及向地方行政機關提供額外資源方面有更認真的承擔，我們便必然會發現在這方面的刑事審訊將會有著顯著的增加。

就偽冒藥品而言，中國應與品牌擁有人採取相類的立場﹕所有贗品均應以相同的方式對待。偽冒藥品應是一項罪行，不管生產商所生產的產品價值是4000元還是40萬元。所作的區分，應只是局限於在判刑方面。中國應在刑法的適當地方進行修訂，對於任何蓄意在成份、來源、特性或效果方面作出虛假標簽的藥品，其生產、分銷和進出口等，均應予以刑事化的制裁。

各部門之間的合作
SFDA只負責偽冒藥品的行政處罰，不能作出刑事懲處。因此，地方的食品藥品管理局的執法行動的大幅增加，不能有助偽冒藥品在相應幅度上的減少。為補救這一情況，SFDA應將焦點投放在與公安人員加強合作，並相互分享技術性資源方面。假如它能就與藥品調查有關的技術和方法，與具經驗的警務人員分享其專門知識，這將有助雙方共同協作，對偽冒行為施加大幅的刑事制裁。

但還應不止於此。偽冒藥品所涉及的範圍，要求SFDA須與郵政部門攜手，打擊通過郵遞來非法運送偽冒藥物的行徑。此外，SFDA亦應與海關合作，確保偽冒藥物，特別是大量的主要藥物成份，不會被出口到外地供非法使用。中國的打擊偽冒努力，必須意識到中國的藥品偽冒者，在環球假藥市場上扮演著主導的角色。

國際合作
最近，國際警察組織與世界衛生組織及牛津大學的科學家共同合作，意圖打擊華南一個生產偽冒抗瘧藥的組織。經過科學家們的分析後，發現該等藥物含有花粉粒和礦物，並能夠指出其來源地是雲南。在成功地採取一項名為「木星行動」的掃蕩中，說明在打擊偽冒藥物方面，除了需要建立有效的監管架構外，還需要大量的財政和資源上的支持。本案所使用的法證技術，在偽冒藥品最為盛行的國家，卻是無法獲得提供。

中國要成功地打擊國內的偽冒活動，她與國際間的合作是十分重要的。中國應繼續與諸如IMPACT及美國食品藥品管理局等組織合作，從而在與偽冒藥品對抗的這一場戰役上加強其裝備。

商業上的解決方法

已經在中國經營的藥業公司，不能只是乾等中國的執法機關及藥品相關法規何時變得更具成效。該等公司應採取若干策略來減輕對其藥品的偽冒。

與地方行政機關合作
從2003年開始，美國輝瑞藥廠在上海簽訂了兩項突破性的諒解備忘錄，一項是與當地的AIC簽訂，而另一項是於2004年與上海市的食品藥品管理局簽訂。在該等備忘錄中，美國輝瑞藥廠承諾提供專門培訓和支援人員，以協助他們打擊在上海地區的偽冒藥品活動。該項行動取得了成功。一年後，中國官員查封了60萬個偽冒威而剛標簽及44萬片偽冒的威而剛藥片，估計約值430萬美元。

美國輝瑞藥廠也並非只有自己孤獨行事。2004年5月，中國當局在執法時與數家國際製藥公司（包括拜意及美國禮來公司）配合，並採取了七次執法行動，搜獲估計約值800萬美元的假藥。透過與地方官員合作並提供技術知識支援，藥業公司不單可以增加搜獲假藥的機會，亦可以藉著向當地行政機關提供支援，得以令偽冒其產品的該些假藥獲得執法機關的留意。

訂立防止偽冒標簽計劃
如以上所述。偽冒藥品生產者的技術越來越高，可以複製藥物生產者所使用的防偽技術，包括全息圖片。但藥業公司應繼續努力發展可持續的防偽技術。其中一個可考慮的選擇是無線射頻身分識別系統，那是一種讓整條供應鏈中的各個實體能夠核實一個藥物包裝的有效性和真確性的技術。理想的情況是，無線射頻身分識別系統可讓藥物生產者在對抗偽冒者的同時，亦能提升生產和分銷效率。不幸的是，發展和執行無線射頻身分識別系統的費用相當昂貴，需要將複雜的軟硬件結合，並引起了對私隱問題的高度關注。因此，藥物生產者仍會不願意投資於無線射頻身分識別系統，直至該技術經過充分的實踐為止。

替代無線射頻身分識別系統的方法有數種，包括安全墨水、無形數字圖像、表面指紋識別，以及紅外線隱形編碼等。無論藥物生產者採用哪一種技術，它們都必須關注中國的特殊需要和偽冒情況，並確保它們所選擇的技術在一個在地理和法規方面均異常多樣的國家具有可行性。

2D及3D商標註冊
中國的任何品牌所有人都必須迅速地為其新產品註冊。藥業公司也不例外，並應確保能在第一時間於中國為其新產品註冊。此外，藥物生產者應將文字標記放在其藥片上，這不單是為了顯示其產品是合法，也為了提高發現侵權行為的可能性。除了正常的文字標記外，藥業公司也應在其生產的藥片上進行獨有的設計，並將該等設計註冊為3D商標。然而，各企業應該積極地將其設計註冊，以及在市場上保護它們。雖然在中國的商標制度下，3D商標獲得明顯的支持，但中國的商標局在審批3D商標註冊申請的過程中極為嚴格。此外，在該等商標的權利執行方面情況如何，目前仍無法知曉。

結語

中國作為偽冒藥品的主要輸出者，有責任對假藥的生產、分銷和出口進行打擊。此外，為了保障中國消費者的健康，故需要全國採取持久的措施，使偽冒藥品不能在市場上出現。近期進行的法規修改及草稿修訂，是朝向正確方向的一步。

目前仍然存在數個問題。中國需要繼續努力，以新一代的能夠就複雜藥物案件作出裁決的法官，來取代力有不棣、不能持平及訓練不足的法官。SFDA已努力進行架構改革，但只有時間才能證明它是否一個有效的執法機關。所須關注的問題依然是，地方上的食品藥品管理局，是否仍然有如地方上的工商行政局一般，屈服於保護主義者所施加的壓力。

最後，與其他的範疇一般，在中國能夠對偽冒藥品嚴格地採取刑事執法以前，所獲得的進展將會是緩慢的，執法的規模將會是受局限的。阻嚇力不足所導致的嚴重後果，應是進行必須的法例修訂的驅動力量。至於執法人員是否也能夠同樣被驅動，這是另一個問題。公安局和食品藥品管理局的人員之間的加強合作和資訊分享，必然會促使在藥品方面的刑事執法更為順利。目前，藥物生產者應採取積極的措施，通過與當地監管機構的有效合作，具創意地實施其商標權利，從而保護其在中國的寶貴知識產權。該等努力將不僅可以使藥業公司從其重大投資中獲益，亦將會在中國及全球消費者的健康方面作出重大建樹。




Tan Loke Khoon
Duncan Willson
Baker & McKenzie
lkt@bakernet.com
duncan.willson@bakernet.com