Friday, February 3, 2012

Spurious medicine scare: Are they faking it?

KM Gopakumar/New Delhi

Although spurious medicines are in circulation, the threat is not as serious as it is made out by big multi-national pharma companies

Initiatives to address the issue of spurious medicine/counterfeit medicine at national and international level is a classic case of propaganda based law and policy making without concrete evidence. It is a fact that the problem of medicine with compromised quality, safety and efficacy (QSE) can endanger the life of patients. No one is denying the circulation of medicines with compromised QSE. However, the dispute is with regard to the scare mongering and the absence of evidence to show the prevalence of the problem. There is an attempt to see it in binary medicines with QSE and medicines with compromised QSE. This approach would lead to hushing up the real issues i.e. availability of affordable medicines with QSE and may help to further the commercial interest by enhancing intellectual property (IP) enforcement standards especially those related to the trademark and patents. Naturally, pharmaceutical multi-national corporations (MNCs), the first beneficiary, are the vociferous campaigner as well as supporter of the campaign to "combat counterfeit " medicines. This aggressive campaign if translated into law and policy may hamper availability of affordable medicines with QSE.
It is important to have a nuanced approach to the issue. The circulation of medicines with compromised QSE is not a black and white story. Manufacturing and distribution of medicine is one of the most regulated industries primarily due to the public health implications including the safety of the patients. All activities starting from manufacture to distribution are regulated through licensing. Licensing requirements are imposed on all actors starting form manufacturer, wholesale dealer and retail chemists. Further, guidelines in the form of good manufacturing, distribution and quality checking practices are in place to regulate procurement of raw material, transportation and storage of finished formulations. Anyone indulging in any activities viz. manufacturing or distribution of medicines without licence is treated as an offence under many national laws, including Drugs and Cosmetic Act.
As a result, there can be two scenarios: First, production and distribution of medicines with compromised QSE by license holders. Second, production and distribution of medicines with compromised QSE. The second situation is already a criminal offence. The first scenario is more complicated and need nuanced approach because QSR of medicine can be compromised in many ways.
QSE can get compromised manufacturing, distribution and storage stage. For instance, QSE of a medicine produced with all quality standards as per the good manufacturing practises may get compromised due to poor transporting and storage facilities. Similarly, QSE may get compromised due to poor quality of raw materials used or due to technical problems in the manufacturing process. QSE can also get compromised without following the good manufacturing practices or poor quality packaging materials. At times QSE is affected due to poor label information, including false information on dosage. For instance, a label information states the dosage of tablet as 50 mg but the actual does is either below or above than 50 mg. Even QSE may be affected even at the hand of patient's hand in the absence of proper storage instructions. The worst case of medicines with compromised QSE is the production and distribution of medicines without any active pharmaceutical ingredients (API) or inadequate API. This should be dealt with stringently without any margin of appreciation. Hence, medicine manufacturer alone cannot be held liable. Each situation demands special particular law and policy intervention and proper incentive and disincentive need to be built in the regulatory system. Therefore, it is not proper to dump all such medicines as counterfeit or spurious products.
Most of the regulatory system requires the manufacturer to provide such information on the label to enable trace and track the origin of medicine. Now, many new technologies are available for track and trace mechanism. However, most of the new technologies are patented and therefore costly to use. Therefore, it is important to use cost effective technologies to ensure affordability.
In policy circles, terms like substandard, spurious, falsely labelled, falsified and counterfeit are used to refer medicines with compromised QSE. One can also find terms like fake medicine, fraudulent medicine. Technically speaking all these terminologies are different and cannot be used interchangeably.

The hidden agenda
The MNC campaign does not follow the above mentioned nuanced approach and just conveys the message that "combating counterfeit medicines" because counterfeit drugs kill. (Spurious medicines in the Indian context). Some of the brochures convey the following messages: Counterfeits have harmful effects on patients' health and can kill; Counterfeits frustrate efforts to deal with high burdens of disease; Counterfeits undermine health care systems; Increased international collaboration is essential to defeat counterfeiting; Combating counterfeiters requires acting at the same time on legislation, regulations, enforcement, technology and communication strategies.
The trap is lies in the word 'counterfeit', which is legally associated with the criminal infringement of trademark. There are two types of infringement of trademarks viz. civil and criminal. A criminal trademark infringement occurs when someone uses a trademark (literal copying of trademark) without the permission of the trademark owner. For instance, someone uses the brand name "Crocin" to sell paracetomol without the permission of the owner of the trademark i.e Glaxo SmithKline Beecham. This is treated as criminal infringement of trademark. However, if someone uses the brand name 'Procin" instead of "Crocin" then it may amount to a civil infringement of trademark but not a criminal offence. The only remedy in that case for Glaxo is to file civil suit and obtain an order against the use of the word "Procin". By projecting counterfeit medicine as a threat to public health, which is essentially an intellectual property issue, MNCs want to use Drug Regulatory Authorities to enforce intellectual property enforcement. In order to achieve this objective MNCs are conflating the QSE issues of medicines with the IP enforcement and advocating for a set of law and policy changes, which would strengthen the IP enforcement.
The hidden agenda behind 'combat counterfeit' campaign at the international level is the enhancement of IP enforcement standards. After the conclusion of the TRIPS Agreement, which obligated all WTO Member States with a few different transitions periods to least developed countries (LDCs) to accept common minimum standard for IP protection and enforcement standards. Immediately, after the conclusion of the TRIPS Agreement MNCs and developed countries together pushing for TRIPS Plus IP protection and enforcement standards through various forums, including Free Trade Agreements ( FTA). The objective of the TRIPS Plus is to close the policy space available on intellectual properties due to the flexibilities in the TRIPS Agreement. Unlike the earlier initiatives, the new ones, especially IP protection and enforcement, are pushed through unilateral, bilateral, plurilateral and multilateral level. At the multilateral level, various multilateral organisations were used to set up multi-stakeholder platforms on IP enforcement viz. WCO (SECURE), WHO (IMPACT), INTERPOL (IP Crime Unit) etc. WHO's IP enforcement platform known as International Medical Products Anti-Counterfeit Task Force (IMPACT) deserves the special mention. This was launched in 2006. G8 Declaration of 2007 states that "Trade in pirated and counterfeit goods threatens health, safety and security of consumers worldwide, particularly in poorer countries. In this regard we welcome work on the WHO initiative to implement the International Medicinal Products Anti-Counterfeit Task Force (IMPACT)." Thus G8 declaration makes it clear that IMPACT is an initiative to enforce IP. The multi-stake holder platform was launched even without the approval WHO governing bodies. Now, the WHO Member States are engaged in a discussion to address the QSE concerns related to medicines and the disengagement of WHO form IMPACT as well as the dropping of the word counterfeit to refer toe QSE of medicine. The upcoming World Health Assembly is to approve Member State mechanism to examine the QSE and access issues of medicine. Raising concerns on WHO's involvement on counterfeit medicines 52 civil society organisations (CSOs) wrote to WHO in November on these issues.
Another important issue related to counterfeit/spurious medicine initiative is the lack of evidence. According to Prof. Kevin Outtersson and Ryan Smith, not only that the evidence for counterfeit drugs is anecdotal rather than empirical but that the only comprehensive collection point for global data on counterfeiting is the Pharmaceutical Security Institute (PSI)-a trade organisation created by the security directors of 14 global drug companies that does not make data available to the public". Thus, there is no independently verifiable data available globally to determine the degree of prevalence of counterfeit/spurious problem. According to humanitarian group Doctors Without Borders, substandard medicines represent far larger risk to public health than spurious medicine. Further, WHO data does not make any difference between substandard, spurious or counterfeit. Therefore, policy makers are not informed the real nature of each problem. As a result, it blocks a nuanced law and policy reforms. MNCs make use of this situation to push their agenda.
Another important problem is that counterfeit/spurious medicine camping mainly focus on stringent and law and its enforcement along with complementary use of technologies to track and trace. There are many technologies existing, including radio frequency technologies to track the final user. Many of these technologies protected under and therefore use of these technologies is not easy and impacts the price of medicines. Similarly many solutions advocated by the MNCs campaigners would result in the high cost of medicine and squeeze generic industry. Therefore the measures on QSE need to be evidence based and should not increase the cost of medicines.
It is not strange that the campaign is not looking at the high price of and unethical promotion of medicines, which are identified as one of the important reasons for the circulation of medicines by fly by night operators.
In India too, the picture is not different from the global context. The campaign on spurious drugs started with a few reports in 2003 citing a WHO study, which WHO later denies even the existence of such a study. According to the alleged WHO study, 35% of global counterfeit medicine produced in India and nearly 20% of medicines available in the domestic market is spurious. In response to the press reports, the Health Ministry appointed a committee under the Chairmanship of then Director General RA Mashelkar to examine the quantity of spurious medicines and strengthening of drug regulation. The Committee recommended capital punishment for those who produce spurious medicines. However, the Government reduced the capital punishment to life imprisonment and amended Drugs and Cosmetic Act accordingly.
Of late, a new partnership has been formed in India which is known as Partnership for Safe Medicine. This new partnership is listed as the India chapter of for Partnership for Safe Medicine USA, a partnership sponsored by pharmaceutical MNCs. Partnership for Safe Medicine USA lists Pharmaceutical Research and Manufactures Association of America (Ph RMA) and Pharmaceutical Security Institute (PSI) as its partners. Further, two board of directors are from industry, one belongs to Pharmaceutical Security Institute, one is the global policy head of Merck & Co and one is from PhRMA.

The way forward
There is a need for a cautious approach and both the government and civil society organisations should not be carried away by the MNC propaganda. Law and policy makers should go beyond headlines and really look at the nature of QSE compromise and make appropriate classification of medicines instead of branding them as spurious or counterfeit. First, the policy response should focus a public health approach to address the genuine public health concerns emerging out of medicines with compromised QSE. Second, the thrust of the policy response should ensure availability of affordable medicines with QSE. Third, strengthen the monitoring capacity of drug regulatory authorities at the central and state level including their coordination action. Four, use the low cost information technology tools to increase the track and trace capabilities’ of regulatory agencies including their capability to recall medicines of compromised QSE. Fifth, increase the consumer awareness through appropriate communication and education strategy. Private actors should not be allowed to carry out such consumer education due to the potential conflict of interest.
(The author is Member, National Working Group on Patent Laws.)

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