Interpol, Pharma Join Hands Against The Crime Of Fake Pharmaceuticals

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Members of the pharmaceutical industry and Interpol have agreed on a plan to fight “fake” medicines and other pharmaceutical crimes, echoing efforts to address the issue at the World Health Organization in recent years.

Announced on 12 March, the initiative, which proposes to address “pharmaceutical crime,” including counterfeits, is somewhat reminiscent of the World Health Organization’s task force against counterfeit medicines. That initiative was considered to mingle intellectual property issues with public health and has been supplanted by a new member state mechanism.

The Interpol Pharmaceutical Crime Programme will focus on the prevention of all types of “pharmaceutical crime,” including branded and generic drug counterfeiting, a press release said, and will also serve to identify and dismantle organised crime networks linked to this activity. Interpol said such products threaten the health of millions of people.

The three-year programme will cost €4.5 million (approximately US$5.8 million) and will build on the work of Interpol’s Medical Product Counterfeiting and Pharmaceutical Crime unit. A total of 29 pharmaceutical companies are part of the agreement, among which are Abbott, Bayer, Bristol-Myers Squibb, Merck, Novartis, Roche and Sanofi. Interpol is the world’s largest international police organisation, with 190 member countries, and is based in Lyon, France.

Interpol Secretary General Ronald Noble said in the release, “With no country, no drug, no medical product immune from counterfeiting, a global effort is needed to combat this threat which puts the lives of millions of people at risk every single day,” adding that the initiative is bridging the public and private sectors to help Interpol and its members to tackle the problem.

[Update:]  India generics companies have raised concerns that the initiative could backfire, as “in the global market place, generics have had to constantly fend off overt and covert efforts to disparage them and label them ‘counterfeit’.” In a story published on 14 March, the Hindu (Business Line) quoted D.G. Shah of the Indian Pharmaceutical Alliance as saying that the Interpol agreement is “a continuation of the efforts by branded companies to use such agencies as Customs and universal postal unions to target generics as counterfeits.” [end update]

Public Awareness, Capacity Building – and Definitions

One of the missions of the programme is to raise public awareness of the dangers of fake drugs, in particular in the digital world, the release said. The programme is expected to include training, capacity building and “targeted enforcement actions to build awareness of the issue, as well as to disrupt and dismantle the organized crime networks involved in the various types of pharmaceutical crimes such as counterfeiting, illicit sales or illicit diversions.”

“In the case of drug counterfeiting, it can mean the difference between life and death for a patient,” Sanofi CEO Christopher Viehbacher said in the release. Interpol illustrated the issue by citing a “counterfeit” cough syrup containing diethylene glycol that caused “eight mass poisonings around the world including in 2006 in Panama where more than 100 people died, many of them children.”

According to a civil society source, the World Health Organization Bulletin reported on a case of poisoning in Panama in 2006 involving a cough syrup containing diethylene glycol provoking acute renal failure, however it does not appear to have been established that the contamination was the result of drug counterfeiting. Rather, it appeared to have been a case of a wrongly labelled imported ingredient.

According to the WHO Bulletin, “Epidemiological and laboratory findings implicated a prescription liquid cough syrup, produced by a CSS [Caja del Seguro Social] hospital pharmaceutical manufacturing facility, as the cause of the outbreak in Panama.” “The presence of DEG was finally confirmed in a single lot number of a product that was labelled as glycerin and that was imported to Panama from China via a European broker,” the bulletin said.

WHO is seen as having competency in determining the quality of medical products, but not in whether there have been intellectual property rights violations. For many, counterfeiting implies IP rights violations. It is not clear whether Interpol and the companies are making this distinction in terms or not.

Interpol defined pharmaceutical crime as involving “the manufacture, trade and distribution of fake, stolen or illicit medicines and medical devices,” it said. “It encompasses the counterfeiting and falsification of medical products, their packaging and associated documentation, as well as theft, fraud, illicit diversion, smuggling, trafficking, and money laundering.”

The use of the denomination of counterfeit medicines in unsafe, falsely labelled or spurious medicines has been fought over by some developing countries and civil society as mixing a trademark issue with the issue of quality, accessibility, and affordability of medicines, and even the sale of legitimate generic versions of medicines. Under global trade rules, counterfeit would refer to a trademark violation, purposely labelled as a brand-name product by someone other than the trademark owner.

But the new programme announcement said that generics can also suffer the same fate as brand names. “Both brand-name and generic pharmaceuticals are susceptible to counterfeiting, putting patient lives at risk,” said Haruo Naito, president and CEO of Eisai. In recent years, a number of brand-name pharmaceutical companies have invested in generic manufacture.

Meanwhile, developing countries have repeatedly asked for help in addressing the problem of counterfeit and substandard medicines.

“Putting an end to counterfeiting requires broad, coordinated action on a global scale,” said John Lechleiter, chairman, president, and chief executive officer of Eli Lilly. “This new initiative between the pharmaceutical industry and Interpol is aimed at helping ensure that patients can trust in the safety and efficacy of the medicines they rely on.”

International Federation of Pharmaceutical Manufacturers & Associations Director for Public Affairs & Global Health Policy, Mario Ottiglio, told Intellectual Property Watch that “IFPMA supports this partnership between Interpol and our industry to combat counterfeit medicines, which is a crime against patients. It complements anti-counterfeiting efforts, such as awareness-raising, that we and our companies have led for several years and will contribute to protecting patients.”

WHO Supportive of Strict Public Health Target, No IP

A WHO source told Intellectual Property Watch that the WHO is supportive of actions that minimise the risks to patients and consumers from substandard/spurious/falsely-labelled/falsified/counterfeit (SSFFC) medical products.

The issue of poor quality medicines has been addressed at the WHO for a number of years. In 2006, the WHO launched, in conjunction with Interpol, the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). But IMPACT’s location within the WHO was criticised by developing countries and civil society as putting a focus on counterfeiting, which they said is an intellectual property rights issue rather than a health issue (IPW, WHO, 3 March 2011).

In 2010, the World Health Assembly (WHA) convened a working group to examine WHO’s role in ensuring the availability of safe and affordable medicines, its role in the prevention of SSFFC medical products, and its relationship with IMPACT, according to the WHO. In 2012, the WHA adopted a resolution to create a new member state mechanism on SSFFC medical products. The first meeting of the member state mechanism took place from 19-21 November 2012 in Buenos Aires, Argentina.

But final agreement on the mechanism was not reached in Buenos Aires, and another meeting is expected to be held before the upcoming WHA from 20-28 May (IPW, WHO, 28 January 2013).

“Interpol will work with all those involved in fighting fake medicines including the WHO and have enjoyed success with them in the past. We intend to continue to work with them in the future,” an Interpol source told Intellectual Property Watch.

The WHO, the source said, is entirely focused upon the detrimental effect upon public health posed by these products as opposed to the enforcement and protection of intellectual property rights, which is a responsibility of other agencies.

According to a WHO spokesperson, the Interpol initiative is completely separate from the new member state mechanism. Meanwhile, IMPACT still exists, and IMPACT’s secretariat is now held by the Italian National Medicines Regulatory Authority, the spokesperson said.

It is estimated that up to 50 percent of medicines supplied through websites which conceal their physical address are supplied illegally or are falsified, according to the WHO.

According to Christopher Paun, a scholar at the University of Bremmen, Germany, “this public-private partnership at Interpol is another sign of how Interpol’s role in fighting counterfeit medicines has increased over the last years, while the role of the WHO has declined.” Paun recently completed his Ph.D. on this subject.

This is the result of the deadlock at the WHO concerning the IMPACT taskforce, he told Intellectual Property Watch, adding that “the pharmaceutical companies are only willing to support a global PPP [public-private partnership] if they think it is worthwhile. While there is deadlock at the WHO, Interpol has shown tangible results, e.g. with the Interpol-led operation Pangea.”

The Pangea operation is coordinated by Interpol and brings together customs, health regulators, national police and the private sector from countries around the world, according to Interpol.

Civil Society Concerns About Confusion

According to Sangeeta Shashikant of the non-profit Third World Network, “In defining medical products with compromised quality, safety and efficacy, WHO is moving away from using the word ‘counterfeit’ which actually refers to a specific type of trademark infringement.”

“The Interpol initiative, rather than assisting in bringing more clarity to the issue, continues to create confusion as to what specifically is being targeted by using the term ‘counterfeit’,” she said. “It is also unclear if the initiative is targeting all forms of poor quality and unsafe medical products or medical products from unlicensed manufacturers or if it includes unsafe medical products from licensed manufacturers.”

“Further, the approach taken by Interpol is rather concerning as it focuses on law enforcement without addressing the critical lack of functioning drug regulatory authorities in most of the developing world and access to affordable medical products,” she told Intellectual Property Watch. “Without addressing these fundamental issues, the problem of medical products with compromised QSE [quality, safety and efficacy] cannot be addressed effectively. Also concerning is the involvement of the private sector in criminal law administration.

 

Catherine Saez may be reached at info@ip-watch.ch.

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