UN Takes On Organised Crime And Fraudulent Medicines

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The United Nations has become a focal point for global efforts to fight organised crime’s trafficking of fraudulent medicines that put millions of people – especially the poor – at risk. And a recent pharmaceutical industry report on such medicines recommended some solutions.

“[W]hat really matters is that fraudulent medicines are a severe public health risk. They deserve our full attention,” said Yury Fedotov, executive director of the UN Office on Drugs and Crime (UNODC). “Where medicine is designed to bring treatment and relief, fraudulent medicines deliver only suffering, misery and even death.”

The UNODC is hosting a meeting on the issue on 14-15 February in Vienna, Austria. The conference brings together international organisations, NGOs, member states, industry representatives, industry associations, and regulatory and law enforcement officials to discuss the illicit production, distribution and trafficking, according to UNODC. Participants were expected to include the research-based pharmaceutical industry.

Several documents from the conference preparations were shared with Intellectual Property Watch, including a draft agenda [pdf], and an invitation letter [pdf].

“The aim of this conference is to raise awareness and to discuss a joint way forward by enhancing synergies to counter the illicit trade in fraudulent medicines,” the invitation letter said.

According to a UNODC press release on 14 February, speakers were expected to include: World Customs Organization Secretary General Kunio Mikuriya; Interpol President Mireille Ballestrazzi; French Ambassador on Organized Crime Michèle Ramis; and World Health Organization Director of Essential Medicines and Health Products Kees de Joncheere.

As much as 30 percent of medicines in parts of Asia, Africa and Latin America could be fraudulent, the UNODC said.

In his remarks, Fedotov said the basis for the work will be the UN Convention on Transnational Organized Crime (UNTOC), which provides for “the exchange of information, the application of investigative powers, and information sharing that is often invaluable in these types of criminal operations.” He called on governments to ratify and implement the convention.

Fedotov also urged the early adoption of an efficient review mechanism for the implementation of UNTOC, and to integrate local national crime strategies and our overall international approach.

The UNODC also is working with others on customs inspection and control (such as shipping containers), and in seizing assets and pursuing leaders of the trade in illicit goods, including fraudulent medicines.

Defining Fraudulent

But what constitutes a fraudulent medicine and how these efforts will take into account public access to affordable medicines remains to be seen. The fight against counterfeit and substandard medicines has in recent years led to policy debates over the balance between aggressively stopping such medicines, and not interfering with the free flow of legitimate generic versions of medicines. Some have also raised concern that brand-name producers from developed countries who offer higher priced patented versions of medicines might have been fuelling public confusion between poor quality medicines and legal less expensive generics with which they compete.

It is worth noting that a few months ago (IPW, United Nations, 2 July 2012), the UNODC was referring to these medicines as counterfeit but now uses the word fraudulent. Debates over terms at the WHO have shown that some parties see the word counterfeit as strictly an intellectual property issue, referring to falsely packaged products that violate trademarks (and regardless of the quality of the contents). This is a reference to the protection of IPR under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS).

WHO members acknowledge there is a problem but have had such difficulty in agreeing on the issue they refer to it formally as “substandard/spurious/falsely-labelled/falsified/counterfeit.”

Report Offers Industry Solutions to Falsified Medicines

By Tiphaine Nunzia Caulier for Intellectual Property Watch

A recent private sector report examined domestic and international issues relating to the prevention and control of falsified medicines, and offered solutions ranging from awareness-raising about the danger of such medicines to strengthening oversight and control and deepening global coordination.

The report [pdf], “Falsified Medicines and the Global Public’s Health,” was commissioned by the Geneva-based International Federation of Pharmaceutical Manufacturers and Associations (IFPMA), whose members comprise leading international companies as well as national and regional pharmaceutical industry associations in both developing and developed countries. The report was independently undertaken by the University College London School of Pharmacy, and Matrix Insight, an international research agency.

The analysis presents some domestic improvements in the drug falsification control. It focusses on the Indian experience where a national drug agency was created to better harmonise national law with the different Indian regional regulations dealing with control and prevention of drug falsification. It also shows that in Brazil, the government extended low-cost access to good quality medicines in the most deprived areas.

Regarding the international solutions, the report acknowledges the prominent role the World Health Organization has in the prevention and control of falsified drugs, but it stresses that the need for more developed and effective intergovernmental cooperation.

The analysis highlights the previous work of IMPACT – the International Medical Products Anti-Counterfeiting Taskforce, jointly launched in 2006 by the WHO, UNODC, and Interpol. According to the report, these joint actions must aim at raising awareness about the danger of falsified medicines. These actions should also tackle the enforcement of laws punishing medicines falsification.

The report highlighted that the poorest regions of the globe are also the biggest victims of falsified drugs. There, one might trace a correlation between poverty, problems in access to genuine drugs and decision to use falsified medication.

The report does hint several times at the problem in access to high quality and affordable medicines. But it heavily relies on the role governments and international actors should play without mentioning the role pharmaceutical companies could take. The high price of original medicines is the main reason why some deprived people end up resorting to falsified drugs. It could be argued that if pharmaceutical companies were to reduce their margin profits and, if the balance between promoting research and development – through patents – and the absolute needs of medication of patients were better addressed, the incentive to buy cheaper yet unsafe drugs would disappear. Under this theory, patients would not seek recourse to falsified drugs if affordable access to reliable drugs were mainstreamed.

Tiphaine Nunzia Caulier recently graduated with a Master in International Law from the Graduate Institute in Geneva and UCLA School of Law. Through her work experiences and academic interests she has specialized in international trade, intellectual property, and public health.

 

William New may be reached at wnew@ip-watch.ch.

Tiphaine Nunzia Caulier may be reached at info@ip-watch.ch.

Creative Commons License"UN Takes On Organised Crime And Fraudulent Medicines" by Intellectual Property Watch is licensed under a Creative Commons Attribution-NonCommercial-ShareAlike 4.0 International License.

Comments

  1. R El Oakley says

    To the Editor; We look forward to the outcome report on this 2 day meeting on “Fraudulent Medicines”. The subject represent a Pandemic of Fake medicine affecting every country particularly those with weak or dysfunctional Pharmaceutical Regulatory Body. Many options are on the card with particular focus on strengthening regulatory agencies and borders control. It is rather fortunate that the pharmaceutical industry have an invested interest in controlling this international problem. One simple solution that can help further is to encourage the manufactures to add a “scratchable” unique identifier code (similar to that of the pre-paid phone cards) to be added to every container, box and vial. These codes can be used to verify the authenticity of; 1. The container, at the point(s) of shipment. 2. The larger box, at the point of storage and distribution. The actual vial, by the end-user.

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