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IP-Watch interns talk about their Geneva experience in summer 2013. 2:42.

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    UN Takes On Organised Crime And Fraudulent Medicines

    Published on 15 February 2013 @ 5:33 am

    By and for Intellectual Property Watch

    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.

     

    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.

    2. International Law Info and Policy says:

      [...] some domestic regulators, sometimes with the assistance of the UN Agencies, have begun to address some international business corruption, they also have been [...]


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    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website. By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    We welcome your participation in article and blog comment threads, and other discussion forums, where we encourage you to analyse and react to the content available on the Intellectual Property Watch website.

    By participating in discussions or reader forums, or by submitting opinion pieces or comments to articles, blogs, reviews or multimedia features, you are consenting to these rules.

    1. You agree that you are fully responsible for the content that you post. You will not knowingly post content that violates the copyright, trademark, patent or other intellectual property right of any third party or which you know is under a confidentiality obligation preventing its publication and that you will request removal of the same should you discover that you have violated this provision. Likewise, you may not post content that is libelous, defamatory, obscene, abusive, that violates a third party's right to privacy, that otherwise violates any applicable local, state, national or international law, that amounts to spamming or that is otherwise inappropriate. You may not post content that degrades others on the basis of gender, race, class, ethnicity, national origin, religion, sexual preference, disability or other classification. Epithets and other language intended to intimidate or to incite violence are also prohibited. Furthermore, you may not impersonate others.

    2. You understand and agree that Intellectual Property Watch is not responsible for any content posted by you or third parties. You further understand that IP Watch does not monitor the content posted. Nevertheless, IP Watch may monitor the any user-generated content as it chooses and reserves the right to remove, edit or otherwise alter content that it deems inappropriate for any reason whatever without consent nor notice. We further reserve the right, in our sole discretion, to remove a user's privilege to post content on our site. IP Watch is not in any manner endorsing the content of the discussion forums and cannot and will not vouch for its reliability or otherwise accept liability for it.

    3. By submitting any contribution to IP Watch, you warrant that your contribution is your own original work and that you have the right to make it available to IP Watch for all purposes and you agree to indemnify IP Watch, its directors, employees and agents against all damages, legal fees and others expenses that may be incurred by IP Watch as a result of your breach of warranty or of these terms.

    4. You further agree not to publish any personal information about yourself or anyone else (for example telephone number or home address). If you add a comment to a blog, be aware that your email address will be apparent.

    5. IP Watch will not be liable for any loss including but not limited to the following (whether such losses are foreseen, known or otherwise): loss of data, loss of revenue or anticipated profit, loss of business, loss of opportunity, loss of goodwill or injury to reputation, losses suffered by third parties, any indirect, consequential or exemplary damages.

    6. You understand and agree that the discussion forums are to be used only for non-commercial purposes. You may not solicit funds, promote commercial entities or otherwise engage in commercial activity in our discussion forums.

    7. You acknowledge and agree that you use and/or rely on any information obtained through the discussion forums at your own risk.

    8. For any content that you post, you hereby grant to IP Watch the royalty-free, irrevocable, perpetual, exclusive and fully sub-licensable license to use, reproduce, modify, adapt, publish, translate, create derivative works from, distribute, perform and display such content in whole or in part, world-wide and to incorporate it in other works, in any form, media or technology now known or later developed.

    9. These terms and your posts and contributions shall be governed and interpreted in accordance with the laws of Switzerland (without giving effect to conflict of laws principles thereof) and any dispute exclusively settled by the Courts of the Canton of Geneva.

     

     
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