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    Inside Views
    Inside Views: WHO / EU “Bad Medicine” Plans: Flaws, Coordination Gaps

    Published on 2 April 2012 @ 1:09 pm

    Disclaimer: the views expressed in this column are solely those of the authors and are not associated with Intellectual Property Watch. IP-Watch expressly disclaims and refuses any responsibility or liability for the content, style or form of any posts made to this forum, which remain solely the responsibility of their authors.

    Intellectual Property Watch

    By Daniele Dionisio

    The latest World Health Organization / European Union plans to counter the trade in counterfeit and substandard medicines aim to ensure that medicines in the developing world are safe. As such, though both plans appropriately address quality issues, they fall short of adequate coordination and collaboration with each other, and also present substantial flaws.

    The poor legislative and regulatory framework monitoring the quality of medicines in the developing countries allows the trade in counterfeit and substandard medicines to boom. This problem must be addressed by ensuring that medicines in the developing world are safe, not by laws and regulations that threaten the availability of affordable generic medications.

    Unfortunately, legislation against counterfeit and substandard medicines too often does not address quality issues, but instead is aimed at protecting monopolistic interests. As such, though the latest WHO and EU plans appropriately address quality, they fall short of effective coordination and collaboration with each other, while including substantial flaws.

    WHO

    On 21 January 2012, the World Health Organization released a Member State Mechanism proposal for international collaboration among member states, from a public health perspective, excluding trade and intellectual property (IP) considerations, regarding substandard/spurious/falsely-labelled/falsified/counterfeit (or SSFFC) medical products.

    Member states were urged to voluntarily participate in the Member State Mechanism and provide sufficient financial resources to strengthen the work in the area.

    Inherently, WHO will engage itself in:
    - ensuring the quality, safety and efficacy of medical products; promoting access to affordable, quality, safe and efficacious medicines; and supporting national drug regulatory authorities, in particular in developing countries and least-developed countries
    - information sharing and awareness creation; norms and standards and technical assistance to countries on country situation assessment; national policy development; and capacity building, supporting product development and domestic production
    - continuing to focus on and intensify its measures to make medical products more affordable, strengthening national regulatory authorities and health systems, which includes national medicine policies, health risk management systems, sustainable financing, human resource development and reliable procurement and supply systems; and enhancing and supporting work on prequalification and promotion of generics, and efforts in rational selection and use of medical products
    - ensuring that combating SSFFC medical products does not result in hindering the availability of legitimate generic medicines
    - helping reduce the profit incentive of counterfeiting by ensuring that genuine medicines are affordable and accessible.

    While the WHO proposal is shareable, concern arises from:

    - possible conflicts of interest bound up with the awareness that WHO’s public financing is decreasing, whereas the private financing is on the rise
    - lack of consensus over provisional definitions of SSFFC medical products that focus on the protection of public health
    - lack of agreement over WHO’s involvement in the International Medical Products Anti-Counterfeiting Taskforce (IMPACT). The IMPACT, set up in 2006 to improve international cooperation and awareness, lacks a mandate from WHO governing bodies, whereas its agenda on IP issues and the inside role of the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) continue to incur criticism concerning conflicts of interest.

    Related articles here and here.

    European Union

    On 1 July 2011, the Directive 2011/62/EU (applicable on 2 January 2013) was released, concerning “medicinal products for human use, as regards the prevention of the entry into the legal supply chain of falsified medicinal products.”

    The Directive introduces stricter rules to improve the protection of public health with pan-European measures to ensure that medicines are safe and that the trade in medicines is rigorously controlled. It includes:
    • an obligatory authenticity feature on the outer packaging of the medicines
    • a common, EU-wide logo to identify legal online pharmacies
    • tougher rules on the controls and inspections of producers of active pharmaceutical ingredients; and
    • strengthened record-keeping requirements for wholesale distributors.

    Despite commendable focus on quality issues, the new Directive incurs criticism relevant to the following flaws and coordination gaps:

    - common logo for sale at the distance (article 85c) only applicable within EU boundaries
    - outer-packaging identifiers only: no measures tabled for chemical composition analysis
    - WHO not mentioned as a partner body for field purposes
    - “falsified medicines” definition not aligning with WHO terms
    - possible conflicts of interest as per the European Medicines Agency (or EMA) fee-for-service relation with industry and distributors it controls
    -funding and staff resources hardly enough to cope with the planned, domestic and overseas, controls and inspections.

    The inadequate EU coordination with WHO is disappointing at a time when the US administration is committed to keenly protecting the IP rules. As per the US President’s order, criminal procedures and penalties against counterfeiters became harsher in 2011, while a novel Trade Enforcement Unit to fight piracy and counterfeiting was announced in January this year.

    These moves add to the Anti-Counterfeiting Trade Agreement (ACTA) and the Trans-Pacific Partnership (TPP) as US-promoted, end-stage international deals reportedly charged with being “closed-doors” initiatives:
    • lacking measures to help national regulatory frameworks tackle the quality problems posed by substandard medicines
    • allowing customs authorities to seize generic medicines on simple allegations of counterfeiting
    • diverting resources from drug quality
    • adopting definitions that make no distinction between the willful infringement of trademark on a commercial scale (the only targeted counterfeiting case in the WTO TRIPS Agreement) and the non-fraudulent civil trademark infringement wherein the names or packages of medicines look accidentally similar.
    • threatening the trade and import of legitimate generic medicines
    • indirectly promoting defective anti-counterfeit legislation pending in some African countries.
    • reinforcing and developing (as per a November 2011 agreement by TPP negotiators) existing WTO rights and obligations

    Related articles here, here, here, and here.

    Priorities for Public Health

    In the light of the flaws, threats and gaps discussed here, shared pathways need to be marked out to fully achieve the goal of safe and high-quality medicines worldwide. These include:

    - more coordination and collaboration among WHO member states to avoid overlapping, conflicts
    - WHO as the most accountable, overarching actor
    - WHO to quickly put the Member State Mechanism into action
    - the Member State Mechanism as a body entitled to call for an international treaty on medicine quality
    - WHO to solve at once the pending questions over “bad medicine” definitions and relations with IMPACT
    - donors to strengthen WHO-aligned quality clauses in tender transactions with non-governmental organizations
    - purchasers to insist that manufacturers and distributors supply medicines that meet WHO requirements
    - governments to authorize export only of products meeting WHO quality, efficacy and safety standards
    - EMA to be financed exclusively through EU budget as per application fees channelled to the European Commission
    - public financing only
    - a Financial Transaction Tax as a resource for relevant funding gaps, as part of global health financing
    - anti-counterfeit laws and law enforcement policies not to substitute for effective national regulatory frameworks
    - legitimate generics industry to be protected from the inappropriate use of IP law to stifle competition.
    - organizations with potential conflicts of interests and IP perspectives to issue statements eschewing the use of IP law to counter generic medicines
    - investment in technologies to detect “bad medicines” to be followed up with provisions to increase public awareness and incident reporting, along with regulations on medicine quality that include definitions as per shared WHO terms.


    Daniele Dionisio is a member of the European Parliament Working Group on Innovation, Access to Medicines and Poverty-Related Diseases. He is reference advisor for “Medicines for the Developing Countries” for the Italian Society for Infectious and Tropical Diseases (SIMIT), and former director of the Infectious Disease Division at the Pistoia City Hospital (Italy). Starting February 2012, Dionisio is head of the research project Geopolitics, Public Health and Access to Medicines (GESPAM). He may be reached at d.dionisio@tiscali.it

     

    Comments

    1. EU Health Cooperation: Room For Improvement | Intellectual Property Watch says:

      [...] quality issues have raised criticism of inadequate coordination and collaboration with each other. [see here] Relevantly, the Directive 2011/62/EU (applicable on 2 January 2013) did not mention WHO as a [...]

    2. WHO Performance Undermined By Inadequate EU Collaboration | Intellectual Property Watch says:

      […] As an example, while the latest WHO and EU plans to address medicine quality issues have raised criticism of inadequate coordination and collaboration with each other, the Directive 2011/62/EU against […]


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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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