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    Ecuador To Define Its Compulsory Licence Legislation

    Published on 23 November 2009 @ 5:27 pm

    By , Intellectual Property Watch

    Since Ecuadorean President Rafael Correa signed a decree on 23 October allowing compulsory licences, the national intellectual property office has been working on a mechanism for issuing those licences, which should be studied case by case, according to the national decree.

    Referring to Article 31 of the World Trade Organization (WTO) Trade-Related Aspects of Intellectual Property Rights (TRIPS) Agreement, the Ecuadorean constitution, and the WTO Doha Declaration on TRIPS and Public Health, Correa declared access to essential medicines of public interest to the Ecuadorean population.

    Ecuador’s intellectual property office is currently working on legislation for issuing compulsory licences that will be TRIPS-consistent and will respect all of Ecuador’s obligations as a member of the WTO, an Ecuadorean official in Geneva told Intellectual Property Watch.

    Article 31 of the TRIPS agreement allows member countries to use patents without the authorisation of the right holders in certain cases such as a national emergency, extreme urgency or for public non-commercial use, although the right holders should be informed in the case of public non-commercial use.

    The Doha TRIPS and Public Health Declaration states that TRIPS “does not and should not prevent members from taking measures to protect public health.” The declaration reinforce the right of countries to use the TRIPS flexibilities, including compulsory licensing, and it was agreed that least-developed countries’ exemption on pharmaceutical patent protection would be extended until 2016.

    In the past some developing countries using the TRIPS flexibilities have faced strong opposition from the developed country pharmaceutical industry challenging on several occasions the legitimacy of compulsory licences.

    The Ecuadorean Institute of Intellectual Property (IEPI) (Instituto Ecuatoriano de la Propiedad Intelectual) will have competency to issue compulsory licences to applicants, based on the legislation, according to the decree, numbered 118. The IEPI will work in coordination with the Ministry of Public Health. The scope, purpose and timeframe of compulsory licences, as well as the amount and conditions of royalty payments will be established by the IEPI, the decree said.

    In Ecuador, the average price of a medicine if competition exists is about US$ 3.85, according to the IEPI, but if there is no competition, the average price is $46, not including cancer and AIDS medicine, which are more expensive.

    According to an IEPI administrative guide presenting a scenario for the issuance of compulsory licences, in 2002, an Ecuadorean national laboratory asked for a compulsory licence for an anti-retroviral drug (Convivir from GSK), which was usually priced $350 for a month of treatment. Just by asking for a compulsory licence, GSK dropped its prices to $60 a month and the compulsory licence was not issued, it said.

    Other countries have sought to issue compulsory licences, according to the guide. For example, Brazil in 2007 issued a compulsory licence for an AIDS treatment. Malaysia also issued a compulsory licence for “government use” for three medicines to treat HIV/AIDS, and started to import generic medicines from India. In Brazil, the costs dropped by 81 percent for patients with HIV/AIDS.

    According to this guide, which was drafted as a basis for discussion, between 0.5 and 10 percent of the sale of the generic medicines could be paid as economic compensation to patent holders.

    As has been the case in other countries, the decision to issue compulsory licences could prompt pharmaceutical companies to reconsider their prices, the Ecuadorean official told Intellectual Property Watch. But for the moment, nothing has happened, he said, and no companies have come forward.

    Compulsory licences also could be issued under the WTO decision of 30 August 2003 on the implementation of paragraph 6 of the Doha Declaration on TRIPS and Public Health, according to the guide.

    This WTO decision, which was approved as a permanent amendment to the TRIPS agreement in December 2005 and is awaiting full ratification, allows members who produce pharmaceutical products under compulsory licences to ship a majority of it to developing countries lacking production capacity. Before this, TRIPS said that drugs produced under compulsory licences had to be for “predominately” domestic use.

    Some of the medicines under compulsory licences will be manufactured by the Ecuador national manufacturing industry, while others will be imported from other countries, according to the Ecuadorean official.

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

     

    Comments

    1. Iván says:

      I congratulate the Ecuadorian government for its intention to issue compulsory licenses for public interest, however, is a bit worrying that the IP Law of that country is restrictive in terms of compulsory licensing. On the other hand, the hierarchy of the Andean Decision 486 on IP Law in Ecuador may be in theory and could be sustainable, but the precedents are not the best (as the case of Decree 2085 in Colombia). Thus, what is making the Ecuadorian government to resolve this? They think a reform of your IP law?

      Thank you very much for your answers!

      Again congratulations to the government of Ecuador for the initiative!


    Leave a Reply

    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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