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    Inside Views
    Inside Views: Focus On Quality For Patients Saves Billions Of Dollars

    Published on 27 May 2013 @ 10:03 am

    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 Daniela Bagozzi

    Ten years of progress in treatment have shown that ambitious health targets can be reached, thanks to global advocacy, increased funding for development and critical technical support to developing countries. Today, more than half of the people needing treatment for HIV are receiving it and quality malaria and TB medicines are more readily available. But there is still a long way to go – and as new health priorities emerge and funding shrinks, the poor in developing countries still struggle to secure quality treatment.

    The WHO Prequalification of Medicines Programme (PQP) prequalified the first generic AIDS medicine in 2002 in a move that proved crucial for access to medicines in the developing world. Until then, triple antiretroviral therapy, the only way to keep the virus at bay and assure a longer lifespan for HIV-infected people, had been priced at an average US$ 12,000 per person yearly – equal to 12 years’ income for the average sub-Saharan African.

    By prequalifying a product by the Indian generic manufacturer Cipla, WHO ensured that people could begin to access the same medicine for as little as US$ 350 per year. With time, more and more generic products were found to comply with WHO standards of quality, and as more producers were prequalified, the prices of crucial medicines to treat AIDS were slashed further.

    Jonathan Quick, who headed WHO’s Department of Essential Medicines from 1996 to 2004, sees the legitimation of generic medicines as the turning point in AIDS treatment access. “There’s no way we could have treated over 8 million people without generics,” he said in a phone interview.

    “Quality assurance made generic competition possible,” he said. “Competition coupled with high-volume purchases by PEPFAR and the Global Fund has brought the annual cost of AIDS medicines to under  $ 100 – 1% of what it was in 2000.”  In just six years of procuring AIDS medicines for PEPFAR, Dr Quick’s current organization, Management Sciences for Health, has saved over one billion dollars, primarily through generic procurement.

    By galvanising wider acceptance of generics and stimulating lower prices, WHO has played a crucial role in introducing medicines that are better adapted to developing country requirements, such as paediatric medicines and combination therapies. Fixed-dose combination pills (several pills in one, which are indicated for better therapy compliance and delayed drug resistance) were first prequalified by WHO in 2003, three years ahead of the US FDA. Most of these medicines are generic.

    In spite of progress, WHO identifies serious quality challenges that continue to prevent access to treatment. An immediate concern is the quality of reproductive health products. Reproductive health is an integral part of the global gender equity agenda and is seen by development experts as crucial to maternal health. In spite of a number of family planning summits, political support and donor pledges to scale up access to contraceptives, numerous reproductive health products in use do not meet international quality standards, with potential risks ranging from mild side effects to infertility and death.

    According to Lembit Rägo, the technical mind behind the Prequalification Programme, the reason why AIDS treatment scale-up worked was that everyone, from countries to civil society, UN agencies and health NGOs were on the same page about the need for affordable quality medicines.

    “That cohesive striving for a common public health goal gave us the space to do some sound quality work with manufacturers and developing country regulators,” Rägo said. “Today, with shifting priorities and less money for health, the focus on quality is dimming and the poor pay.”

    A similar problem is emerging with neglected tropical diseases, which account for roughly 11% of the global disease burden. “Aid agencies are not pushing to supply these medicines, so there is little incentive for manufacturers to apply international quality standards and compete for donor funds,” explained Jacques Pinel, former Coordinator of the Research Group on Essential Drugs at Médecins Sans Frontières.

    Another crucial health area for the near future is noncommunicable diseases, such as cardiovascular conditions, cancer, asthma and diabetes. As these take a bigger toll on developing countries, availability of affordable quality medicines will pose a challenge potentially resulting in a proliferation of substandard medicines as more patients seek treatment. In addition, with less money to invest in local capacity building, developing countries could be left hanging with weak regulatory mechanisms and less external assistance.

    “The international community’s universal health coverage agenda, including ‘good quality medicines for all’, is still a long way away from reality,” concluded Dr Rägo.

    Daniela Bagozzi is a former UNDP, WHO and UNITAID communicator now working independently on global health and development.

     


    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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