SUBSCRIBE TODAY!
Subscribing entitles a reader to complete stories on all topics released as they happen, special features, confidential documents and access to the complete, searchable story archive online back to 2004.
IP-Watch Summer Interns

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

Inside Views

Submit ideas to info [at] ip-watch [dot] ch!

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.

Latest Comments
  • So simply put, we have the NABP saying that all ph... »
  • The original Brustle decision was widely criticise... »

  • For IPW Subscribers

    A directory of IP delegates in Geneva. Read more>

    A guide to Geneva-based public health and intellectual property organisations. Read More >


    Monthly Reporter

    The Intellectual Property Watch Monthly Reporter, published from 2004 to January 2011, is a 16-page monthly selection of the most important, updated stories and features, plus the People and News Briefs columns.

    The Intellectual Property Watch Monthly Reporter is available in an online archive on the IP-Watch website, available for IP-Watch Subscribers.

    Access the Monthly Reporter Archive >

    East African Community Doubles Efforts To Boost Local Pharmaceutical Production

    Published on 28 March 2013 @ 3:27 pm

    By for Intellectual Property Watch

    EAC TRIPS PolicyArusha, Tanzania – Pharmaceutical manufacturers in East Africa have joined forces to strengthen their production capacity to meet at least half of the region’s demand for affordable, quality medicines. The East African Community is supporting this ambitious goal through various initiatives, including a regional intellectual property policy to guide partner states on developing national legislation that fosters local pharmaceutical production.

    Today, partner states of the East African Community (EAC) – Burundi, Kenya, Rwanda, Tanzania, and Uganda – import about 70 percent of the medicines the region’s population consumes. The EAC, a regional intergovernmental organisation, has made reducing the region’s dependence on pharmaceutical imports a priority.

    From a public health perspective, EAC policymakers argue that stronger regional production capacity would improve the reliability of supply, market surveillance, and sustainability. It would also support the region’s economy through job creation and capacity building.

    Inaugurated in 2012, the new East African Community (EAC) headquarters are located in Arusha, Tanzania (Photo Credit: RMH, IP-Watch)

    Inaugurated in 2012, the new East African Community (EAC) headquarters are located in Arusha, Tanzania (Photo Credit: RMH, IP-Watch)

    In this context, the EAC has initiated several processes to improve the region’s operating environment and promote local pharmaceutical manufacturing. This includes supporting the establishment of the Federation of East African Pharmaceutical Manufacturers (FEAPM), and most recently, approving the “Regional Intellectual Property Policy on the Utilisation of Public Health-Related WTO-TRIPS Flexibilities and the Approximation of National Intellectual Property Legislation” [pdf].

    Taking full advantage of the public health-related exceptions provided under the World Trade Organization Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) is a key tenet of the EAC’s strategy to produce more quality medicines at home.

    A Health and Development Opportunity

    Founded in 2011, the FEAPM represents 30 local pharmaceutical manufacturers, of 40 that exist in the region, and is the industry’s voice to the EAC. Its mission is to “strengthen local production capacity to meet at least 50 percent of the EAC’s demand for affordable, quality medicines, by the year 2020” in part through the “utilisation of WTO-TRIPS flexibilities.”

    The establishment of the federation has been supported by the EAC and the Deutsche Gesellschaft für Internationale Zusammenarbeit (GIZ), an international enterprise owned by the German government. GIZ is one of the EAC’s main partners and has been supporting TRIPS and the promotion of the region’s pharmaceutical sector.

    According to a TRIPS and Pharmaceutical Sector Promotion brochure [pdf], “Import of generic medicines from India or China initially increased access of the EAC population to high quality and inexpensive medicines. The Agreement on TRIPS has however restricted the production and export of inexpensive generic medicines by advanced developing countries.”

    EAC and GIZ partners warn that the price of newer essential medicines, such as increasingly important second- and third-line anti-retroviral medicines to treat HIV/AIDS, is still high, in many cases prohibitively so.

    Here’s where local pharmaceutical manufacturers have an opportunity to step in. Walter Thomas, an expert on TRIPS and Pharmaceutical Sector Promotion component of the EAC-GIZ Programme on Regional Integration, told Intellectual Property Watch that local companies have a unique advantage.

    “In the context of HIV/AIDS, patients in the region are developing resistance to first-line treatments. And most of the generics are first-line treatments, so they need to move to second- and third-line treatments. But they are extremely expensive, like ARVs before generics came into play,” he said.

    Walter Thomas (left) and Wesley Ronoh (right) of the EAC-GIZ Programme on Regional Integration (Photo Credit: RMH, IP-Watch)

    Walter Thomas (left) and Wesley Ronoh (right) of the EAC-GIZ Programme on Regional Integration (Photo Credit: RMH, IP-Watch)

    “India may not be able to produce cheap second- and third-line ARVs as generics,” he said. “So, this would be a huge opportunity for LDCs [Least Developed Countries] to tap into the market, with support of multinational companies and technology transfers, with the ability to produce generics without infringing IP laws.”

    Amending National IP Laws

    However, this is largely not happening today, partly due to limitations of national legislation. According to a 2008 study by the EAC and the United Nations Conference on Trade and Development (UNCTAD), which analysed the extent to which partner states’ patent laws reflect TRIPS flexibilities relevant for the access to medicines, countries are at “various stages of domesticating TRIPS flexibilities in their national laws.”

    Moses Mulumba, executive director of the Center for Health, Human Rights and Development (CEHURD), a non-governmental organisation based in Uganda, told Intellectual Property Watch, “East African countries are struggling to understand what they need to incorporate into their national laws in order to benefit fully from TRIPS flexibilities.”

    The EAC hopes that the regional IP policy, which was approved in February, will help to change that. The “Regional Intellectual Property Policy on the Utilisation of Public Health-Related WTO-TRIPS Flexibilities and the Approximation of National Intellectual Property Legislation” provides guidelines on how to amend national legislation to be TRIPS-compliant, taking into account all public health-related flexibilities accorded in the TRIPS Agreement.

    Aiming to harmonise IP laws across the EAC region, the policy identifies the lowest common denominator of IP legislation that can be used across all of the partner states and promotes a maximum use of public health flexibilities. This protocol, or model law, is included in Annex 1 of the policy document.

    Four of the five EAC countries are LDCs, with only Kenya being classified as a Developing Country by the United Nations. Therefore, the transition period under TRIPS exempting LDCs from the obligation to protect patents on pharmaceutical products or clinical test data until 1 January 2016 – or later – is of particular importance. The policy calls on EAC LDCs to “take advantage” of this transition period and to allow for an eventual extension (IPW, WTO/TRIPS, 6 March 2013).

    Mboi Misati, a senior patent examiner at Kenya’s Industrial Property Institute, participated in the development of the IP policy as a regional expert. He told Intellectual Property Watch that parallel importation, a flexibility that allows a product made legally abroad to be imported without the permission of the IPR holder, is a “very important benefit for Kenya.”

    In Kenya, parallel importation is provided for under a provision of the Industrial Property Act of 2001, however, it is not harmonised with the Pharmacy and Poisons Act. Misati said that the “policy is important for all EAC partner states” and should help countries to “adjust their legislation so they can enjoy all of the TRIPS flexibilities”.

    Harvinder Singh Alag, CEO of Zenufa Laboratories Ltd Photo Credit: RMH, IP-Watch)

    Harvinder Singh Alag, CEO of Zenufa Laboratories (Photo Credit: RMH, IP-Watch)

    Pushing Back on Tougher IPR Laws

    The timing of this policy is particularly important, as there has been a wave of national and regional legislation threatening to hack away at countries’ potential to benefit from certain flexibilities.

    “In Uganda, the Industrial Properties Bill has been a point of particular concern since it was presented to parliament in 2009. It was developed in part by consultants from the US, who did not incorporate flexibilities to the extent that we actually need. For example, post-grant procedures were not articulated in the bill,” Mulumba told Intellectual Property Watch.

    “Working with our national policymakers on how to revise it has been a very long and tedious process. The situation is improving however now that they see that the EAC is using some of the same language that we have been suggesting,” he said.

    On a regional level, an EAC Anti-Counterfeit draft bill [doc] has come under fire for contradicting with the EAC TRIPS policy of promoting the maximum use of flexibilities for public health. However, it was referred to the EAC Sectoral Council on Legal and Judicial Affairs for legal input, including from the EAC Health committee, in October 2012.

    While the EAC Health committee agreed that an anti-counterfeiting bill is long overdue, health experts stressed the importance of generics medicines to the region and the importance of safeguarding TRIPS flexibilities, according to sources.

    The Council of Ministers will consider comments during its next meeting before the bill moves any further.

    WHO Prequalification: Essential for Growth

    In order for local pharmaceutical manufacturers in the EAC to grow, accessing the regional donor market is particularly important as it represents about 80 percent of the priority endemic disease market. However, donors such as the Global Fund to Fight HIV/AIDS, Tuberculosis, and Malaria and the US President’s Emergency Plan for AIDS Relief (PEPFAR), require that manufacturers meet strict quality assurance requirements, such as WHO prequalification.

    Only two of the region’s pharma manufacturers – Uganda’s Quality Chemical Industries Ltd and Kenya’s Universal Corporation Ltd – have met this requirement. However, FEAPM is working with companies to help them upgrade their standards through training programmes.

    Zenufa Laboratories Inc., one of Tanzania’s four operating pharmaceutical manufacturers, has been meeting Good Manufacturing Practices (GMP) requirements since 2009. Today, the company is pursuing WHO prequalification on several products, including an anti-malarial combination drug developed in partnership with the Drugs for Neglected Diseases Initiative (DNDi).

    A blistering machine in Zenufa’s Dar es Salaam plant, which gained GMP status in 2009 (Photo Credit: RMH, IP-Watch)

    A blistering machine in Zenufa’s Dar es Salaam plant, which gained GMP status in 2009 (Photo Credit: Zenufa)

    Harvinder Singh Alag, CEO of Zenufa Laboratories Ltd, told Intellectual Property Watch, “Once we are WHO-prequalified, we can begin to look at new markets, with better margins. It will open doors for us.”

    Today, the company reports an annual turnover of USD 6 million, employs about 150 people, and projects continued growth. WHO-prequalification is a key part of the company’s growth strategy, which would allow the company to move from producing smaller molecule drugs to advanced molecule treatments, according to Alag.

    While Zenufa is performing well, Alag pointed to key challenges operating in the region including high financing costs, a lack of skilled workers, and a dearth of raw materials.

    However, Alag said that recent efforts to improve operating conditions in the region have been helpful. Zenufa is a member of the FEAPM and regularly sends employees to trainings.

    Additionally, Alag said that the federation is an effective mechanism to communicate with policymakers, noting that local pharmaceutical manufacturers are “definitely looking at a better scenario.”

    Related Articles:

    http://www.ip-watch.org/2013/03/25/diverging-views-on-ipr-protection-needs-in-africa-emerge-at-ip-workshop/

    http://www.ip-watch.org/2013/03/20/at-us-led-workshop-african-stakeholders-call-for-home-grown-ip-agenda/

     

    Rachel Marusak Hermann may be reached at info@ip-watch.org.

     


    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.

     

     
    Your IP address is 54.197.61.88