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Posted on Categories News

Revise and re -introduce the Industrial Properties Bill No.5 of 2009

TO: Major General Kahinda Otafiire
Minister of Justice & Constitutional Affairs

RE: Revision and re-introduction the Industrial Property Bill for consideration in Parliament ahead of 2013

Dear Sir,
We (the undersigned) are writing this Letter as Civil Society Organisations in Uganda working in areas of Intellectual Property and access to Medicines.

The purpose of this letter is to express our concerns about the delay to review and re-introduction of the Industrial Properties Bill to Parliament for debate. This Bill was read to the eighth Parliament as Bill no.5 of the year 2009. However, there were concerns that were raised on provisions of the Bill which threaten access to medicines and since then the Bill has been shelved and it lapsed with the eighth parliament.

We are aware that Uganda is party to the World Trade Organisation’s agreement on Trade Related Aspects of Intellectual Property (TRIPS). The TRIPs agreement seeks to bring strong enforcement of intellectual property even on essential goods such as medicines. It however, has flexibilities which apply to least Developed Countries like Uganda before the expirely of the transitional period in 2013 for general provisions and 2016 for pharmaceutical products’ patents.

Ten years ago on the 14th of November while at Doha, member states to the WTO agreed that the TRIPS Agreement does not and SHOULD NOT prevent Members from taking measures to protect public health. The Doha declaration is a reaffirmation of members’ rights to exploit the flexibilities as provided under the TRIPS agreement. Uganda is a least developed country with very limited technological capacity to support the pharmaceutical needs of its population. It should be noted that almost 90% of drugs in Uganda are imports of which most are generic versions which need protection from patent owners who may want to stop their sale in a bid to get market for their expensive brand name drugs; this would be a disadvantage to Ugandans as they will not be able to access cheap drugs.

It is for this reason that we seek your attention to ensure that the Industrial Properties Bill takes maximum advantage of the flexibilities detailed under the TRIPS Agreement and as provided by the Doha Declaration. We for these reasons call upon government under the leadership of your ministry to ensure that:
• The Bill should expressly provide under section 8 (3) that pharmaceutical products are excluded from patent protection until 1st January 2016 or such other date as may be extended in the future;
• The Bill should under section 28 (13) & (14) indicate that applications for pharmaceutical products should only be filed after 1st January 2016 or such other date as may be extended in the future;
• The government should enhance the effectiveness of third party patent oppositions under section 28 (7) through providing the necessary technical capacity to Registrar General’s office to enable them examine the substance of the opposition;
• The Bill should be amended under section 8 to exclude natural substances from patentability;
• The Bill should properly define the public emergency provision and indicate that public health crises, including those relating to HIV/AIDS, tuberculosis, malaria and other epidemics, can represent a national emergency;
• The bill (section 66(3)) should be brought in line with the minimum standards under article 31(h) of the TRIPS Agreement by 1 July 2013;
• Section 61(2)(e) of the Industrial Property Bill should be amended to provide that when using the draft article 31bis TRIPS system as an importing country, the patent holder in Uganda does not need to be remunerated, to the extent that adequate remuneration has already been paid to the patent holder in the exporting country;
• Section 61(1) of the Industrial Property Bill should be amended to include the possibility of administrative (as opposed to judicial) grants of compulsory licences for private third parties acting on their own behalf and account. The ministry of health should be authorized to issue the compulsory licence in the area of pharmaceuticals;
• On re-exportations of pharmaceuticals produced under compulsory licence under the WTO 30 August 2003 Waiver Decision, section 102(8) should not only refer to COMESA, but also to the partner States of the EAC;
• Section 60(1) (a) should be amended to include a reference to a maximum period of negotiations with the right holder before granting a compulsory licence;
• As regards parallel importations, the reference to “importation into Uganda” of patented products under section 43(2) should be deleted to provide for a rule of international patent exhaustion;
• The Bill should introduce a provision enabling Uganda to take advantage of August 30th Decision

As currently drafted, the Bill does not make full and maximum use of the TRIPS flexibilities and as such impedes access to medicines initiatives of Ugandans. It is important that the laws of our country aim at putting the citizenry’s priorities into perspective in order to promote public health for all. We therefore strongly urge you to consider review and subsequent tabling of this Bill soon, as in its proposed form; it would destroy the traditional balance between intellectual property protection and public access, a balance that is essential to our nation’s economic growth and competitiveness.

We are looking forward to working with you to address our Concerns in this Bill.
Sincerely,

1. The center for Health Human rights and development (cehurd)
2. SEATINI Uganda
3. The International HIV/AIDS Alliance in Uganda
4. Open Society Innitiative for Eastern Africa (OSIEA)
5. KIOS

CC: Mr. Frederic Ruhindi
State Minister for Justice & Constitutional Affairs
CC: Hon. Amelia Kyambadde
Minister of Trade, Industry and cooperatives
CC: Uganda Law Reform Commission

Posted on Categories Featured 42 Comments on Letter to WIPO From 45 Civil Society Groups: IP Enforcement

Letter to WIPO From 45 Civil Society Groups: IP Enforcement

The letter below was sent to Mr. Francis Gurry on 30th November 2011. The contents were also communicated during the Advisory Committee on Enforcement that met on 30th November to 1st December 2011.
Regards,
Sangeeta Shashikant
Third World Network
—————————————————————————-
CIVIL SOCIETY LETTER
29th November 2011
Mr. Francis Gurry
Director General
World Intellectual Property Organization
Intellectual Property Enforcement activities in WIPO
Today it is widely known that proponents of a “maximalist agenda” on intellectual property (made up of OECD businesses and governments) are on a campaign to increase IP protection and enforcement far beyond the minimum standards of the TRIPS Agreements in ways that are “TRIPS-Plus-Plus”.[1] However such an approach disregards the development dimension, undermines public interests and compromises fundamental human rights such freedom of expression over the internet.[2]

In 2007, the WIPO General Assembly adopted Recommendation 45 of Development Agenda that explicitly mandates WIPO: “To approach intellectual property enforcement in the context of broader societal interests and especially development-oriented concerns, with a view that ‘the protection and enforcement of intellectual property rights should contribute to the promotion of technological innovation and to the transfer and dissemination of technology, to the mutual advantage of producers and users of technological knowledge and in a manner conducive to social and economic welfare, and to a balance of rights and obligations’, in accordance with Article 7 of the TRIPS Agreement.”

A number of other recommendations call for more transparency in WIPO’s activities particularly its technical assistance activities and stress on the need to infuse development considerations into WIPO¹s activities and debates.
Against this background, the undersigned are seriously concerned with WIPO’s approach to IP enforcement. In particular we would highlight the following concerns:

1. Transparency: Despite the adoption of Rec. 1 and 5, little information is provided on WIPO¹s website on technical assistance activities undertaken by WIPO. For instance in the Annex of WIPO/ACE/7/2 WIPO provides a list of activities it has undertaken in the area of IP enforcement however no information is available on the nature of such activities including participants lists, lists of speakers, content presented, outcome of the meetings etc. In fact several of the meetings mentioned in the Annex are not even listed on WIPO¹s website. The lack of transparency is unbecoming of an intergovernmental organization and undermines implementation of Development Agenda in WIPO.

2. Unbalanced Approach to Enforcement & Conflicts of Interest: Evidence available suggests that WIPO¹s approach to enforcement is unbalanced, lacking a development and public interest orientation. The limited information available on certain WIPO¹s enforcement activities suggests that its activities are aimed at protecting corporate interests rather than ensuring a balanced debate that addresses the development dimension (including flexibilities available, developmental implications of excessive or inappropriate enforcement standards, safeguards against abusive enforcement practices), protects public interests and takes into account the socio-economic realities of beneficiary countries.[3]

The recently released External Review of WIPO¹s technical assistance also notes the lack of activities in WIPO that ensures efforts to address counterfeiting and piracy are aligned with national needs and conditions. The Review also found that certain WIPO tools on national IP strategy placed over emphasis on IP enforcement with questions that would lead beneficiary countries to think that its enforcement provisions were inadequate.
The unbalanced approach to IP enforcement is further reinforced by WIPO’s continuous partnership with entities whose interests’ lies in ever-stronger IP enforcement. For instance the Global Congress Combating Counterfeiting
and Piracy is organized by WIPO in partnership with intergovernmental organizations such as Interpol, the World Customs Organization, as well as industry related stakeholders i.e. International Trademark Association (INTA) and Business Action to Stop Counterfeiting and Piracy (BASCAP).

We are of the view that WIPO¹s partnership with such industry related stakeholders hampers its ability to take a balanced approach to IP enforcement, and undermines Development Agenda particularly implementation of Recommendation 45 of Development Agenda. Further such one-sided pro business partnership raises issues of conflict of interests. WIPO being an intergovernmental and a specialized agency of the UN must take immediate measures to ensure that all its activities are evidence based, free of conflicts of interests and undue influence of the industry.
3. Public Health and Safety: The link between IP enforcement and public health and safety has been promoted extensively with the aim of frightening people into accepting inappropriate standards of IP enforcement agenda. In reality, the link between IP enforcement and public health and safety is questionable and tenuous at best. In fact an IP enforcement framework will not deliver effective protection of public health as IP rights are not granted on the basis of the quality and safety of the product. Instead inappropriate standards of IP enforcement are likely to hinder public health particularly access to affordable medicines.
This has been amply demonstrated by the seizures of quality generic medicines at various European ports as a result of inappropriate standards of IP enforcement. In the East African region several anti-counterfeiting bills have been enacted or are in the process of being enacted. And while the proclaimed rationale for such bills is to protect the public from unsafe products, these bills are in actual fact only about protecting the rights of IP holders to the detriment of access to affordable generic pharmaceuticals. Most of these bills define “Counterfeit” products as being substantially
similar or identical to IP protected products, which effectively makes every generic pharmaceutical a counterfeit. In Kenya, enactment of the Anti-Counterfeit Act 2008 has been challenged by people living with HIV/AIDS on the grounds that enforcement and application of the Act will deny them access to affordable essential medicines and thus deny their Right to Life.
Further we stress that addressing the issue of substandard, poor quality and unsafe medicines (also often labeled as “counterfeit medicines”) is not within the mandate of WIPO but a responsibility of the World Health Organization. Moreover dealing with the problem of “counterfeit medicines” requires a focus not on IP enforcement but on building regulatory capacity and ensuring access to affordable medicines.
Following from the above-mentioned concerns, we demand that:
WIPO urgently make publicly available all information (e.g. participants and speakers¹ list, presentations, list of documents distributed, outcome of the meetings), with regard to WIPO¹s activities in the area of IP enforcement. Where information is protected due to its confidential nature, this should be mentioned explicitly.

WIPO review its partnership with industry related stakeholders and take measures to ensure that its enforcement activities are evidence based, objective, free conflicts of interests and undue influence of the industry related stakeholders.

WIPO ensures that all its enforcement activities take a balanced approach, do not undermine existing flexibilities; comprehensively addresses development and public interests considerations and takes into account the socio economic realities of countries.

WIPO ceases to push for IP enforcement on the grounds that it protects public health and safety.

Signatories:
1. Act UP Paris
2. AGIHAS (People Living with HIV Support group), Latvia
3. AIDS ACCESS Foundation
4. All India Drug Action Network, India
5. All Nepal Peasants’ Federation, Nepal
6. Alianza Social Continental Capitulo Perú
7. Berne Declaration, Switzerland
8. Centad, India
9. Center for Health, Human Rights and Development, Uganda
10. Center for Technology and Society at FGV Law School, Brazil
11. CNCD-11.11.11 (Centre National de Coopération au Développement), Belgium
12. Communication is Your Right
13. Drug Study Group, Thailand
14. Drug System Monitoring and Development Program, Thailand
15. Diverse Women for Diversity, India
16. European AIDS Treatment Group (EATG)
17. Foundation for AIDS Rights, Thailand
18. Foundation for Consumers, Thailand
19. FTA Watch
20. Health Action International Africa
21. Health Consumers Protection Program, Thailand
22. Health and Development Foundation, Thailand
23. Health GAP, USA
24. Indonesia AIDS Coalition, Indonesia
25. Initiative for Health & Equity in Society, India
26. Internet Governance of Pakistan
27. IP Justice, USA
28. La Quadrature du Net (France / Europe)
29. LES ANGES DU CIEL
30. Marcha Mundial de las Mujeres, Perú
31. National Institute of Intellectual Property organisation (NIPO), India
32. Organization Butere focused women in development (BUFOWODE), Kenya
33. Oxfam
34. Peoples Health Movement
35. Red Mexicana de Accion frente al Libre Comercio (RMALC), Mexico
36. Research Foundation for Science Technology & Ecology, India
37. Rural Pharmacists Foundation, Thailand
38. Society for Knowledge Commons, India
39. Thai Holistic Health Foundation, Thailand
40. Thai NGO Coalition on AIDS, Thailand
41. Thai Network of People living with HIV/AIDS (TNP+), Thailand
42. Third World Network
43. Urdu Internet Society, Pakistan
44. Vietnamese Network of PLHIV (VNP+)
45. Vrijschrift, Netherlands
—————————————————————————————-
NOTES:
[1] For an overview of anti-counterfeiting initiatives see Susan Sell (2008), “The Global IP Upward Ratchet, Anti-counterfeiting and piracy enforcement efforts: The State of Play” available at
http://digitalcommons.wcl.american.edu/research/15/ See also Ermias Tekeste Biadleng and Viviana Munoz Tellez (2008) “The Changing Structure and Governance of Intellectual Property Enforcement” Research Paper 15, South Centre, available at www.southcentre.org (http://www.southcentre.org)
[2] See the joint declaration on Freedom of Expression and the Internet (http://www.law-democracy.org/wp-content/uploads/2010/07/11.06.Joint-Declaration.Internet.pdf) issued by the UN Special Rapporteur on Freedom of Opinion and Expression, the Organization for Security and Co-operation (OSCE) Representative on Freedom of the Media, and the Organization of American States (OAS) Special Rapporteur on Freedom of Expression, and the African Commission on Human and People¹s Rights (ACHPR) Special Rapporteur on Freedom of Expression and Access to Information.
[3] See for example http://craphound.com/PROGRAMManilaEdited10212011-FINAL.pdf

Source: http://infojustice.org/archives/6285

Posted on Categories Featured 358 Comments on Why the anti-counterfeit bill could block access to reading materials

Why the anti-counterfeit bill could block access to reading materials

By Patricia Oyella

On the 14th of November, Uganda and the rest of the world marked DOHA declaration. The declarations adopted by the World Trade Organization requires that its member states have put in place domestic legislation that protect intellectual property rights among others . Uganda like other least developing countries have up to 2013.

However in this report by Patricia Oyella, experts on Intellectaul Property and Human Rights warn that Uganda has not taken advantage of flexibilities provided in the trips agreement which could impede access to education materials. They also warn that the Anti Counterfeit law bill as it is would also affect the right to education.

It is the norm at higher institutions of learning to have photocopying services to help students get access to reading materials. Photocopying costs range from extracts of books, pamphlets to whole books that could go for as high as 200,000 shillings but when photocopied go for a tidy fee of a maximum of 15,000 shillings. But all that could rapidly change if the Country’s Anti counterfeit bill meant to protect domestic manufacturers is made into law in its current state.

An expert on Intellectual Property Rights and Human Rights, Mulumba Moses with the Center for Health, Human Rights and Development (CEHURD) says the law could stifle access to education materials. He instead pushes for a provision in the law that could instead of levying criminal sanctions could introduce a user fee that photocopiers could pay.

Yet the time is also ticking on the implementation of the Trips agreement signed ten years ago in 2001 in Doha. Domestically Uganda should implement its laws already passed like the Trade Act and the Copy Right Act after 2013 that protect intellectual property.

The Copyright act currently makes provisions for fair use where users can photocopy for personal use but not for profit. After 2013, government will increasingly come under pressure to crack its whip and education institutions that normally mass photocopy will pay the price. That impact could reduce if the country’s Copyright law were amended to incorporate flexibilities like parallel importation.

The Executive Director of the National Book Trust Uganda, Richard Batambuze knows too well the cost of not having a provision in the law that allows parallel importation.

Its currently estimated that 80% of books at the primary level and 60% at secondary level are produced by local authors…. That percentage dwindles heavily at higher institutions of learning.

Dr. Kakungulu Mayambala with the HumanRights and Peace Center Makerere University, however also argues that even with efforts to improve access to education, some people just abuse the process.

As DOHA agreement reaches its ten year mark, Uganda and other Least Developed Countries hope to push for an extension to allow them put in place legislation that take into account flexibilities in the agreement but with politics often taking the fore in national debates. Countries like Uganda will only move forward once that start looking at Intellectual property rights in terms of Human rights and how they affect the national development plan.

Source:http://www.wbs-tv.co.ug/index.php?option=com_content&view=article&id=1983:why-the-anti-counterfeit-bill-could-block-access-to-reading-materials&catid=1:current-affairs&Itemid=77

Posted on Categories News 563 Comments on Lives at risk as 90 per cent of Aids drugs in Uganda could be declared illegal

Lives at risk as 90 per cent of Aids drugs in Uganda could be declared illegal

By Henry Zakumumpa

Thousands of Ugandans enrolled on antiretroviral treatment in Uganda risk an Aids drugs shortage unless a grace period placed on the manufacture of generic Aids drugs imposed under TRIPS, an international trade law, is extended beyond July 2013. According to Denis Kibira of the Health Rights NGO, HEPS-Uganda, almost 90 per cent of Aids drugs available on the Ugandan market are generic drugs from India.

A generic drug is an identical copy of a brand name. Under World Trade Organisation (WTO)’s TRIPS agreement, to which Uganda is a signatory, poor countries were given a transitional period to consume generic Aids drugs based on original formulas developed by mainly Western pharmaceutical companies such as Pfizer and Smith Kline Beecham, which invest heavily in developing new Aids drugs. For pharmaceutical products, this ban will take effect in 2016.

According to the WHO, ‘Developing countries are failing to make full use of flexibilities built into the World Trade Organisation’s (WTO) Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) to overcome patent barriers and, in turn, allow them to acquire the medicines they need for high priority diseases, in particular, HIV/Aids.

According to Mr Kibira, almost all Aids drugs used in Uganda are manufactured in India and Uganda under an international intellectual property law that permits drug manufacturers in developing countries to manufacture pharmaceutical products that imitate those originally made by Western pharmaceutical companies on account of public health emergencies in poor countries.

For developing countries such as India, the ban on manufacture of generic Aids drugs came into force in 2005 under the TRIPS agreement of the WTO whereas a similar ban on poorer developing countries such as Uganda will take effect in 2016 unless Uganda passes a national law that allows for extension of this deadline.

Pharmaceutical products have a deadline of 2016. UNAIDS,UNDAP and WHO have urged all developing countries to enact TRIPS ‘flexibilities’ or provisions with the international trade law that allows poor countries to use patented medicines under a public health emergency provision.

“Unless the Ugandan Parliament revisits and passes the Industrial Properties Bill, the permission to manufacture cheap generic ARV drugs will cease in 2016 with thousands affected since Quality Chemicals manufactures generic Aids drug,’’ said Moses Mulumba,Executive Director of CEHURD, a healthcare access rights NGO advocacy group.

With the expiry of the TRIPS grace period, the alternative in Uganda would be to buy these drugs much more expensively from the original Western manufacturers at prices beyond the reach of the majority Ugandan ARV user.

Aids triple-combination therapy, which costs $10,000 per patient per year in industrialised countries, can now be obtained from Indian generic drugs company, Cipla, for less than $200 per year. Generic Aids drugs enabled millions gain access to Aids treatment in poor countries. The 2013 and 2016 TRIPS deadlines threaten to reverse these gains and turn Aids treatment into a preserve of patients in rich Western world.

Recently, Dr Raymond Byarugaba, head of Uganda Aids Information Centre, announced that this year, there will be 150,000 new HIV infections in Uganda up from 130,000 last year and 100,000 in years before adding to the already rising number of those in need of antiretroviral treatment which they can’t access.

At the moment, passing the Industrial Properties Bill in Uganda, after amending it to take full advantage of the ‘flexibility’ in the TRIPS agreement, which would, inter alia, extend the grace period for manufacturing generic Aids drugs remains the best hope for the thousands on Aids treatment most of whom rely on generic drugs manufactured by Indian pharmaceutical companies such as CIPLA or its subsidiaries in Africa.

On Monday, November 14, the world marked 10 years since the DOHA Declaration, which secured a grace period for developing countries to implement patents for pharmaceutical products. Sadly, poor countries, including Uganda, have not taken full advantage of this grace period and this puts the lives of millions at stake as the clock ticks to the 2013 and 2016 deadlines.

Mr Zakumumpa is an HIV/Aids specialist at Makerere University and a key correspondent for the International HIV/Aids Alliance.
zakumumpa@vetmed.mak.ac.ug

source: http://www.monitor.co.ug/OpEd/Commentary/-/689364/1273764/-/12p0ybxz/-/index.html

Posted on Categories General News, News 443 Comments on Property Rights Leave Access to Medicine Wanting

Property Rights Leave Access to Medicine Wanting

By Flavia Lanyero

Experts have decried the sluggish stride Uganda is making to utilise provisions for flexibilities under the Trade Related Aspects of Intellectual Property Agreement (Trips), saying such failures will hamper access to medicine in the near future.

The experts highlighted the need to incorporate the flexibilities under the Patent Law to comply with obligations under the World Trade Organisation on protection and enforcement of intellectual property rights. “Almost 90 per cent of drugs in Uganda are imports, most of which are generic versions which need protection from patent owners, who may want to stop their sale in a bid to sell their expensive brand name drugs instead; Ugandans would not be able to access cheap drugs,” said Mr Moses Mulumba, a lawyer with Centre for Health Human Rights and Development.

The Doha Declaration, a flexibility of Trips, provides an opportunity to place the protection of public health beyond private commercial interests. It affirms the right of countries to use safeguards such as compulsory licences to overcome patents when necessary to promote access to medicines for all.

Today marks 10 years of the Doha Declaration but the Industrial Property Bill, which is supposed to incorporate Trips, has not been passed into law. Technocrats in the Ministry of Trade say the Bill has been delayed in Parliament since 2009.

Mr Mulumba said it will be unfortunate if by 2013 Uganda has not made an effort to pass the industrial property law.

Source: All Africa.com/The Monitor

http://allafrica.com/stories/201111140191.html

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