[Ip-health] WIPO SCP16: Joint proposal of the African Group and the Development Agenda Group on a work program on Patents and Health
b.baker at neu.edu
Fri May 20 01:58:32 PDT 2011
There's no doubt that the gross abuse of power by rich countries acting on behalf of their monopoly-based pharmaceutical companies is a major impediment to proactive IP/health/trade reform in African countries. Global health movements have to intensify our collective campaigns to prevent the IP-ratchet, such as that represented in the EU-India EPA, the TPP, and ACTA.
That said, African countries have more policy space to act than they are using. The 2001 President Clinton Executive Order prohibits the USTR from taking action against sub-Saharan Africa countries attempting to make use of TRIPS-compliant flexibilities in order to increase access to medicines. Although the US abused its Special 301 powers and trade preferences against South Africa in an aborted effort to derail the 1998 Amended Medicines and Related Substances Act, the US has not used such powers since against sub-Saharan African countries. Although there continues to be back-door pressure both the US and EU, especially in the form of the new enforcement agenda and anti-counterfeiting legislation, several African countries have issued CLs (usually but not always to satisfy Global Fund and PEPFAR requirements) without retaliation. Thus, far sub-Saharan African countries have succeeded in keeping TRIPS-plus IP proposals off the table in FTA and EPA negotiations.
As I see it, African country governments remain complicit in keeping their hands tied with TRIPS-plus measures. Pro-MNC forces in their own countries, corrupt alliances with Pharma, and false hopes for trade and investment all help explain, but do not excuse, this complicity. It is ten-years post Doha. In my view there should be major coordinated campaigns on the ten-year anniversary to demand that African governments roll-up their sleeves, shelve their fears, and pass legislation that will ensure maximum access to affordable, life-saving medicines. There is available expertise within many African countries and international expertise eager to assist.
Professor Brook K. Baker
Health GAP (Global Access Project) &
Northeastern U. School of Law, Program on Human Rights and the Global Economy
Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
400 Huntington Ave.
Boston, MA 02115 USA
b.baker at neu.edu
From: ip-health-bounces at lists.keionline.org [ip-health-bounces at lists.keionline.org] On Behalf Of Riaz K Tayob [riaz.tayob at gmail.com]
Sent: Friday, May 20, 2011 4:20 AM
To: ip-health at lists.keionline.org
Subject: Re: [Ip-health] WIPO SCP16: Joint proposal of the African Group and the Development Agenda Group on a work program on Patents and Health
Deere has written about the differential implementation of the legal
"flexibilities" available in the numerous international agreements and
describes how developing countries have not used their "policy space".
The problem is the ascription of why this happens.
With the greatest respect, I think we need to look at the hard and soft
power of Health Imperialism. Countries face enormous pressure from the
rich countries to be more protective than necessary, and also
questionable advice from international bodies including WIPO (who
favours protection while largely ignoring the diffusion and access to
information) and WHO (who is churlish about IPR flexibilities).
South Africa, in Big Pharma vs Mandela, received advice from Carlos
Correa on the Mbeki position for Compulsory Licenses for medicines in
the public interest. Since that time, despite catalysing and making
enormous impact on A2M, this flexibility is STILL not being used.
Countries like Thailand faced the Spanish Inquisition to use
flexibilities, which European countries called the use of the nuclear
option. The Special 301 also comes to the fore on this.
The yin of the WHO/rich country notion of Health Diplomacy has to find
its yang in Health imperialism. This would show up not only the
shortcomings of the developing countries, and the power of the rich
countries in ensuring these arrangements. The influence of the rich
countries needs to be taken into account especially given how
"progressive" government officials and advisors are "hounded" out of the
system to disappear into obscurity for pushing access to medicines. This
smacks of degrees of influence and control that are more reflective of
hard power, rather than soft power.
On 2011/05/18 09:04 PM, Baker, Brook wrote:
> Although the Africa Group sets forth a proposal for action within the Development Agenda at WIPO, almost everything it talks about in terms of amending IP laws could be initiated by African governments without waiting for WIPO to act. Particularly with respect to amending domestic laws, what are we waiting for? There's plenty of local and international talents for technical assistance available right now. The imperative to amend domestic legislation has at least been clear since the Doha Declaration 10 years ago and was raised 15 years ago. South Africa in particular has a patent regime that accepts any patent filed and leaves it to patent challenges to overturn improvidently granted patents. Telling WIPO to act and to help is clearly warranted, but it does not excuse procrastination in African countries, many of which are adopting counter-productive enhanced IP enforcement measures, like misleading anti-counterfeiting legislation that may actually interfere with the availability of affordable generic medicines. I think people can hold this submission up to governments in national and regional bodies as a mirror and say "Let's get started."
> Professor Brook K. Baker
> Health GAP (Global Access Project)&
> Northeastern U. School of Law, Program on Human Rights and the Global Economy
> Honorary Research Fellow, Faculty of Law, Univ. of KwaZulu Natal, SA
> 400 Huntington Ave.
> Boston, MA 02115 USA
> (w) 617-373-3217
> (c) 617-259-0760
> (f) 617-373-5056
> b.baker at neu.edu
> From: ip-health-bounces at lists.keionline.org [ip-health-bounces at lists.keionline.org] On Behalf Of Jamie Love [james.love at keionline.org]
> Sent: Wednesday, May 18, 2011 6:42 AM
> To: Ip-health
> Subject: [Ip-health] WIPO SCP16: Joint proposal of the African Group and the Development Agenda Group on a work program on Patents and Health
> WIPO SCP16: Joint proposal of the African Group and the Development
> Agenda Group on a work program on Patents and Health
> By Thiru Balasubramaniam
> Created 18 May 2011
> On May 18, 2011, during a WIPO meeting of the Standing Committee on
> the Law of Patents (SCP), the topic of Patents and Health is being
> discussed. The agenda item was requested by the Africa Group. When the
> SCP turned to Patents and Health, South Africa made a lengthly and
> substantive intervention on behalf of the Africa Group and the
> Development Agenda Group. Albert Tramsposch, the USPTO official
> chairing the SCP, referred to the proposal as "comprehensive and well
> thought out." The reaction by public health NGOs was very positive.
> The text of the proposal follows:
> JOINT PROPOSAL BY THE AFRICAN GROUP AND THE DEVELOPMENT AGENDA GROUP
> SCP WORK PROGRAM ON PATENTS AND HEALTH
> SCP 16, 16-20 MAY 2011
> 1. At the 15th session of the Standing Committee on the Law of Patents
> (SCP) the African Group proposed that the Committee should undertake a
> work program on the topic “patents and health.” The African Group and
> the Development Agenda Group are of the view that the patent system
> should be consistent with fundamental public policy priorities, and in
> particular the promotion and protection of public health.
> 2. The issue of patents and its impact on public health has been the
> subject of discussion in many fora. In 2003, the 56th World Health
> Assembly of the World Health Organization (WHO) had urged Member
> States “to reaffirm that public health interests are paramount in both
> pharmaceutical and health policies,” and “to consider, whenever
> necessary, adapting national legislation in order to use to the full
> the flexibilities contained in the Agreement on Trade-Related Aspects
> of Intellectual Property Rights (TRIPS).” Furthermore, the 2001 Doha
> Ministerial Declaration on the TRIPS Agreement and Public Health
> affirmed, inter alia, that the TRIPS Agreement does not and should not
> prevent Members from taking measures to protect public health.
> 3. The WHO Global Strategy and Plan of Action (GSPOA) on Public
> Health, Innovation and Intellectual Property adopted in 2008 states
> that while international IP agreements contain flexibilities that
> could facilitate increased access to pharmaceutical products by
> developing countries, they may face obstacles in the use of
> flexibilities. Thus, there is a need to address this problem and
> remove obstacles faced by developing countries in making full use of
> the public health related flexibilities. The GSPOA also states that
> IPRs should not prevent Member States from taking measures to protect
> public health, and that international negotiations on issues relating
> to IPRs and health should be coherent in their approaches to the
> promotion of public health.
> 4. In order to protect public health, the flexibilities and safeguards
> contained and allowed by the TRIPS Agreement would need to be
> incorporated in the national legislation. There is equally the need to
> ensure that international commitments, including regional and
> bilateral arrangements, do not restrict these flexibilities and
> safeguards. Moreover, these safeguards and flexibilities have to be
> workable in practice, particularly with respect to ensuring access to
> 5. In this context, it will be pertinent for the Committee to discuss
> the issue of patents and health and draw up a work program that
> assists countries in adapting their patent regimes and make full use
> of the patent flexibilities. In this regard, the African Group and the
> Development Agenda Group are presenting the following work program.
> WORK PROGRAM:
> 6. The proposed work program seeks to enhance the capacities of Member
> States, and particularly developing countries and least developed
> countries (LDCs), to adapt their patent regimes to make full use of
> the flexibilities available in the international patent system to
> promote public policy priorities related to public health. This work
> program is composed of three interlinked elements that are to be
> pursued simultaneously.
> 7. These three elements are respectively: i) the elaboration of
> studies to be commissioned by the WIPO Secretariat, following
> consultations with the Member States at the SCP, from renowned
> independent experts; ii) information exchange among Member States and
> from leading experts in the field; and iii) the provision of technical
> assistance to Member States, and particularly developing countries and
> least developed countries (LDCs), in relevant areas, and building upon
> work undertaken in the first two elements of the work program.
> ELEMENT I – STUDIES:
> 8. Commission a framework study by leading independent experts to
> examine the challenges and constraints faced by developing countries
> and least developed countries (LDCs) in making full use of the public
> health related patent flexibilities both in the pre-grant and in the
> post-grant stage. This study should also include:
> a. A component on the law and practices with regard to compulsory and
> government use licenses in WIPO Member States. Such a study will also
> provide as detailed information as possible, as to Member States that
> have issued or that have attempted to issue compulsory and government
> use licenses, the details of the license issued, the challenges faced
> as well as the impact on public health. This should also include the
> provision of empirical data on the royalty rates set in each case.
> b. An examination on the extent to which countries use exhaustion of
> rights to allow parallel trade in medicine.
> c. An assessment of the benefits of mandatory disclosure of
> International Non-Proprietary Names (INNs) in the abstract or title of
> patent applications. This would enable an easier identification of the
> generic name of the medical product subject of the patent application.
> d. Conduct a cost-benefit analysis of the admissibility of Markush
> claims (broad patent claims that may apply to a broad range of
> compounds). It could be worthwhile to analyze whether such claims
> based merely on theoretical inference can be considered to satisfy the
> criteria for patentability.
> ELEMENT II – INFORMATION EXCHANGE:
> 9. Invite the UN Special Rapporteur on the Right to Health, Mr. Anand
> Grover, to the seventeenth session of the SCP, to present his report
> to the Human Rights Council on Intellectual Property Rights and Access
> to Medicines.
> 10. Organize during SCP 17 and 18, experience sharing sessions on
> countries’ use of patent flexibilities for promoting public health
> objectives. The specific health related flexibilities to be discussed
> in those sessions should be determined in consultation with Member
> 11. Organize a technical workshop on state practice involving the
> compulsory licensing of medical technologies, including the
> application of TRIPS Articles 30, 31 and 44.
> 12. Develop a database on the patent status in WIPO Member States of
> relevant diagnostic tools and medicines for at least 10
> non-communicable and communicable diseases. Such information will also
> include information on the availability of generic versions of the
> tools and medicines. The list of 10 non-communicable diseases and
> communicable diseases will be identified in consultation with Member
> States with the support of the WHO. The database will be useful in
> identifying the patent status of medicines for both communicable and
> non-communicable diseases and how access to these medicines can be
> better ensured by making full use of the available flexibilities. It
> should be noted that this request is not new, where in 2003 the WHO
> had requested the WIPO Secretariat to provide information about the
> patent status of essential medicines.
> ELEMENT III – TECHNICAL ASSISTANCE:
> 13. Flowing from the outcomes of the studies and information exchange
> as contained in elements I and II above, the WIPO Secretariat, in
> consultation with Member States, should develop targeted technical
> assistance programs.
> 14. Develop a technical assistance module that explicitly demonstrate
> the difference between compulsory licenses that are granted under the
> procedures of Part II of the TRIPS Agreement, concerning patent
> rights, and those granted under Part III of the Agreement, concerning
> the remedies for infringement of those rights. These technical
> assistance programs would explain both approaches, and focus on the
> flexibilities afforded to both systems, noting that under the
> structure of the TRIPS Agreement, Article 44 compulsory licenses are
> not subject to the restrictions that exist for Article 30 and 31 of
> the Agreement. These targeted technical assistance programs would
> proceed from the study identified in paragraph 8 above.
> DEVELOPMENT AGENDA LINKS:
> The proposed work program has links to Development Agenda
> recommendations 1, 7, 9, 14, 31 and 40.
> 1. WIPO technical assistance shall be, inter alia,
> development-oriented, demand-driven and transparent, taking into
> account the priorities and the special needs of developing countries,
> especially LDCs, as well as the different levels of development of
> Member States and activities should include time frames for
> completion. In this regard, design, delivery mechanisms and evaluation
> processes of technical assistance programs should be country specific.
> 7. Promote measures that will help countries deal with intellectual
> property-related anti-competitive practices, by providing technical
> cooperation to developing countries, especially LDCs, at their
> request, in order to better understand the interface between IPRs and
> competition policies.
> 9. Request WIPO to create, in coordination with Member States, a
> database to match specific intellectual property -related development
> needs with available resources, thereby expanding the scope of its
> technical assistance programs, aimed at bridging the digital divide.
> 14. Within the framework of the agreement between WIPO and the WTO,
> WIPO shall make available advice to developing countries and LDCs, on
> the implementation and operation of the rights and obligations and the
> understanding and use of flexibilities contained in the TRIPS
> 31. To undertake initiatives agreed by Member States, which contribute
> to transfer of technology to developing countries, such as requesting
> WIPO to facilitate better access to publicly available patent
> 40. To request WIPO to intensify its cooperation on IP related issues
> with United Nations agencies, according to Member States’ orientation,
> in particular UNCTAD, UNEP, WHO, UNIDO, UNESCO and other relevant
> international organizations, especially the WTO in order to strengthen
> the coordination for maximum efficiency in undertaking development
> James Love. Knowledge Ecology International
> http://www.keionline.org, +1.202.332.2670, US Mobile: +1.202.361.3040,
> Geneva Mobile: +41.76.413.6584, efax: +1.888.245.3140.
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