Intellectual Property and Sustainable Development

Berkeley Declaration on IP, Enforcement, and Access to Medicines

A set of access to medicines groups and experts met last week at the University of California at Berkeley Law School, and have prepared the
attached "Berkeley Declaration on Intellectual Property Enforcement
and Access to Medicines."  The declaration calls attention to the
dangers that the new IP enforcement agenda poses to access to
medicines -- please distribute widely.  It's also available at http://www.law.berkeley.edu/files/Berkeley_Declaration.pdf

The Berkeley Declaration is being released on the occasion of Friday's
joint WTO, WIPO and WHO "Technical Symposium on Access to Medicines."

The Declaration, along with the below cover letter, will be delivered
tomorrow to Director-General Lamy, Director-General Chan, and Director
General Gurry.

Amy Kapczynski
Assistant Professor of Law
University of California at Berkeley Law School
---
Berkeley Declaration on Intellectual Property Enforcement and Access
to Medicines

All people have the right to access the medicines they need to be
healthy. As public health groups, humanitarian and inter-governmental
organizations, experts and academics that work on access to medicines,
we gathered at the University of California at Berkeley to analyze the
serious threats that recent ?intellectual property enforcement?
initiatives pose to this right.  The enforcement agenda threatens the
last decade of efforts to achieve access to medicines for people in
low- and middle-income countries, and compromises the attainment of
health-related Millennium Development Goals. We make this Declaration
to call upon policy makers in governments and international
organizations to reject the cynical and dangerous efforts that have
been made through this agenda to prioritize commercial interests over
the right to health.

The IP enforcement agenda promotes new standards that will require
increased surveillance of goods and more intrusive police powers for
government officials without adequate procedural protections. It aims
to substantially increase the penalties for people alleged to have
infringed patents, trademarks, and copyrights. It would require judges
to consider a range of measures that would restrict the freedom of
people to use knowledge goods, and would impose new punishments for
third parties without due regard for the implications on access to
medicines.

Access to medicines in developing countries depends on the ability of
countries to produce, export, and import generic medicines.
Restrictions on generics impede competition, leading to increased
prices, and preventing people with limited resources from accessing
the medicines that they need. New enforcement measures have been used by customs officials to disrupt the supply of legal generic medicines
between developing countries as they transit through Europe. The draft
Anti-Counterfeiting Trade Agreement (ACTA) represents a deliberate and
non-transparent attempt to bypass multilateral institutions, while
ultimately aiming to impose its standards on developing countries. The
enforcement agenda commandeers public money for private gain, and has
a chilling effect on the manufacturing of and trade in legitimate
generic medicines. Contrary to assurances, it undermines key public
health safeguards that allow countries to balance the right to health
with their obligations under the World Trade Organization’s Trade
Related-Aspects of Intellectual Property Rights Agreement (TRIPS).
While enforcement norms are typically considered procedural, it is
clear that this new agenda goes far beyond procedures and has serious
implications for substantive areas of intellectual property law.

The recent IP enforcement agenda is being promoted in many fora:
globally, in the ACTA negotiations; regionally, with the East African
Community draft ?anti-counterfeit? policy and Bill; and nationally in
free trade agreement negotiations with the European Union and national
”anti-counterfeiting” laws, among others. Additional sites of these
initiatives include the World Customs Organization SECURE project, the
World Health Organization International Medical Products Anti-
Counterfeiting Taskforce (IMPACT), and Interpol. Public safety is
being cynically used as a pretext to promote these initiatives.  In
particular, we reject the attempt to conflate the serious public
health issue of medicines quality with private concerns about the
enforcement of intellectual property rights.

IP enforcement initiatives must not interfere with access to
medicines, and should:
-       Be grounded in human rights principles
-       Protect innovation, competition, and consumer rights
-       Be negotiated through a transparent, inclusive, and open
process, that does not bypass existing multilateral institutions
-       Protect the full use of TRIPS flexibilities that promote
access to medicines

ACTA represents some of the worst enforcement practices on both
substance and process. The agreement has been conducted through a
secretive, illegitimate process, and there is no evidence that its
procedural or substantive shortcomings can be remedied in the current
structure.  ACTA should be abandoned.

The European Union should cease its efforts to export its much-
criticized enforcement policies to low- and middle-income countries.
We call for a moratorium on exporting these policies through free
trade agreements and technical and financial assistance. The review of
EU customs regulations that was prompted by the recent generic drug
seizures must be concluded with amendments to these regulations that
remedy the threat that they pose to access to medicines.
The East African Community ?anti-counterfeiting? draft policy and
proposed legislation introduces unprecedented IP norms at the regional
level, threatens access to medicines, and should be discarded.  It is
particularly inappropriate because it seeks to impose TRIPS-plus
provisions when TRIPS itself does not require the majority of the
participating countries to enforce patents on medicines. The East
African Legislative Assembly, national governments affected, and the
EU Parliament should investigate the origins of such laws at the
national and regional level. We also welcome efforts made to challenge
the recent ?anti-counterfeiting? law in Kenya in court.
We recommend all developing countries approach IP enforcement and
?anti-counterfeiting? initiatives with caution and reject any such
initiatives that affect the ability to produce, export, import, and
use generic medicines. We also call for enhanced South ? South
collaboration in developing frameworks for the management of IP from a
public health perspective.

Finally, WHO should immediately disengage from IMPACT, and instead
take a public health approach to the problem of medicines quality,
safety, and efficacy.  Such an approach must strengthen drug
regulatory authorities, ensure the availability and affordability of
medicines to diminish incentives for unregulated and unsafe medicines,
promote rational use, and require transparency and accountability in
the pharmaceutical sector. WHO should scrutinize and publicize the
implications of IP and its enforcement on public health, and WHO
member states should focus on and lead the implementation of the
Global Strategy and Plan of Action on Public Health, Innovation and
Intellectual Property.

Against the background of continued problems with excessive drug
prices, falling donor commitments, the real danger of not meeting
Millennium Development Goals targets, and the failure of the TRIPS
Agreement to meet the expectations of developing countries on access
to medicines, innovation for unmet health needs, and technology
transfer, a focus on IP enforcement is hypocritical and immoral.  It
will deepen global health inequality, and exacerbate inequity in
access to medicines.

Signed
Farmamundi
Health Action International Africa
Knowledge Ecology International
Public Citizen
Third World Network
Universities Allied for Essential Medicines
William L. Aldis MD, Assistant Professor (Global Health), Faculty of
Public Health, Thammasat University, Bangkok, Thailand
Kajal Bhardwaj, Lawyer (HIV, health and human rights), India
Michelle Childs, Director Policy Advocacy, M?dicins Sans Fronti?res
Campaign for Access to Essential Medicines
Gwen Hinze, International Director, Electronic Frontier Foundation
Busingye Kabumba, Lecturer on Law, Human Rights and Peace Centre
(HURIPEC), Makerere University
Amy Kapczynski, Assistant Professor of Law, University of California
at Berkeley Law School
Els Torreele, Project Director, Access to Essential Medicines
Initiative, Open Society Institute
German Velasquez, Senior Adviser for Health and Development, The South
Centre, Geneva
July 15, 2010

Human Rights, Technology Transfer & Climate Change

On the margins of the WIPO Committee on Development and IP (CDIP), CIEL organized a series of presentations and commentary on the topic of Human Rights and Technology Transfer, in the context of climate change.  Information on what agreements were reached in the CDIP can be found on the CIEL IP Quarterly Update, Second Quarter of 2010.

The speakers included:

• Mr. Robert Archer, Executive Director of the International Council on Human Rights Policy (ICHRP)
• Mr. Michael Waibel, Post-doctoral researcher at Cambridge University
• Mr. Baskut Tuncak, Law Fellow, Center for International Environmental Law (CIEL)
• Ms. Caroline Dommen, Quaker United Nations Office (QUNO)
• Mr. Subhas Gujadhur, First Secretary of the Permanent Mission of Mauritius to Geneva

Mr. Archer began the event with a summary of the Human Rights dimension of climate change, based in part on their earlier publication “Climate Change and Human Rights: A Rough Guide.” 

Mr. Waibel followed with an overview of Technology Transfer in the International Agreements on intellectual property and environmental protection.  His presentation can be viewed here.

Mr. Tuncak then spoke of how and to what benefit human rights obligations can inform discussions on technology transfer.

Finally. Ms. Dommen and Mr. Gujadhur provided their perspective on the preceding presentations. 

For further information, please see IP Watch’s coverage here and/or contact Baskut Tuncak at btuncak [at] ciel [dot] org

WIPO Committee on Patents (SCP) Concludes with No Agreement on Future Work & Fragmentation Apparent

The 14th session of the WIPO Standing Committee on the Law of Patents (SCP or SCP 14) concluded late Friday evening, with no agreement on future work (see the IP Quarterly for a summary of the meeting).  The tenor of the negotiations of how to proceed and on which studies are extremely divided in the SCP.  Developing countries are pushing for studies on topics where IP is known to be an impediment, and industrialized countries are pushing for topics that would appear to support arguments for harmonizing some aspects of national patent laws.  The agenda item on the future work of the SCP was never discussed in the plenary and NGOs did not have the opportunity to comment specifically on the future work and/or direction of the Committee.

Discussions regarding Technology Transfer, Opposition Systems, Exceptions and Limitations in the SCP highlighted the development dimension of patents, which in all cases were emphasized as lacking appropriate consideration by the Secretariat, according to intervening developing countries.  One of the most interesting and unresolved issues of the meeting is how, exactly, the SCP will interact with the Committee on Development and IP (CDIP) to coordinate the implementation of the WIPO Development Agenda. 

Work on the subject of Technology Transfer in WIPO is suffering under the Member States' and the Secretariat's confusion regarding how to reconcile and coordinate Development Agenda recommendations with the work of the Standing Committees of WIPO. 

Intra-organizational Fragmentation?

A long-standing concern in international law has been the issue of fragmentation, i.e. the concern that treaties and institutions on specialized topics will be implemented without due regard for the activities of other related bodies of international law or organizations.  Regarding the specialized topic of IP, numerous fora have dealt with the topic, including: the World Health Organization, the Food and Agriculture Organization, the World Trade Organization (WTO), the UN Office of the High Commissioner for Human Rights, the UN Conference on Trade and Development - and the list goes on. 

What is especially troubling with the subject of Technology Transfer under WIPO's Development Agenda is the potential for there to be intra-organizational fragmentation within WIPO, i.e. the inability for topics to be coherently addressed between Committees.  Transfer of Technology is currently discussed and debated in the SCP and the Standing Committee on Copyright and Related Rights (SCCR), as well as the Committee on Development and IP (CDIP).  The issue of a Coordination Mechanism for WIPO was left unsettled at the last CDIP meeting (see related documents CDIP/4/11, CDIP/4/9 and CDIP/4/10 and a transcript of the debate in CDIP/4/14 Prov, from paragraph 242).  The CDIP is mandated with approving and monitoring project to implement the WIPO development agenda.  However, the last CDIP failed to approve the project on Technology Transfer (see earlier posting)

Other fora have also seen the problem on intra-organizational fragmentation.  On the topic of Environmental Goods and Services (EGS), division of the topic among three different WTO committees has compounded the pre-existing problem of diverging economic, social and commercial interests.  As of July 2007, Members of the WTO had failed to agree on a common approach to the methodology for EGS negotiations.

Besides mainstreaming the development dimension into all of WIPO's activities, the Development Agenda is also expected to "explore...policies and measures Member States, especially developed countries, could adopt for promoting transfer and dissemination of technology to developing countries" (per Rec. 28).  One way of doing this is to create a mechanism to gather and compile data in a useful format, for developing countries "to explore IP-related policies and initiatives necessary to promote the transfer and dissemination of technology, the benefit of developing countries.." (per Rec. 25). 

Creating scientific methodologies should not be a far reach for a science oriented organization like WIPO.  These methodologies to explore policies and measures with empirical evidence, incarnated as "projects" in the CDIP, would help produce useful information for use and deliberation in other committees. There would be no fear of a hierarchy of committees, which is a major concern in discussions in the CDIP on the Coordination Mechanism.  Rather, the CDIP could enable objective criteria to facilitate evidence-based policy making in WIPO, while the debate over coordination continues.  

Moreover, the issues selected for preliminary study by the SCP also indicate intra-organizational fragmentation.  For example, both the ongoing study on exceptions and limitations and the suggested study on climate-related technologies have technology transfer components.  These are three different studies at various stages of examination.  How do these studies harmonize and synergize with each other?  Are the outside experts commissioned for work on Exceptions and Limitations to ensure that their findings do not conflict with that of the Secretariat?  Would the Secretariat revise the Technology Transfer study based on the findings of 2 out of the 5 experts on Exceptions and Limitations?  

These and other, more existential questions regarding the viability of the SCP long-term remain to be seen.  But, it will take a while.  The report on exceptions and limitations to patent rights, commissioned to outside experts, will be ready to review 18 months after it was approved in SCP 13.  With another 1 to 2 sessions of the SCP for revisions and expansion, it does not appear that any action will be taken on this report for about 2 years from now.  Given the pace of progress and the absence of any sense of urgency in WIPO, one could easily forget that what we are really talking about in the report on exceptions and limitations is how to improve lives with medicines, educate our youth, and preserve a rapidly deteriorating environment, for starters.  Lets hope technology transfer doesn't hold up the discussion too.

3rd Quarter CIEL-South Centre IP Quarterly Released

The latest edition of the CIEL-South Centre joint publication, IP Quarterly, has been released.  It is available here:  http://www.ciel.org/Publications/pubipqu.html

This Focus Piece discusses the new mandate of the WIPO Intergovernmental Committee on Genetic Resources, Traditional Knowledge and Folklore (IGC) that was renewed by the WIPO General Assembly IN 2009 and identifies challenges that lie ahead in the future work of the IGC under the new mandate for text based negotiations towards an international legal instrument or instruments for the effective protection of GR, TK and TCEs. It points to the need for greater coordination on the part of developing countries between themselves and with their national stakeholders to overcome these challenges and also stresses on the need to ensure that the work of the WIPO IGC complements the work currently undertaken on related issues in other multilateral fora, particularly the WTO negotiations on the relationship between TRIPS and CBD, and the CBD International Access and Benefit Sharing Regime.

Following the Focus Piece is a summary of major developments in the third quarter of 2009 on IP related issues in multilateral organizations including: UNFCCC, WTO, WIPO, WHO, CBD, FAO, regional and bilateral free trade agreements, national legislations, and other related processes like ACTA and G8.

Technology Transfer for Development Stalls in WIPO

Last week, the World Intellectual Property Organization (WIPO) Committee for Development and IP (CDIP) met to discuss the organizations latest proposals for implementing WIPO's Development Agenda (for the background of the WIPO's Development Agenda, see CIEL's Citizen's Guide to WIPO, and IP Quarterly Updates for recent developments in the CDIP).  As it has in the past, CIEL participated in the Committee as a permanent observer.

On the agenda was the "Project on Intellectual Property and Technology Transfer: Common Challenges - Building Solutions" (document CDIP/4/7).  Details on the project and CIEL's concerns and suggestions are available below (see Oct 15th 2009).

Consistent with many of the problems identified by CIEL, a coalition of self-professed "like-minded" developing countries immediately began to articulate a long list of additional considerations for the technology transfer project.  One such country, Brazil, intervened that it would refuse to feel pressured to prematurely adopt this or any project on technology transfer, particularly without any discussion in the CDIP of the Development Agenda Recommendations on which technology transfer projects were based.  Another "like-minded" country, Egypt, relayed a long-list of considerations that it wished to have discussed before any project on technology transfer was undertaken.

The outpouring of concerned interventions appeared to catch both the WIPO Secretariat and Developed Countries off-guard.  Because the "like-minded" countries were unprepared to submit their lengthy list of comments, concerns and suggestions in writing, technology transfer discussions were postponed until the following meeting, in the spring of 2010.  The "like-minded" countries are to submit a written statement by the 15th of December, 2009, with responses due the 31st of January, 2010. 

The possibility of examining the transfer of climate-related technologies (for mitigation and adaptation), or at least a small subset of them, appears slim.  One small - but vocal - developing country, Sri Lanka, explicitly stated that her delegation did not want climate technologies included in the Technology Transfer Project. 

If this represents the view of developing countries as a whole, it is a strong shift from what India stated recently in the 2009 WIPO General Assembly, when they stated, "[w]e need to speed up the development and deployment of new green technologies" implying a greater role of WIPO in making this happen (see 24th Sept. 2009). 

At the same 2009 WIPO General Assembly, WIPO's Director General announced that he did not see IP posing a barrier to the development and transfer of climate technologies (see 23rd Sept. 2009).  Simultaneously at the General Assembly, the US Chamber of Commerce was also lobbying strongly against what they called the "rhetoric" that IPRs impede access to climate technologies. 

Group B (the coalition of developed countries) expressed support for studying "environmental technologies" under the Technology Transfer project.  

If developing countries are indeed shying away from examining Climate Technologies within WIPO, it could be perceived that they no longer see IP as being a significant barrier to accessing climate technologies, which has been their position at the UNFCCC negotiations leading up to Copenhagen later this year.  Giving this impression is not necessarily in the best interest of developing countries because it is not clear whether IPRs present a significant barrier with respect to many climate technologies.

Or rather, the Director General's blanket assertion - that IPRs are not a barrier - has given the impression that any study by WIPO on the transfer of climate technologies will have a predetermined outcome.  Given the breadth of technologies implicated by climate change, from drought resistant plants to diseases to large engineering endeavors, this blanket assertion should not dissuade developing countries from examining in an empirical fashion, which technologies are or are not being transferred over what alternatives.  A well-structured empirical analysis on technology transfer will not permit WIPO to interject its own conclusion on the results, while it would allow for the analysis of the effect of policy decisions on technology transfer to be examined from a baseline level by independent experts. 

WIPO's Committee on Development Begins Work on Technology Transfer

Formed in 2007 to address Development concerns associated with IP, WIPO's Committee on Development and IP (CDIP) is - finally - starting to address Technology Transfer. By way of background, the Development Agenda is comprised of 45 Recommendations, ranging from Capacity Building, to Norm-Setting, to the Governance of WIPO . Recommendations 24-26, and 28-31 (cluster C) are directed to Technology Transfer. At the most recent CDIP, the Member States agreed to take a thematic approach" to implementing Recommendations - realizing that there was some overlap between individual recommendations. However, one key pre-condition to the thematic approach was that the individual recommendations would be discussed before projects were decided upon. In making progress towards the implementation of Recommendations 19, 25, 26 and 28, WIPO presented its "Project on Intellectual Property and Technology Transfer: Common Challenges - Building Solutions" at the Open-ended Forum on Proposed Development Agenda Projects. As far as we can tell, none of these Recommendations have been discussed in the Plenary of the CDIP, as required under the thematic approach. The proposed project consists of five "Key Activities:"

1. Organize a high-level forum to facilitate Access to Knowledge/Technology and to form the "New Platform" on Technology Transfer and IP collaboration
2. Perform a series of studies
3. Hold a WIPO forum on transfer and collaboration
4. Hold regional consultations
5. Strengthen existing activities within WIPO

The project is projected to cost about 1.5 million CHF, and take 27 months. How these figures were arrived at, without having concrete plans for which studies would be carried out and how existing activities would be strengthened, is uncertain. Thankfully, WIPO is holding its anticipated "Conference on Building Partnerships for Mobilizing Resources for IP and Development" in a few weeks, just in case additional resources are needed. Moreover, the function of this new platform is quite vague, which is perhaps an appropriate precaution, given the fact that WIPO's Member States have not discussed these recommendations in the plenary. Briefly, CIEL, while welcoming this activity, would recommend that:

1. Individual Recommendations be discussed first in the CDIP so as to not provide for definitions of individual Recommendations through their associated projects for implementation;
2. WIPO view holistically the issue of Technology Transfer and include WIPO's Copyright Section in the relevant divisions implementing Technology Transfer recommendations. The proposal included Patent and Information Communication Technology sections, but not Copyright;
3. WIPO create a mechanism to gather empirical evidence regarding the International Transfer of Technology to help generate evidence based policies for issues of global concern; and
4. WIPO create distinct points of contact and input with relevant Intergovernmental Organizations, as required under Recommendations 30 and 40, in order to capitalize on previous efforts on Technology Transfer by the WTO, WHO, UNEP, UNCTAD and other IGOs.

Labels: Development, ESTs, Green Innovation, IP, Technology Transfer

Member States of WIPO Support Enabling and Enhancing Transfer of Clean Tech

At the World Intellectual Property Organization's (WIPO's) Assembly of Member States, in support of Director General Francis Gurry's opening remarks to the Assembly (see 23 Sept 2009), many nations have also called for accelerated efforts to be made in the cross-border transfer of Environmentally Sustainable Technologies (ESTs). One such country, playing a key role in climate change negotiations, India, stated: We need to speed up the development and deployment of new green technologies across sectors so that the economies of scale bring the benefit of lower costs. Our national IPR regime and the global IP system need to be seen as facilitating the resolution of the key global challenges of climate change, sustainability and food security. - Opening Statement of the Indian Delegation However, no delegation has, as of yet, provided specific information on how it believes the cross-border transfer of ESTs could be accelerated. Perhaps tangentially related, the Korean IP Office is pushing its initiative on increased Access to Information on Appropriate Technologies (http://www.ipforliving.org/).

Labels: Climate Change, Development, ESTs, Green Innovation, IP, Technology Transfer, WIPO

WIPO Director General Gurry comments on Climate Change and IP

In his opening remarks and Report to the General Assembly of the World Intellectual Property Organization (WIPO), which is being held from 22 Sept. - 01 Oct. 2009 in Geneva, the Director General stated:

"...Let me conclude by referring to WIPO and intellectual property (IP) in the broader global agenda. We have, as an Organization, set a new objective of engagement with global policy issues....We have held a successful conference on IP and public policy issues in July to stimulate greater dialogue. But perhaps the most important public policy issue of all is now arising for discussion, namely, the challenge of climate change.There is a perception that intellectual property may be a negative influence in the range of policy initiatives that are needed to deal with climate change. I do not believe that this perception corresponds to reality. It is generally recognized that technological innovation will be central to global efforts to deal with the challenges associated with climate change. It is also coming to be recognized that this innovation will be needed across the whole infrastructure of the economy to give that infrastructure ultimately a carbon-free or carbon-neutral character. In this context, it is difficult to imagine how a property right on an individual piece of technology could constitute an obstacle. On the contrary, IP as a systemic stimulus to the creation and diffusion of technology has a very positive contribution to make to our efforts to develop green innovation. It will assist the economy to adjust by favouring investment in green innovation. Some countries have started to use IP in a dynamic way to favour desired outcomes by creating fast-track channels for processing green innovations. Much more is possible. Given that climate change is global, green innovation will be of relatively little benefit if it is applied in only one country. Transfer of technology is thus fundamental to effective action. The policy challenge of shepherding, through a public process, the transfer of such an extensive range of technology held in private hands is daunting and, frankly, has never been achieved before. Here again, the experience of the intellectual property system and community in the creation, commercialization and diffusion or transfer of technology can make a valuable contribution." - Dr. Francis Gurry, Director General of WIPO

Labels: Climate Change, ESTs, Green Innovation, IP, WIPO