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

Columbian IP Agreement continues to Raise Human Rights Concerns

During Columbia’s periodic review by the Office of the UN High Commissioner for Human Rights, specifically the Committee on Economic, Social and Cultural Rights, several recommendations were made relating to intellectual property (IP) rights. 

The official UN report can be found here and CIEL’s publications relating to Trade Agreements and IP can be accessed here.

With respect to Access to Medicines, examining the US-Columbia Free Trade Agreement, the Committee noted that: 

The Committee is also concerned that the Free Trade Agreement (FTA) signed between the State party and the United States contains provisions on intellectual property that may result in increase of prices of medicines and negatively impact on the enjoyment of the right to health, in particular of those with low income (arts. 1, 12).

…In this regard, the Committee recommends that the State party consider revising the intellectual property provisions of the Free Trade Agreement signed with the United States, in order to ensure protection against the increase of the price of medicines, in particular for those with low income.  (para. 10)

With respect to development projects, including those that would be under the ambit of the Clean Development Mechanism (CDM) of the Kyoto Protocol, the Committee noted:

The Committee recommends that the State party take concrete measures to review the processes concerning infrastructure, development and mining projects and fully implement decisions of the Constitutional Court in this regard. The Committee also recommends that the State party review the Presidential Directive 001 and the draft bill elaborated by the Working Party on Prior Consultation of the Ministry of the Interior. The Committee further recommends that the State party adopt legislation in consultation with and the participation of indigenous and afro-colombian people, that clearly establishes the right to free, prior and informed consent in conformity with ILO Convention 169 concerning Indigenous and Tribal Peoples in Independent Countries, as well as the relevant decisions of the Constitutional Court.  (para. 9)

On Biofuels, the committee notes that:

The Committee is concerned that the policy encouraging agro-exporting goods, such as agro-fuels, may deprive peasants from cultivating their lands. The Committee is also concerned about the unequal distribution of lands owned by a minority of the population, as well as about the absence of a genuine agrarian reform, as recommended in the previous concluding observations of the Committee (art. 11).

The Committee recommends that the State party develop agricultural policies which prioritize the production of food; implement programs that protect national food production with incentives for small producers; and ensure the restitution of lands taken from indigenous and afro-colombian peoples, as well as peasant communities.   (para. 22)

Regarding Access to Knowledge and Education:

The Committee recommends that the State party take immediate measures to ensure access of all children without discrimination, to free and compulsory primary education.  (para. 29)

In addition to these recommendations by the Committee, on GMOs the Seeds Group presented its report on Genetically Modified Organisms and the Human Rights of Indigenous Peoples in Columbia.  The report states: 

The policies and practices of the Colombian State concerning genetically modified organisms (GMOs) have violated, and threaten to continue violating, the rights of indigenous peoples in Colombia, including their rights to self-determination, prior consultation, participation, property, culture, food, heath, and a healthy environment.

In 2005, the Colombian State issued a decree that regulates the approval of GMOs. Though indigenous peoples will be affected by the release of genetically modified (GM) seeds, they were not consulted before the approval of this decree; nor does the decree provide for any consultation during the approval process for each seed. Under this decree, the processes by which certain GM seeds have been approved have violated the Colombian State’s obligation to apply the precautionary principle, and have not taken into account scientific studies that have demonstrated the threat that GM seeds pose to native seeds, human health, and the environment.

The next periodic report of Columbia is due to be submitted by July 2015.