[Ip-health] Berkeley Declaration on Intellectual Property Enforcement and Access to Medicines

Amy Kapczynski akapczynski at law.berkeley.edu
Thu Jul 15 22:28:06 PDT 2010

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  

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.



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, Médicins Sans Frontières  
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


Dr. Margaret Chan
World Health Organization
Geneva, Switzerland

Director General
Dr. Francis Gurry
World Intellectual Property Organization
Geneva, Switzerland

Pascal Lamy
World Trade Organization
Geneva, Switzerland

July 15, 2010

Re: Berkeley Declaration on Intellectual Property Enforcement and  
Access to Medicines

Dear Dr. Chan, Mr. Gurry, and Mr. Lamy,

I write in light of your jointly-organized July 16 symposium on Access  
to Medicines: Pricing and Procurement Practices, in Geneva,  
Switzerland.  According to the details available, your meeting will  
address "drug procurement, pricing and relevant intellectual property  
issues."  As such, I urge your consideration of an important  
declaration released today by access to medicines experts and  
organizations highlighting the dangers that the new intellectual  
property enforcement agenda poses to access to medicines.  The  
statement builds on the results of a two-day meeting convened on July  
7-8, 2010 at the University of California at Berkeley Law School.

You are aware of the recent and widely condemned seizures of generic  
medicines transiting through the EU.  These medicines were not covered  
by patents in India (where they originated) or in the developing  
countries to which they were sent, but were nonetheless seized in  
various European ports on the fiction that they violated local  
patents.  These seizures are a danger to the generic medicine supply,  
and have recently been challenged in the WTO by India and Brazil.  But  
the enforcement agenda reaches far beyond such seizures.  European  
Partnership Agreements seek to export unbalanced EU enforcement  
standards to developing countries such as India.  The new "Anti- 
Counterfeiting Trade Agreement" that is being negotiated outside of  
multilateral fora threatens to further fragment the process of  
international IP lawmaking, and despite assurances to the contrary,  
includes many provisions that threaten to restrict generic access and  
raise drug prices.  Local enforcement measures being proposed and  
passed in East African countries threaten the principle of  
independence of intellectual property rights, and give extraordinary  
powers to local officials to act on the basis of accusations by rights- 
holders, without adequate procedural safeguards.

A fuller account of the threat posed by this new agenda can be found  
in the attached Berkeley Declaration on Intellectual Property  
Enforcement and Access to Medicines. The statement will be released  
today, and will be made broadly available to the public.

I urge you to consider this statement in light of your joint meeting  
and plans for continued dialogue on access to medicines and IP  
issues.  No attempt to ensure access to medicines today can ignore the  
dangers that the new IP enforcement agenda poses to access, as well as  
to free trade, competition, procedural fairness, and human rights.


Amy Kapczynski
Assistant Professor of Law
University of California at Berkeley Law School
Berkeley, California, USA

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