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It is not too late to add your comments to this dialogue. New Tactics joined together with New York Law School Fellow Christopher Wong, students from his Intellectual Property & Activism class and an amazing group of practitioners in the field for this dialogue on Improving Access to Health: Activating in the intellectual property and health nexus that took place January 26 to February 1, 2011.

Intellectual property (IP) laws have a significant impact upon global welfare.  In particular, IP law, as it relates to healthcare, is a substantial factor in determining the accessibility of essential medicines, treatments, and medical literature by those in need.  For example, patents on pharmaceuticals can lead to prices that are unaffordable by affected populations in developing countries, while copyright law may contribute to the inability of affected populations to access treatment information for basic ailments.

IP law also plays a large role in the way scientists conduct research.  IP protection on everything from indigenous knowledge and human genes can serve as obstacles to the downstream innovation and dissemination of better, cheaper treatments.

Practitioners are working to change the system to improve access to critical resources such as essential medicines and indigenous knowledge.  Read the dialogue summary below to learn more about the approaches and tactics being used by practitioners in the intersecting areas of IP and health.

The featured resources practitioners in this dialogue included:

• Christopher Wong - New York Law School Fellow, United States
• Dr. Gopal Dabade of the All India Drug Action Network (AIDAN), India
• William New - Director / Editor-in-Chief for Intellectual Property Watch, Switzerland
• Ethan Guillen, Sara Crager and others from the Universities Allied for Essential Medicines, United States
• Jeremy Malcom - Project Coordinator for Consumers International, Malaysia
• Frank A. Pasquale - Schering-Plough Professor in Health Care Regulation & Enforcement at Seton Hall Law School and also Visiting Fellow at Princeton University Center for Information Technology Policy, United States
• Bhaven Sampat - Professor of Health Policy and Management at Columbia University Mailman School of Public Health
• Felipe de Carvalho and others from the Working Group on Intellectual Property (GTPI), Brazil
• Khaled Fourati and Chaitali Sinha of the African Copyright and Access to Knowledge (ACA2K) Project, South Africa
• Francisco Viegas Neves da Silva, a lawyer focused in intellectual property, access to medicines and competition law, Brazil

[Photo:Clinic in Kenya - by davida3]

Dialogue Summary

Intellectual Property Laws & Health Nexus – Discussing intellectual property laws as a factor in determining access to medicine.

Intellectual property (IP) laws have had a significant impact on the global access to medicines problem. For example, IP law plays a large role in determining the way scientists conduct research.  IP protection can also serve as an obstacle to access, for example, with the lack of downstream innovation and disruptive dissemination systems that fail to provide treatments to those in need. This online dialogue provided an opportunity to learn more about the approaches and tactics used by practitioners in the intersecting areas of IP and health.

Access to Essential Medicines is a Global Concern

It generally takes 15 to 20 years to introduce a vaccine in developing countries after they are made in developed countries. In short, essential medicines are out of reach for poor people.

• The UAEM website points out that nearly a third of world’s population does not have regular access to essential medicines. Each year, ten million people die from diseases that have available cures. During the fifteen seconds it takes to read this paragraph, five people have died from preventable causes.

Cost as an Obstacle to Access to Essential Medicines

Cost represents a substantial obstacle for those in need of essential medicines. Many medicines are too expensive for the very people that suffer from the treatable illnesses.  On the other hand, pharmaceutical companies enjoy large profits form the production of these medicines.

• The WHO Essential Medicines List (EML) defines essential medicines as those that are affordable. Essential medicines are selected based on disease prevalence, efficacy and safety, cost-effectiveness, and offered at a price the individual and the community can afford. The EML is used by many countries to set drug purchasing priorities for their national health systems.

• Researchers suggest that a more ethical definition of an essential medicine should be one that does not include reference to cost. Instead, medicines should be defined as essential based purely on an assessment of medical need and that for any medicine deemed ‘essential’ on this basis, measures should be taken to make it affordable.

IP as a Barrier to Access to Essential Medicines

Patent, data exclusivity, and trade secret protection are among the IP-related factors that represent a barrier to access to essential medicines.

Patent

Pharmaceutical companies patent their drugs to prevent other companies from creating generic versions of these drugs. 

• The first barrier presented by patent law is in determining what constitutes “patentable subject matter.”
• Another barrier presented by patent law relates to the production of essential medicines. There are two basic types of medicines: small molecular drugs and biosimilars. Small molecular drugs can be chemically synthesized and can be produced in a generic and commercial form. Biosimilars, like vaccines, cannot be are significantly more expensive to produce than traditional small molecule generics because they cannot be synthesized. Generic companies will have to perform some amount of clinical trials before making biosimiliars available to the public.

Data Exclusivity

Data exclusivity is a protection given to data that is used by the drug authority (such as the FDA) to approve the drug for market.

• Unlike patents, data exclusivity is simply granted and therefore cannot be challenged or invalidated.  For example, with generic biologics, researchers have a sure shot at 12 years from data exclusivity whether you have valid patents or not.
• One solution that has been aggressively promoted by the EU drug companies on is the EU-India Free Trade Agreement, which sought to introduce data exclusivity and prevent generic drug companies from producing drugs, without running its only lengthy and expensive trials. Given that India is the pharmacy of the developing world, it is essential that the generic drugs made in India continue to be made.

Trade Secret Protection

The fundamental right of a trade secret owner is the right to restrict access to, and use and disclosure of a trade secret.

• Purposeful confusion of legitimate generics with counterfeits are critical impediments to access. 
• There are two ways of addressing trade secret policies – these policies protect process information regarding the manufacturing of biologics: 1) disclosure requirements and 2) technology transfer hubs or Patent Materials Know How pool – compiling all available information about a process.

IP Tactics Aimed at Improving Access to Healthcare

• TRIPS Agreement put forward by World Trade Organization, which sets out minimal standards of IP laws to be upheld by member states.
• In 2001, WTO put forth the WTO Doha Declaration on TRIPS (Agreement on Trade-Related Aspects of Intellectual Property Rights) and Public Health of 2001 in response to developing countries challenging the TRIPS agreement and demanding more flexibility to allow for better access to essential medicines.
• The United States Trade Representative's (USTR) Special 301 Report, which rates how strong the standards of intellectual property protection and enforcement are in other countries around the world. 
• In response to the suggested one-sidedness of the Special 301 Report, Consumers International publishes an IP Watchlist, which provides analysis on which countries have the fairest IP laws and enforcement practices for consumers, rather than the strongest for rights holders.
• Technology transfer to developing country manufacturers has been recognized as a potentially important strategy in a couple of prominent places.
• The Medicines Patent Pool appears to be a step in the right direction that could be powerful if it expands. Its goal - is to negotiate "with patent holders to share their intellectual property with the Pool, and then licensing it to other producers to facilitate the production of affordable generic medicines well-adapted for use in resource-poor settings." Patent pooling as a possible means of cost reduction

Obstacles to Influencing IP Policies

• Barriers to upholding the Doha Declaration’s provisions.
• The use of the TRIPS protocol have been too complicated for most developing countries to use. 

• Providing the public with a clear narrative.
• Upholding laws that protect public interest, for example, the Bayh-Dole Act, which endows the US government with the right to allow others to use patents for medicines discovered with federal funds.
• Politics as a Barrier to Access to Medicine:
  • Addressing conflicts of interest between Congress and Big Pharma.
  • Free trade agreements are never free and are less and less about trade. .  ACTA is a perfect example of this, where the first request for the text of the document was denied by the US government on national security grounds. 

Activism: Breaking Down Barriers to Access Created by IP

• Activists can encourage boycotting products from a particular company. This approach is going to be effective in achieving our goals in conflicts with pharma companies needs to directly on indirectly threaten their income stream Boycott pharmaceutical products – an example of Novartis Boycott in India. (See also People's Health Movement - India (http://phm-india.org/) and All India Drug Action Network (AIDAN) (www.aidanindia.wordpress.com) have launched a boycott campaign against Novartis: www.novartisboycott.org).
• Applying political pressure – utilizing TRIPS flexibilities and openly critiquing the United States Trade Representative’s Special 301 Report
• Fostering strategic partnerships: an example from South Africa – Treatment Action Campaign from South Africa addressed issue of high cost of HIV/AIDS drugs by collaborating with WHO and MSF to allow generic drugs to enter the country.

Resources

• The Dilemma Demonstration: Using nonviolent civil disobedience to put the government between a rock and a hard place.
• "Intellectual Property in Free Trade Agreements" by Sanya Reid Smith
• The WHO list of essential medicines: http://www.who.int/mediacentre/factsheets/fs325/en/index.html
• http://lawlib.wlu.edu/CLJC/index.aspx?mainid=119&issuedate=2009-07-28
• Resources on Access to Medicine – American University (PIJIP)
• MSF Newsletter: http://www.msfaccess.org/
• UAEM resources
  • http://essentialmedicine.org/chapters/resources
  • http://essentialmedicine.org/our-work/publications
  • http://essentialmedicine.org/archive
• IP Watch: http://www.ip-watch.org/weblog/category/themes/public-health/.
• "Drugs, Doctors and Dinners: How drug companies influence health in the developing world".  You can download a copy from http://www.consumersinternational.org/media/311707/drugs,%20doctors%20an...
• http://www.deolhonaspatentes.org.br/default.asp?idiomaId=2
• http://www.patentes.org.br/sulsul/http://www.nyls.edu/innovateactivate.  
• PIJIP's medicines related materials: http://www.wcl.american.edu/pijip/go/research-and-advocacy/access-to-med...
• Online curriculums on Human Rights and access to medicines at:
• http://www.wcl.american.edu/pijip/go/additionalmaterials and http://www.wcl.american.edu/pijip/go/humanrights
• Doctors and Dinners: How drug companies influence health in the developing world
• http://www.peertopatent.org