[Ip-health] AMA Jrnl of Ethics: Intellectual property and access to medicine for the poor

[Sheila.SHETTLE@geneva.msf.org]

Virtual Mentor, December 2006=E2=80=94Vol 8 www.virtualmentor.org=0D
834=0D
Virtual Mentor=0D
American Medical Association Journal of Ethics=0D
December 2006, Volume 8, Number 12: 834-838.=0D
Health law=0D
Intellectual property and access to medicine for the poor=0D
by Tara Leevy, LLB, LLM=0D
India is a significant source of affordable generic medicines for=0D
developing and least=0D
developed countries (LDCs). About 80 percent of the AIDS drugs that the=0D
international medical humanitarian organization Medecins Sans Frontieres=0D
(MSF)=E2=80=94=0D
better known in the U.S. as Doctors without Borders=E2=80=94uses to treat o=
ver=0D
60,000=0D
patients in more than 30 countries are generics from India [1]. Novartis, a=
=0D
Swiss=0D
pharmaceutical company, has filed a challenge against India=E2=80=99s paten=
t law,=0D
specifically a part of the law that restricts the patenting of trivial=0D
improvements. MSF=0D
warns that this case, which is being heard in the Chennai High Court in=0D
India, may=0D
have widespread implications for India=E2=80=99s ability to sell affordable=
 generic=0D
drugs.=0D
=0D
Many factors affect the procurement of essential medicines at prices people=
=0D
in poor=0D
countries can afford, including knowledge and understanding of domestic and=
=0D
international intellectual property law; market intelligence concerning the=
=0D
pricing=0D
and supply of medicines and how to forecast demand; global coordination=0D
among=0D
governmental and nongovernmental agencies; opportunities for local=0D
production of=0D
medicines in low and middle-income countries; capacities of health systems=
=0D
and=0D
budgets; and regulatory capability [2].=0D
=0D
Far more critical than these factors in facilitating the global and=0D
regional availability=0D
of essential medicines, however, is the use of exemptions and amendments,=
=0D
called=0D
=E2=80=9Cflexibilities,=E2=80=9D in the Agreement on Trade-Related Aspects =
of Intellectual=0D
Property=0D
Rights, known as TRIPS.=0D
=0D
The TRIPS regime=0D
TRIPS and the patent right. TRIPS, which is part of the Agreement=0D
Establishing the=0D
World Trade Organization (WTO), is the most comprehensive international=0D
agreement on intellectual property protection ever established [3].=0D
Articles 27 to 34=0D
of TRIPS protect patents; that is, they provide the patent owner with the=
=0D
legal means=0D
to prevent others from making, using or selling the new invention for a=0D
limited=0D
period of time, subject to exceptions. Patent protection has to last at=0D
least 20 years=0D
from the date the patent application was filed [4].=0D
=0D
Exceptions to the patent right. Article 27 of TRIPS allows for certain=0D
exceptions to=0D
patent protection. Governments can refuse to grant patents for three=0D
reasons that may=0D
relate to public health: (a) when commercial exploitation of an invention=
=0D
must be=0D
prevented to protect human, animal or plant life or health; (b) when new=0D
diagnostic,=0D
therapeutic and surgical methods for treating humans or animals are=0D
invented; and=0D
(c) in the case of certain plant and animal inventions [5].=0D
Article 30 of TRIPS allows governments to make limited exceptions to patent=
=0D
rights=0D
if certain conditions are met; if, for example, the exceptions do not=0D
unreasonably=0D
conflict with the normal exercise of the patent. Under this article,=0D
researchers may=0D
use a patented invention for research in order to understand it more fully,=
=0D
or the=0D
patented invention may be used to obtain marketing approval from public=0D
health=0D
authorities.=0D
=0D
Compulsory licensing. Compulsory licensing is the granting of permission by=
=0D
a=0D
government to a party or entity (the licensee) to produce the patented=0D
product or=0D
process without the consent of the patent owner. Although TRIPS does not=0D
specify=0D
what requirements must normally be met for a party to obtain a compulsory=
=0D
license,=0D
Article 31 states that a compulsory license may be granted in an unusual=0D
situation=0D
(for example, an emergency) without requiring a party to meet requirements=
=0D
that=0D
would normally apply.=0D
=0D
Parallel imports/gray imports. Parallel importation (also known as=0D
participation in=0D
the gray market) involves the buying of goods in a foreign country at a=0D
price that is=0D
lower than the price at which they are sold in the domestic country and the=
=0D
reselling=0D
of those goods in the domestic country at a price less than or equal to the=
=0D
market=0D
price in that country. For example, the distributor of medicine X in=0D
Australia buys=0D
medicine X in Thailand at a low price, then re-imports it into Australia to=
=0D
sell at a=0D
price that is the same as, or lower than, the price at which it is directly=
=0D
offered to=0D
Australian consumers.=0D
=0D
Pre-Doha Round: 1995-2001. When TRIPS went into effect in 1995, the LDCs=0D
were=0D
exempted from TRIPS patent rules, but most of them lacked production=0D
capacity and=0D
depended on cheap imports from other countries, such as India, where=0D
low-cost=0D
generics were available. This general shortage of pharmaceutical=0D
manufacturing=0D
capacity in LDCs meant that once the generic supplier countries (often=0D
other=0D
developing countries) became subject to TRIPS patent rules, both the=0D
developing and=0D
LDC countries would be faced with the prospect of unaffordable drug prices.=
=0D
While=0D
theoretically TRIPS provided for some flexibilities (for example,=0D
compulsory=0D
licensing), poorer countries were pressured by more powerful interests=0D
against using=0D
such mechanisms.=0D
=0D
This crisis in drug availability led to another round of multilateral trade=
=0D
negotiations,=0D
known as the Doha Round, out of which came the Doha Declaration on the=0D
TRIPS=0D
Agreement and Public Health or the Doha Declaration on Public Health for=0D
short, in=0D
November 2001. The Declaration was revised in 2002) [6].=0D
=0D
Doha Declaration on Public Health. In the Doha Declaration, ministers of=0D
WTO=0D
member countries recognized the gravity of public health problems=0D
afflicting poor=0D
countries, especially HIV/AIDS, tuberculosis, malaria and other epidemics.=
=0D
They=0D
declared that TRIPS should not prevent WTO member countries from taking=0D
measures to protect public health and affirmed the right of WTO members to=
=0D
use the=0D
exemptions in TRIPS, which provide flexibility for this purpose. They=0D
underscored=0D
some of the key flexibilities in the agreement, for example, parallel=0D
imports and=0D
compulsory licenses.=0D
=0D
Nevertheless, it was recognized that compulsory licenses remained subject=
=0D
to some=0D
conditions in Article 31 of TRIPS, which caused difficulties for developing=
=0D
countries=0D
and LDCs that relied on cheap imported medicines. One provision of TRIPS,=
=0D
for=0D
example, required that the bulk of all drugs manufactured under a=0D
compulsory=0D
license be sold only on the domestic market.=0D
=0D
      Paragraph 6 of the Doha Declaration attempted to override this hurdle=
=0D
      by stating:=0D
      We recognize that WTO Members with insufficient or no=0D
      manufacturing capacities in the pharmaceutical sector could face=0D
      difficulties in making effective use of compulsory licensing under=0D
      the=0D
      TRIPS Agreement. We instruct the Council for TRIPS to find an=0D
      expeditious solution to this problem=E2=80=A6.=0D
=0D
A solution was reached with the 2003 Implementation of Paragraph 6 of the=
=0D
Doha=0D
Declaration on the TRIPS Agreement and Public Health [7]. It took the form=
=0D
of a=0D
temporary waiver that was converted to a permanent amendment of the TRIPS=
=0D
Agreement in December 2005. The amendment allows a WTO member country to=0D
modify its domestic patent law so that exports under a compulsory license=
=0D
can assist=0D
a country that lacks manufacturing capacity. In accordance with this=0D
amendment, an=0D
exporting country=E2=80=99s total production may be exported to meet the ne=
eds of=0D
an=0D
importing country.=0D
=0D
TRIPS: post-2005. Despite the TRIPS flexibilities discussed above, WTO=0D
member=0D
countries cannot avoid their obligations to protect patents in accordance=
=0D
with the=0D
provisions of TRIPS. In 2005 the transitional period for developing=0D
countries like=0D
India to become fully TRIPS-compliant came to an end.=0D
=0D
Conclusion=0D
MSF has cautioned repeatedly that if measures are not found to reduce the=
=0D
prices of=0D
expensive patented medicines, the ability of those in poor countries to get=
=0D
essential=0D
medicines will worsen [8-10]. Swift action is necessary to prevent further=
=0D
crisis in=0D
developing countries and LDCs. One solution that has been advanced is the=
=0D
creation=0D
of regional pharmaceutical supply centers that can better access affordable=
=0D
medicines=0D
by virtue of economies of scale and cooperation. As discussed above,=0D
however, the=0D
major obstacle to procuring affordable medicines continues to be the TRIPS=
=0D
regime.=0D
In the absence of further amendment, developing countries and LDCs should=
=0D
utilize=0D
the existing TRIPS flexibilities as far as is possible.=0D
=0D
www.virtualmentor.org Virtual Mentor, December 2006=E2=80=94Vol 8 837=0D
=0D
References=0D
1. As Novartis challenges India=E2=80=99s patent law, MSF warns access to m=
edicines=0D
is=0D
under threat [press release]. New Delhi, India, and Geneva, Switzerland:=0D
Medecins Sans Frontieres; September 26, 2006. Available at:=0D
http://www.doctorswithoutborders.org/pr/=0D
2006/09-26-2006_1.cfm. Accessed November 10, 2006.=0D
2. Reichman JH. Procuring essential medicines under the amended TRIPS=0D
provisions: the prospects for regional pharmaceutical supply centers. Paper=
=0D
presented at: Intellectual Property, Trade and Development Conference,=0D
Chicago-Kent College of Law; October 12-13, 2006; Chicago, Ill.=0D
3. Carvalho NP. The TRIPS Regime of Patent Rights. Norwell, Mass: Kluwer=0D
Law International; 2002.=0D
4. World Trade Organization. TRIPS and Public Health: Dedicated Webpage=0D
for Notification. Available at:=0D
http://www.wto.org/English/tratop_e/trips_e/public_health_e.htm. Accessed=
=0D
November 10, 2006.=0D
5. World Trade Organization. Agreement on Trade-Related Aspects of=0D
Intellectual Property Rights (TRIPS). Annex 1C. Available at:=0D
http://www.wto.org/english/docs_e/legal_e/27=0D
-trips.pdf. Accessed November 10, 2006.=0D
6. World Trade Organization Doha WTO Ministerial. Declaration on the TRIPS=
=0D
Agreement and Public Health. November 14, 2001. Available at:=0D
http://www.wto.org/English/thewto_e/minist_e/min01_e/mindecl_=0D
trips_e.htm. Accessed November 10, 2006.=0D
7. World Trade Organization WTP General Council. Implementation of=0D
Paragraph 6 of the Doha Declaration on the TRIPS Agreement and Public=0D
Health. August 30, 2003. Available at:=0D
http://www.wto.org/English/tratop_e/trips_e/implem_para6_e.htm. Accessed=0D
November 10, 2006.=0D
8. The second wave of the access crisis: unaffordable AIDS drug=0D
prices=E2=80=A6again=0D
[briefing note]. Medecins Sans Frontieres; December 10, 2005. Available at:=
=0D
http://www.doctorswithoutborders.org/news/hivaids/=0D
briefing_doc_12-10-2005.cfm. Accessed November 10, 2006.=0D
9. Amendment to WTO TRIPS agreement makes access to affordable medicines=0D
even more bleak: MSF concerned that patients the world over will have to=0D
pay the price [press release]. Geneva, Switzerland: Medecins Sans=0D
Frontieres;=0D
December 6, 2005. Available at:=0D
http://www.doctorswithoutborders.org/pr/2005/12-06-2005_1.cfm. Accessed=0D
November 10, 2006.=0D
10. Testimony of the MSF on IP provisions in DR-CAFTA & consequences for=0D
access to essential medicines [speeches and open letters]. Medecins Sans=0D
Frontieres; April 2005. Available at: http://www.doctorswithoutborders.org/=
=0D
publications/speeches/2005/testimony_ guatemala_4-2005.cfm. Accessed=0D
November 10, 2006.=0D
Virtual Mentor, December 2006=E2=80=94Vol 8 www.virtualmentor.org=0D
838=0D
Tara Leevy, LLB, LLM, is a health law fellow at Loyola University Chicago.=
=0D
Her=0D
bachelor of law degree is from the University of the West Indies, Cave=0D
Hill, and her=0D
master of law is from Georgetown University in Washington, D.C.=0D
Virtual Mentor welcomes your response to recently published articles and=0D
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=0D
necessarily=0D
reflect the views and policies of the AMA.=0D
Copyright 2006 American Medical Association. All rights reserved.=0D
=0D
=0D
=0D
+++++++++++++++++++++=0D
Sheila Shettle=0D
Senior Communications Officer=0D
M=C3=A9decins Sans Fronti=C3=A8res=0D
Campaign for Access to Essential Medicines=0D
Rue de Lausanne 78=0D
1211 Geneva=0D
Switzerland=0D
+ 41.22.849.8403=0D
+ 41.79.293.0270 (m.)=0D
sheila.shettle@geneva.msf.org=0D
www.accessmed-msf.org=0D
=0D