[Pharm-policy] UNAIDS on IP: shame shame shame.

[Paul Davis]

Forwarded from the HealthGAP list.

Subject: 
           TRIPS Q & A: Shame on UNAIDS?
     Date: 
           Mon, 24 Jul 2000 15:32:46 -0400 (EDT)
     From: 
           richard@atdn.org (Richard Jefferys)


Has anyone else seen this? I just came across it on the UNAIDS
site, and
unless I'm missing something it seems corrosively incomplete and
PhRMA-friendly. Not one mention of parallel importing, and just
one mention
of compulsory licensing at the end:

"In addition, if exceptions to patent rights and compulsory
licences are
incorporated in patent legislation, they should be, respectively, limited
and conditional to conform with the TRIPS Agreement."

- and yet, although this is supposed to be a Q & A on TRIPS, if you're
looking for an answer on this part of the agreement you can forget about
it.

Richard Jefferys

http://www.unaids.org/publications/documents/health/index.html

Pharmaceuticals and the WTO TRIPS Agreement:

Questions and Answers

Geneva, March 2000

Acknowledgements

This document is based on data and analysis provided by Ms P.
Boulet, WHO
Department of Essential Drugs and Medicines Policy.  The author is very
grateful to Dr J. Perriens (UNAIDS), Dr J.D. Quick, Dr F.
Renaud-Thιry, Dr
M. Scholtz and Dr G. Velαsquez (all from WHO) for their constructive
comments.  Mr R. Wilder (WIPO), Mr A. Otten (WTO), Professor C.M. Correa
(University of Buenos Aires) and Ms S. Zarilli (UNCTAD) are also
acknowledged for their technical review and contributions to the document.

The views expressed in this document by named authors are solely the
responsibility of those authors.

Suggestions and comments are welcome and should be sent to medmail@who.int

This document is not a formal publication of either UNAIDS or WHO,
and all
rights are reserved by the organizations.  The document may,
however, be
freely reviewed, abstracted, reproduced and translated, in part or in
whole, but not for sale nor for use in conjunction with commercial
purposes.

What is TRIPS?

The Agreement on Trade Related Intellectual Property Rights
(TRIPS) was
negotiated with other international trade agreements during the Uruguay
Round trade negotiations of the GATT (General Agreement on Tariffs and
Trade) from 1986 to 1994.  As one of the World Trade Organization (WTO)
agreements, it is totally binding for all WTO Member States
(whether a
previous GATT Member or a new WTO one) .

The TRIPS Agreement sets minimum standards in the field of intellectual
property (IP) protection (such as copyrights, patents, and
trademarks) that
all WTO Member countries have to respect. To achieve this goal,
WTO Members
have to modify their intellectual property laws to make them consistent
with the new WTO standards.  For instance, the TRIPS Agreement
states that
all patents shall be available for at least 20 years from the
filing date,
whereas before TRIPS the patent term varied greatly among
countries (7, 10,
17 or 20 years).  All WTO Members have to incorporate this 20-year patent
term in their own patent law.

What will change with TRIPS?

Before the Uruguay Round and TRIPS, pharmaceutical patents and other
intellectual property rights on drugs were widely recognized among major
industrialized countries, but not in many developing countries. 
As there
were no international standards on the scope of patent protection,
countries had very different regulations on IP protection
according to
their own needs.  In the pharmaceutical sector, some 40 countries
did not
provide patent protection for pharmaceutical products.  Patents
were simply
not available for pharmaceutical inventions in these countries, which
implied that no one could claim an intellectual property right on such
products.  As a result, copies of medicines protected by a patent
in other
countries were widely available, usually at a lower price than the original
patented drug.  The copies were either manufactured by local
companies or
imported, without having to ask the patent holders' permission.  This
practice is now coming to an end.  Copies of patented drugs will
remain on
the market but it will no longer be possible to manufacture and market
copies of new patented medicines in those 40 countries, unless the original
manufacturer has chosen not to seek any patent protection there.

Under the TRIPS Agreement, all WTO Members have to make patents available
for pharmaceutical inventions in their countries1.  A company that has
invented a new pharmaceutical product or process has, since 1
January 1995,
been able to apply for at least a 20-year patent protection in any WTO
Member country.  The inclusion of pharmaceutical patents in the new
WTO/GATT rules has the potential to exacerbate the problem of
access to
drugs in developing countries, by limiting or even disabling direct
competition (generics) to new medicines until the relevant patents expire
(unless licences are granted).

When does TRIPS apply?

It is only in regard to transitional periods that the TRIPS
Agreement takes
into consideration Member States' different levels of economic development.
Developed countries were given until 1996 to comply with TRIPS standards
by modifying their patent law if necessary, developing countries
had until
2000, and least-developed countries have until 2006 (with possible
renewal).  The transition periods were provided to developing and
least-developed countries to give them enough time to implement
the various
TRIPS standards on intellectual property rights (copyrights, trademarks,
patents, etc) at national level.

However, as patents were not available for any pharmaceutical
products in
some developing countries in the pre-TRIPS era, a supplementary
transitional period is allowed for countries still not granting
patents for
pharmaceutical products when the WTO came into force in 1995. 
This 5-year
supplementary period means that the developing countries affected
do not
have to grant pharmaceutical products patents before 2005, unless they
decide to revise their patent law before then.

Which drugs will be affected by the new patent rules?

The TRIPS Agreement requires WTO Member States to introduce patent
protection only to products "invented" after 1 January 1995 , i.e. products
for which a patent application has been filed in a WTO Member
State after
1995.  This means that, in accordance with TRIPS, products already
on the
market cannot be given patent protection, because if they are already
marketed, they are not new, and so do not meet the TRIPS conditions
necessary to grant a patent.  Therefore, only new drugs or new indications,
formulations or processes invented after 1995 should be patentable
in all
WTO Member countries.

However, because developing and least-developed countries are
entitled to
transitional periods, and some will not grant drug patents before 2000,
2005 or 2006, a special provision in the TRIPS Agreement preserves the
novelty of drugs that may be invented between 1995 and the end of the
transitional periods.  Developing and least-developed countries not
granting drug patents must have a system, often referred to as a "mail-box"
system, to store patent applications as from 1995 until the transitional
period expires.  At this time, the various patent applications
waiting in
the "mail-box" will be examined according to the TRIPS standards
and, if
granted, the patent term, which starts from the filing date, will
last for
what remains of the 20 years.

What are developing countries' obligations under TRIPS?

Since all WTO Members are bound by the TRIPS Agreement, its minimum
standards for IP protection must be included and implemented in national
laws within the transitional periods allocated.  These are only minimum
standards however, and WTO Member countries may provide for
greater IP
protection than required in the Agreement.  For instance, in
Europe and the
United States, pharmaceutical patents may be extended (beyond 20
years) for
up to 5 years, to compensate for the long delays in obtaining marketing
approval for a drug.  The patent extension will vary from country to
country (since there is no international standard) depending on
the date of
marketing approval.  However, the pharmaceutical patent cannot be extended
for more than 15 years from the date of marketing approval in European
countries, and 14 years in the United States.

The main TRIPS standards, relating to pharmaceuticals, that
countries must
include in their patent law are:

… availability of patents for both pharmaceutical products and processes
inventions that are new, involve an inventive step (i.e.
non-obvious) and
are capable of industrial application (or useful);
… protection of the product directly obtained using a patented process;
… availability of procedures at national level to enable patent
owners to
protect their rights against infringement.

In addition, if exceptions to patent rights and compulsory
licences are
incorporated in patent legislation, they should be, respectively, limited
and conditional to conform with the TRIPS Agreement.

Further reading
Further information on intellectual property rights for
pharmaceuticals and
on aspects of access to HIV/AIDS related drugs are available in the
following references and web links:

… Patent situation of HIV/AIDS related drugs in 80 countries
… http://www.who.int/medicines/
… http://www.unaids.org/


Intellectual property rights and pharmaceuticals

… WHO/EDM. Globalization, patents and drugs - an annotated bibliography.
Health Economics and Drugs, EDM Series No. 9. Geneva: World Health
Organization; 1999 (WHO/EDM/PAR/99.6).
… WHO/EDM. Globalization and access to drugs - perspectives on the WTO
TRIPS Agreement. Health Economics and Drugs, EDM Series No.7.
Geneva: World
Health Organization; 1999 (WHO/EDM/98.9 Revised).
… Otten A. The implications of the TRIPS Agreement for the
protection of
pharmaceutical inventions. WHO Drug Information. 1997(11):1.
… UNCTAD. The TRIPS Agreement and developing countries. Geneva: United
Nations Conference on Trade and Development; 1996 (UNCTAD/ITE/1).
… South Centre. The TRIPS Agreement - a guide for the South.
Geneva: South
Centre; 1997.
… IFPMA. The question of patents. Geneva: International Federation of
Pharmaceutical Manufacturers Associations; 1998.
… Health Action International. Power, patents and pills - an
examination of
GATT/WTO policies and essential drug policies. Seminar Report. Amsterdam:
HAI-Europe; 1997.

Access to HIV/AIDS-related drugs

… Technical update: Access to drugs. UNAIDS Best Practice
Collection, 1998.
… WHO. Model prescribing information. Drugs used in HIV-related infections
(WHO/DMP/DSI/99.2).
… WHO/DAP. Guidelines on standard treatments and essential drugs for
HIV-related conditions. Access to HIV-related drugs. Geneva: World Health
Organization, 1997.
… WHO/UNAIDS. The implications of antiretroviral treatment.
Geneva: World
Health Organization; 1997 (WHO/ASD/97.2).
… WHO. Technical and policy guidance modules on antiretroviral treatments
for health planners and policy makers (WHO/ASD/98.1 and UNAIDS/98/7).


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