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[e-drug] Report ASEAN workshop on TRIPS and Pharmaceuticals

E-drug: Report ASEAN workshop on TRIPS and Pharmaceuticals
---------------------------------------------
Dear Colleagues,

Some of you may be interested in the the report of the ASEAN Workshop
on the TRIPS Agreement and its Impact on Pharmaceuticals, which is
now available on the web. It can be found at: http://www.who.or.id/
then select "current events"  then "drugs" and then the report title.
You should also be able to download it directly via:
http://www.who.or.id/currentevent/Drugs/Trips%20Agreement.pdf
See summary and table of contents below.

Best regards,
Karin

Karin Timmermans
Pharmaceutical Advisor
WHO  Indonesia
Email:  KarinT@who.or.id

-------------------------------------
Outline of the report:
The report aims to give an overview of the TRIPS Agreement and its
possible implications on the pharmaceutical sector in developing
countries; what are the issues and what are the options? It only
sketches the broad picture - in order to address these issues at
national level and to draft legislation that balances the interests of
producers and users of technology, cooperation among the Ministry of
Health, the Ministry of Trade and the Intellectual Property Rights
Office will be of utmost importance.

The first -and main- part of this report has been compiled on the basis
of input from the resource persons at the workshop. It starts, in
section I, with a short introduction. Thereafter, section II "general
issues" provides briefly some essential background information on WTO
and IPR; moreover a substantial portion is based on input from major
stakeholders, since policy makers will encounter their important,
differing and firm views - and will have to take them into
consideration. Section III deals with technical issues and how they
translate into social and public health realities; and section IV
"special issues" provides some initial reflections on how several of
these concepts translate into the specific areas of traditional
medicine(s) and biotechnology.

The second -smaller- part of the report (sections V and VI) lists some
of the issues discussed, and contains the recommendations. See also
table of contents, at the end of this message.

Executive Summary:

Most ASEAN Countries are either members or observers of the World Trade
Organization (WTO); this means they are committed to follow the rules
laid down in its Agreements, or intend to make these commitments in
future. One of these WTO Agreements is the Agreement on Trade Related
aspects of Intellectual Property Rights (TRIPs). The TRIPs Agreement
makes the granting of patents for pharmaceuticals obligatory. Since
previously many developing countries allowed only for limited patent
protection in this area, this represents a significant change in the
pharmaceutical sector. Proponents believe this will lead to an increase
in investment and in R&D, yet numerous public health experts, as well as
consumer groups, have expressed concern about the impact of the TRIPS
Agreement on the availability and prices of drugs. Moreover, worldwide,
there is growing concern about the impact of the intellectual property
rights system on innovation and on investment. A global process of
rethinking is starting, in which developing countries should actively
participate.

The TRIPS Agreement is not a uniform law, but a framework that sets
(minimum) standards and conditions for the protection of intellectual
property. These are made operational via the national intellectual
property rights (IPR) legislation. Within the TRIPs framework, there is
some room for manoeuvre, which can be used to design legislation which
is in the best interest of the country. Measures to protect the public
interest ought to be included in the national legislation, and should
encompass public health aspects. In fact, TRIPS provides for a number of
safeguards which may be used to protect public health and promote
competition, such as compulsory licensing, and allows for exceptions
which may facilitate the marketing of generic drugs ("Bolar exception").
These safeguards can be used to mitigate potential negative impacts of
increased IPR protection in the pharmaceutical sector on access to
drugs. However, these safeguards can only be used if they have been
incorporated in the national legislation.

Safeguards such as provisions for compulsory licensing are an essential
element of IPR legislation, since they signal to the patent holder that,
in the case of abuse of rights and/or non-availability of the product, a
third party could be allowed to use the invention. As such, they reduce
the risk of misuse of the monopoly rights conferred by a patent.
However, to ensure that such safeguards can be used effectively, it is
important to carefully state the grounds and conditions for their use in
the national legislation.

TRIPS requires that patents are granted when the typical standards for
patentability, that is, novelty, inventive step and industrial
applicability, are met. But the Agreement does not specify how these
criteria should be defined; WTO member countries may decide how to apply
these criteria. In the pharmaceutical sector, applying these criteria in
a flexible way will facilitate the granting of 'secondary' patents, such
as formulation patents, patents on polymorphs etc. Even if such
secondary patents are relatively weak, they can be used aggressively to
(threaten to) litigate, in order to stop competition. Therefore,
defining the scope of patentability at the national level is an
important issue.

Similarly, enforcement rules can have significant implications, since,
once a patent has been granted, there is a presumption of validity. If
countries have strong provisional measures under their enforcement
system, these can be used to prevent competition for instance while a
lawsuit is pending (which can be several years).

In the absence of competition, monopolistic pricing may reduce people's
access. However, if eventually a patent is found to be invalid or an
enforcement rule to be unjustified, from a societal point of view it is
important to consider who will reimburse the consumers, and how many
people have in the meantime been denied access to essential medicines.

Table of Contents:

EXECUTIVE SUMMARY

I. INTRODUCTION

    1.. GENERAL ISSUES
2.1 Background
2.1.1 The World Trade Organization
2.1.2 The philosophy of Intellectual Property Rights
 
1.. The importance of intellectual property rights for national
development
2.1.4 The World Intellectual Property Organization
2.2 WHO's perspective on globalization and access to drugs
2.3 History of the TRIPs negotiations
2.4 Stakeholders' views
2.4.1 The international innovative pharmaceutical industry
2.4.2 A national pharmaceutical industry perspective
2.4.3 A consumer's perspective

2.5 Country experiences
   2.5.1 Experiences with the introduction of patents  for
pharmaceuticals                     2.5.2 Development of
TRIPs-compliant legislation in developing countries

III. TECHNICAL ISSUES

3.1 General overview of the TRIPs Agreement
3.2 Standards for patentability
3.3 Compulsory license
3.4 Parallel import
3.5 Exceptions to the exclusive rights
3.6 Enforcement
3.7 Opposition procedures
3.8 Increasing access to HIV/AIDS drugs - Thailand's experience
3.9 Undisclosed information
3.10 Trademarks, public health and drugs
3.11 State practice and WTO participation
3.12 TRIPs Review

IV. SPECIAL ISSUES
4.1 Traditional medicinal knowledge & intellectual property rights
4.2 Implications of the TRIPs Agreement on biotechnology
4.3 Biodiversity
4.3.1 Biodiversity Convention
4.3.2 Geographical Indications

V. ISSUES DISCUSSED IN WORKING GROUPS

VI. RECOMMENDATIONS

ANNEXES
A. Workshop Agenda
B. Opening Remarks
C. Selected Articles of the TRIPs Agreement
D. List of participants
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