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ECUO's efforts in avoiding TRIPS +
in Eastern Europe and Central Asia
ECUO
23 July, 2014
Melbourne Australia
Alexandra Volgina and Tetyana Pinska
East Europe and Central Asia Union of PLWH (ECUO)
Background
• Anti-Retroviral (ARV) treatment coverage EECA region-wide is low at
25%.
• Countries are characterized by low commitment to national funding,
dependence on Global Fund (GF) funding, high ARVs cost (especially
2nd and 3rd-line regimens), difference in quality between ARVs in
national programs and GF programs.
• On the threshold of signing Association agreement between the European
Union and Georgia, Moldova and Ukraine, thread of access to medicines
restriction became evident. Embedded in Association, Agreement on
Trade Related Aspects of Intellectual Property Rights (TRIPS)
introduced Intellectual Property (IP) protection and enforcement at a
breadth never before seen at multilateral level. In 2013 ECUO launched
AIDSFonds-funded project1 in Georgia, Moldova, Ukraine, Belarus
to address emerging challenge.
What was done
• ECUO conducted educational trainings and technical
support for both civil society organizations and state
structures in Belarus, Moldova, Georgia and Ukraine
and managed to attract high attention of the national
parliaments and state authorities to the TRIPS issue.
What was done
• ECUO prepared the analytic report “Implementation
of TRIPS-flexibilities to improve access to medicines
in Belarus, Georgia, Moldova and Ukraine”.
Report is available at
http://ecuo.org/en/ecuo/news/2013/08/01/analyticreport-implementation-trips-flexibilities-improveaccess-medicines-belarus-georgia-moldova-and-ukraine/
• ECUO initiated and constantly supports the
negotiations between civil society organizations and
state authorities to avoid implementation of TRIPS+
regimens.
Advocacy campaign
Appeals from NGOs on issues of IP were sent to:
• Moldova Prime Minister, Minister of Foreign Affairs and
European Integration, Head of the State Agency on Intellectual
Property of the Republic of Moldova, Ministry of Health;
• Georgia - Prime Minister, Minister of Foreign Affairs, the
Minister of Health, Labour and Social Welfare.
• Ukraine, "Ukrainian Network of PLWH" with the support of
other organizations, sent an appeal to the President of Ukraine,
the Prime Minister, Secretary of the National Security and
Defense of Ukraine, Head of the Health Committee of the
Verkhovna Rada, the Minister of Foreign Affairs.
As a result of complaints initiated dialogue with government
representatives
Link between activities at
National and International level
• In addition to the activities at the country level,
ECUO at the regional level with the support of
ITPC-ru www.itpcru.org and EHRN www.harmreduction.org and EECA РЎAB www.eecacab.org/ru sent appeal to the President of the
European Parliament, and heads of relevant
committees of the European Parliament (Committee
on human Rights, Committee on Petitions of the
European Parliament, Committee on Foreign
Affairs of the European Parliament)
Target groups
• People who make decisions, stakeholders, structures at the
national level (Parliaments, Ministries of Health and Social
Development, other relevant Ministries of the countries)
• NGOs working on national, regional, international levels –
able to influence politics in HIV treatment sphere,
• International organizations and committees
• Mass media covering health, social policy, human rights
issues on national, regional, international level
• PLWHA community - TRIPS issue is hard for understanding
and working with, – ECUO have provided experts and
education, which helped PLWHA community within their
countries to held negotiations with such structures as
intellectual property and patent departments
Results
• PLWHA community within their countries was
prepared to held negotiations with such structures as
intellectual property and patent departments
• The attention of structures was attracted, allies were
found (for example Parliament in Georgia supported
the appeal of patients to President and Ministries).
The level needed to start negotiations was reached.
HOWEVER
Challenges
• All the time we were late – it seems we were trying to catch a
train already running away – increasing level of understanding
of professionals when it was time for already aggressive
advocacy and etc.
• Within the countries: the political situation was changing – we
were actually to stop the campaign in Ukraine - could be
regarded as opposition to European integration. In other
countries – as the political situation was changing, time
remaining shortened it was becoming increasingly difficult to
advocate.
• Outside: we were not ready for full-scale advocacy at European
level, low level of interaction with partners at the European
level, a poor understanding of European structures and
mechanisms.
Comparative table of of TRIPS-plus provisions contained in Association
Agreements of the European Union (EU) with Georgia, Moldova and
Ukraine - 1
TRIPS +
Extending patent
term
Georgia
Moldova
Ukraine
yes
yes
yes
For a period of delay between a
For a period of delay between a
For a period of delay between a
patent and obtaining permission to patent and obtaining permission to patent and obtaining permission to
turnover reduced by 5 years.
turnover reduced by 5 years.
turnover reduced by 5 years.
Such a period shall not exceed 5
Such a period shall not exceed 5
years.
years.
Additional 6 months may be added
Additional 6 months may be added Additional 6 months may be added
to this deadline extension, for
to this deadline extension, for
to this deadline extension, for
products for which pediatric studies
products for which pediatric
products for which pediatric studies
were conducted and their results
studies were conducted and their
were conducted and their results
are reflected in the product
results are reflected in the product
are reflected in the product
information.
information.
information.
(Article 220)
(Article 186)
(Article 314)
[The law of Ukraine already
[Georgian legislation already
[In verse. 69 of the Law of Moldova envisaged extension of the period of
provides for such provisions in Art. "On Protection of Inventions" has
delay, but not more than 5 years]
5 of the Patent Law of Georgia]
provided these provisions]
Comparative table of of TRIPS-plus provisions contained in Association
Agreements of the European Union (EU) with Georgia, Moldova and
Ukraine – 2
TRIPS +
Data exclusivity
Georgia
Moldova
Ukraine
yes
yes
yes
6 years of data exclusivity and
market exclusivity from the date of
registration in Georgia or the EU
5 years of data exclusivity
5 years of data exclusivity
+
2 years of market exclusivity
1 year if there is a new indication
with significant clinical benefit in
comparison with existing indication.
+
Period starts from the date of
registration of the original drug in
Georgia or the EU
+
1 year extension of market
exclusivity if there is a new
indication with significant clinical
benefit
= 8 years of exclusivity
(Article 187)
(Article 315)
[Georgian legislation does not
provide for data exclusivity regime]
[Moldovan legislation does not
provide for data exclusivity
regime]
(Article 222)
[Art. 9 of the Law of Ukraine
"On Medicines" provides 5 (one
year for the additional indication
of having a special advantage
over existing) market exclusivity]
Comparative table of of TRIPS-plus provisions contained in
Association Agreements of the European Union (EU) with Georgia,
Moldova and Ukraine – 3
TRIPS +
Customs register
Georgia
Moldova
Ukraine
no
yes
The right to the patent holder to
demand arrest of suspect
shipments by customs. Right of
Customs authorities without the
patent owner's statement to detain
suspect goods.
yes
[Georgian legislation does not
provide for the protection of patent
rights through customs register]
(Article 330)
[Section 12 of the Customs Code of
Moldova include such provisions]
The right to the patent holder to
demand arrest of suspect
shipments by customs. Right of
Customs authorities without the
patent owner's statement to
detain suspect goods.
(Article 250)
[Art. 397-403 of the Customs
Code of Ukraine provides for
similar provisions]
What is now
• Still some chance for Ukraine – political situation is on our side if
we will try to work with EU
• Lessons have to be learned – good communication with partners,
close cooperation – we need to ask for help very loudly
• Opportunities have to be used( Italian Conference on HIV and etc.)
• Allies have to be found inside countries – agrarian political parties
and etc., outside – student movements – we do need help
• mitigate the consequences of TRIPS within the countries:
пѓ� Advocate for regional / international procurement mechanism
пѓ� Advocate change legislation in the area of registration - the use of
unregistered medicines
пѓ� Advocate delay in the beginning of use of the TRIPS+ (5-10 years)
Thank you!
www.ecuo.org
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