ECUO's efforts in avoiding TRIPS + in Eastern Europe and Central Asia

ECUO23 July, 2014

Melbourne Australia

Alexandra Volgina and Tetyana PinskaEast 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 athttp://ecuo.org/en/ecuo/news/2013/08/01/analytic-

report-implementation-trips-flexibilities-improve-access-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 campaignAppeals 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.harm-reduction.org and EECA СAB www.eeca-cab.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.

in the end - the train left

Comparative table of of TRIPS-plus provisions contained in Association Agreements of the European Union (EU) with Georgia, Moldova and Ukraine - 1

TRIPS + Georgia Moldova Ukraine

Extending patent term

yes For a period of delay between a

patent and obtaining permission to turnover reduced by 5 years.

Such a period shall not exceed 5 years.

Additional 6 months may be added to this deadline extension, for products for which pediatric

studies were conducted and their results are reflected in the product

information. (Article 186)

[Georgian legislation already provides for such provisions in Art.

5 of the Patent Law of Georgia]

yes For a period of delay between a

patent and obtaining permission to turnover reduced by 5 years.

Such a period shall not exceed 5 years.

Additional 6 months may be added to this deadline extension, for products for which pediatric

studies were conducted and their results are reflected in the product

information. (Article 314)

[In verse. 69 of the Law of Moldova "On Protection of Inventions" has

provided these provisions]

yes For a period of delay between a

patent and obtaining permission to turnover reduced by 5 years.

Additional 6 months may be added to this deadline extension, for products for which pediatric

studies were conducted and their results are reflected in the product

information. (Article 220)

[The law of Ukraine already envisaged extension of the period of

delay, but not more than 5 years]

Comparative table of of TRIPS-plus provisions contained in Association Agreements of the European Union (EU) with Georgia, Moldova and

Ukraine – 2

Data exclusivity yes

 

6 years of data exclusivity and market exclusivity from the date of registration in Georgia or the EU

+

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

(Article 187)

[Georgian legislation does not provide for data exclusivity regime]

yes

 

5 years of data exclusivity

+

2 years of market exclusivity

+

1 year extension of market exclusivity if there is a new

indication with significant clinical benefit

= 8 years of exclusivity

(Article 315)

[Moldovan legislation does not provide for data exclusivity

regime]

yes

 

5 years of data exclusivity

 

 

 

 

(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]

TRIPS + Georgia Moldova Ukraine

Comparative table of of TRIPS-plus provisions contained in Association Agreements of the European Union (EU) with Georgia,

Moldova and Ukraine – 3

Customs register no

 

 

 

 

 

[Georgian legislation does not provide for the protection of patent

rights through customs register]

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.

(Article 330) [Section 12 of the Customs Code of Moldova include such provisions]

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.

 

(Article 250)

[Art. 397-403 of the Customs Code of Ukraine provides for

similar provisions]

TRIPS + Georgia Moldova Ukraine

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: Advocate for regional / international procurement mechanism Advocate change legislation in the area of registration - the use of

unregistered medicines Advocate delay in the beginning of use of the TRIPS+ (5-10 years)

Thank you!www.ecuo.org