[Ip-health] Possible data exclusivity in free trade agreement negotiations in the Republic of Moldova (South-Eastern Europe)

Stela Bivol sbivol at gmail.com
Tue Sep 18 02:57:55 PDT 2012

I am a public health professional representing the organization Center for
Health Policies and Studies (PAS), an NGO working in policy analysis and
research in health in Moldova. In June 2012 we became aware of the
intention of the government to change patent legislation by introducing
data exclusivity as an additional IPR measure in addition to TRIPS
provisions and started to inquire as to the origins of this initiative.

The Republic of Moldova, a country in the Eastern European region, has
started in 2011 the process of confidential negotiations for Deep and
Comprehensive Free Trade Agreement with the European Union (EU). In these
negotiations the EU requires the Republic of Moldova to introduce in the
national legislation data exclusivity as a new form of protection of
intellectual property for the maximum period of 11 years (8+2+1). There was
first round of negotiations where Moldova has opposed introduction of data
exclusivity because of the impact on price of drugs, but the official
answer of DG trade was that EU interpretation of unfair commercial use is
in line with TRIPS agreement.

The Republic of Moldova is a lower-middle income country where health
expenditures for pharmaceuticals are already high and exceed the regional
prices. Health expenditures from public and health insurance sources for
pharmaceuticals cover only 27.9% from total drug expenditure, and most part
of drug expenditures is paid directly by the population. Drug expenditures
represent 70% of out-of-pocket health expenditures in a household and are
the main factor that reduces financial protection of the citizens when they
access health services.  A comparative study conducted in eight countries
in the former Soviet Union has shown that the main reason for two thirds
(63.9%) of Moldovans who did not seek health care when they felt it was
justified was the cost of drugs and health services. Given this alarming
situation, the Government of the Republic of Moldova has expressed its
concern about its pharmaceutical market and regulation and has set as a
priority medicines price reduction and decrease of financial burden on its
citizens. Introduction of *data exclusivity* would be counterproductive to
this effort.

Therefore, we have started advocacy efforts with both NGO sector, the
Ministry of Health and sent a common letter to the Prime Minister, the
Ministry of Economy and Ministry of External Affairs to continue efforts to
oppose introduction of data exclusivity.  We have also conducted an express
analysis on data exclusivity and its consequences for Moldova that can be
found at:  http://www.pas.md/libview.php?l=en&idc=45&id=1301

Has anyone been in direct negotiations for FTAs and has been successful in
finding compromise solutions? What specific arguments work? What are the
limits of these negotiations from DG Trade? What are the best advocacy

Also, please support us by posting this e-mail on other health or IP lists
as well.

Many thanks!

Stela Bivol, MD, MPH

Policy and Research Director

Center for Health Policies and Studies

Access to Essential Medicines (AEMI) Fellow, OSF

Email: sbivol at gmail.com

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