Health advocates have asked the EU not to include data exclusivity requirements in the “Deeply Comprehensive Free Trade Agreement” that is being negotiated between the EU and Moldova. Article 9 of the agreement is rumored to contain an obligation for at least eight years of data exclusivity, as is standard in other European trade agreements. The TRIPS Plus provision would prevent generic firms from gaining regulatory approval without repeating costly clinical trials, effectively keeping generics off the market.
A recent letter from Anna Zakowics (European AIDS Treatment Group) and Lella Cosmaro (AIDS Action Europe) to Trade Commissioner Karel De Gucht points out that
- data exclusivity “would block many people in Moldova from realising the right to achieving the highest attainable standard of health which is reflected in Article 2 of the International Covenant on Economic, Social and Cultural Rights to which every European Union Member State is a signatory.”
- the World Health Organization recommends that “it is preferable not to grant data exclusivity.”
- “The European Parliament resolution of 12 July on the TRIPS Agreement and access to medicines called on the European Council to refrain from negotiating ‘TRIPS-plus’ provisions including specifically data exclusivity provisions. Article 9 of the DCFTA with the Republic of Moldova contradicts this resolution.”
An earlier Infojustice post by Stela Bivol describes the degree to which people in Moldova could be affected by a jump in medicine prices: “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.”
The Center for Health Policies and Studies (PAS Center) based in the Moldovan capital of Chisinau has published a report that delves more deeply into the issue of data exclusivity and its possible effect in the country.