Thai CSOs’ comments on the data exclusivity measure in the RCEP given at the stakeholder consultation meeting hosted by the RCEP trade negotiators at Hyderabad, India on July 25, 2017.
Good afternoon, trade negotiators of the ASEAN countries and the other 6 negotiating countries.
My name is Chalermsak Kittitrakul, representative of civil society in Thailand which are the network of people living with HIV and AIDS, Peoples’ Health Systems Movement, and FTA Watch.
We do have a grave concern over the ongoing RCEP negotiation, particularly the Data Exclusivity (DE) under the IP chapter that proposed by Japan and South Korea.
Data Exclusivity is a form of protection of clinical data to be submitted to obtain a marketing approval.
We do have concrete evidence of negative impact of DE proposed and accepted in previous FTAs.
Our evidences are based on at least 2 technical studies conducted by IP and pharmacy academic of a state university in Thailand, Chulalongkorn University, and by International Health Policy Program, an independent health policy research unit under the MoPH of Thailand.
And the studies were complied with the Thai Constitution in 1997 and 2007 that required the Thai government to conduct comprehensive studies on “health impact assessment of FTAs” as information for the FTA negotiation. It happened when Thailand had FTA negotiation with the EU.
Based on those 2 studies, it clearly shows that if Thailand accepts DE with 5-year protection of data in 2005, the country will have to spend additional medicine expenditure at the cost over 2.7 billion USD in 2013, 3.3 billion USD in 2023, and 5.2 billion USD in 2033.
Another example, it already happened to Jordan. This is based on a report of Oxfam, a well-known international humanitarian organization. Jordan accepted DE in the FTA they had with the EU. After the agreement was signed and effective, 110 drugs with no patent were registered in Jordan in 2000- 2004. Without generic medicines’ competition in Jordan, it made price difference in original drugs in Jordan and generic medicines in other countries as high as 55%. And, prices of medicines increased dramatically 17% in that 5 years.
DE is a measure that undermines access to live-saving medicines of the world. It prevents or delays competition of generic medicines at much lower prices. DE can be applied with not new medicines, with medicines without patents filed in the countries, with medicines whose patents are expired, revoked, or invalid. DE also prevents the use of compulsory licensing to be possible.
On behalf of the Thai civil society, we would like to urge the governments of the 16 countries involved in the RCEP negotiation “NOT” to include DE in the negotiation. We also urge the ASEAN members to have a thorough and comprehensive health impact assessment study with transparency and active involvement of all the stakeholders as information for the negotiation. Lastly we would like to urge the governments of Japan and South Korea to stop proposing and pushing for TRIPs-plus provisions, including DE, in the RCEP negotiation. Patients in your countries are suffering from super high costs of medicines. That was a big mistakes you have done in your FTAs with the US and the EU. Please don’t copy those measures and give it to us. We do not want it.
Thank you for your attention.