(U) SAMPLE SHARING AND VACCINE ACCESS IN VIETNAM

UNCLAS SECTION 01 OF 02 HANOI 000890 SIPDIS STATE FOR EAP/MLS, IO, G/AIAG AND ISN STATE PASS TO HHS/OGHA (STIEGER, BHAT, D. BELL) STATE PASS TO CDC (COX, MOHEN, and BLOUNT) USDA PASS TO APHIS DEPARTMENT OF DEFENSE FOR OSD/ISA/AP (LSTERN) ROME FOR FAO SENSITIVE SIPDIS E.O. 12958: N/A TAGS: TBIO AORC PREL PNIR KFLU WHO OTRA VM SUBJECT: (U) SAMPLE SHARING AND VACCINE ACCESS IN VIETNAM (C-TNT-00406) HANOI 00000890 001.2 OF 002 SENSITIVE BUT UNCLASSIFIED REF: STATE 62177, 62181, and 62185 (all the same cable) ¶1. (U) As requested (reftel),below is the Mission's assessment of the position of the Government of Vietnam (GVN) with regard to sharing H5N1 avian influenza (AI) samples. ¶2. (SBU) The GVN supports the World HEALTH Organization (WHO) policy on sharing of (AI) viral samples and readily shares animal and human material. The GVN has not evoked restrictive agreements, such as material transfer agreements when sharing with FAO or WHO networks. We do not think the GVN believes that countries contributing samples of virus are entitled to more than analysis, technical assistance, and recommendations. The GVN has not alluded to compensation related to sample sharing. ¶3. (SBU) The GVN seeks to promote approaches to sample sharing that are equitable and fair, especially with regard to getting credit as further information and knowledge are generated from research and development. GVN officials have suggested that Ministry of HEALTH (MOH) staff and scientists could be involved and consulted in processes after samples leave the country. The GVN is considering a position that explains the value of sample sharing to Vietnam -- beneficial reputation, stronger international cooperation and support, capacity building for domestic vaccine manufacture, and direct benefits to the people of Vietnam. This point seems to be absent from international level dialogue and may be helpful in finding a constructive way forward with less cooperative nations. According to the International Cooperation Department of the MOH, the GVN will not/not take a stance that allies itself with other countries against a country with a different position, such as that of Indonesia. ¶4. (SBU) Equitable access to influenza vaccines in Vietnam would start with an analysis of sustainability and domestic production. Based on its experience with the WHO's Expanded Program on Immunization (EPI),the GVN recognizes the balance -- both in terms of cost and quality -- between domestic manufacture and the importation of vaccines. It has a tradition of long-term vaccine planning, which aims at eventual domestic production. Human and animal AI vaccines are primary targets for domestic production. Substantial overseas direct assistance, including from the United States, has supported this effort. International cooperation in terms of technical assistance and financial support is valued in this light. Mission does not know the GVN's view on tiered pricing of vaccines. However, the GVN is a regional manufacturer of vaccines (e.g., exporting some EPI vaccines to Laos and Cambodia) and thus would be subject to both advantages and disadvantages of tiered pricing. ¶5. (SBU) The GVN probably does not support regional production facilities of commonly needed, larger volume vaccines. With the support of a HHS-CDC cooperative agreement project to build a sustainable human influenza (not just to detect AI, but all influenza) national sentinel surveillance network, combining both a syndromic and laboratory-confirmation approach, the GVN now has a greater appreciation for the public HEALTH and advocacy value in addressing seasonal and routine influenza in AI and pandemic influenza prevention efforts. The GVN is not ready for large scale purchase and importation of vaccine products for seasonal influenza (due to costs). Human influenza vaccine commonly available in market economies is available in Vietnam in the private sector driven by market demand; consumption is very limited. ¶6. (SBU) The GVN understands the influenza vaccine production process but does not yet have the capacity to follow it. Ownership of Vietnam's pharmaceutical industry is mixed with both private equity companies and government institutes and companies. There is one company and two institutes, all government owned, producing vaccines. There are limited examples of international pharmaceutical industry partnerships and a moderate degree of international academic collaboration. Substantial progress in the research and development of human and animal AI vaccines has been made (including two-way sample sharing through the WHO Influenza Collaborating Center Network). The GVN's main concern about vaccine production is cost and efficacy; the GVN has a supportive position HANOI 00000890 002.2 OF 002 that research and development must be staged (small scale followed by large scale in-country field evaluation). There is insufficient drug and vaccine regulatory and oversight capacity (including in good clinical practice and good manufacturing practice) to evaluate new products by international standards. The MOH is working with the U.S. Food and Drug Administration to build a sustainable training program to address this need. ¶7. (SBU) The GVN established the Partnership for Avian and Human Influenza (PAHI) on November 1, 2006, a maturation of ongoing multilateral and bilateral collaborative efforts to combat first SARS and then AI. The United Nations Development Programme (UNDP) is the international lead, but works closely with WHO, Food and Agriculture Organization (FAO),World Bank and the bilateral development agencies to ensure the success of this medium-term response to build capacity in the public HEALTH sector. The first task was to broadly coordinate donor funding and technical assistance. A PAHI secretariat will be established in a few weeks. The Mission expects that issues pertaining to sample sharing and vaccine access will be addressed in this forum. MARINE