Joint UNICEF-UNFPA-WHO meeting with pharmaceuticals and diagnostics manufacturers and suppliers
On 23−26 November 2015 at UN City Copenhagen, Denmark, manufacturers; quality, safety and efficacy experts; procurement agencies; and international donors working in public health discussed issues regarding the production and supply of quality in vitro diagnostics, essential medicines, vaccines and contraceptive devices needed for vulnerable populations.
The United Nations Children's Fund (UNICEF), the United Nations Population Fund (UNFPA) and WHO cohosted the meeting. More than 400 representatives from all WHO regions, and representatives of more than 65 individual manufacturers attended the meeting. All plenary sessions were webstreamed live.
Day 1: product priorities and market demand
Day 1 consisted of plenary sessions that covered:
- product priorities for HIV/AIDS, tuberculosis, malaria, reproductive health and maternal/neonatal/child health
- market demand for priority in vitro diagnostics, medicines, vaccines and contraceptive devices.
Day 2: technical and product updates
Day 2 provided participants with technical updates on WHO prequalification of diagnostics, finished pharmaceutical products, active pharmaceutical ingredients and vaccines, and WHO/UNFPA prequalification of contraceptive devices. With respect to contraceptive devices, sessions focused on different products (i.e. male condoms, female condoms and Copper T 380A intrauterine devices), and included updates on the International Organization for Standardization standards and specifications. Data integrity – a topic that was of great interest to manufacturers – was looked at from the point of view of a manufacturer, a regulatory team and the WHO prequalification team.
Day 3: from product evaluation to quality-assured manufacturers
Day 3 covered a range of issues. The session on product evaluation for urgently-needed products introduced the emergency evaluation mechanism developed by WHO as a result of the recent Ebola outbreak in West Africa. The session on processes for accelerating regulatory approval included updates on the Expert Review Panel for Diagnostics – successfully piloted in 2014 – and on WHO's procedure for collaborative registration, which get products to patients more quickly, and saves resources of manufacturers and regulators alike.
Also on day 3, a session on avoiding regulatory pitfalls explained how early consultation with the WHO Prequalification Team can help public‒private partnerships involved in drug development, and manufacturers working to develop new products or new dosage forms, choose an appropriate regulatory pathway.
The final session of the third day was dedicated to determining what is needed to ensure a viable commercial environment for quality-assured manufacturers in low-income countries. This issue has been on the agenda for a long time. Manufacturers who invest in improving product quality have seen some commitment from other stakeholders that demonstrates that their efforts will be recognized in commercial terms.
A finished pharmaceutical product manufacturer presented its view on the current commercial environment for African manufacturers of prequalified products. A representative of The Global Fund to Fight AIDS, Tuberculosis and Malaria, and a representative of the United Nations Industrial Development Organization each described how they think such manufacturers can and should be supported.
Day 4: capacity-building sessions
On day 4, participants could attend introductory capacity-building sessions on:
- renewable energy supply chains and energy efficiency in the production process of suppliers and manufacturers in the global health aid market; and
- waste water treatment with a focus on hazardous substances in the production process of suppliers and manufacturers.
The sessions were organized by the United Nations Development Programme and UNFPA (with the support of the Sustainable Procurement in the Health Sector Secretariat). They reflected the commitment of UN agencies to base their procurement process on more sustainable production and consumption patterns.
UN support to manufacturers
All days of the meeting, WHO Prequalification Team members were available to meet with representatives of manufacturers. Manufacturers could ask questions relating to current or proposed applications for WHO prequalification and seek further information regarding prequalification requirements.
Manufacturers who required detailed information regarding the procurement requirements and procedures of UNFPA, UNICEF and/or the Global Drug Facility had meetings with members of the procurement teams of these agencies.
The success of the meeting was supported by the well-coordinated teamwork of staff from WHO headquarters, WHO/Europe, UNICEF Supply Division and UNFPA with valuable input of the UN City Copenhagen Common Services team.
