At the end of the meeting there was a general discussion of a draft of an executive summary document that had been prepared by the secretariat. This session allowed meeting participants to highlight important issues discussed at the meeting. Many of the comments have been incorporated into the final version of the executive summary.

Ramesh Panchangnula (NIPER, India) urged that a single drug comparator be used for quality control of FDCs. He called on WHO to develop a rapid protocol for testing, as had occurred for bioequivalence testing of TB FDCs and he suggested that surrogate markers for FDCs should be developed and agreed. He called for operational research (OR) on all aspects of the use of FDCs.

Roger Webber (USP, USA) highlighted the need for bioequivalence testing to be an integral part of the approval process. He suggested that under some circumstances new product studies might be necessary.

Bernard Pécoul (MSF, France) stressed that from an operational standpoint there was a clear hierarchy of needs. The first priority was for FDC products, the second priority was for co-blistered products and the third priority was to have single products. In discussion the point was made that there may be a need to co-blister FDCs to deal with different therapeutic eventualities, such as simultaneous treatment of TB and AIDS. Jeff Sturchio (Merck-USA) pointed out that to achieve WHO s 3 by 5 goals many routes were needed and a range of different approaches would have to be tried. He stressed that the innovative pharmaceutical industry could contribute their expertise once it was clear what they were being asked to do. He stressed as Professor Joep Lange had previously stated that “It is not simple to make things simple!”

Hemadri Sen (Lupin, India) focused his comments on practical technical issues. He agreed with prior comments that the comparator product should have been used for validating clinical products. He stressed that formulation and packaging were an important part of quality and could facilitate effective dispensing. He mentioned the need for storage conditions to be defined so that manufacturers can produce products suitable for the expected markets. Hanne Bak-Pedersen (UNICEF, Copenhagen) expressed concern at the lack of emphasis on procurement issues in the meeting and executive summary. She pointed out that with the limited number of prequalified producers there were difficulties in procuring all the products that were requested, particularly for malaria and TB.

Renee Ritson (Gates Foundation, USA) suggested that many different approaches would be needed for effective treatment programmes, and many different options would need to be considered. Operational research (OR) was required on topics such as MTCT and treatment, dealing with women in treatment programmes, co-infection with TB in child bearing women, rifampicin and neverapine interactions. She stressed the need for pharmacovigilance to be built into any programme to proactively collect information on drug reactions or treatment failures. Leonard Sachs (FDA, USA) expressed doubts that combination therapy was always required for malaria. He stressed that in the same way that there was a need to test the quality of products there was also a need to monitor the quality of programmes.

William Haddad (Cipla, USA) stressed the need for an adverse event report system that would allow early recognition of problems. He called for an agreement on a first line regimen, and for a statement of support for the WHO prequalification scheme. He mentioned his concern about the effect of Hepatitis B co-infection with HIV and the use of lamivudine causing possible fatal interactions. David Stanton (Department of State, USA) suggested a need for OR on the interaction between contraception and AIDS therapy. Jaideep Gogtay (Cipla, India) urged that existing FDCs should be used more widely. Ellen t'Hoen (MSF, France) called on participants to remember the background to the meeting. The 3 by 5 Programme aims to dramatically increase the number of AIDS patients under treatment. At present, very few of these patients are on ARV treatment and the widespread provision of FDC ARVs is a critical component of treatment expansion.

The meeting ended with thanks extended to participants by the co-chairs (David Hoos and Jonathan Quick). They expressed appreciation for the constructive atmosphere created by the willingness of everyone to interact in a frank, respectful manner. Participants agreed to continue work on the topics discussed.

Background documents

The following documents were prepared by the named authors as background resources for the meeting. The authors are solely responsible for the content of the papers.