own levels of quality there needs to be “some mechanism for the smaller countries who aren’t going to be able to reach that critical mass on their own even if they can define quality in a robust manner.”

Participants discussed that some countries with non-donor-funded MDR TB programs opt not to procure PQ drugs. Meg O’Brien, Director, Global Access to Pain Relief Initiative, American Cancer Society, cited the need to determine those governments’ rationale for choosing non-PQ suppliers. She speculated that if governments had access to better data about the quality difference between PQ and non-PQ drugs, then their procurement practices might change. Peter Cegielski, CDC, noted that in practical terms, most countries favor domestic manufacturers whenever possible. Norbert Ndjeka, MDR TB Director, Department of Health, South Africa, noted that South Africa’s primary objective is better-quality drugs. He said that because the NTP does not have in-house technical expertise, it outsources QA to laboratories, academics, and experts. These advisory bodies determine the type and quality of drugs to be purchased by the government and also liaise with procurement agents. Thus QA in South Africa is largely dependent on separate, nongovernmental entities that advise the NTP.

Seiter suggested that emphasizing the commercial aspect—that it is easier to export products that adhere to a global quality standard—could serve as an incentive to national governments. Nina Schwalbe, Managing Director, Policy and Performance, GAVI Alliance (“GAVI”), remarked that a similar strategy was used by GAVI in India to address vaccine QA.

Cegielski suggested developing a system of regulatory reciprocity, in which one country accepts the regulatory processes and decision making of another, such that countries without SRA could accept approval from countries that do have stringent standards. Vincent Ahonkhai, BMGF, pointed out, though, that countries have a “statutory responsibility to regulate the product that circulates within their borders” and also that the reviews conducted by SRAs in other countries might not take into account factors specific to other countries, such as their health systems, environments, coincident diseases, and so on. Hedman remarked that regulatory reciprocity between countries does not exist anywhere except in the European Union via the EMA. In contrast to regulatory reciprocity, regulatory harmonization seeks to standardize methodologies, reduce the regulatory burden, and minimize delays.

Seiter explained that in the absence of stringent regulatory oversight, the buyer needs to ensure quality of the drugs procured. Usually a procurement agent is involved, and this agent has an in-house QC and QA system. A working group, under the leadership of WHO and participation of most relevant international funding and procurement agencies, has developed a tool for a standardized assessment of procurement agencies. This tool is based on WHO’s Model Quality Assurance System for procurement agencies

The National Academies of Sciences, Engineering, and Medicine
500 Fifth St. N.W. | Washington, D.C. 20001

Copyright © National Academy of Sciences. All rights reserved.
Terms of Use and Privacy Statement