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Julie Milstien

Publications and source records attributed to Julie Milstien.

9 recordsLinked to original sources
PubMed2006

Managing the effect of TRIPS on availability of priority vaccines.

The stated purpose of intellectual property protection is to stimulate innovation. The Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS) requires all Members of the World Trade Organization (WTO) to enact national laws conferring minimum standards of intellectual property protection by certain deadlines. Critics of the Agreement fear that such action is inconsistent with ensuring access to medicines in the developing world. A WHO convened meeting on intellectual property rights and vaccines in developing countries, on which this paper is based, found no evidence that TRIPS has stimulated innovation in developing market vaccine development (where markets are weak) or that protection of intellectual property rights has had a negative effect on access to vaccines. However, access to future vaccines in the developing world could be threatened by compliance with TRIPS. The management of such threats requires adherence of all countries to the Doha Declaration on TRIPS, and the protections guaranteed by the Agreement itself, vigilance on TRIPS-plus elements of free trade agreements, developing frameworks for licensing and technology transfer, and promoting innovative vaccine development in developing countries. The role of international organizations in defining best practices, dissemination of information, and monitoring TRIPS impact will be crucial to ensuring optimal access to priority new vaccines for the developing world.

Developing Countries↗
PubMed2004

Regulatory pathways for vaccines for developing countries.

Vaccines that are designed for use only in developing countries face regulatory hurdles that may restrict their use. There are two primary reasons for this: most regulatory authorities are set up to address regulation of products for use only within their jurisdictions and regulatory authorities in developing countries traditionally have been considered weak. Some options for regulatory pathways for such products have been identified: licensing in the country of manufacture, file review by the European Medicines Evaluation Agency on behalf of WHO, export to a country with a competent national regulatory authority (NRA) that could handle all regulatory functions for the developing country market, shared manufacturing and licensing in a developing country with competent manufacturing and regulatory capacity, and use of a contracted independent entity for global regulatory approval. These options have been evaluated on the basis of five criteria: assurance of all regulatory functions for the life of the product, appropriateness of epidemiological assessment, applicability to products no longer used in the domestic market of the manufacturing country, reduction of regulatory risk for the manufacturer, and existing rules and regulations for implementation. No one option satisfies all criteria. For all options, national infrastructures (including the underlying regulatory legislative framework, particularly to formulate and implement local evidence-based vaccine policy) must be developed. WHO has led work to develop this capacity with some success. The paper outlines additional areas of action required by the international community to assure development and use of vaccines needed for the developing world.

Developing Countries↗
PubMed2003

Issues in selection of DTwP-based combination vaccines.

This study examines regulatory, supply, acceptance and financing issues of combinations based on diphtheria-tetanus-pertussis (whole cell) vaccines (DTwP). These combination vaccines are currently produced in Europe mostly for export. Future regulatory oversight issues could have an impact on their availability. Before use of acellular pertussis-containing vaccines, the number of doses of DTwP vaccines offered in response to United Nations agency procurement tenders far exceeded the projected demand. Current demand and supply are converging. Most of that supply comes from developing country manufacturers, a potential new source of combination vaccines as well. The expected development and use of DTwP-based combination vaccines raises antigen allocation issues that could further affect supply. These combination vaccines have strong programmatic advantages, but pose complex selection issues involving disease burden, presentation, and availability of long-term financing. Vaccine price is not the major driving factor. A model examining important selection factors for regional country groupings provides predictions that have been validated by decisions on use of DTwP-based combination vaccines. This model may be useful in providing long-term uptake projections for other combination vaccines.

Diphtheria-Tetanus-Pertussis Vaccine↗
PubMed2003

Immunization safety priority project at the World Health Organization.

In 1999, the World Health Organization's (WHO) Department of Vaccines and Biologicals launched the Immunization Safety Priority Project with the aim of establishing a comprehensive system to ensure the safety of all immunizations given in national immunization programs. Countries are the primary focus of the project. WHO has a role, not only because of its technical and normative role, but also because of its privileged relationship with country authorities and other partners, and its global vision and mandate. The four major areas of focus in the project are to (1) promote and coordinate research and development of safer and simpler delivery systems; (2) ensure vaccine safety, from vaccine development all the way through clinical trials and vaccine distribution until use; (3) broaden access to safer and more efficient systems for vaccine delivery and management of sharps waste; and (4) establish efficient mechanisms to detect serious or potentially serious adverse events following immunization, and enable prompt and effective response. The project emphasizes the importance of advocating safety and building capacity at national levels.

Advisory Committees↗
PubMed2003

Emergency response vaccines: lessons learned in response to communicable diseases.

In response to recent political and epidemiological events, the availability of emergency response vaccines has received high priority on the global agenda. An emergency response vaccine is defined as a vaccine of public health importance that should be available to all people at risk against epidemic, pandemic or global threat situations. This review focuses on global threat vaccines, those that would be used in the case of an emerging pathogen or the intentional release of an agent to which there is a low level of population immunity. The development and use of such vaccines requires attention to simultaneous actions on seven fronts: development, forecasting, supply sources, regulation, procurement, financing and allocation. Neglect of any one of these aspects will threaten the success of the project. A case study on smallpox vaccines illustrates this. Although many public health experts fear that attention to stockpiling emergency response vaccines could draw resources from other areas, some aspects of such an effort could positively impact the supply of other needed vaccines.

Communicable Disease Control↗
PubMed2002

Emergency response vaccines--a challenge for the public sector and the vaccine industry.

In partnership with industry, WHO has developed a number of strategies to facilitate access to vaccines recommended for use in national immunization programs. These strategies have been necessitated by the increasing fragility of vaccine supply for developing markets. The potential global spread of epidemic disease has made it imperative to expand these efforts. A new concept is proposed, that of essential vaccines, defined as "vaccines of public health importance that should be accessible to all people at risk". Essential vaccines will include emergency response vaccines that have become important due to resurgent outbreaks, threatening global pandemics, and situations where a global emergency immunization response may be needed. While some of the approaches already developed will be applicable to emergency response vaccines, other novel approaches requiring public sector intervention will be necessary. Procurement, financing and allocation of these emergency response vaccines, if left to governments or private individuals based on ability to pay, will threaten equitable access. The challenge will be to ensure development of and equitable access to these vaccines while not threatening the already fragile supply of other essential vaccines.

Emergencies↗
PubMed2002

Vaccine quality--can a single standard be defined?

To analyze the current global situation with respect to vaccine quality and to monitor progress in attaining it, it is first necessary to define what this means. While acknowledging that manufacturers are responsible for the quality of the vaccines they produce, World Health Organization (WHO) proposes a definition for "vaccines of assured quality" which depends on the existence of a competent and fully functional regulatory authority as assessed by an external expert team using widely agreed indicators to regulate the product. A vaccine of assured quality is defined as one that consistently meets appropriate levels of purity, potency, safety and efficacy as judged through an independent review system competent to take an evidence-based decision on the product for a specified population in a specific context. Such a review system would make use of all available information, such as licensing dossiers, surveillance of field performance, lot-by-lot scrutiny, appropriate laboratory testing, cGMP inspection of manufacturers, and evaluation of clinical trials, generally assumed by a fully functional regulatory authority. This definition implies that, faced with the same risk/benefit, any competent group would come to the same decision. The definition also indicates clear pathways to improve vaccine quality by strengthening national regulatory authorities and WHO is actively engaged in this task. By insisting on competent regulatory oversight, while recognizing the role of risk analysis in the selection of vaccines for use, WHO strongly reiterates the need for a single standard of quality. Only vaccine of assured quality should be considered for use in national immunization programs on the basis of the risk/benefit ratio for the particular population.

Drug and Narcotic Control↗
PubMedDate not supplied

Development of priority vaccines for disease-endemic countries: risk and benefit.

Decisions regarding vaccine regulation and use made by institutions in industrialized countries can have an unintended impact on vaccines' availability in disease-endemic countries. However, regulatory and programmatic decision making by such countries, taking into consideration local risks and benefits, requires adequate resources, both human and financial. Such differing risk-benefit determinations between industrialized and disease-endemic countries will increase product divergence. We propose a single universal standard for risk assessment, based on maximizing net benefit, and an action plan to improve access to priority vaccines through a more robust determination of risk and benefit.

Developing Countries↗