Political challenges

In this global economy, important barriers to vaccine development and production include complex, sometimes conflicting regulatory environments that vary from one region or country to another, increasing the importance of the establishment and protection of intellectual property rights associated with vaccine discovery and development, and the burden of the legal defense of vaccines (Offit, 2005b). Harmonization of regulations between nations could help to address vaccine shortages by expanding the number of vaccine suppliers. For example, US vaccine shortages might be mitigated by facilitating US licensing of vaccines that are licensed and in widespread use in other countries. By standardizing vaccine production and licensing requirements, harmonization could also reduce costs and barriers associated with the introduction of new vaccines. The FDA committee established in response to the 2002 Institute of Medicine report on vaccine financing reported in the last year that progress has been made toward streamlining manufacturing requirements and harmonizing US and European regulations (Coleman et al., 2005).

Intellectual property rights can also impede new vaccine development and production. Whereas patent protection is vital to encourage innovation, intellectual property rights protection can also be a barrier to vaccine development because collaboration and the sharing of knowledge from previous discoveries can lead to new avenues of inquiry. Finding the right balance between intellectual property rights protection and the need to share knowledge in the process of discovery remains a major challenge in the twenty-first century (Levine, 2004; Plotkin, 2005).

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