Vaccines and Global Health: The Week in Review has expanded its coverage of new reports, books, research and analysis published independent of the journal channel covered in Journal Watch below. Our interests span immunization and vaccines, as well as global public health, health governance, and associated themes. If you would like to suggest content to be included in this service, please contact David Curry at: email@example.com
MEDICINE AND VACCINE SHORTAGES – WHAT IS THE ROLE OF GLOBAL REGULATORY COMPLEXITY FOR POST APPROVAL CHANGES?
The Economist Intelligence Unit Limited 2018 :: 35 pages
This study aims to explore whether the varying regulatory requirements for pharmaceutical products across the world are associated with medicine and vaccine shortages. This research project included a rapid literature review involving database and grey literature searches and a series of interviews with representatives of academia, industry, regulatory authorities, international organisations and global non-governmental organisations.
Key messages from the findings of the literature review and insights from the expert interviews are presented below.
:: Medicine and vaccine shortages are a global problem affecting rich and poor countries alike
Medicines and vaccines shortages are a global problem with significant impact on populations and health care systems. Shortages continue to persist, despite increased efforts from a range of stakeholders including international organisations, governments, regulators, healthcare providers, pharmacists and industry over the past decade. Vaccines shortages in particular are a serious public health issue, as they can lead to reduced population coverage and delays in prevention and control programmes for infectious diseases.
:: Causes for shortages are complex, multifaceted and not well understood
Causes for shortages are complex and interrelated, and vary for different products and countries. To channel the activities for prevention and mitigation of shortages, we need more research into the interplay of related causes, with a particular emphasis on economic and market-related causes. There is a need to identify critical products such as vaccines and risk factors that could affect the uninterrupted supply of these products to the people who need them.
:: This study found little evidence for the existence of a direct correlation between the global complexity of regulatory requirements for post approval changes and shortages
This study explored the question of whether the global complexity of regulatory requirements for post approval changes (PACs) to the terms of marketing authorisation could be a contributing factor for medicine and vaccine shortages; however we found little evidence in support of this hypothesis. In situations of shortages however, the regulatory complexity for PACs on a global scale could be an aggravating factor that delays or hinders mitigation actions.
:: There is a universal agreement that regulatory convergence and harmonisation are beneficial to all stakeholders
Regulatory harmonisation has been supported by the World Health Organization (WHO) since the 1980s. Numerous global and regional initiatives have been set up, including the European Regulatory System for medicines and the International Council on Harmonisation (ICH). There is a trend towards greater co-operation and regulatory convergence in the Americas, Asia-Pacific and South-East Asia, which could only be positive in terms of strengthening the regulatory systems in these regions and building trust between national regulatory authorities (RAs). The developments in Africa leading towards the establishment of an African Medicines Agency that follows the European model will also have a positive effect on the processes and timelines for PACs. © The Economist Intelligence Unit Limited 2018 4
:: Trust and strong political will are required for harmonisation and convergence initiatives to succeed
It is important to develop an understanding of the expectations and priorities of all stakeholders, and to pursue the harmonisation goal, even though progress may seem slow at times. A look at the history of the European Medicines Agency (EMA) since its establishment in 1995 shows that it has taken decades of work and strong political will to achieve the current level of harmonisation. The recent increase in mutual recognition agreements between the EMA and other RAs shows that regulators can work together to avoid duplication in effort and rely on each other’s expertise in challenging areas for regulatory science. The adoption of WHO guidelines for procedures and data requirements for changes to approved vaccines by national RAs, and further developments related to ICH quality guideline proposals for product lifecycle management, would help to reduce the complexity of requirements for the same changes across different jurisdictions.
:: Finding a permanent solution for shortages is critical for achieving global health goals
We hope that this report will help to raise awareness about the global impact of medicine and vaccine shortages, and the need for coordinated action from multiple stakeholders at international and national level. Finding a permanent solution for shortages is crucial for achieving the UN Sustainable Development Goal for health, including access to “safe, effective, quality and affordable essential medicines and vaccines for all” by 2030.