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Sean Milmo is a freelance writer based in Essex, UK.
Leading nations are backing moves to strengthen WHO’s central role in international health security following the Ebola crisis, which sparked criticisms on the organization’s ability to address a pandemic outbreak.
The worldwide role of the World Health Organization (WHO) looks likely to be revitalized in a way that could lead to changes in the loose network of agencies and non-state organizations in global health governance. WHO may, as a result, be exerting far more influence than at present on international organizations involved in setting international standards and regulations, such as those for GMPs.
Lessons from the Ebola crisis
The Geneva-based United Nations body, which was founded in 1948, has been heavily criticized in a number of respected studies (1, 2) on the 2013-15 Ebola outbreak in West Africa for its slow and initially inadequate response to the crisis. There have even been calls for the replacement of the agency by a number of separate bodies with different public health responsibilities. The most favored option, however, is a strengthening of the organization so that it can be given a much bigger role in the protection of health.
“This is a defining moment for the health of the global community,” said a report (1) issued in July 2015 by a panel of outside independent experts commissioned by WHO to assess its response to the Ebola outbreak. “WHO must re-establish its pre-eminence as the guardian of global public health, which will require significant changes throughout WHO,” it added.
Another independent group of 19 international experts convened by the London School of Hygiene and Tropical Medicine (LSHTM) and the Harvard Global Health Institute concluded in a report (2) on the outbreak issued in November 2015 that WHO had shown a failure of leadership. Nonetheless, it decided that the crisis should be followed by a radical improvement in the running of the global health system but with the focus on WHO.
“WHO is an essential hub in the global system for health security,” the report (2) says. It is uniquely placed to carry out core functions because of its near-universal state membership, governance structure, and deep relationship with health ministries across the world. The organization has lost so much trust and authority, however, that it will have to undertake fundamental reforms within a tight time line before being able to assume a leadership role, the report says. There are signs of a response among at least the larger and richer UN member states to calls for a more powerful WHO.
Addressing funding issues
The recent G7 summit in Germany of the world’s leading nations backed moves to strengthen WHO in its central role in international health security. “We must draw lessons from [the Ebola] crisis,” said the G7 communiqué (3). The meeting acknowledged the need for action on the funding of WHO. It backed the World Bank’s initiative, in close co-operation with WHO, to organize the funding of a Pandemic Emergency Facility (PEF).
The World Bank has warned that the costs of the next pandemic could be far greater than the Ebola outbreak, which infected more than 28,000 people and claimed more than 11,000 lives. A Spanish-flu-like pandemic, like that in the 1920s, would kill more than 33 million people in 250 days, according to the Bank (4).
The G7’s response could mean that some progress will soon be made in resolving the financial problems of the WHO. Currently, only 25% (5) of WHO’s funds come from the member states with the remainder being provided by voluntary contributions. The Bill & Melinda Gates Foundation is WHO’s biggest funder, bigger than any of the member states.
Harmonizing international standards
A revived WHO could mean changes in the balance of responsibilities between the UN organization and the myriad of agencies and bodies involved in creating international health norms and standards. One of these organizations could be the Geneva-based International Council for Harmonization (ICH), which currently has global leadership in the creation of harmonized guidelines and standards for drug development and registration.
ICH, founded jointly in 1990 by the regulatory agencies of Europe, the United States, and Japan as well as the international research-based pharmaceutical industry, is seeking an even broader role after becoming a wholly independent Swiss-registered legal entity in early 2016. Regulators will be given more control of the organization, which will have a broader membership including, for example, regulatory agencies from emerging economies such as China and India. Harmonization of GMP standards is one of ICH’s main responsibilities. WHO, which will continue to have an observer status at ICH, also draws up GMP standards, but usually in line with those at ICH.
International Coalition of Medicines Regulatory Agencies
At the same time as a reformed ICH dominated by regulators becomes active, the International Coalition of Medicines Regulatory Authorities (ICMRA) is due to become fully operational. The idea behind it is to provide strategy and direction to regulators in the belief that they must act globally as well as domestically.
“To date, there has not been co-ordinated, consistent, and strategic global regulatory leadership, and ICMRA endeavours to fill that gap,” the organization said in a fact sheet (6) when its launch was announced in 2014. At present, ICMRA has 19 members, eight of whom are from Europe, including the European Union’s European Medicines Agency, with the remainder being national agencies. Other members include the regulatory authorities of China, Brazil, and Nigeria. WHO has an observer status.
GMP is already one of ICMRA’s major areas of activity, with a working group headed by the United Kingdom’s Medicines and Healthcare products Regulatory Agency (MHRA). “This project continues to make progress in developing a framework to allow greater mutual reliance on other regulators’ inspection outcomes and assist in better utilization of inspection resources by global regulators,” Mark Birse, group manager of MHRA’s Inspection, Enforcement & Standards Division, told Pharmaceutical Technology.
Management of emergency health crises is currently for ICMRA a priority area in which the know-how of its members and advances made by them in research science can be of vital assistance. “Supporting innovation and regulatory science underpins ICMRA,” said John Lynch, compliance director at Ireland’s Health Products Regulatory Agency (HPRA). “While ICMRA is not a research organization, by creating better global regulatory responses to emerging crises such as Ebola, it can support the quicker access and availability of vaccines or treatment of these diseases,” he said in an interview with Pharmaceutical Technology.
The HPRA, which is a member of ICMRA’s management committee, has recently helped to set up Research Science Ireland, a network embracing academia, the pharmaceutical and medical devices industries, the HPRA, and other government agencies. ICMRA has yet to sort out fully its relationship with the new ICH and, in particular, with WHO. In August 2014, after WHO officially categorized the Ebola outbreak as a public health emergency of international concern, ICMRA pledged to co-operate with WHO on fast access to investigational treatments for patients most in need.
Since the outbreak was brought under control, WHO has been quick to react to pleas for it to establish an R&D scheme on vaccines, diagnostic tests, and other relevant medicinal products for combating potentially dangerous pathogens. The scheme would cover the preclinical and early clinical stages of drug development. The new products would then be ready to go through emergency clinical trials in the event of a pandemic before full-scale manufacture.
Preparing for emergency production
The Ebola virus, which causes an haemorrhagic, often-fatal, fever, was first discovered in 1976 (7). WHO, however, brought together technical experts to discuss possible vaccines for the disease only recently, in September 2014, when two advanced vaccines for accelerated development were identified. The panel set up by the London School of Hygiene and Tropical Medicine and the Harvard Global Health Institute has recommended the earmarking of large-scale manufacturing facilities for the rapid production of vaccines and diagnostic tests. WHO has responded to these suggestions by inviting submissions of ideas to improve R&D readiness for potentially threatening infectious diseases.
The initiative would specifically include propositions for “flexible development and production platform technologies” for vaccines, therapeutics, and diagnostics against 5-10 priority diseases, as defined by WHO. The vetting of suitable production facilities is likely to be similar to that applied in WHO’s existing prequalification program under which plants and laboratories have to go through an evaluation and inspection process before taking part in UN drug procurement schemes. One drawback for potential participants in the R&D readiness project is that WHO will not be providing direct financial support for any proposal. Instead, it intends to hold a dedicated workshop in 2016. Some experts, however, fear that WHO’s responses to the Ebola crisis will not extend much further than initiatives in R&D preparedness because of a lack of political will to conduct a shake-up of the organization.
“The issue is whether even after fundamental changes in the agency, the member states will trust it enough to give it much more authority,” said Charles Clift, senior consulting fellow, Center on Global Health Security, Royal Institute of International Affairs (Chatham House), London, in an interview with Pharmaceutical Technology. “There could now be a prolonged period of uncertainty about the future role of WHO, which could extend to other agencies and organizations in global health governance,” he added.
1. WHO, Final Report of the Ebola Interim Assessment Panel (Geneva, July 2015).
2. S. Moon et al., The Lancet, online http://dx.doi.org/10.1016/S0140-6736(15) 00946-0 (Nov. 22, 2015).
3. G7 Summit, “Leaders’ Declaration-Think Ahead. Act Together,” G7 Germany (Schloss Elmau, June 2015).
4. World Bank, Pandemic Emergency Facility-Frequently Asked Questions (Washington DC, September 2015).
5. Center on Global Health Security, Royal Institute of International Affairs (Chatham House), What is the World Health Organization for? (London, May 2014).
6. ICMRA, Fact Sheet (September 2014).
7. WHO, “Ebola Virus Disease,” Updated Fact Sheet 103 (Geneva, August 2015).
Article DetailsPharmaceutical Technology
Vol. 40, No. 1
When referring to this article, please cite it as S. Milmo, "A Call for Radical Reformation of the World Health Organization," Pharmaceutical Technology 40 (1) 2016.