European drug regulators approved the world’s first Malaria vaccine in June, recommending that it was safe and effective to use in babies at risk for the mosquito-borne disease.
The vaccine, developed by the British pharmaceutical giant GlaxoSmithKline and funded in part by the Bill and Melinda Gates Foundation, has the potential to prevent a disease that infects an estimated 200 million people and kills more than 500,000 per year.
But the drug faces one significant hurdle before it can be administered in Africa: The World Health Organization (WHO) says it needs to make its own assessment.
To global health economist Helen M. Lapsley, the delay is an unfortunate example of how too much regulation can potentially harm global health.
“WHO has promised to provide its advice by the end of the year,” said Dr. Lapsley on Thursday in a full classroom at the Milken Institute School of Public Health. “So, we can all calculate how many children will die while we wait for something that has already been effectively regulated by a rigorous European agency.”
Dr. Lapsley weighed the positive and negative impacts of regulation in the health sector during the seventh annual Richard and Janet Southby Distinguished Lectureship in Comparative Health Policy. The lecture series, dedicated to topics in domestic health policy that relate to global issues, is made possible by a gift from Richard and Janet Southby. Dr. Richard Southby is a founder and dean emeritus of the Milken Institute SPH. Dr. Janet Southby is a retired U.S. Army Nurse Corps officer.
Dr. Lapsley is a faculty member at the University of New South Wales in Sydney, Australia, who has worked with WHO, the World Bank, the International Red Cross and the Australian government. As to whether regulation—especially when it cannot be enforced—helps or damages global health, Dr. Lapsley remained diplomatic in her assessment.
“I think the answer has to be the classic economic reply, that on the one hand, and on the other hand,” Dr. Lapsley said with a laugh and a shrug.
The health economist offered the WHO Global Framework Convention on Tobacco Control as an example of “aspirational” (or not enforceable) regulation that had an overwhelming positive effect on global health. The treaty was signed by 168 countries and helped to implement comprehensive tobacco control programs and strategies at national, regional and local levels.
Despite arguments from the tobacco industry that regulation would cause economic harm, studies presented by Dr. Lapsley and her colleagues refuted such claims. And the Framework Convention is known to have been very helpful in several developing countries where tobacco industry arguments still have much greater influence, she added.
“I think this stands as an example of how globalization and global health need to be considered together,” she said. “Often health ministers are low on the pecking order in cabinet and in politics generally. The economic arguments in the Framework Convention, while aspirational in the implementation, are known to have been effective in convincing lawmakers in several countries on the positive impacts of these regulations.”
Dr. Lapsley concluded the discussion by offering her rather nuanced view of the health regulation debate.
“Some regulations are essential, some are necessary, some discretionary, some for patient safety and for public protection, and yet still should enable research and commercial opportunities.”
