The WHO Must Do No Harm
May 25, 2018
The World Health Assembly is meeting this week in Geneva to agree on new five-year General Program of Work. As another Ebola crisis threatens Africa, and the dawn of summer threatens to bring back Zika and Chikungunya viruses with a vengeance the world needs the World Health Organization to be prepared and focused
Yet, on the agenda this week at the WHO are a variety of unproven and controversial policies that hardly relate to the WHO’s core mission, and if carried out could seriously harm access to better health for all.
For instance, the WHO is now targeting intellectual property (IP) rights. These are the ownership rights that guarantee control, for a limited time, of new medical breakthroughs. The bureaucrats at the WHA, and experts that contributed to the United Nations High-Level Panel on Access to Medicine (UNHLP-AM), claim these rights and the “market-driven innovation system” actually prevent access to medicine.
Nothing can be further from the truth, and any policy agenda that threatens to undermine IP rights would violate the first principle of the Hippocratic oath: do no harm. International coalitions have issued open letters to both the WHO and WIPO, the UN’s World Intellectual Property Organization, demanding IP rights remain protected.
To create a new medicine today requires an average of 12 years to complete research, development, and clinical trials and costs an estimated $2.8 billion per drug. By all accounts the sunk cost is a risky investment, less than 10 percent of investigational drugs make it through clinical trials and to the market.
Not to mention that least developed countries (LDCs) that are members of the WTO are not obligated to protect IP rights, and 95% of the medicines of the WHO’s essential medicine list are off patents as well.
Throughout the discovery process science advances allowing technology spillovers and knowledge transfers between universities systems and other connected organizations connected to the innovation ecosystem. One policy directly attacked by the UNLHP-AM report, that is referred to as a background document for the WHA despite half of its authors issuing dissenting commentary, is the U.S.’s Bayh-Dole Act that allows universities to patent inventions created through federally funded research.
The Act has been praised by Congress, economists, doctors, and researchers for its ability to get medical advances into the hands of healthcare workers in record time, and it has been replicated by countries all over the world.
The WHO’s antipathy towards IP has led it to completely whitewash it from reports where it is indeed necessary. To illustrate, in 2017 the WHO member state mechanism replaced “counterfeit” from its report on dangerous medicines and now uses “substandard, and falsified medicines” in order to ensure a “public-health perspective”.
It is much more than a re-definition, it is a policy shift in combatting the “safety” of medical products. Counterfeits, by definition, are made by criminals that don’t care about their efficacy. They are often made of poisons and kill patients. Importantly, there are dedicated law enforcement entities and reporting mechanisms to combat counterfeit medicines which have penetrated every therapeutic category in legitimate global supply chains.
On the other hand, “substandard and falsified” communicates a regulatory labeling issue instead of the criminal and fatal nature of these products. It has also required the WHO to create its own voluntary reporting mechanism to detect and respond to their appearance.
While the WHO concerns itself with intellectual property real barriers remain unaddressed. Many countries still have prohibitive tariffs on medical diagnostic tools and other products that can save lives. For example, a WTO working paper found tariffs on insecticide-treated bed nets used to ward off malaria spreading mosquitos reduced demand by $7 million dollars “equivalent to around 3.1 million bed nets… contributing to 2.9 million malaria cases and over 5,000 fatalities”.
The lack of competitive insurance markets, workforce shortages, and proper infrastructure like roads to transport people to hospitals remain as other real barriers to health access. Member states are addressing these issues in innovative ways. President Paul Kagame of Rwanda recounted at the opening session how their health system has overcome infrastructure issues by using flying drones to deliver blood and medical supplies to rural hospitals.
If the WHO can return to its core mission of coordination and information sharing it can help member states multiply such efforts to continue saving lives. If the WHO continues to attack intellectual property rights and jeopardize the market-driven innovation system, it will violate the first ethical standard of health practice.