The unholy trinity of the WHO, intellectual property rights, and development of drugs

By The Policy Advisory Group 

Will the forthcoming board meeting of the World Health Organisation in early February 2020, which will deal with, inter alia the topic of public health, innovation, intellectual property and trade, which proposes tighter regulation and looser IPR (Intellectual Property Rights), kill innovation in the pharma sector?  

Regulatory bodies in recent years have seen an intensified focus on the role of medical technologies – both the innovation processes that lead to new technologies and the ways in which these technologies are disseminated in health systems, since the invention of the polio vaccine in 1948 to the coronavirus, has been mostly research led by private equity. Even high-end research at top end university labs such as Cambridge, Oxford, Harvard, MIT, University of Washington, University of Copenhagen, etc. is funded by the pharma industry, as well as spending billions of dollars on R&D on their private company labs. 

The cost of innovation in medical technologies is higher and the risk of failure greater than in other spheres, hence the pharma industry depends on patents as an incentive to absorb the high cost, associated risks and liabilities in pharmaceutical R&D. Some countries believe that patents contribute to poorer healthcare, by making medicines too expensive. They have argued for a number of measures to weaken intellectual property rights, including the adoption of compulsory licensing to allow governments to override intellectual property rights to manufacture patented medicines without the patent-owner’s consent. Such measures will be discussed at the aforesaid WHO meeting. 

Much has changed in the world since the WHO was founded in 1948; politically, economically, as well as in global health. As a result of steady economic growth, the health status of most people all over the world has improved. Better resourcing of health services and improvement in living conditions, particularly investments in education, sanitation, and water, have yielded tangible results. Further, many low- and middle-income countries are projected to experience substantial economic growth into the next decade, which should enable them to spend more on health themselves.

Meanwhile, a fundamental shift in global health is underway: the rising burden of non-communicable diseases (NCDs). The ageing of the population – a key driver in the rise of NCDs – represents a significant challenge to global health. NCDs have displaced infectious diseases as the world’s leading causes of both morbidity and mortality. Globally, four of the five leading causes of death are NCDs. In every region excluding sub-Saharan Africa, the three leading causes of death were NCDs. The WHO has identified four behavioural risk factors as key drivers of NCDs: tobacco use, lack of exercise, excessive alcohol consumption, and unwholesome diet. In dealing with NCDs, the emphasis needs to be on preventive measures, rather than cures.

While the world as whole has been getting richer, there are still far too many places that face abject poverty, giving rise to the so-called problem of neglected diseases. These are diseases that disproportionately affect the poorer countries of the world. This problem falls outside the current IP framework, as market-based innovation models fail to address these. There is little incentive to develop cures if few can afford to buy them. 

Since this research gap was identified, non-profit entities with philanthropic funding have worked to increase the number of products in development to address neglected diseases. Some pharmaceutical companies have set up philanthropic research institutes to research neglected diseases and participate in cooperative projects to share knowledge. While this approach is commendable, it is woefully inadequate.

According to a report published by Chatham House, a think-tank focused on international issues, although global R&D spending has more than quintupled since 1990, reaching $248 billion in 2009, only 1–2% of total R&D funding is channelled into research for neglected diseases. Significant action will thus be needed to facilitate R&D for neglected and poverty-related diseases; an area which can bring into play the unique expertise of the WHO.

The Chatham House report contains a number of useful recommendations in this respect including:

Increase R&D financing through a global responsibility framework obliging all countries to contribute to R&D funding. Lower and middle income states would be obliged to commit 0.05−0.1% of GDP, and high income countries 0.15−0.2% of GDP, to government-funded health research. A global health R&D observatory, under the auspices of the WHO would address gaps in information by collecting information on the R&D pipeline and financing, and sharing lessons learned.

Develop a partnership for investors to coordinate blended financing for global health innovations. This would bring together a group of public and private investors to engage in coordinated and targeted finance deals for global health innovations. To increase the impact of investments and reduce the transaction costs resulting from the increasingly fragmented financing for global health innovations, this partnership would serve as a forum, curator, syndicator and bridge across the public and private actors involved in taking health technology from proof of concept to delivery at scale.

The Medicines Patent Pool (MPP) is a United Nations-backed public health organisation working to increase access to, and facilitate the development of, life-saving medicines for low- and middle-income countries. The core remit of the MPP already covers the major diseases that affect poor countries: HIV, hepatitis C, and tuberculosis. What is most needed now is cures for neglected diseases.

Thus, the WHO objective of managing intellectual property to contribute to innovation and public health facilitating may be better furthered by working towards increasing research in the areas of neglected diseases, than in tinkering with the current patent regime.