Intellectual property refers to intellectual activity in the industrial, scientific, literary and artistic fields. In the context of health care, the concept relates to topics such as the use of generic medicines, specifically how companies can market and sell these products within specific geographic regions. Intellectual property rights and the laws that govern them are important both to the control of standards and access to medicines, but also as an incentive for the development of new pharmaceuticals and health care products.
There has been great debate in recent years about the issue of intellectual property protection relating to access to generic medicines. This is particularly the case in areas where drug development is needed to treat a disease endemic to the region, but where the market is not large enough to support the costs of research. The balance needed between access and profit are at the heart of these debates and continue through discussions of free trade and regulation.
Much of WHO’s work with intellectual property and trade relates to the World Trade Organization framework from 2001, known as the Doha Declaration and the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). In 2006, the WHO Commission on Intellectual Property Rights, Innovation and Public Health (CIPIH) submitted its report containing 60 recommendations aimed at fostering innovation and improving access to medicines.Since the entry into force of the TRIPS Agreement, many resolutions of the World Health Assemblies have requested WHO to address the impact of trade agreements and intellectual property protection on public health and access to medicines. WHO closely collaborates with other relevant international and regional organizations, such as the World Trade Organization and the World Intellectual Property Organization, to support Member States on matters of intellectual property and trade policies, conduct training on the health impact of trade agreements, research innovation and intellectual property, and facilitate access to patent information.
Intellectual property rights to medicines and other medical products can be an incentive for the private sector to pursue innovation. However, this system is made more complicated for products intended for populations where the potential paying market is small or uncertain. Low- and middle-income countries, which account for more than 80% of the world’s population, are responsible for just 10% of global sales of many drugs due to the difficulty in affording or accessing necessary products. Poverty affects purchasing power, and the inability of poor people to pay reduces effective demand, which in turn affects the degree of interest of for-profit companies.
Member States, the pharmaceutical industry, charitable foundations and nongovernmental organizations have taken initiatives in recent years to develop new products against diseases affecting poor and middle-income countries and to increase access to existing health products and medical devices. International intellectual property agreements also contain flexibilities that could facilitate increased access to necessary pharmaceutical products. However, these initiatives are not sufficient to surmount the challenges of ensuring access and innovation for needed health products and medical devices. Much work is required to reverse the skewing of world drug markets towards the wealthiest nations.