Intellectual property, innovation and public health

The development of new essential medicines and access to those medicines is crucial for advancing public health and is a prerequisite for having functioning health systems.

Pharmaceutical patents are at the core of today’s medicines innovation model. A patent is a form of intellectual property (IP) granted to an inventor for the creation of something new, non-obvious to a person who is knowledgeable in the field, and useful. Patents grant a temporary monopoly of minimum 20 years, during which time the patent holder can prevent others from making, using, or selling their invention.

Private commercial companies are often the holder of medicines patents and play an important role in the development and supply of new essential medicines. In practice this means that companies set the price for medicines and thereby determine who and how access to these medicines is provided.

The Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS) adopted in 1994 and administered by the World Trade Organization (WTO) set out minimum standards for the protection of several forms of IP that WTO member countries need to comply with. The agreement also contains several important flexibilities to preserve the rights of nations to protect the public interest. Examples of such flexibilities are transition periods that allow certain groups of countries to delay the full implementation of TRIPS, exceptions and limitations to patent rights, including compulsory licensing and government use of patents.

The magnitude of the HIV/AIDS crisis in the late nineties brought the consequences of the globalised patent system to the public attention, when millions of people in developing countries died from an illness for which medicines existed in wealthy nations, but were not available or affordable elsewhere. In the early 2000 the HIV/AIDS crisis put pressure on the new global IP framework to recognise and strengthen flexibilities that could be used by governments to protect public health. In 2001, the WTO adopted the Doha Declaration on TRIPS and Public Health. As a result developing countries began to use flexibilities such as compulsory licensing and many least developed countries suspended the enforcement of medicines patents and the granting of patent to enable the procurement and supply of low priced generic antiretroviral medicines.

Important progress has been made in access to medicines for HIV and many lessons can be learned from that experience. It is particularly important to examine whether those lessons can be applied for other diseases. Today’s pharmaceutical patent regime affects almost all medicines developed since 1995 in most countries. The high prices of new medicines, such as for cancer, tuberculosis and hepatitis C, cause huge access challenges globally, in both high- and low-income countries. There is also a growing recognition that the patent driven innovation system leaves important medical needs unaddressed when they do not provide sufficient profit prospect. One pressing example is the lack of investment by companies to develop new antibiotics. These developments have spurred a search for alternative innovation incentives, away from market monopolies and more equitable.

This research project focuses on the new global challenges for access to medicines and aims at answering the question whether the public health approaches to medicines patents developed in response to the HIV/AIDS crisis are exclusive to HIV or whether they can be applied more broadly.

Publications

Report of the Lancet Commission on Essential Medicines Policies: Wirtz VJ, Hogerzeil HV, Gray AL, et al. Essential medicines for universal health coverage. The Lancet. 2016; doi: http://dx.doi.org/10.1016/S0140-6736(16)31599-9.
‘t Hoen E., Private Patents and Public Health. Changing Intellectual Property Rules for Access to Medicines. Diemen, The Netherlands: AMB Press; 2016.
‘t Hoen E., Indian hepatitis C drug patent decision shakes public health community. The Lancet. 2016 May 26,2016. http://dx.doi.org/10.1016/ S0140-6736(16)30656-0 [http://www.thelancet.com/pb/assets/raw/Lancet/pdfs/S0140673616306560.pdf]
‘t Hoen E., Access to Cancer Treatment. A study of medicine pricing issues with recommendations for improving access to cancer medication. Oxfam, February (2015). Report available: http://apps.who.int/medicinedocs/documents/s21758en/s21758en.pdf
't Hoen E, Hogerzeil H, Quick J, Sillo H, A quiet revolution in global public health: The World Health Organization’s Prequalification of Medicines Programme. Journal of Public Health Policy (2014) Vol. 35, 2, 137–161. DOI: 10.1057/jphp.2013.53
Moon S, Bermudez J, ‘t Hoen E, Innovation and Access to Medicines for Neglected Populations: Could a Treaty Address a Broken Pharmaceutical R&D System, PLoS Medicine, Public Library of Science, 2012, 9:5.
‘t Hoen E, Berger J, Calmy A, Moon S, Driving a decade of change: HIV/AIDS, patents and access to medicines for all, Journal of the International AIDS Society 2011, 14:15

Intellectual property, innovation and public health

Publications

Links: