Balancing IP and human rights: the case of medicines

What is the correct balance between human rights and IP when it comes to medicines? This is the question posed by Suleman Ali (Holly IP) in this guest post. He reflects as follows:

"A recent paper from the Yale Law School and Yale School of Public health discusses how human rights relate to IP and medicines, and in particular describes how human rights laws are increasingly being used to challenge IP rights in order to gain access to medicines in the developing world. The paper sees itself as a resource for activists, as well as policymakers, and sets out strategies for deploying human rights arguments against IP rights in court cases: it provides specific examples of cases in Thailand, India, South Africa and Peru where such arguments have succeeded.

Essentially, patents mean that medicines are more expensive, and in the developing world that means they will be unaffordable and unattainable for many people. The paper supports the idea of creating human rights norms that would allow patent rights to be overridden when providing medicines. One aspect of this is to establish the principle that corporations, such as pharmaceutical companies, have a human rights obligation to provide medicines at affordable prices. However, the Human Rights Council of the UN has not yet accepted that principle, and one wonders whether making human rights stronger is the way to resolve the issue.

A trilateral report by the World Health Organization, the World Intellectual Property Organization and the World Trade Organization (WTO) published last year also discusses the topic of access to medicines. The purpose of the report is to bring together information as a resource for policy-makers and to offer paper's findings as a platform for debate. That means unfortunately that the report does not aim to propose solutions to the problem, and one wonders how many more years it will take before practical solutions are proposed and implemented. A central part of the debate revolves around whether developing countries should resort to compulsory licensing to bring down the price of patented medicines. Several have already done so, including Brazil, Ecuador, India and Thailand. The Doha Declaration of 2001 supports the right of WTO member states to grant compulsory licences on public health grounds. Generic versions of medicines produced under compulsory licencing are often around 60% cheaper. Other approaches include having an international exhaustion policy, so that patent rights cannot prevent importation, as well as imposing drug pricing.

The present debate comes at a time when pharmaceutical companies are under increasing pressures. Many of their patents on blockbuster drugs are expiring (the so called ‘patent cliff’), the cost of developing drugs is increasing ($5bn per drug according to a recent estimate) and regulation of drugs is becoming stricter. In addition, governments in the developed world are negotiating ever harder over drug prices as they try to keep their health budgets under control.

It must also be accepted that the world continues to need new drugs, and that the developing world still has huge problems with infectious diseases. Ultimately large pharmaceutical companies are best at developing new drugs. Few other organisations have the expertise and resources that are needed. It seems therefore that the preferred solution would be for the developing world learning to work with pharmaceutical companies, rather than resorting to undermining IP rights. The developing world must accept that the research that led to present day drugs was not funded by them, and that pharmaceutical companies do deserve to be financially rewarded for developing them. Perhaps the wealthier people in developing countries should continue to pay higher prices for drugs, while they are made cheaper for the poor. At the same time, pharmaceutical companies must accept there may be conditions for being allowed to enter the markets of the developing world, which still remain lucrative. They should therefore be open to resolving the issue, rather than stubbornly insisting on selling drugs at high prices, perhaps accepting some form of preferential treatment in return for lowering drug prices. That certainly seems preferable to the prospect of an increasing number of countries turning to compulsory licencing to provide cheaper medicines".

This blog, which has many readers from the proprietary and generic sectors of the pharmaceutical industry as well as from medicinal regulatory bodies -- and even more readers from the developing world -- is happy to let this space be a forum for serious and constructive discussion.  It cannot be expected that any consensus will be achieved but, if nothing else, it would be good of issues could be clarified, misconceptions destroyed, assertions supported by reliable data and so on.