Least developed countries (LDCs) will continue to have access to affordable medical technologies for an additional extra eight years before they are required to implement the World Trade Organization’s Trade-Related Aspects of Intellectual Property (TRIPS) Agreement, following a series of negotiations.
The TRIPS Agreement contains minimum standards of protection for pharmaceutical intellectual property, but also accommodates developing countries’ needs. For example, it gives countries the right, under specific situations such as public health emergencies, to issue compulsory licences - an authorization given by a government to a third party to produce a patented invention without the permission of the patent-holder.
The consensus decision allows for negotiation for a further extension once the eight-year period is up; the current extension was due to expire on 1 July 2013. LDCs initially sought an extension at least until each individual country was no longer considered an LDC, a move resisted by developed countries, who own most intellectual property rights.
“This is important and positive, though it is regrettable that the exemption will expire in 2021, instead of being indefinite, that is, until a county no longer is `least-developed’,” said Catherina Timmermans, an intellectual property expert for international health financing mechanism UNITAID.
“The benefit of this is that LDCs are not under an obligation to comply with the TRIPs standards - whether it’s patents, trademarks, copyright or design - and therefore have the flexibility to adjust their domestic laws, many of which were inherited from the colonial period, in appropriate ways to allow for the manufacture of cheap drugs for their populations,” Aziz ur Rehman, intellectual property adviser for Médecins Sans Frontières’s (MSF) Access Campaign.
“LDCs should take advantage of this flexibility to learn from countries like India and other developing countries that have used it to developed manufacturing capacities, especially in the field of pharmaceuticals,” he added.
More than 80 percent of all donor-funded antiretroviral drugs used in developing countries are Indian generics; the availability of cheap ARVs has enabled more than eight million people globally to access essential HIV treatment.
More work ahead
The current decision will not affect a deadline on LDC exemption from intellectual property rules on pharmaceutical products that expires in 2016, and stakeholders are concerned that continued resistance to a further extension by developed nations could jeopardize the treatment of millions.
“Withdrawal of pharmaceutical products from the extension agreement is a significant lost opportunity and LDCs will now be required to ask for a similar extension request in 2015,” an MSF statement said. “Given the crucial importance of pharmaceutical products, LDCs should insist on an unconditional extension, which should last as long as a WTO member is classified as ‘least developed’.”
“Hopefully it will be possible to extend at least this exemption for pharmaceuticals indefinitely. This would facilitate access to medicines for sick people in LDCs - who are among the most vulnerable of all human beings,” said UNITAID’s Timmermans.
MSF’s ur Rehman said it would be important for LDCs to be united and work with middle-income countries to lobby for an extension on pharmaceutical products in 2015. He also urged them to take advantage of the flexibilities available to them to boost access to cheap health products for their populations, and cautioned against entering into agreements with developed countries that effectively circumvented the very TRIPS provisions that protect LDCs from adhering to strict intellectual property rules.
Through Free Trade Agreements (FTAs) and Economic Partnership Agreements, developed countries can make bilateral or regional agreements that limit the circumstances under which compulsory licences may be issued or extend the life of patents beyond 20 years - a practice known as TRIPS-plus.
“LDCs have a responsibility to make the best use of the exemptions - Free Trade Agreements and unilateral agreements on intellectual property being made by regional bodies like the African Union to harmonize intellectual property laws are harmful to the flexibilities afforded by the TRIPS exemptions and should be avoided,” said MSF’s ur Rehman. “LDCs should keep the same spirit they have when fighting for exemptions in Geneva even while they are at home dealing with developed countries bilaterally.”