We monitor trade negotiations, and challenge attempts to protect intellectual property at the expense of public health.
Under the guise of free trade and economic cooperation, rich nations such as the United States and the European Union, are negotiating and signing Free Trade Agreements (FTAs) with low and middle income countries (LMICs). In such agreements the richer nations are pushing for strict protection of intellectual property rights to benefits their economic interests. In bilateral agreements they insist on standards and commitments to intellectual property protection that goes beyond those stipulated under the Agreement on Trade Related Aspects of Intellectual Property Rights (TRIPS Agreement). Such agreements, which are frequently negotiated behind closed doors, often force developed nations to give up public health considerations in exchange for market access and beneficial tariffs.
Trade agreements often force developed nations to give up public health considerations in exchange for market access and beneficial tariffs.
The pharmaceutical industry fiercely lobbies their own governments for these agreements, which include the so-called “TRIPS-plus” obligations. In the area of public health, TRIPS-plus obligations are provisions on intellectual property protection that go beyond what is requested by TRIPS, and that restrict the use of public health safeguards and flexibilities available in TRIPS. So when signing such agreements low and middle income countries inadvertently undermine their access to affordable medicines.
Some existing and proposed Free Trade Agreements (FTA) put severe restrictions on the use of flexibilities related to, for example, the scope and quality of patents. Some agreements forbid countries from excluding patentability of existing medicines and methods, for new uses or treatments. FTA negotiations have also been used to restrict flexibilities used to promote patent quality, by forbidding pre-grant patent oppositions. Existing FTAs also restrict the grounds on which countries may grant compulsory licenses. While TRIPS allowed countries the discretion to decide when and why to grant such licenses, FTAs may restrict the grounds, so they can only be used, for example, in national emergencies.
US and EU bilateral agreements also include data exclusivity protection. This restricts the use of clinical test data on pharmaceutical products by regulatory authorities to approve generic medicines. Such protection prevents generic producers from using such data to establish the efficacy and safety of their products, in some cases requiring unethical and expensive repetition of clinical trials. This results in delays to the entry of generic drugs into the market. Data exclusivity may apply even if no patent protection exists, and may also curb the exercise of compulsory licensing.
What we do
We monitor ongoing trade negotiations. We work closely with governments and key stakeholders to increase transparency and accountability to ensure that the public, as well as health experts, have meaningful opportunities to participate in the negotiation processes. We seek to reject any provisions that reduce the safeguards provided by TRIPS flexibilities in bilateral and multilateral trade agreements.