By creating a procedure for third world countries to access and produce patented medications under circumstances of extraordinary demand, curable and treatable diseases will become a significantly less threatening obstacle to universal millennium development.
Since 1995, member countries of the World Trade Organization have been subject to the TRIPS (Trade-Related Aspects of Intellectual Property Rights) Agreement. TRIPS forces these countries, many of which are developing nations, to obey 20-year patent holding laws on pharmaceutical developments, monumentally impeding access to medications in immediate demand in countries without the resources to pay for expensive patented pharmaceuticals. In an attempt to balance the benefits of creative development fostered by pharmaceutical patents with the obvious need for better access to medical resources, TRIPS legalizes a process called compulsory licensing, which allows patent rights within a country to be extended to a generic company that can produce the medications needed at high volume without incurring massive costs. In emergency situations, this provision often represents the only possibility of medical relief. However, this process is poorly regulated and confusing, often backfiring on the country making use of the compulsory licensing provision. Member countries that have employed this emergency exception have faced trade pressure from first-world countries and costly lawsuits from the patent holding pharmaceutical companies themselves.
Forcing countries to become individually responsible for fighting patents and organizing generic manufacture has become a significant barrier to the use of compulsory licensing. An oversight committee with the power to govern compulsory licensing procedures would allow for a buffer between countries and pharmaceutical companies, streamline the licensing process, and ensure that production of generic medications was only occurring in crisis situations. The Council for TRIPS already exists; it is a committee open to all World Trade Organization members that regulates the provisions included in TRIPS. In order to function fairly and effectively, the power to deliberate and decide on compulsory licensing requests should be delegated to this council.
In South Africa, the percentage of the population infected with AIDS has reached epidemic proportions. 5.6 million of the 50 million current citizens of South Africa are infected. Under current patent law, treating all 5.6 million citizens in need of medication in South Africa would require impossible investment. Without access to less expensive generic drugs, only .001 percent of known AIDS patients in all of Africa have access to medication that dramatically improves both length and quality of life. In an attempt to take advantage of the access possibilities offered by compulsory licensing, South Africa passed the Medicines Act, which set up procedures for producing generic medications.
Although compulsory licensing is specifically legalized in TRIPS, South Africa faced dangerous commerce pressure from the United States and trade threats from 39 powerful pharmaceutical companies.6 A committee system would have prevented this first-world bullying by making compulsory licensing a democratic choice and forcing all member countries to be equally responsible for the decision. Trade pressure would then no longer be a concern, as member countries would have had an opportunity for dialogue and a democratic decision.
The direct costs of delegating compulsory licensing decisions to the WTO Council on TRIPS would not, in itself, create a burden of additional cost. The structure of the committee is already secure, and this addition of responsibility is only measurably relevant under emergency conditions. Long term, it is possible that this policy will result in an increase in compulsory licensing. However, because first-world member countries are given an opportunity to influence policy decisions, this increase should be small and low-impact.
This policy should be acted on immediately by the WTO and enforced by the addition of an addendum to TRIPS delegating the power of making compulsory licensing decisions to the Council on TRIPS. Requests from countries to the committee for generic access would be decided on a case-by-case basis because emergencies that may require access to a compulsory license cannot be predicted under current circumstances. The current WTO selection process, which gives all member countries access to the Council on TRIPS, will remain in place to ensure and maintain the democratic nature of the decision process.
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