International Intellectual Property laws with respect to pharmaceuticals patents in Africa, part 5

II. IMPLICATIONS BECAUSE AFRICA IS STILL IN A STATE OF NATIONAL EMERGENCY

Currently, the main goal of any act dealing with AIDS vaccinations is to provide access and affordable medicine to countries in need.  One such country is South Africa.  Obtaining antivirals in the South Africa can range from $750- $2000 annually. [1]Problems dealing with affordability of these expensive drug treatments are compounded with the fact that the median household income in South Africa is $1000. [2]This section of the paper examines the TRIPs framework for a National State of Emergency, problems to access to antivirals in South Africa and human related factors to intellectual property reform.

 A. TRIPS framework for a National State of Emergency

TRIPS provides a minimal framework for international intellectual property rights. [3] Additionally, TRIPS allows for cheap access to antiviral medications if a member nation is in the state of national Emergency. [4] TRIPS allows cheap and accessible antivirals to nations in the state of a national emergency by bypassing the required negotiations with pharmaceutical companies and compulsory license requirements. [5]

Moreover, TRIPS gives the individual member nations the power to define what a national emergency is. [6] However, article 31(b) of TRIPS sets a basic framework for a national emergency dealing and AIDS and requires several questions to be answered, including: Can the AIDS epidemic of South Africa be viewed as a national emergency, what is required for South Africa to declare national emergency, how long can a state of national emergency be upheld, and does a compulsory license granted under the state of emergency prohibit future good faith negotiations? [7]

First, is South Africa’s AIDS epidemic a national emergency? In 2001, the TRIPS council met and determined that each member state would determine for themselves when to declare a national emergency. [8]Thereafter, the South African Government with its respected power declared that the AIDS epidemic was a national emergency. [9]Due to the fact that TRIPS is a minimal standard for international patent rights it is important to analyze how giving individual member states the ability to declare national emergencies affects global patent rights.  [10]In this particular case, South Africa can lower international patent protection and bypass negotiations required by TRIPS and bypass the requirement of negotiating for a compulsorily license by declaring it is in a state of National Emergency. [11] It is important member states do not to take advantage of the clause in TRIPS that allows individual member states to declare national emergencies, because if this clause is taken advantage developed nations would move for an amendment to the act requiring stronger international patent rights. [12]Developed nations realize and want to help poorer, developing nations by giving the developing nation’s access to cheaper Antivirals. [13]

Second, to control when a nation can declare a national emergency, the member state must follow domestic laws. In accordance to the South African constitution, “A state of emergency shall be proclaimed prospectively under an act of Parliament, and shall be declared only where the security of the Republic is threatened by war, invasion, general insurrection or disorder or at a time of national disaster, and if declaration of a state of emergency is necessary to restore peace and order.” [14] In view of that, the language of the South African constitution does not directly deal with disease as a national emergency. However, South Africa has a good case to argue that indirectly the HIV epidemic is a national disaster.  [15] Many factors, such as the national economy declines every year due to the shrinking workforce, the drop in life expectancy, the increase of AIDS related deaths, when combined can may be viewed as a national disaster. [16] Through the factors necessary to determine a national disaster it is apparent that human conditions play an important role when dealing with internationally patent policy.

Third, to be protected by TRIPS South Africa must determine when the AIDS epidemic may be deemed cured. Due to the fact there is currently no cure for AIDS, the only possible treatment is to minimize AIDS symptoms. [17] Therefore because there is no immediate cure of the AIDS epidemic, the solution and status when the epidemic is cured must be long term. TRIPS states that compulsory licenses will end “if and when the circumstances which lead to it cease to exist and are unlikely to recur.”[18] Therefore, it is important that there may be a date or goals reached where South Africa can state that the epidemic is cured. [19] Nonetheless, nations do not typically declare a state of national emergency for decades because of foreign trade agreements. [20] Thus, South Africa will not be able to declare a national emergency and will eventually lose its compulsory license.[21] Although South Africa is able to claim a national emergency for an indefinite period of time there will come a time when even the poorest of regions of South Africa have cheap access to antivirals which may lead to the end of the epidemic.  [22]Consequently, by not allowing countries to declare a state of emergency for an infinite length, this is one way TRIPS maintains a strong international patent policy. [23]

Fourth, it must also be analyzed if after the AIDS epidemic is over compulsory licenses can be transferred over based on good faith negotiations. [24] If good faith negotiations occur after compulsory licenses are given, then South Africa could eliminate tension between the nation and pharmaceutical companies. [25] Additionally, South Africa entering into good faith negotiations with pharmaceutical companies indirectly strengthens international intellectual property law and trade agreements. Good faith negations strengthens international patent policy by allowing both developed and developing nations to enter into compulsory licenses, which allow developing nations cheap access to the antivirals and allowing developed nations reimbursements for the drugs they produce. If South Africa is able to set a precedent for the rest of the world to follow, pharmaceutical companies will be more likely to issue compulsory licenses quickly and eliminate lengthy negotiations. [26]



[1] TRIPS, supra note at 26.

[2] Ellen Hoen, Pharmaceutical Patents, and Access to Essential Medicines: A long Way from Seattle to Doha, 3 Chi. J. Int’L. 27 (2002)

[3] TRIPS, supra note at 7.

[4] Id.

[5] Id.

[6] Id.

[7] Id.

[8] I Patrick Marc, Compulsory Licensing and the South African Medicine Act of 1997: Violation or Compliance of the Trade Related Aspects of Intellectual Property Rights Agreement?, New York Law School, 21 N.Y.L. SCH. J. INT’L & COMP. L. 109 (2001)

[9] Id.

[10] Id

[11] Id.

[12] Id.

[13] Id.

[14]  Patrick Marc, Compulsory Licensing and the South African Medicine Act of 1997: Violation or Compliance of the Trade Related Aspects of Intellectual Property Rights Agreement?, New York Law School, 21 N.Y.L. SCH. J. INT’L & COMP. L. 109 (2001)

[15] Id.

[16] Id.

[17] TRIPS, supra note at 4.

[18] TRIPS, supra note at 7.

[19] Kara Bombach, can South Africa Fight AIDS? Reconciling the South African Medicines and Related Substances Act with the TRIPS Agreement, 19 B.U. INT’L L.J. 273 (2001).

[20] Id.

[21] Id

[22] Id.

[23] Id.

[24] Id.

[25] Id.

[26] Ellen Hoen, Pharmaceutical Patents, and Access to Essential Medicines: A long Way from Seattle to Doha, 3 Chi. J. Int’L. 27 (2002)

By | 2012-10-30T18:37:42+00:00 October 30th, 2012|Foreign Patent Prosecution|Comments Off on International Intellectual Property laws with respect to pharmaceuticals patents in Africa, part 5