10 Examples of the Use of Compulsory Licenses for AIDS-Related Pharmaceuticals in Africa

Pharmaceuticals
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NLIPW Patents Law Volume 1 Number 9

eDigest

August 2, 2013

1. Cameroon

CameroonOn January 8, 2005, Essential Inventions, a non-profit, asked the Cameroon Minister of Public Health to approve compulsory licenses for patented ARVs in the country. The licenses were required for the importation, manufacture and sale of generic versions of Nevirapine, Lamiduvine and fixed dose combinations of Lamiduvine and Zidovudine (Combivir). Prior to the application for the compulsory license, Essential inventions had sought voluntary licenses on the patents relevant to the importation and sale of the drugs from GlaxoSmithKline (GSK) and Boehringer Ingelheim. According to Essential Inventions, they received no response from GSK as of the date of the request for compulsory license and an outright denial from Boehringer Ingelheim.

2. Eritrea

ERITREAOn June 8, 2005, the Eritrean Minister of Health, Mr. Saleh Meky, issued compulsory license Reference No: PMU/833/2005 for the importation of generic ARV medicines into Eritrea. Relying on the provisions of the Trade Related Aspects of Intellectual Property Agreement (TRIPS) and the DOHA declaration, the Minister declared a state of emergency with regards to HIV/AIDS and stated that the ARVs will be used to treat people living with HIV/AIDS without commercial purpose.

3. Ghana

GHANAOn October 26, 2005, Ghanian Minister of Health, Major Courage Quashigah (Rtd) declared an emergency situation with regard to HIV/AIDS in Ghana. According to the Minister, after carefully considering the TRIPS Agreement and the DOHA Declaration, a compulsory license for importation into Ghana of generic HIV/AIDS medicines was approved. The declaration stated that the generic HIV/AIDS medicines will be used by the government to treat people living with HIV/AIDS in Ghana without any commercial purpose.

4. Guinea

GUINEAOn April 18, 2005, the Ministry of Health in Guinea issued compulsory licenses for the importation of drugs used in the treatment of AIDS from generic producers in developed countries.

5. Mozambique

MOZAMBIQUEIn April 2004, Mozambique’s  Deputy Minister of Industry and Commerce, Salvador Namburete, issued Compulsory License no. 01/MIC/04 for Lamivudine, Stavudine and Nevirapine. In issuing the compulsory license, the Deputy Minister cited the HIV/AIDS pandemic in Mozambique, estimated at the time to be 1.5 million Mozambicans infected by HIV, of whom more than 100,000 were suffering from full-blown AIDS and with a death toll over 200,000 as of 2002. The Deputy Minister granted the license to Pharco Moçambique Lda (a company incorporated under the laws of Mozambique) to manufacture a triple compound under the names PHARCOVIR 30 and PHARCOVIR 40 with a maximum royalty rate of 2% to be paid to the patent right owner.

6. South Africa

SOUTH AFRICAIn March 2001, CIPLA, an Indian pharmaceutical manufacturer, petitioned South Africa’s Department of Trade and Industry to issue compulsory licenses on Abacavir, Didanosine, Efavirenz, Indinavir, Lamivudine, Nevirapine, Stavudine, and Zidovudine, which are all used in treatment of HIV. In September 2002, Hazel Tau, in collaboration with the Treatment Action Campaign, filed a complaint at South Africa’s Competition Commission against GSK and Boehringer Ingelheim for excessive pricing of Nevirapine, Lamivudine, Ritonavir, and Ritonavir & Lamivudine.

In October 2003, following an extended investigation, the Commission found that GSK and BI had denied a competitor access to an essential facility and had engaged in excessive pricing and in an exclusionary act. The Commission subsequently reached independent settlements with GSK and BI. The terms of the settlement required GSK to extend a voluntary license granted to Aspen Pharmacare in October 2001 in respect of the public sector to include the private sector; to grant up to three additional voluntary licenses on terms no less favorable than those granted to Aspen Pharmacare; to permit the licensees to export the ARVs to sub-Saharan African countries; to permit the importation of the drugs for distribution in South Africa if the licensee does not have manufacturing capability in South Africa; to permit licensees to combine the relevant ARV with other ARV medicines; and to charge royalties of no more than 5% of the net sales of the relevant ARVs.

7.Rwanda

RWANDAOn July 17, 2007, Rwanda notified the World Trade Organization’s (WTO) Council for TRIPS of its plan to use Paragraph 6 of the DOHA Declaration, which is designed for those countries that do not have the facilities to manufacture pharmaceuticals. Rwanda stated that it intended to import 260,000 packs of the HIV/AIDS drug TriAvir from the Canadian company Apotex, based on its public health needs. Apotex had been unable to reach an agreement with the patentees, GlaxoSmithKline, Shire and German pharmaceutical Boehringer Ingelheim.

On October 4, 2007, Canada also issued a compulsory license that allowed Apotex to use nine (9) patented inventions for manufacturing TriAvir to Rwanda and notified the Council for TRIPS of the compulsory license.

8. Swaziland

On April 20, 2004, the Ministry of Health and Social Welfare in Swaziland announced the existence of an emergency with regard to HIV/AIDS and authorized the importation of medicines for HIV/AIDS irrespective of the existence of any patent or other intellectual property protection applicable in Swaziland until such time as it is no longer considered essential to address the public health crisis related to  HIV/AIDS in Swaziland at the time.

9. Zambia

ZAMBIAOn September 21, 2004, Zambian Minister of Commerce, Trade and Industry, Dipak Patel issued compulsory license No. CL.01/ 2004 for Nevirapine, Lamivudine, stavudine. Relying on the provision of the TRIPS Agreement, Section 40 of the Zambian Patent Act and the high rates of death suffered by Zambians as a result of the HIV/AIDS pandemic, a license was granted to PHARCO LTD, a company incorporated in Zambia, to produce a triple compound under the names Normavir 30 and Normavir 40 with a maximum royalty rate of 2.5% to be paid to the patent right owner.

10. Zimbabwe

ZIMBABWEOn May 24, 2002, Zimbabwe’s Minister of Justice, Legal and Parliamentary Affairs, P. A. Chinamasa, issued a notice declaring a period of emergency in  order to override ARV drug patents for a period of 6 months.

Under the declaration, which relied on provisions of Section 34 and 35 of the Zimbabwe Patent Act, the Minister announced an emergency period of 6 months to enable the government to make, use or import generic HIV/AIDS medicines. In 2003, Zimbabwe  extended the period of emergency  for an additional 5 years.

This article is intended to provide general information about the subject matter. Professional legal advice should be sought about specific circumstances.

 

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About Bob Aroture 555 Articles
Bob is a Senior Editor and Content Development Manager at Nigerian Law Intellectual Property Watch. He holds a BS degree, with a major in biochemistry. He works directly with the Newsroom Team. His focus areas are technology and innovation, and pharmaceutical technology. Email: editorial@nlipw.com