SOUTH AFRICA: Activists urge change to patent laws
No third-line ARVs are available in the public health sector
CAPE TOWN, 21 November 2011 (IRIN) - Ten years ago, the Doha Declaration
allowed countries to circumvent patent rights to access life-saving medicines, particularly those used to treat HIV/AIDS, tuberculosis and malaria. However, the South African government has failed to take advantage of these provisions, and increasingly important TB medication and second- and third-line antiretrovirals (ARVs) remain out of reach, activists warn.
"Pre-Doha, treating [HIV] without generics... meant HIV was a death sentence," said Gilles van Cutsem, medical coordinator for Médecins Sans Frontières (MSF).
In South Africa, with the world's highest HIV infection rate, the availability of generic
first-line ARVs meant a drop from an annual cost of more than US$10,000 per patient to $60. Now, with more than one million people on treatment, the country will need to put more HIV-positive people on second- and third-line
Right to health
The Doha Declaration, or the Declaration on the TRIPS
Agreement (Agreement on Trade-related Aspects of Intellectual Property Rights), was signed by members of the World Trade Organization (WTO) in response to concerns that patent protection granted by the TRIPS Agreement would undermine the ability of countries to protect their right to health and access to medicines.
The 1995 TRIPS Agreement made all WTO members beholden to a pharmaceutical patent period of 20 years, during which time no generic could be produced. Before TRIPS, countries such as Brazil and India did not respect patent periods at all, and many other nations observed shorter time-spans (16 years in South Africa).
With the 2001 Doha Declaration, provisions within the TRIPS agreement to protect public health were reaffirmed, as were the rights of member countries to "use, to the full, the provisions in the TRIPS Agreement, which provide flexibility for this purpose".
This included the granting of compulsory licences, which allow a government to formulate or import generic versions of medicines essential to public health but still under the 20-year patent period.
To take advantage of public health flexibilities such as compulsory licensing, however, it must be enacted into national legislation. Unfortunately, few countries, including South Africa, have taken advantage of their rights.
“Despite significant health burdens in the decade since the Doha Declaration, very few developing countries have amended their laws to fully utilize the flexibilities to protect health,” said Mara Kardas-Nelson of MSF’s Campaign for Access to Essential Medicines.
South African law has no clause allowing for the issuing of compulsory licences on prohibitively expensive drugs, and retains patent protection beyond what is required by the TRIPS agreement.
“There are a number of amendments that South Africa must make to its Patents Act to promote public health,” said Catherine Tomlinson, a senior researcher with the Treatment Action Campaign (TAC).
Besides compulsory licensing, health advocates are calling for South Africa to stop granting new formulation patents (existing medicines with slight chemical changes that do not necessarily represent a change that is beneficial for patients), and to institute both a review process for patenting and a mechanism for third parties to oppose a patent.
“Unlike South Africa, India, Brazil and Thailand, among others, have used flexibilities allowed for under TRIPS to curb excessive patenting of pharmaceuticals and promote public health," Tomlinson pointed out. South Africa granted 2,442 pharmaceutical patents in 2008 alone, while Brazil only granted 278 pharmaceutical patents between 2003 and 2008.
Counting the cost
Under the Doha Declaration, middle-income countries were given until 2005 before they had to enact TRIPS-compliant national legislation.
“If it had not been for this window period where middle-income countries could produce generic versions of antiretroviral therapy [ART], India could not have produced high-quality, low-cost ART,” noted Van Cutsem.
“But that window period is now closed and we are deeply concerned about the lack of options to bring generic versions of new medicines to the market. Without generic competition, we’re seeing the cost of second- and third- line ARVs up to 20 times more expensive than first-line ARVs. It is vital now more than ever that countries use all of the flexibilities available to them to protect public health.”
In South Africa, a limited range of second-line ARVs is available in the public sector for people who have built up resistance to the various first-line options. However, due to a price tag of over $4,000 a year per patient, no third-line ARVs are available in South Africa's public health sector.
This could change if South Africa amended its Patents Act to make better use of the Doha Declaration flexibilities. However, health advocates say that pressure from the EU, the US, and pharmaceutical companies has kept many developing nations such as South Africa from making the needed changes.
South Africa's Department of Trade and Industry is reviewing the intellectual property policy, and TAC and MSF are calling on them to make changes that would, among other things, include national legislation allowing South Africa to issue compulsory licences.
"Under the Constitution, the South African government is obligated to take reasonable legislative and other measures, within its available resources, to achieve the progressive realization of the right to have access to healthcare services, which includes access to medicines. Given the massive health needs of the country, government should amend South Africa’s Patents Act to take full advantage of provisions in the TRIPS agreement, including but not limited to those outlined in the Doha Declaration, to protect public health," TAC said in a recent press release.