South Africa grants almost every patent application it receives, making its patent regime one of the world’s most lenient. While pharmaceutical companies cash in, patients face staggering healthcare costs, and medicines like cancer treatments, third-line antiretrovirals (ARVs) and treatments for drug-resistant tuberculosis (DR-TB) are often priced out of reach.
A form of intellectual property protection, patents are typically awarded to companies that can prove their product is new. Not so in South Africa, say activists and researchers, who claim the country’s patent system allows pharmaceutical companies to apply for new patents on existing drugs based on immaterial changes - like adding table salt to a formulation or changing a pill’s colour.
According to activists from Médecins Sans Frontières’s (MSF) Campaign for Access to Essential Medicines and the South Africa AIDS lobby group the Treatment Action Campaign (TAC), easy patents mean companies can extend their exclusive right to manufacture and sell certain drugs, a process known as evergreening.
With competition eliminated, drug prices stay high - often out of reach of South African patients, activists argue.
In South Africa, third-line ARVs - all under patent - costs about US$4,000 per patient per year in private-sector health facilities. This high cost means patients in need of these medicines, which are considered drugs of last resort, often go without. The medicines aren’t offered by public health facilities, according to MSF and TAC.
Additionally, the country diagnoses about 7,500 cases of multidrug-resistant TB (MDR-TB) annually, but one of the few drugs available to treat MDR-TB, linezolid, costs about $2,500 per month of treatment because of patent protection. Linezolid is also not available from public sector healthcare providers.
While its patent expires in 2014, a patent on a crystallized form of the drug may block generics from entering the South African market until 2022. An Indian generic, currently restricted because of linezolid’s patent, costs about $70 per month.
The country is preparing a new draft policy on intellectual property, so now is the time to fix the patent laws that allow for these high prices, said Vuyiseka Dubula, TAC’s secretary general.
“In the past 13 years, we have been fighting [patents] drug by drug. Today is about fixing the problem once and for all, to deal with our issues and ensure access to ARVs and DR-TB drugs,” Dubula told IRIN/PlusNews. “I’m saying this as a person openly living with HIV who is alive today because of access to affordable medicines.”
Patent reform will likely have implications for the government’s efforts to initiate local ARV production and implement national health insurance - policy decisions announced by the National Department of Health. The health department has little control over the country’s new intellectual patent policy, which is largely the domain of the Department of Trade and Industry (DTI).
Easy come, easy go?
How easy is it to get a patent in South Africa? The Mailman School of Public Health, at Columbia University in the US, examined about 2,400 patent applications filed with European Union, US and South African patent regulators between 2000 and 2002. While European and American officials approved about 60 percent of these applications, South African patent administrators approved almost every application submitted, according to the study’s preliminary findings, which were recently presented in Johannesburg by associate professor Bhaven Sampat.
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A study by South Africa’s University of Pretoria found that 80 percent of patents in South Africa would not have been granted if the country actually scrutinized patent applications. Study authors also found that country’s patent laws did not widely support local innovation, but instead facilitated exploitation by foreign companies and created substantial social costs.
The most recent review of South African patents, conducted in 2008 by Yousuf Vawdaw, a professor of law at South Africa’s University of KwaZulu-Natal, found that about half of all South African patents that year were granted to US companies, followed by companies from the UK, Germany and France.
New policy to be released in December
The DTI’s draft of the new intellectual property policy is set to be submitted to the cabinet on 5 December. A three-month period of public comment on the policy will then be opened before the policy becomes a bill, according to MacDonald Netshitenzhe, the department’s chief director of policy and legislation.
Despite calls from organizations such as TAC and MSF, the draft policy has not yet been made public, but Netshitenzhe says provisions to oppose patents are in the draft policy. Vawdaw and other experts say they hope the policy includes provisions to dissuade evergreening and to allow for compulsory licences.
When the World Trade Organization (WTO) was created, it introduced standards to protect intellectual rights through its Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS). Aware that the protection of intellectual property rights might hinder access to public health resources such as generic medicines, the WTO, in 2001, reaffirmed governments’ right to use TRIPS’s built-in flexibilities to increase access to public health resources such as essential medicines.
Compulsory licences are one of the most commonly used TRIPS flexibilities. When it is in the national interest, governments in countries with insufficient pharmaceutical manufacturing capacity can authorize the use of a patent-protected invention without the consent of the patent-holder. Patent holders are then compensated, usually in the form of royalties.
Although historically opposed to compulsory licenses, the US issued one for the drug Ciprofloxacin, an antibiotic used to treat anthrax, in the wake of the September 11 attack. But DTI’s Andre Kudlinski has argued compulsory licenses are unnecessary when large pharmaceutical companies like Aspen have received voluntary licenses on ARVs in the past.
The ‘BRICS’ group of advanced emerging countries - Brazil, Russia, India, China and South Africa - is coming under increased pressure to impose stricter patent laws, particularly through fair trade agreements, and Leena Menghaney, head of MSF’s Access Campaign in India, warns that the choices South Africa makes now may set the tone for discussions in countries like Brazil and India.
*This article was amended on 18 January 2013 to correct the number of MDR-TB cases diagnosed annually.