Two months after releasing a draft policy for governing intellectual property, South Africa has decided to amend its patent legislation so the government can use parallel importing and compulsory licensing that is allowed under international agreements, according to a statement by Rob Davies, who is National Policy on Intellectual Property, Trade and Industry Minister (here is the draft policy and here is the statement).
The move comes after patient advocacy groups complained that South Africa has not amended its patent laws to incorporate or implement the 2001 WTO agreement on Trade Related Aspects of Intellectual Property Rights, or TRIPS, which offers compulsory licensing as an option to countries to make patented drugs more affordable for citizens.
The issue was raised in order to make it possible for other companies to sell lower-cost HIV and AIDS medications, since the country has one of the highest infection rates in the world. Patient advocacy groups such as Doctors Without Borders and Treatment Action Campaign have waged an aggressive campaign to convince the South African government to take such steps.
“We are the world capital of HIV/AIDS, we have a serious burden of TB linked to that… and we have to have the freedom and ability to use the policy space that’s been made available to us under TRIPS and public health for us to take that option,” Davies told a media briefing, according to Business Day.
“Although we’ve been a major champion of all these processes internationally we haven’t necessarily incorporated them into domestic law. That’s one of the issues that we need to follow through. I’ve interacted with a few of the patent medicine manufacturers, saying to them ‘we are not doing anything that you won’t be familiar with in other jurisdictions.’”
The effort comes more than a decade after South Africa figured prominently in the battle over AIDS drugs. More than a dozen global drugmakers filed a
lawsuit to prevent the country from allowing low-cost generics of AIDS medicines to be made, a move that backfired when the pharmaceutical industry encountered widespread criticism for a strategy that emphasized profits at the expense of a growing population of very ill people.
In its statement, the ministry also says that “there is no patent extension or restoration, but we are under pressure to provide for such. In this regard, an initial recommendation is that there should be no patent extension/restoration as there is no standardized timelines in the world to deal with common granting standards. Until such time that harmonization takes place, it would be difficult for South Africa to introduce patent extension or restoration.”
As for parallel imports, the current patent law does not mention prescription drug pricing, but the proposed policy will do so, and grants and incentives may be introduced in order to encourage innovation by the domestic pharmaceutical industry through the policy options available to member states of WTO, according to the ministry statement.
We asked the Innovative Pharmaceutical Association South Africa, the industry trade group, for a response and will update you accordingly.