Medicine patent draft policy set to go to Cabinet
The Trade and Industry Department expects to submit a revised version of its draft intellectual property policy to the Cabinet by the end of March, a senior official says.
The department is facing intense lobbying from health activists and pharmaceutical companies as the draft policy proposes closer scrutiny of patent applications for medicines, a simpler system for issuing compulsory licences and mechanisms for tightening the criteria for granting patents.
The national government has never yet issued a compulsory licence for a medicine, preferring to negotiate with pharmaceutical companies for lower prices in exchange for guaranteed volumes.
It has had marked success in negotiating lower prices for HIV medicines and some vaccines, but has faced a tougher task with other drugs such as those used for treating cancer.
The draft intellectual property policy was published for comment in August 2017, and interested parties had until November 17 to comment.
Thirty-two submissions were received, some of which were submitted by stakeholders that had coordinated their responses into a single submission, said Xolelwa MlumbiPeter, the Department of Trade and Industry’s deputy directorgeneral for international trade and economic development.
Mlumbi-Peter emphasised that the draft policy covered only the first phase of the government’s overhaul of its intellectual property regime, which targeted public health and intergovernmental coordination.
The next step would be to work on a consultative framework document to solicit inputs
for the second phase of the policy, she said.
Phase two will include intellectual property rights in the informal sector, agriculture and genetic resources, as well as the branding of South African goods and services.
The Fix the Patent Laws coalition has previously said it supports the draft policy’s proposals, saying they will boost competition between rival drug manufacturers and drive down prices.
However the Innovative Pharmaceutical Association of SA criticised the draft policy when it was released, saying it placed too much emphasis on drug firms’ “ever-greening” patents on medicines. This fuelled misconceptions about the practice.
The Innovative Pharmaceutical Association of SA is a trade body representing multinational drug firms that hold the patents on brand-name products.
Its members have come under fire from health activists for patenting modifications on old medicines, which the activists say should not be seen as new inventions.
In 2017, Innovative Pharmaceutical Association CEO Konji Sebati said critics misunderstood the concept of incremental innovation.
“[It] is still seen as a means to block generics, which is a total misconception," said Sebati.
“If you move from injecting a drug four times a day to longrelease, a lot of research has gone into that,” she said.
THE DRAFT POLICY COVERS ONLY THE FIRST PHASE OF THE GOVERNMENT’S OVERHAUL OF ITS INTELLECTUAL PROPERTY REGIME