With no word on when the long-awaited National Policy on Intellectual Property will be finalised, activists are anxious "big business" is getting a chance to sway policymakers' opinions.
"It seems those who wanted to delay the policy have succeeded because nothing was finalised before the national elections, as previously promised by the department of trade and industry," said Julia Hill from medical humanitarian aid organisation Médecins Sans Frontières (MSF).
MSF is campaigning for intellectual property (IP) reform to enable access to cheaper generic drugs, particularly for tuberculosis, hepatitis and cancer.
The draft regulations were published on September 4 2013 and the public had until mid-October that year to submit comments.
Health activists are outraged that, more than a year later, the policy seems to be in limbo. They say this has negative implications for the availability of affordable medicines: the current legislation allows the patent rights for expensive medicines to be extended for "unreasonable periods", preventing cheaper generic medicines from entering the market.
'Satanic plot'In January, the Mail & Guardian reported on an alleged plot by multinational pharmaceutical companies that were attempting to lobby against the new draft policy guidelines. In its current form, the policy suggests stricter management of patents, making them more difficult to get and renew.
At the time, Health Minister Aaron Motsoaledi labelled this bid by the pharmaceutical companies a "satanic plot" and
tantamount to "genocide".
Hill said the department of trade and industry's (DTI) "silence" and "slow progress" with the proposed policy has led activists to question "whether policymakers are acting of their own free will or whether something else is going on".
But according to lawyer David Cochrane, although he does not oppose IP reform, the National Patent Act does not need to be changed because it allows for special circumstances in which a patent can be overturned and public health advocates have space to challenge patents as needed. But this would have to be done by taking legal action through the courts.
"Legal processes are prohibitively expensive and can take years to finalise, and in the context of serious diseases and public health this is not a solution," said Hill.
Not practical?In South Africa's current "rubber-stamp" system, a patent is granted without it being checked if the individual or company deserves the patent.
The department's proposed system would require appropriately qualified scientists to check the validity of each of the roughly 7 000 patents submitted each year, 2 500 of which relate to pharmaceuticals, said Cochrane.
Cochrane said this system was labour-intensive, time-consuming, expensive and, if not implemented efficiently, "runs the risk of being worse than the current system".
"Instead, I would suggest an oppositional system be implemented, where patents can be opposed after they have been granted and the decision would be made by a tribunal of experts."
In this way, Cochrane said, expensive court battles would be avoided and only contentious patents would require interrogation.
Vital implementationHill said this might be "an interim solution" while the department gets a fully equipped and manned patents office off the ground.
"It is urgent to get these processes going as soon as possible. We need access to medicines for life-threatening diseases and these patients can't wait. So, while the DTI will need time to build the capacity for an extensive search and examination system, starting off with an oppositional system is a good idea – as long as it doesn't distract from IP reform in the long run," Hill said.
While interested parties continue to lobby and debate, the department has already recruited and started training 20 patent examination officers.
"This is a good sign. Even though there are doubts about whether the DTI will meet its deadlines and have a final policy in Cabinet by the end of this year, it shows that things are moving in the right direction," said Hill.
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