Change in policy opens the way for generics

123rf.com

This will pave way for the introduction of substantive search and examination of patents to do away with companies that use loopholes to extend patents on drugs by decades and in the process, stop other manufacturers from accessing their research knowledge to manufacture the same drug and sell it at a lower price.

The Agreement on Trade-Related Aspects of Intellectual Property Rights (Trips) in Doha, which was signed in 1995, gave pharmaceuticals room to register patents on drugs they researched and manufactured for a 20-year period. Thereafter, the research is made public for other companies to use.

“With extraordinarily expensive pharmaceuticals… we might find a solution, especially with the issue of the substantive search and examination for patents. Most health activists have been complaining about this issue. When the Tripts flexibilities were agreed upon in 1995 in Doha, it was agreed that all the companies that manufacture originator drugs through research are given a 20-year patent period, meaning after 20 years, everybody who has the skill could manufacture a similar drug. That drug has to be [labelled] a generic,

“Generics and originator drugs are exactly the same thing chemically. It is just that they are manufactured by different people,” Health Minister, Aaron Motsoaledi said.

The flexibilities that were agreed upon left room for abuse, as companies would partially modify their drug and register them as a new patent.

“Now the problem is that… at the expiry of the 20 years, instead of generics flowing and drugs getting cheaper, the companies do what… is called evergreening, which means you [take] drug, change one molecule and apply for a patent as a new drug and you are given another 20 years. So meaning the 20 year period will not come to an end - it is forever," he said.

The new policy would change this practice.

“This policy brings that to an end because through substantive examinations, we will be able to tell a company that there is not substantive change on the drug - it is still the same drug that has been there for 20 years,” he said.

Striving for better access to health

Giving the background to how the policy has evolved over the years, Trade and Industry Minister, Rob Davies, said in 2008, the department was mandated by Cabinet to develop a national Intellectual Property Policy, under the coordination of an Inter-Ministerial Committee, around intellectual property matters. The policy was approved by Cabinet in 2013.

He said after broad consultations with stakeholders, it was decided that further research was needed and that there was a need to have a phased approach in the development of the policy.

“What we have now released is phase one, which went through a process of consultation and it is being approved by Cabinet,” said Motsoaledi, adding that there is also an Inter-Ministerial Committee on Intellectual Property.

Davies said another challenge in the past was that companies would register patents in South Africa for drugs that are already available in other markets at a lower price due to the fact that substantive examinations are currently not being done.

The examinations will also introduce a system of objections to patents before and after they are registered.

“So what we are doing right now is we have developed a team and there will be a pre- and post-patent objection process that takes place. So people can challenge the granting of a particular patent, either before or after it is registered and then that will go through a substantive examination of patents,” said Davies.