For the past three years, South Africa’s drug patent wars have been in and out of the spotlight, but when the Department of Trade and Industry (dti) said it expected to submit its intellectual property (IP) policy to the cabinet before elections, claws came out.
The public campaign document leaked to the media in January, where the Washington-based lobbying firm Public Affairs Engagement (PAE) prepared a plan to derail the patent reforms and delay the finalisation of the IP policy before elections, stirred things up like never before.
Even though the Innovative Pharmaceutical Association SA – for which the PAE proposal was prepared – put out a statement distancing itself from the planned “robust” campaign, it is clear Health Minister Aaron Motsoaledi and health activists’ gloves have also come off.
Yesterday the minister said there were many instances where pharmaceutical firms just tweaked one molecule when a drug patent was about to expire and then applied for a new patent.
That is the kind of practice that needs to be rooted out, but how will the reforms affect the granting of patents in general?
For starters, everyone knows that the Medicines Control Council has not been the most efficient body when it comes to getting drugs registered in the country.
However, the mooted establishment of a patent examination office raises questions as to whether this will not introduce new delays in the system.
And another point to ponder is that companies put in large amounts of money to research and develop their originator drugs.
So companies need to get returns on their research investment and the government would not want to be seen as not recognising this intellectual property.
If Motsoaledi says South Africa needs to start using more flexibility provisions in the World Trade Organisation’s Trade Related Aspects of Intellectual Property Rights, a more detailed explanation of how that would work would ease the anxiety in the industry.
An explanation of whether this refers to drugs that received a second patent or all patented drugs and how long after the originator drug has been on the market will surely shape the debate.
Alarm bells may have sounded when the information and communications technology regulator announced yesterday its intentions to launch a high-level inquiry into the state of competition in the industry.
The Independent Communications Authority of SA’s (Icasa’s) industry-wide inquiry into the state of competition is possibly the first of its kind in democratic South Africa, at a time when such a probe might be considered a little too late, as one analyst explained yesterday.
Over time, the dominant incumbents have been allowed to grow unfettered in an ineffectively regulated market to the extent that, as Icasa awakened to its role and began to increasingly exert the correct pressure, it became problematic.
The general market consensus is that the inquiry is positive. Analysts are calling for a constructive approach such as the consideration of the number of players, the market share that each enjoys, whether or not they abuse their dominance and how many people access their products and services. “The developmental issue is how [current] competition in that industry is contributing to the economy,” Avhasei Mukoma, a telecoms attorney, said.
And, yet, in the same breath that Icasa said it would assess competition in the local market, it pointed out in a statement that there was an “assumption that greater competition will lead to a reduction in the cost to communicate”.
Where were Icasa councillors during the early 1990s when customer premises equipment was liberalised and Telkom clients could buy their landline handsets from places other than the Telkom monopoly? Over the past 15 years the price of a gigabyte of data has declined from about R70 to about R2 today, after competition was introduced for fixed data.
It is suggested wireless network operators should provide access to infrastructure as Telkom had to, because access to cellphones is no longer a concern but affordability is where the gap exists.
Edited by Peter DeIonno. With contributions from Londiwe Buthelezi and Asha Speckman.