Motsoaledi expects resistance to new medicines IP policy

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Health Minister Dr Aaron Motsoaledi says he expects resistance from pharmaceutical companies against the implementation of the government’s new intellectual property policy which was adopted by Cabinet recently, reports Business Day.

Many of the changes to regulations, practices and laws in the offing will affect the health sector, Trade and Industry Minister Rob Davies said at a joint media briefing with Motsoaledi, detailing the policy.

According to the report, the health minister said it was unlikely that pharmaceutical companies would “just fold their arms” in the face of the pending changes. He added, however, that they would be flying in the face of the Trade-Related Aspects of Intellectual Property Rights (TRIPS) rules of the World Trade Organisation, which allow countries to introduce flexibilities into their intellectual property regimes in order to promote the health of their citizens.

“When we start implementing these policies there is going to be a new dawn as far as the healthcare system is concerned,” he said. The domestication of TRIPS rules will, for example, allow for the use of biosimilars (biological compounds) for breast cancer drugs.
The Treatment Action Campaign hailed the new policy, saying it heralded new access to medicines.

The report says the TRIPS rules that South Africa plans to domesticate over time include those related to compulsory licensing and the resort to parallel imports to facilitate the import of cheap products. Davies said that these rules would not be used immediately but as the need arose. The aim of the changes, he said, was to modernise South Africa’s intellectual property system and make it more developmental.

The new regime will require the disclosure of the ingredients and technology of patented goods on registration to allow generic manufacturers to prepare themselves for manufacture when the patent expires though they will be prohibited from using it beforehand.

A system of substantive examination of patents will be introduced to replace the current depository system, which requires that the applicant for a patent to simply make a submission to the Companies and Intellectual Property Commission.

The report says the commission does not assess whether the patentability criteria have been met or whether the patent is valid. The registration process relies on submissions made by intellectual property lawyers and on whether the patent is recognised in other jurisdictions. About 90% of patents registered in South Africa are not based on South African-generated knowledge but on foreign patents.

“One of the results of this is that we have a situation in which we are registering a number of low-quality patents,” Davies said. These included patents that involved ever-greening, the process of making a minor change to a patent in order to secure a further 20-year patent period. Ever-greening would not be possible under a system of substantive patent examination, Davies pointed out.

He is quoted in the report as saying that there would be a pre-and post-patent objection process to allow people to challenge the granting of a patent before or after it is registered.

Business Day report

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