Drug examining office mooted

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BR Tablets  19036 Bloomberg Bayer Schering Pharma packages its Yasmin birth control pills in its factory in Berlin, Germany. Pharma Dynamics is seeking to overturn the Yasmin patent. Photo: Supplied

Johannesburg - The Minister of Health, Aaron Motsoaledi, has mulled the possibility of establishing an office dedicated to examining drug patent applications in South Africa, saying it was not currently being done.

Speaking at a business briefing in Fourways, Johannesburg, about the Department of Trade and Industry’s draft intellectual property (IP) policy which contains draft drugs patent reforms, Motsoaledi said 30 percent of drug patents that had been rejected in the US and Europe because of evergreening practices were approved in South Africa.

NGO Médecins Sans Frontières (MSF), which has been running a campaign termed “fix the patents laws” since 2011, said that that number was more likely about 40 percent.

Evergreening is a term that refers to the renewal of a patent for another 20 years simply by tweaking one molecule in the protected drug so that no other firm can produce a generic version.

The patent examination office “is something that we know we need to do, not that there are concrete plans or any documents drafted to establish it”, said the minister’s spokesman, Joe Maila.

But he said that even if the office was established, the department could not say that it was wrong to award patents to companies whose applications were rejected in other parts of the world. “There is no regulatory framework to help us or to revoke those patents because we were wrong to accept them in South Africa.”

One drug whose patent was rejected in Europe is Bayer Schering Pharma’s oral contraceptive Yasmin. Generics manufacturer Pharma Dynamics is currently involved in a court bid to have its supplementary patent reversed.

Pharma Dynamics chief executive Paul Anley said its generics were being produced in Europe, the US and Canada.

Motsoaledi said the government’s IP policy was not proposing to abolish the World Trade Organisation’s (WTO’s) 20-year patent regime, which protects pharmaceutical firms’ intellectual property. He said, however, that it was time that South Africa started using the WTO flexibility provisions that it had not used.

“They say South Africa is ground zero, if things are allowed to change here, then they are going to spread all over the developed world,” he said, adding that this was the reason the pharmaceutical industry conspired in a plot to derail the reforms on the IP policy.

The WTO’s Agreement on Trade Related Aspects of Intellectual Property Rights (Trips) gave countries a chance to incorporate necessary flexibilities in their policies and laws.

The government can apply those flexible arrangements on certain drugs that can cure or manage an epidemic disease, but are protected by patents where there are no alternatives that have their therapeutic capabilities in the country.

In South Africa, the list compiled by MSF for such drugs includes biologic treatment of breast cancer and schizophrenia or bipolar disorder.

“Since 1995, South Africa has never, in a way that is adequate, incorporated Trips flexibilities from the WTO,” Motsoaledi said.

Val Beaumont, the executive director at Innovative Pharmaceutical Association of SA, said the country had had a few Trips flexibilities and had a special provision to start the production of generics before the originator drugs expired under certain circumstances.

“We don’t have a problem with Trips flexibility and we don’t have a problem with the examination office, either. But we are saying it must be implemented in the context of the National Development plan so that we make sure it does not slow the process,” she said.

MSF’s access officer, Julia Hill, who led a march of more than 1 500 health activists on Parliament yesterday demanding that the Department of Trade and Industry finalise the IP policy before the May elections, said even if South Africa adopted stricter criteria for drug laws, the policy would not change much without the patent examination office.

“It is great that the minister of health is also supporting the patents examination because this requires more than the Department of Trade and Industry to push things,” she said.

Hill said the Department of Trade and Industry had told MSF it was in the process of finalising the IP policy and expected to present it to the cabinet at its final meeting before elections next week.

Cobus Venter, the chief economist at Stellenbosch Economics, said it would be too expensive for South Africa to develop its own drug research and discoveries. - Business Report

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