South Africa: Multinational pharmaceutical companies push back on new patent policy

In early October, Health-e News broke the story of Andaleeb Rinquest-January. Diagnosed with XDR-TB in 2011, Rinquest-January fought for her life and eventually she said began to recover after being prescribed the XDR-TB drug linezolid.

However, her family was left to pay at least R12,000 per month for the drug, which is not widely available in the public sector, in part after Discovery Medical Aid refused her claim. Discovery Medical Aid recently agreed to cover the drug after public interest law organisation Section27 intervened.

Fellow XDR-TB patient Morgan Scholtz, who only has hospital cover, continues to pay R12,000 a month for linezolid. Both appeared before dti officials in Pretoria yesterday to ask for the speedy release of the country’s overdue new intellectual property policy.

“I know what it was like to be in specialised care and I’ve seen many friends die,” Rinquest-January told Health-e News. “South Africa is a new South Africa now and we all deserve this.”

While linezolid is not part of South Africa’s initial standard drug-resistant TB treatment regimens, guidelines say the drug can be considered for patients with few other options if cost permits.

Patented by the pharmaceutical company Pfizer, linezolid sells for about R700 per daily tablet and usually must be taken for about two years.

“No generic is legally available due to the patent laws that exist (and) the result is that many XDR-TB patients are being denied this key drug,” Scholtz said. “My plea is that the South African government move to make the generic legally available.”

Only eight patients in country have access to Hepatitis B drug

According to doctors at the meeting, the country’s lax patent laws are also to blame for the high cost of low side effect birth control as well as the preventable deaths of Hepatitis B patients.

Tygerberg Hospital’s Dr Monique Anderson called Hepatitis B the “white elephant in the room” as the virus – together with Hepatitis C – kills more in Africa than HIV or malaria but remains largely undiagnosed and untreated. The Hepatitis B treatment entecavir currently costs more than R4700 month in South Africa.

“Only eight patient in the entire country access entecavir, but hundreds could benefit from less expensive alternatives if South Africa stopped granting further patents on this drug,” Anderson said.

A 2008 University of the Witwatersrand study found that 5 percent of those surveyed had Hepatitis B. Past from mother to child and between young children, Hepatitis B can lead to deadly liver disease in 25 percent of patients. 

Pharma fights back?

Almost exactly one year ago, public comment closed on the draft of a new patent policy that could increase the availability of generic drugs in the country. According to dti Deputy Director General of Consumer and Corporate Regulation Zodwa Ntuli, the department received about 600 pages of public comment.

Activists were initially happy with the draft policy that called for patent regulation in line with global standards, including more stringent patent criteria, or “substantive search and examination,” as well as the ability to grant “compulsory licenses.” This kind of license would enable the generic manufacture of drugs still under patent when, for instance, a public health rationale exists.

However, dti officials have revealed that these were also among those most highly contested by multinational pharmaceuticals in submissions in response to the draft policy.

“We are dealing with pharm companies, many that are multinationals,” said the dti’s Chief Director of Policy and Legislation Macdonald Netshitenzhe. “They are eating well under the system so therefore we are under extreme pressure to not come with substantive search and examination by the multinationals.”

A University of Pretoria study found that 80 percent of patents in South Africa would not have been granted if the country actually examined patent applications. Only about 1000 of the 7000 patents granted annually by South Africa’s Companies and Intellectual Property Commission (CIPC) are awarded to local companies, according to CIPC senior manager Elena Zdravkova.

According to Ntuli, the dti will finalise the policy by the end of the year and has already begun work on the related amendments to translate the policy into law. Meanwhile, the CIPC has already begun planning for tougher patent criteria and will in April recruit and train 20 varsity graduates in patent review. According to Zdravkova, patents pertaining to the mining and pharmaceutical sectors will likely be prioritised for review as the body moves to phase in more stringent patent reviews should Cabinet approve the policy.

Currently, the high cost of medicine in South Africa is the fifth largest driver of the country’s trade deficit, according to the Treatment Action Campaign.

Access to linezolid lagging globally

The US-based health advocacy organisation the Treatment Action Group (TAG) has been tracking access to linezolid internationally and says it is lagging. According to Assistant Director of TAG’s TB/ HIV Project Erica Lessem, Pfizer has already signalled its disinterest in TB but refuses to negotiate to lower linezolid’s cost.

“Pfizer has completely stopped doing research in (infectious diseases) and they’ve shuttered their infections diseases unit,” Lessem said. “They are not making any concessions on price and they are also not willing to work on TB.”

“They could also just make agreements that they would not enforce their this patent for TB, a market which they have already indicated that they are not interested in,” she added. “The drug is going to become increasingly important, and we really need to find ways to make it accessible and affordable.”

Pfizer Senior Director of Media Relations in Africa Andrew Widger confirmed that the company had shifted its research focus and is focusing its resources on a small number of areas in which it believes it can “deliver the greatest medical and commercial impact.”

He added that while the company remains committed to working with government and nongovernmental organisations, it did not promote the off-label use of its drugs.

According to Lessem, current research shows that the benefits of linezolid outweigt the risks for people with XDR-TB. She added that the larger, randomised controlled clinical trials needed to support changes in the drug’s labelling will be impossible without the kind of big investment that accompanies pharmaceutical company research.

“To get it World Health Organisation approved or on essential medicines lists, what we really need is a rigourous clinical trial,” she said. “That’s why Pfizer getting out of the research side of things is bad.”

Source: Health-e