The battleground might be far from home, but the repercussions will be felt keenly in South Africa. Healthcare activists have warned that the result of the court battle in question, between pharmaceuticals giant Novartis and the Indian government, could set a dangerous precedent that will impede local access to affordable drugs.
On Thursday healthcare NGOs, supported by doctors, lawyers and academics, marched to Parliament to warn about the impact the lawsuit may have on access to healthcare in South Africa.
Sydney Makgai, a person living with HIV who relies on generic medicines, called on Novartis to drop the case. "This may be about profits for them, but it is about life and death for me," he said.
Novartis has challenged a provision in Indian patent law, which prevents drug companies from extending monopolies on life-saving drugs. India produces 80% of the antiretrovirals (ARVs) used in Africa and victory for the pharmaceutical company could endanger the supply of cheap generic drugs to developing countries.
Novartis has challenged section 3(d) of the Indian Patent Act, which was instrumental in blocking its application to patent the leukemia drug Gleevec. Section 3 (d) prevents companies from patenting old drugs that differ only slightly in formulation but not in their action or effectiveness, and from patenting an old drug for which a new use has been found. India’s patent law is in line with international trade agreements, which allow countries the flexibility to circumvent patent rights in order to improve access to essential medicines.
Novartis says the case is about protecting intellectual property to advance the development of medicines, and not about changing access to medicines. "We strongly believe safeguarding incentives for innovation through the granting of patents leads to better medicines for patients without options," it said.
Daygan Eagar, a researcher at health lobby group Section27, said if Novartis wins the case, it would complicate matters when South Africa sets about trying to change its patent laws. "Our government looks to India for guidance on these issues. If they start reversing this legislation and start allowing for new patents on old drugs, it becomes difficult for us to convince our government to work towards a more progressive legislative approach to patents, particularly drug patents," he said.
Eagar said the argument that pharmaceutical companies need to hold on to patents in order to recover the costs of developing of don't hold water. "Many of the drugs we're talking about have come off patent and companies are looking at ways to put them back on patent and continue to profit off them," he said.
"Those [concerns] need to be balanced with patient rights and human rights."
Gleevec generated sales of $4.7-billion (R38.5-billion) for Novartis last year.
Leena Menghaney, manager of Médecins Sans Frontières’s (MSF’s) Access Campaign in India, pointed out the huge difference that generics and competitive pricing can produce. In South Africa, Gleevec is available in the private sector for R862 per 400mg; while in India, a generic version of the same drug is available from generic drug company Cipla for just R86.
"The Indian [patent] system is quite unique and it’s worth protecting for developing countries," said Menghaney, adding that some developing countries are now considering ways to implement similar, more stringent systems for examining and approving patents.
"Pharmaceutical companies don’t want the system to be replicated across the developing world and that's why this is becoming one of the biggest patent fights in the world," she said.
South Africa is already investigating ways to tighten up its patent laws. MacDonald Netshitenzhe, chief director of policy and legislation at the department of trade and industry, said a draft policy on intellectual property will soon be made available for public comment. "We’re putting the final touches on it, and it will go to Cabinet soon – at the end of this month or in August," he said.
The current system for approving patents has been criticised for allowing companies to register new patents for old drugs to which minor changes have been made or for which new uses have been found. This allows companies to extend the period in which they can hold a monopoly on a drug, and prevents other companies from developing cheaper generics.
Netshitenzhe said the government is considering ways to incrementally introduce a system of substantive examination that would investigate whether a product is new and inventive, alongside the existing system. "In the policy we're saying, why can't we use both," he said.
Catherine Tomlinson, senior researcher for the Treatment Action Campaign (TAC), said access to cheap and effective generics is essential to dealing with public healthcare problems. "We saw this with first line medicines [for HIV]," she said.
In 2001, an umbrella group comprised of 39 pharmaceutical companies sought to prevent the South African government from making changes to the Medicines and Related Substances Act in order to import cheap generics into the country.
The case, which drew huge international media coverage, was dropped after it became apparent that the pharmaceutical companies would have to divulge sensitive and possibly damaging information concerning business practices, pricing guidelines and profit levels.
It was a public relations disaster for the pharmaceuticals giants and a coup for activists seeking to broaden access to healthcare. The cost of first-line drugs for HIV treatment plummeted once generics became available.
"In [the year] 2000 they cost R75 000 per patient per year. Those same medicines are now being purchased for less than R1 500 per patient per year," she said.
"It was only when these generics became available at low prices that they were rolled out. Now South Africa has the largest ARV programme in the world."
Tomlinson pointed out that third-line medicines for HIV are still under patent and so are not provided in the public sector because, at a cost of R35 000 per patient per year, they're too expensive.